Long term safety of tildrakizumab in psoriatic arthritis

Abstract

The disclosure relates to methods of treating psoriatic arthritis in a patient comprising administering an anti-IL-23p19 antibody hum13B8-b to the patient. The disclosure also relates to pharmaceutical compositions of an anti-IL-23p19 antibody hum13B8-b for the treatment of psoriatic arthritis in a patient. The disclosure further relates to the use of an anti- IL-23p19 antibody hum13B8-b for the manufacture of a medicament for treating psoriatic arthritis in a patient. The disclosure further relates to methods, compositions, or uses wherein administration of hum13B8-b results in minimal or no serious or other side effects after up to at least about 208 weeks.

Description

Attorney Docket No.24-1507-WOLONG TERM SAFETY OF TILDRAKIZUMAB IN PSORIATIC ARTHRITISCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority of U.S. Provisional Patent Application No.63 / 701,493, filed September 30, 2024, which is incorporated herein by reference in its entirety.REFERENCE TO AN ELECTRONIC SEQUENCE LISTING

[0002] This application is being filed electronically and includes an electronically submitted sequence listing. The sequence listing is entitled "24-1507-WO-Sequence-Listing.xml" and was created on September 29, 2025, and has a size of 11,121 bytes. The sequence listing contained in this xml file is part of the specification and is herein incorporated by reference in its entirety.FIELD OF THE DISCLOSURE

[0003] The disclosure relates to methods of treating psoriatic arthritis in a patient comprising administering an anti-IL-23p19 antibody hum13B8-b to the patient. The disclosure also relates to pharmaceutical compositions of an anti-IL-23p19 antibody hum13B8-b for the treatment of psoriatic arthritis in a patient. The disclosure further relates to the use of an anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for treating psoriatic arthritis in a patient. The disclosure further relates to methods, compositions, or uses wherein administration of hum13B8-b results in minimal or no serious or other side effects after up to at least about 208 weeks.BACKGROUND

[0004] Psoriasis is a chronic inflammatory skin disorder affecting approximately 1% to 2% of people worldwide. Psoriatic arthritis has been defined as a unique inflammatory arthritis associated with psoriasis. The precise prevalence is unknown, but estimates vary from 0.3% to 1% of the population; among patients with psoriasis, the observed prevalence of inflammatory arthritis varies from 6% to 42%. Clinical features typically present as an oligoarticular and mild disease. However, with time psoriatic arthritis becomes polyarticular, and a severe disease in at least 20% of patients. Gladman et al., Ann. Rheum. Dis.64(Suppl II): ii14–ii17 (2005). Symptoms include tenderness, pain, and stiffness in and around the joints, dactylitis, spondylitis, pain and swelling in the heels, nail disfiguration (discoloration,1Attorney Docket No.24-1507-WOsplitting, or pitting), and generalized fatigue. Patients with psoriatic arthritis who present with polyarticular disease are at risk for disease progression. In addition to progression of clinical and radiological damage, health related quality of life is reduced among patients with psoriatic arthritis. Gladman et al. (2005).

[0005] Current treatment options for psoriatic arthritis include non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, skin topical treatments, light therapy (for skin), physiotherapy, and disease-modifying anti-rheumatic drugs. There are also two types of biologics approved for the use in treating psoriatic arthritis, and more recently an agent that targets interleukin-12 (IL-12) and IL-23. Methotrexate is approved by the U.S. Food and Drug Administration (FDA) for the skin condition psoriasis, but it is frequently used off-label for psoriatic arthritis. Methotrexate has been reported as providing symptomatic relief to some patients with multiple joint involvement and psoriasis but there is little scientific evidence to support the use as a disease-modifying agent for psoriatic arthritis.SUMMARY

[0006] Provided herein is a method of treating psoriatic arthritis, the method comprising administering an anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein hum13B8-b comprises: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2. The method for treating psoriatic arthritis provided herein may comprise a treatment phase and an extension phase.

[0007] Also provided herein is a pharmaceutical composition comprising an anti-IL-23p19 antibody hum13B8-b for use in the treatment of psoriatic arthritis in a patient in need thereof, wherein the anti-IL-23p19 antibody hum13B8-b comprises: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2. The pharmaceutical composition comprising hum13B8-b for the treatment of psoriatic arthritis may comprise a treatment phase and an extension phase.

[0008] Further provided herein is an anti-IL-23p19 antibody hum13B8-b for use in the treatment of psoriatic arthritis in a patient in need thereof, wherein the anti-IL-23p19 antibody hum13B8-b comprises: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2. The use of hum13B8-b for the treatment of psoriatic arthritis may comprise a treatment phase and an extension phase.2Attorney Docket No.24-1507-WO

[0009] Further provided herein is the use of an anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for treating psoriatic arthritis, wherein the anti-IL-23p19 antibody hum13B8-b comprises: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2. The use provided herein may comprise administration of the medicament during a treatment phase and an extension phase.

[0010] Further provided herein is a method, composition, or use of an anti-IL-23p19 antibody hum13B8-b for the treatment of psoriatic arthritis, wherein administration of hum13B8-b results in minimal or no serious adverse events (SAEs) in the patient after up to at least about 208 weeks of administration of hum13B8-b.

[0011] Further provided herein is a method, composition, or use of an anti-IL-23p19 antibody hum13B8-b for the treatment of psoriatic arthritis, wherein administration of hum13B8-b results in minimal or no other adverse events (OAEs) in the patient for up to and after at least about 208 weeks of administration of hum13B8-b.DETAILED DESCRIPTION

[0012] The disclosure relates to methods of treating psoriatic arthritis in a patient comprising administering an anti-IL-23p19 antibody hum13B8-b to the patient. The disclosure also relates to pharmaceutical compositions of an anti-IL-23p19 antibody hum13B8-b for the treatment of psoriatic arthritis in a patient. The disclosure further relates to the use of an anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for treating psoriatic arthritis in a patient. The disclosure further relates to methods, compositions, or uses wherein administration of hum13B8-b results in minimal or no serious or other side effects for up to and after at least about 208 weeks.

[0013] The disclosure also relates to a study in which patients with psoriatic arthritis who were previously enrolled in a 52-week study were administered either a high dose (200 mg) or low dose (100 mg) of hum13B8-b for up to 208 weeks, wherein hum13B8-b was administered every four weeks (Q4W) or every 12 weeks (Q12W).

[0014] The disclosure further relates to an anti-IL-23p19 antibody hum13B8-b and its use in the treatment of psoriatic arthritis. In some embodiments, the disclosure provides a method of treating psoriatic arthritis comprising administering an anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein a first dose of hum13B8-b is subcutaneously administered to the patient on week 0 and a subsequent dose is subcutaneously administered to the patient every 12 weeks thereafter for up to about 208 weeks; and wherein hum13B8-b3Attorney Docket No.24-1507-WOcomprises (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2. In some embodiments of the methods, pharmaceutical compositions, and medicaments for treating psoriatic arthritis, treatment results in the patient experiencing no increase in serious adverse events (SAEs) or other adverse events (OAEs) for at least up to and after about 208 weeks.

[0015] Before describing the present disclosure in detail, a number of terms will be defined. Unless otherwise required by context, singular terms shall include pluralities, and plural terms shall include the singular. For example, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. It should be understood that the terms "a" and "an" as used herein refer to "one or more" of the enumerated components unless otherwise indicated or dictated by its context. The use of the alternative (e.g., "or") should be understood to mean either one, both, or any combination thereof of the alternatives unless otherwise indicated.

[0016] In the present disclosure, any concentration range, percentage range, ratio range, or integer range is to be understood to include the value of any integer within the recited range and, when appropriate, fractions thereof (such as one tenth and one hundredth of an integer), unless otherwise indicated.

[0017] The term "about" or "approximately" means within an acceptable error range for the particular value as determined by one of ordinary skill in the art, which will depend in part on how the value is measured or determined, i.e., the limitations of the measurement system. For example, "about" can mean within 3 or more than 3 standard deviations, per the practice in the art. Alternatively, "about" can mean a range of up to 20%, preferably up to 10%, more preferably up to 5%, and more preferably still up to 1% of a given value.Alternatively, particularly with respect to biological systems or processes, the term can mean within an order of magnitude, preferably within 5-fold, and more preferably within 2-fold, of a value. With regard to the administration of the anti-IL-23p19 antibody hum13B8-b as described herein, the term "about" when used with respect to a number of weeks means the number of weeks + / - 7 days.

[0018] It is noted that terms like "preferably," "commonly," and "typically" are not used herein to limit the scope of the claimed subject matter or to imply that certain features are critical, essential, or even important to the structure or function of the claimed subject matter. Rather, these terms are merely intended to highlight alternative or additional features that can or cannot be used in a particular embodiment of the present disclosure.4Attorney Docket No.24-1507-WO

[0019] For the purposes of describing and defining the present disclosure, it is noted that the term "substantially" is used herein to represent the inherent degree of uncertainty that can be attributed to any quantitative comparison, value, measurement, or other representation. The term "substantially" is also used herein to represent the degree by which a quantitative representation can vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

[0020] Unless expressly specified otherwise, the term "comprising" is used in the context of the present disclosure to indicate that further members may optionally be present in addition to the members of the list introduced by "comprising". It is, however, contemplated as a specific embodiment of the present disclosure that the term "comprising" encompasses the possibility of no further members being present.

[0021] As used in accordance with the present disclosure, unless otherwise indicated, all technical and scientific terms shall be understood to have the same meaning as commonly understood by one of ordinary skill in the art.

[0022] The term "antibody" as used herein refers to a protein that is capable of recognizing and specifically binding to an antigen. Ordinary or conventional mammalian antibodies comprise a tetramer, which is typically composed of two identical pairs of polypeptide chains, each pair consisting of one "light" chain (typically having a molecular weight of about 25 kDa) and one "heavy" chain (typically having a molecular weight of about 50-70 kDa). The terms "heavy chain" and "light chain," as used herein, refer to any immunoglobulin polypeptide having sufficient variable domain sequence to confer specificity for a target antigen. The amino-terminal portion of each light and heavy chain typically includes a variable domain of about 100 to 110 or more amino acids that typically is responsible for antigen recognition. The carboxyl-terminal portion of each chain typically defines a constant domain responsible for effector function. Thus, in a naturally occurring antibody, a full-length heavy chain immunoglobulin polypeptide includes a variable domain (VH) and three constant domains (CH1, CH2, and CH3) and a hinge region between CH1and CH2, wherein the VH domain is at the amino-terminus of the polypeptide and the CH3 domain is at the carboxyl-terminus, and a full-length light chain immunoglobulin polypeptide includes a variable domain (VL) and a constant domain (CL), wherein the VL domain is at the amino-terminus of the polypeptide and the CLdomain is at the carboxyl-terminus.

[0023] Within full-length light and heavy chains, the variable and constant domains typically are joined by a "J" region of about 12 or more amino acids, with the heavy chain also including a "D" region of about 10 more amino acids. The variable regions of each5Attorney Docket No.24-1507-WOlight / heavy chain pair typically form an antigen binding site. The variable domains of naturally occurring antibodies typically exhibit the same general structure of relatively conserved framework regions (FR) joined by three hypervariable regions, also called complementarity determining regions or CDRs. The CDRs from the two chains of each pair typically are aligned by the framework regions, which may enable binding to a specific epitope. From the amino-terminus to the carboxyl-terminus, both light and heavy chain variable domains typically comprise the domains FR1, CDR1, FR2, CDR2, FR3, CDR3, and FR4.

[0024] The term "antigen binding fragment" as used herein refers to a portion of an intact antibody and / or refers to the antigenic determining variable domains of an intact antibody. It is known that the antigen binding function of an antibody can be performed by fragments of a full-length antibody. Examples of antibody fragments include, but are not limited to, Fab, Fab′, F(ab′)2, and Fv fragments, linear antibodies, single chain antibodies, diabodies, and multispecific antibodies formed from antibody fragments.

[0025] In particular embodiments, the anti-IL-23p19 antibody hum13B8-b is tildrakizumab. The term "tildrakizumab" as used herein refers to a humanized anti-IL-23p19 monoclonal antibody, also known as SCH 900222 or MK-3222. Tildrakizumab is a high-affinity (297 picomolar [pM]) humanized immunoglobulin G1 / kappa (IgG1 / ĸ) antibody that specifically binds to the p19 protein of the IL-23 heterodimer but does not bind human IL-12 (IL-12 / 23p40 and IL12p35 heterodimer) or human IL-12 / 23p40. Tildrakizumab pharmacokinetics increases proportionally over a dose range from 50 mg to 200 mg (0.5 to 2 times the approved recommended dosage) following subcutaneous administration in subjects with plaque psoriasis. Steady-state concentrations were achieved by Week 16 following subcutaneous administration of tildrakizumab at Weeks 0, 4, and every 12 weeks thereafter. At the 100 mg dose at Week 16, the mean (± SD) steady-state trough concentrations ranged from 1.22 ± 0.94 mcg / mL to 1.47 ± 1.12 mcg / mL. The geometric mean (CV%) steady-state Cmax was 8.1 mcg / mL (34%). The absolute bioavailability of tildrakizumab was estimated to be 73-80% following subcutaneous injection. The peak concentration (Cmax) was reached by approximately 6 days.

[0026] In some embodiments, the anti-IL-23p19 antibody tildrakizumab can refer to ILUMYA®. ILUMYA® is administered by subcutaneous injection at a recommended dosage of 100 mg at weeks 0, 4, and every 12 weeks thereafter. In some embodiments, tildrakizumab is formulated in a 1 mL single-dose prefilled syringe containing 100 mg of tildrakizumab (i.e., 100 mg / mL). In some embodiments, ILUMYA® (tildrakizumab-asmn)6Attorney Docket No.24-1507-WOinjection, for subcutaneous use, is a sterile, clear to slightly opalescent, colorless to slightly yellow solution. ILUMYA® is supplied in a single-dose prefilled syringe with a glass barrel and 29-gauge fixed, 1 / 2-inch needle. In some embodiments, tildrakizumab can be formulated in: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, and / or sucrose, in Water for Injection, with a pH of 5.7-6.3. In some embodiments, tildrakizumab is formulated in a 1 mL single-dose prefilled syringe containing 100 mg of tildrakizumab-asmn formulated in: L-histidine (0.495 mg), L-histidine hydrochloride monohydrate (1.42 mg), polysorbate 80 (0.5 mg), sucrose (70.0 mg), and Water for Injection, USP with a pH of 5.7-6.3.

[0027] In particular embodiments, the anti-IL-23p19 antibody hum13B8-b (tildrakizumab) comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1 and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2, and which is disclosed in U.S. Patent Nos.8,404,813 and 8,293,883, the disclosures of each of which are hereby incorporated by reference in their entireties. In other embodiments, the anti-IL-23p19 antibody hum13B8-b or an antigen-binding fragment thereof comprises a heavy chain variable domain and a light chain variable domain, wherein the heavy chain variable domain comprises CDR1, CDR2, and CDR3 sequences of the amino acid sequences of SEQ ID NOs: 3-5, and wherein the light chain variable domain comprises CDR1, CDR2, and CDR3 sequences of the amino acid sequences of SEQ ID NOs: 6-8.

[0028] Hum13B8-b Light Chain (SEQ ID NO: 1) DIQMTQSPSSLSASVGDRVTITCRTSENIYSYLAWYQQKPGKAPKLLIYNAKTLAEGV PSRFSGSGSGTDFTLTISSLQPEDFATYYCQHHYGIPFTFGQGTKVEIKRTVAAPSVFIF PPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYS LSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC

[0029] Hum13B8-b Heavy Chain (SEQ ID NO: 2) QVQLVQSGAEVKKPGASVKVSCKASGYIFITYWMTWVRQAPGQGLEWMGQIFPAS GSADYNEKFEGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARGGGGFAYWGQGT LVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVH TFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTC PPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVE VHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKA KGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPP VLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK

[0030] Hum13B8-b Heavy Chain CDR1 (SEQ ID NO: 3)GYIFITYWMT7Attorney Docket No.24-1507-WO

[0031] Hum13B8-b Heavy Chain CDR2 (SEQ ID NO: 4) QIFPASGSADYNEKFE

[0032] Hum13B8-b Heavy Chain CDR3 (SEQ ID NO: 5)GGGGFAY

[0033] Hum13B8-b Light Chain CDR1 (SEQ ID NO: 6)RTSENIYSYLA

[0034] Hum13B8-b Light Chain CDR2 (SEQ ID NO: 7)NAKTLAE

[0035] Hum13B8-b Light Chain CDR3 (SEQ ID NO: 8)QHHYGIPFT

[0036] As used herein, the term "subject" and "patient" are interchangeable. In some embodiments, subjects and / or patients are mammals.

[0037] A "disorder" is any condition that would benefit from treatment using the antibodies of the disclosure. "Disorder" and "condition" are used interchangeably herein and include chronic and acute disorders or diseases, including those pathological conditions that predispose a patient to the disorder in question.

[0038] The terms "treatment" or "treat" as used herein refer to both therapeutic treatment and prophylactic or preventative measures. Those in need of treatment include patients having plaque psoriasis as well as those prone to have plaque psoriasis or those in which plaque psoriasis is to be prevented. In some embodiments, the plaque psoriasis is moderate to severe plaque psoriasis.

[0039] In one embodiment of the disclosure is a method of treating psoriatic arthritis, comprising administering an anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein the anti-IL-23p19 antibody hum13B8-b comprises: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0040] In one embodiment of the disclosure is a pharmaceutical composition comprising an anti-IL-23p19 antibody hum13B8-b for use in the treatment of psoriatic arthritis in a patient in need thereof, wherein the anti-IL-23p19 antibody hum13B8-b comprises: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0041] In one embodiment of the disclosure is an anti-IL-23p19 antibody hum13B8-b for use in the treatment of psoriatic arthritis in a patient in need thereof, wherein the anti-IL-23p19 antibody hum13B8-b comprises: (i) a light chain polypeptide comprising the amino8Attorney Docket No.24-1507-WOacid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0042] In one embodiment of the disclosure is the use of an anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for treating psoriatic arthritis, wherein the anti-IL-23p19 antibody hum13B8-b comprises: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0043] In one embodiment of the disclosure, the method, composition, or use for treating psoriatic arthritis comprises a treatment phase and an extension phase.

[0044] In one embodiment of the disclosure, hum13B8-b is administered to the patient for up to about 52 weeks during the treatment phase.

[0045] In one embodiment of the disclosure, hum13B8-b is administered to the patient at week 0, at about week 4, and about every 12 weeks thereafter during the treatment phase.

[0046] In one embodiment of the disclosure, hum13B8-b is administered to the patient at week 0, at about week 4, and about every 4 weeks thereafter during the treatment phase.

[0047] In one embodiment of the disclosure, a therapeutically effective amount of hum13B8-b is administered to the patient during the treatment phase.

[0048] In one embodiment of the disclosure, about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the treatment phase.

[0049] In one embodiment of the disclosure, about 100 mg of hum13B8-b is administered to the patient during the treatment phase.

[0050] In one embodiment of the disclosure, about 200 mg of hum13B8-b is administered to the patient during the treatment phase.

[0051] In one embodiment of the disclosure, hum13B8-b is administered to the patient subcutaneously during the treatment phase.

[0052] In one embodiment of the disclosure, hum13B8-b is administered to the patient by subcutaneous injection during the treatment phase.

[0053] In one embodiment of the disclosure, hum13B8-b is administered to the patient using an auto-injector or prefilled syringe during the treatment phase.

[0054] In one embodiment of the disclosure, a first dose of hum13B8-b is administered to the patient on week 0, a second dose of hum13B8-b is administered to the patient at about week 4, and subsequent doses of hum13B8-b are administered to the patient at about every 12 weeks thereafter during the treatment phase.9Attorney Docket No.24-1507-WO

[0055] In one embodiment of the disclosure, the first dose of hum13B8-b, the second dose of hum13B8-b, and subsequent doses of hum13B8-b are the same.

[0056] In one embodiment of the disclosure, the first dose of hum13B8-b, the second dose of hum13B8-b, and subsequent doses of hum13B8-b are different.

[0057] In one embodiment of the disclosure, the first dose of hum13B8-b, the second dose of hum13B8-b, and subsequent doses of hum13B8-b comprise about 100 mg of hum13B8-b.

[0058] In one embodiment of the disclosure, the first dose of hum13B8-b, the second dose of hum13B8-b, and subsequent doses of hum13B8-b comprise about 200 mg of hum13B8-b.

[0059] In one embodiment of the disclosure, the first dose of hum13B8-b comprises about 100 mg of hum13B8-b.

[0060] In one embodiment of the disclosure, the second dose of hum13B8-b comprises about 100 mg of hum13B8-b.

[0061] In one embodiment of the disclosure, the subsequent doses of hum13B8-b comprise about 100 mg of hum13B8-b.

[0062] In one embodiment of the disclosure, the first dose of hum13B8-b comprises about 200 mg of hum13B8-b.

[0063] In one embodiment of the disclosure, the second dose of hum13B8-b comprises about 200 mg of hum13B8-b.

[0064] In one embodiment of the disclosure, the subsequent doses of hum13B8-b comprise about 200 mg of hum13B8-b.

[0065] In one embodiment of the disclosure, the first dose of hum13B8-b comprises about 100 mg of hum13B8-b, and the amount of hum13B8-b administered in the second dose and subsequent doses is different from the first dose.

[0066] In one embodiment of the disclosure, the first dose of hum13B8-b comprises about 200 mg of hum13B8-b, and the amount of hum13B8-b administered in the second dose and subsequent doses is different from the first dose.

[0067] In one embodiment of the disclosure, hum13B8-b is administered to the patient for up to about 208 weeks during the extension phase.

[0068] In one embodiment of the disclosure, hum13B8-b is administered to the patient during the extension phase at the same interval as hum13B8-b is administered during the treatment phase.10Attorney Docket No.24-1507-WO

[0069] In one embodiment of the disclosure, about 100 mg to about 200 mg of hum13B8-b is administered to the patient about every four weeks (Q4W) during the extension phase.

[0070] In one embodiment of the disclosure, hum13B8-b is administered to the patient about every 4 weeks during the extension phase for at least up to about 4 weeks, for at least up to about 8 weeks, for at least up to about 12 weeks, at least up to about 16 weeks, for at least up to about 20 weeks, for at least up to about 24 weeks, for at least up to about 28 weeks, for at least up to about 32 weeks, for at least up to about 36 weeks, for at least up to about 40 weeks, for at least up to about 44 weeks, for at least up to about 48 weeks, for at least up to about 52 weeks, for at least up to about 56 weeks, for at least up to about 60 weeks, for at least up to about 64 weeks, for at least up to about 68 weeks, for at least up to about 72 weeks, for at least up to about 76 weeks, for at least up to about 80 weeks, for at least up to about 84 weeks, for at least up to about 88 weeks, for at least up to about 92 weeks, for at least up to about 96 weeks, for at least up to about 100 weeks, for at least up to about 104 weeks, for at least up to about 108 weeks, for at least up to about 112 weeks, for at least up to about 116 weeks, for at least up to about 120 weeks, for at least up to about 124 weeks, for at least up to about 128 weeks, for at least up to about 132 weeks, for at least up to about 136 weeks, for at least up to about 140 weeks, for at least up to about 144 weeks, for at least up to about 148 weeks, for at least up to about 152 weeks, for at least up to about 156 weeks, for at least up to about 160 weeks, for at least up to about 164 weeks, for at least up to about 168 weeks, for at least up to about 172, for at least up to about 176 weeks, for at least up to about 180 weeks, for at least up to about 184 weeks, for at least up to about 188 weeks, for at least up to about 192 weeks, for at least up to about 196 weeks, for at least up to about 200 weeks, for at least up to about 204 weeks, or for at least up to about 208 weeks.

[0071] In one embodiment of the disclosure, about 100 mg to about 200 mg of hum13B8-b is administered to the patient about every twelve weeks (Q12W) during the extension phase.

[0072] In one embodiment of the disclosure, hum13B8-b is administered to the patient about every 12 weeks during the extension phase for at least up to about 12 weeks, for at least up to about 24 weeks, for at least up to about 36 weeks, for at least up to about 48 weeks, for at least up to about 60 weeks, for at least up to about 72 weeks, for at least up to about 84 weeks, for at least up to about 96 weeks, for at least up to about 108 weeks, for at least up to about 120 weeks, for at least up to about 132 weeks, for at least up to about 144 weeks, for at least up to about 156 weeks, for at least up to about 168 weeks, for at least up to about 18011Attorney Docket No.24-1507-WOweeks, for at least up to about 192 weeks, for at least up to about 204 weeks, or for at least up to about 216 weeks.

[0073] In one embodiment of the disclosure, hum13B8-b is administered to the patient during the extension phase at different time intervals than the time intervals that hum13B8-b is administered to the patient during the treatment phase.

[0074] In one embodiment of the disclosure, hum13B8-b is administered to the patient Q4W during the treatment phase and hum13B8-b is administered to the patient Q12W during the extension phase.

[0075] In one embodiment of the disclosure, a therapeutically effective amount of hum13B8-b is administered to the patient during the extension phase.

[0076] In one embodiment of the disclosure, about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the extension phase.

[0077] In one embodiment of the disclosure, about 100 mg of hum13B8-b is administered to the patient during the extension phase.

[0078] In one embodiment of the disclosure, about 200 mg of hum13B8-b is administered to the patient during the treatment phase.

[0079] In one embodiment of the disclosure, hum13B8-b is administered to the patient during the extension phase at a different dose than the dose of hum13B8-b administered to the patient during the treatment phase.

[0080] In one embodiment of the disclosure, about 200 mg hum13B8-b is administered to the patient during the treatment phase and about 100 mg hum13B8-b is administered to that patient during the extension phase.

[0081] In one embodiment of the disclosure, about 200 mg hum13B8-b is administered to the patient Q4W during the treatment phase and about 100 mg hum13B8-b is administered to the patient Q12W during the extension phase.

[0082] In one embodiment of the disclosure, the same dose of hum13B8-b is administered to the patient during the extension phase and during the treatment phase.

[0083] In one embodiment of the disclosure, about 100 mg of hum13B8-b is administered to the patient during the treatment phase and about 100 mg of hum13B8-b is administered to the patient during the extension phase.

[0084] In one embodiment of the disclosure, about 200 mg of hum13B8-b is administered to the patient during the treatment phase and about 200 mg of hum13B8-b is administered to the patient during the extension phase.12Attorney Docket No.24-1507-WO

[0085] In one embodiment of the disclosure, the treatment phase is 52 weeks in length, and the extension phase is an additional up to about 208 weeks, wherein 100 mg to 200 mg of hum13B8-b is administered to the patient during the extension phase.

[0086] In one embodiment of the disclosure, hum13B8-b is administered to the patient subcutaneously during the extension phase.

[0087] In one embodiment of the disclosure, hum13B8-b is administered to the patient by subcutaneous injection during the extension phase.

[0088] In one embodiment of the disclosure, hum13B8-b is administered to the patient using an auto-injector or prefilled syringe during the extension phase.

[0089] In one embodiment of the disclosure, administration of about 100 mg of hum13B8-b during the extension phase results in minimal or no serious adverse events (SAEs) in the patient.

[0090] In one embodiment of the disclosure, administration of about 200 mg of hum13B8-b during the extension phase results in minimal or no serious adverse events (SAEs) in the patient.

[0091] In one embodiment of the disclosure, the SAEs include blood or lymphatic disorders, cardiac disorders, gastrointestinal disorders, general disorders, hepatobiliary disorders, infections or infestations, injuries, poisoning, or procedural complications, investigations, metabolism or nutrition disorders, musculoskeletal or connective tissue disorders, neoplasms, nervous system disorders, renal or urinary disorders, reproductive system or breast disorders, respiratory, thoracic, or mediastinal disorders, surgical or medical procedures, or vascular disorders.

[0092] In one embodiment of the disclosure, the blood or lymphatic disorder is anemia.

[0093] In one embodiment of the disclosure, the cardiac disorder is acute myocardial infarction, cardiac failure, coronary artery stenosis, or tachycardia.

[0094] In one embodiment of the disclosure, the gastrointestinal disorder is abdominal hernia, hemorrhagic erosive gastritis, or intestinal obstruction.

[0095] In one embodiment of the disclosure, the general disorder is generalized oedema.

[0096] In one embodiment of the disclosure, the hepatobiliary disorder is cholelithiasis.

[0097] In one embodiment of the disclosure, the infection or infestation is abdominal abscess, COVID-19 pneumonia, gallbladder empyema, intestinal sepsis, septic shock, or upper respiratory tract infection.13Attorney Docket No.24-1507-WO

[0098] In one embodiment of the disclosure, the injury, poisoning, or procedural complication is craniocerebral injury, hip fracture, humerus fracture, ligament rupture, subdural hematoma, or tibia fracture.

[0099] In one embodiment of the disclosure, the investigation is a kidney biopsy.

[0100] In one embodiment of the disclosure, the metabolism or nutrition disorder is diabetes mellitus.

[0101] In one embodiment of the disclosure, the musculoskeletal or connective tissue disorder is intervertebral disc disorder, lumbar spinal stenosis, osteoarthritis, or rhabdomyolysis.

[0102] In one embodiment of the disclosure, the neoplasm is adenocarcinoma metastatic, colorectal adenoma, invasive ductal breast carcinoma, oesophageal carcinoma, or uterine leiomyoma.

[0103] In one embodiment of the disclosure, the nervous system disorder is dizziness, metabolic encephalopathy, retinal migraine, subarachnoid hemorrhage, or tension headache.

[0104] In one embodiment of the disclosure, the renal or urinary disorder is acute kidney injury, calculus urinary, end stage renal disease, or ureterolithiasis.

[0105] In one embodiment of the disclosure, the reproductive system or breast disorder is hydrocele female or uterine hemorrhage.

[0106] In one embodiment of the disclosure, the respiratory, thoracic, or mediastinal disorder is bronchitis chronic or interstitial lung disease.

[0107] In one embodiment of the disclosure, the surgical or medical procedure is gastric bypass.

[0108] In one embodiment of the disclosure, the vascular disorder is aortic dissection, arteriosclerosis, deep vein thrombosis, hypertension, or hypertensive crisis.

[0109] In one embodiment of the disclosure, administration of about 100 mg of hum13B8-b during the extension phase results in minimal or no other adverse events (OAEs) in the patient.

[0110] In one embodiment of the disclosure, administration of about 200 mg of hum13B8-b during the extension phase results in minimal or no other adverse events (OAEs) in the patient.

[0111] In one embodiment of the disclosure, the OAEs include blood or lymphatic system disorders, cardiac disorders, congenital, familial, or genetic disorders, ear or labyrinth disorders, endocrine disorders, eye disorders, gastrointestinal disorders, general disorders, hepatobiliary disorders, immune system disorders, infections or infestations, injuries,14Attorney Docket No.24-1507-WOpoisoning, or procedural complications, investigations, metabolism or nutrition disorders, musculoskeletal or connective tissue disorders, neoplasms benign, malignant, or unspecified (including cysts or polyps), nervous system disorders, psychiatric disorders, renal or urinary disorders, reproductive system or breast disorders, respiratory, thoracic, or mediastinal disorders, skin or subcutaneous tissue disorders, surgical or medical procedures, or vascular disorders.

[0112] In one embodiment of the disclosure, the blood or lymphatic system disorder is anemia, leukocytosis, leukopenia, lymphadenopathy, lymphopenia, neutropenia, or neutrophilia.

[0113] In one embodiment of the disclosure, the cardiac disorder is acute myocardial infarction, atrial fibrillation, atrioventricular block first degree, cardiac failure, cardiac failure congestive, coronary artery stenosis, diastolic dysfunction, mitral valve incompetence, myocardial ischemia, palpitations, pericardial cyst, sinus tachycardia, tachycardia, or tricuspid valve incompetence.

[0114] In one embodiment of the disclosure, the congenital, familial, or genetic disorder is accessory spleen, Gilbert's syndrome, or hydrocele.

[0115] In one embodiment of the disclosure, the ear or labyrinth disorder is ear pain or vertigo.

[0116] In one embodiment of the disclosure, the endocrine disorder is autoimmune thyroiditis, goiter, hypothyroidic goiter, hypothyroidism, or thyroid mass.

[0117] In one embodiment of the disclosure, the eye disorder is astigmatism, blepharitis, blindness transient, cataract, cataract nuclear, diabetic retinopathy, keratitis, myopia, retinal vascular disorder, or visual acuity reduced.

[0118] In one embodiment of the disclosure, the gastrointestinal disorder is abdominal hernia, abdominal pain, abdominal pain upper, abdominal rigidity, anal fistula, aphthous ulcer, Barrett's oesophagus, chronic gastritis, coeliac artery stenosis, constipation, dental caries, diaphragmatic hernia, diarrhea, diverticulum, diverticulum intestinal, duodenitis, dyspepsia, enteritis, food poisoning, gastric ulcer, gastritis, gastritis erosive, gastrointestinal disorder, gastroesophageal reflux disease, gingival swelling, hemorrhagic erosive gastritis, hemorrhoids, hiatus hernia, intestinal metaplasia, intestinal obstruction, irritable bowel syndrome, large intestine polyp, nausea, pancreatitis chronic, rectal polyp, retained deciduous tooth, toothache, or vomiting.

[0119] In one embodiment of the disclosure, the general disorder is asthenia, chest pain, chills, drug intolerance, fatigue, generalized oedema, influenza like illness, injection site15Attorney Docket No.24-1507-WOerythema, injection site pain, injection site pruritus, injection site rash, injection site reaction, injury associated with device, oedema peripheral, pyrexia, vaccination site pain, or xerosis.

[0120] In one embodiment of the disclosure is a method, composition, or use for treating psoriatic arthritis, wherein the hepatobiliary disorder is biliary dyskinesia, cholecystitis, cholelithiasis, cholestasis, diabetic hepatopathy, gallbladder polyp, hepatic steatosis, hepatitis, hyperbilirubinaemia, hypertransaminasaemia, non-alcoholic steatohepatitis, or steatohepatitis.

[0121] In one embodiment of the disclosure, the immune system disorder is an allergy to an arthropod bite or allergy to plants.

[0122] In one embodiment of the disclosure, the infection or infestation is abdominal abscess, acute sinusitis, adenovirus infection, bacteriuria, Bartholin's abscess, breast abscess, bronchitis, COVID-19, COVID-19 pneumonia, cellulitis, chronic sinusitis, conjunctivitis, coronavirus infection, cystitis, diverticulitis, erythema migraines, Escherichia infection, furuncle, gallbladder empyema, gastroenteritis, gastroenteritis viral, gastrointestinal bacterial overgrowth, gastrointestinal infection, gingivitis, helicobacter gastritis, helicobacter infection, Herpes simplex, Herpes zoster, Hordeolum, influenza, intestinal sepsis, joint abscess, laryngitis, localized infection, lower respiratory tract infection, nasopharyngitis, oral herpes, otitis externa, otitis media, periodontitis, pharyngitis, pharyngotonsillitis, pneumonia, pneumonia bacterial, pulmonary tuberculosis, pulpitis dental, purulent discharge, pyelonephritis, pyelonephritis acute, respiratory tract infection, respiratory tract infection viral, rhinitis, septic shock, sinusitis, skin infection, suspected COVID-19, tonsillitis, tooth infection, tracheitis, tracheobronchitis, upper respiratory tract infection, urinary tract infection, vaginal infection, viral infection, viral pharyngitis, viral upper respiratory tract infection, vulvovaginal mycotic infection, or wound infection.

[0123] In one embodiment of the disclosure, the injury, poisoning, or procedural complication is second degree burns, concussion, contusion, craniocerebral injury, cuboid syndrome, epicondylitis, fall, fibula fracture, foot fracture, hand fracture, hip fracture, humerus fracture, iliotibial band syndrome, immunization reaction, joint injury, ligament rupture, ligament sprain, limb injury, meniscus injury, muscle strain, nail avulsion, post vaccination syndrome, skin abrasion, skin laceration, soft tissue injury, spinal compression fracture, subdural hematoma, synovial rupture, tendon injury, thermal burn, tibia fracture, or tooth fracture.

[0124] In one embodiment of the disclosure, the investigation is alanine aminotransferase increased, apolipoprotein B increased, aspartate aminotransferase increased, bilirubin conjugated increased, bilirubin urine present, biopsy kidney, blood bilirubin increased, blood16Attorney Docket No.24-1507-WOcholesterol increased, blood creatine phosphokinase increased, blood creatinine increased, blood glucose increased, blood pressure increased, blood triglycerides increased, blood urea increased, C-reactive protein increased, Gamma-glutamyltransferase increased, glomerular filtration rate decreased, hematocrit decreased, hemoglobin decreased, hepatic enzyme increased, low density lipoprotein increased, lymphocyte count decreased, monocyte count decreased, neutrophil count decreased, platelet count decreased, prostatic specific antigen increased, red blood cell count decreased, transaminases increased, urinary casts, weight decreased, weight increased, or white blood cell count decreased.

[0125] In one embodiment of the disclosure, the metabolism or nutrition disorder is cholesterosis, copper deficiency, dehydration, diabetes mellitus, diabetes mellitus inadequate control, dyslipidemia, glucose tolerance impaired, hypercholesterolemia, hyperglycaemia, hyperlipidemia, hypertriglyceridemia, hyperuricemia, hypokalemia, hypomagnesaemia, hyponatremia, impaired fasting glucose, insulin resistance, obesity, type 2 diabetes mellitus, or vitamin D deficiency.

[0126] In one embodiment of the disclosure, the musculoskeletal or connective tissue disorder is arthralgia, arthritis, back pain, bursitis, dactylitis, exostosis, fracture pain, greater trochanteric pain syndrome, intervertebral disc disorder, intervertebral disc displacement, intervertebral disc protrusion, jaw cyst, joint contracture, joint effusion, joint swelling, lumbar spinal stenosis, metatarsalgia, muscle spasms, musculoskeletal discomfort, musculoskeletal stiffness, myalgia, neck pain, osteoarthritis, osteochondrosis, osteoporosis, pain in extremity, periarthritis, periarticular disorder, plantar fasciitis, pseudoarthrosis, psoriatic arthropathy, rhabdomyolysis, rotator cuff syndrome, sacroiliitis, spinal disorder, spinal osteoarthritis, spinal pain, spinal stenosis, spondylolisthesis, synovial cyst, tendonitis, tenosynovitis, tenosynovitis stenosans, or trigger finger.

[0127] In one embodiment of the disclosure, the neoplasm benign, malignant, or unspecified (including cysts or polyps) is adenocarcinoma metastatic, adrenal adenoma, anogenital warts, benign oesophageal neoplasm, colorectal adenoma, haemangioma of liver, invasive ductal breast carcinoma, oesophageal carcinoma, prostatic adenoma, or uterine leiomyoma.

[0128] In one embodiment of the disclosure, the nervous system disorder is anosmia, bradykinesia, carpal tunnel syndrome, cervicobrachial syndrome, diabetic neuropathy, dizziness, encephalopathy, headache, hypoaesthesia, lumbar radiculopathy, lumbosacral radiculopathy, metabolic encephalopathy, migraine, myotonia, neuralgia, neuritis, Parkinson's17Attorney Docket No.24-1507-WOdisease, restless legs syndrome, retinal migraine, sciatica, sensory loss, spinal cord hematoma, subarachnoid hemorrhage, syncope, or tension headache.

[0129] In one embodiment of the disclosure, the psychiatric disorder is adjustment disorder, affective disorder, anxiety, depression, insomnia, irritability, mixed anxiety and depressive disorder, sleep disorder, or stress.

[0130] In one embodiment of the disclosure, the renal or urinary disorder is acute kidney injury, calculus urinary, chronic kidney disease, cystitis hemorrhagic, cystitis noninfective, end stage renal disease, glomerulonephritis chronic, hematuria, hypertonic bladder, nephrolithiasis, nephrosclerosis, pollakiuria, proteinuria, renal colic, renal cyst, stress urinary incontinence, ureterolithiasis, or urinary tract inflammation.

[0131] In one embodiment of the disclosure, the reproductive system or breast disorder is abnormal uterine bleeding, adenomyosis, Bartholin's cyst, erectile dysfunction, hydrocele female, intermenstrual bleeding, menstruation irregular, prostatitis, prostatomegaly, uterine hemorrhage, or vaginal discharge.

[0132] In one embodiment of the disclosure, the respiratory, thoracic, or mediastinal disorder is bronchitis chronic, cough, dysphonia, interstitial lunch disease, nasal congestion, oropharyngeal pain, respiratory failure, rhinorrhea, sinus congestion, sleep apnea syndrome, or upper respiratory tract inflammation.

[0133] In one embodiment of the disclosure, the skin or subcutaneous tissue disorder is alopecia, angioedema, dermatitis allergic, dermatitis contact, dermatitis psoriasiform, ecchymosis, erythema, hidradenitis, pruritis, psoriasis, rash, skin exfoliation, or skin ulcer.

[0134] In one embodiment of the disclosure, the surgical or medical procedure is gastric bypass.

[0135] In one embodiment of the disclosure, the vascular disorder is aortic arteriosclerosis, aortic dissection, arteriosclerosis, bleeding varicose vein, blood pressure fluctuation, deep vein thrombosis, diabetic microangiopathy, essential hypertension, hypertension, hypertensive crisis, lymphostasis, peripheral venous disease, phlebitis, or thrombophlebitis.

[0136] The terms "administration" or "administering" as used herein refer to providing, contacting, and / or delivering an antibody or fragment thereof by any appropriate route to achieve the desired effect. Administration may include, but is not limited to, oral, sublingual, parenteral (e.g., intravenous, subcutaneous, intracutaneous, intramuscular, intraarticular, intraarterial, intrasynovial, intrasternal, intrathecal, intralesional, or intracranial injection),18Attorney Docket No.24-1507-WOtransdermal, topical, buccal, rectal, vaginal, nasal, ophthalmic, via inhalation, and implants. In one embodiment, administration is subcutaneous via a pre-filled syringe (PFS).

[0137] In some embodiments, the anti-IL-23p19 antibody hum13B8-b, pharmaceutical composition of an anti-IL-23p19 antibody hum13B8-b, or anti-IL-23p19 antibody hum13B8-b medicament is administered to the patient subcutaneously. In some embodiments, the anti-IL-23p19 antibody hum13B8-b, pharmaceutical composition of an anti-IL-23p19 antibody hum13B8-b, or anti-IL-23p19 antibody hum13B8-b medicament is administered to the patient by subcutaneous injection. In some embodiments, the anti-IL-23p19 antibody hum13B8-b, pharmaceutical composition of an anti-IL-23p19 antibody hum13B8-b, or anti-IL-23p19 antibody hum13B8-b medicament is administered to the patient using an auto-injector or prefilled syringe.

[0138] In some embodiments, the anti-IL-23p19 antibody hum13B8-b, pharmaceutical composition of an anti-IL-23p19 antibody hum13B8-b, or anti-IL-23p19 antibody hum13B8-b medicament is administered about every two weeks, about every four weeks, about every six weeks, about every eight weeks, about every ten weeks, or about every twelve weeks.

[0139] As used herein, the term "Week 0" refers to the first day the anti-IL-23p19 antibody hum13B8-b, pharmaceutical composition of an anti-IL-23p19 antibody hum13B8-b, or anti-IL-23p19 antibody hum13B8-b medicament is administered.

[0140] In some embodiments, the anti-IL-23p19 antibody hum13B8-b is administered over a two week treatment period, over a four week treatment period, over a six week treatment period, over an eight week treatment period, over a twelve-week treatment period, over a twenty-four week treatment period, over a thirty-six week treatment period, over a forty-eight week treatment period, or over a one year or more treatment period, such as over a sixty week treatment period or over a seventy-two week treatment period,.

[0141] The therapeutic dose of the anti-IL-23p19 antibody hum13B8-b or an antigen-binding fragment thereof will vary depending, in part, upon the size (body weight, body surface, or organ size) and condition (the age and general health) of the patient. In some embodiments, the patient is administered one or more doses of the anti-IL-23p19 antibody hum13B8-b or an antigen-binding fragment thereof wherein the dose is 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, 160 mg, 180 mg, or 200 mg. In some embodiments, the first dose and the subsequent doses of the anti-IL-23p19 antibody hum13B8-b or an antigen-binding fragment thereof are the same. In some embodiments, the first dose and the subsequent doses of the anti-IL-23p19 antibody hum13B8-b or an antigen-binding fragment thereof are different. In some embodiments, the first dose is 100 mg. In some embodiments,19Attorney Docket No.24-1507-WOthe first dose is 200 mg. In some embodiments, the subsequent doses are 100 mg. In some embodiments, the subsequent doses are 200 mg. In some embodiments, the first dose and the subsequent doses are 100 mg. In some embodiments, the first dose and the subsequent doses are 200 mg.

[0142] In some embodiments, the disclosure provides a method, composition, or use for treating psoriatic arthritis, wherein an anti-IL-23p19 antibody hum13B8-b is administered to a patient in need thereof during a treatment phase, wherein hum13B8-b comprises: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; followed by a long term extension phase, wherein hum13B8-b is administered to the patient for up to about 208 weeks.

[0143] In some embodiments, the disclosure provides a method, composition, or use for treating psoriatic arthritis, wherein administration of hum13B8-b results in minimal or no serious adverse events (SAEs) in a patient following administration of hum13B8-b for up to about 208 weeks.

[0144] As used herein, the term "minimal" refers to the number of at-risk patients affected by an adverse side effect as a percentage of the total number of patients at risk for the adverse side effect. Similarly, when used in reference to other side effects, the term "minimal" refers to the number of at-risk patients affected by another side effect as a percentage of the to the total number of patients at risk for the other side effect.

[0145] The terms "pharmaceutical composition" or "therapeutic composition" as used herein refer to a compound or composition capable of inducing a desired therapeutic effect when properly administered to a patient. One embodiment of the disclosure provides a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of at least one antibody of the disclosure.

[0146] The terms "pharmaceutically acceptable carrier" or "physiologically acceptable carrier" as used herein refer to one or more formulation materials suitable for accomplishing or enhancing the delivery of one or more antibodies of the disclosure.

[0147] Pharmaceutical compositions comprising tildrakizumab, either alone or in combination with prophylactic agents, therapeutic agents, and / or pharmaceutically acceptable carriers are provided herein. The pharmaceutical compositions comprising tildrakizumab provided herein are for use in, but not limited to, diagnosing, detecting, or monitoring a disorder, in preventing, treating, managing, or ameliorating a disorder or one or more symptoms thereof, and / or in research. The formulation of pharmaceutical compositions,20Attorney Docket No.24-1507-WOeither alone or in combination with prophylactic agents, therapeutic agents, and / or pharmaceutically acceptable carriers, is known to one skilled in the art.Embodiments

[0148] Embodiment 1: A method of treating psoriatic arthritis, the method comprising administering an anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein the anti-IL-23p19 antibody hum13B8-b comprises: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0149] Embodiment 2: The method according to embodiment 1, wherein the method comprises a treatment phase and an extension phase.

[0150] Embodiment 3: The method according to embodiment 2, wherein the treatment phase comprises administering hum13B8-b to the patient for up to about 52 weeks.

[0151] Embodiment 4: The method according to embodiment 2, wherein the treatment phase comprises administering hum13B8-b to the patient at week 0, at about week 4, and about every 12 weeks thereafter.

[0152] Embodiment 5: The method according to embodiment 2, wherein the treatment phase comprises administering hum13B8-b to the patient at week 0, at about week 4, and about every 4 weeks thereafter.

[0153] Embodiment 6: The method according to embodiment 2, wherein a therapeutically effective amount of hum13B8-b is administered to the patient during the treatment phase.

[0154] Embodiment 7: The method according to embodiment 2, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the treatment phase.

[0155] Embodiment 8: The method according to embodiment 7, wherein about 100 mg of hum13B8-b is administered to the patient during the treatment phase.

[0156] Embodiment 9: The method according to embodiment 7, wherein about 200 mg of hum13B8-b is administered to the patient during the treatment phase.

[0157] Embodiment 10: The method according to embodiment 6, wherein hum13B8-b is administered to the patient subcutaneously during the treatment phase.

[0158] Embodiment 11: The method according to embodiment 6, wherein hum13B8-b is administered to the patient by subcutaneous injection during the treatment phase.21Attorney Docket No.24-1507-WO

[0159] Embodiment 12: The method according to embodiment 6, wherein hum13B8-b is administered to the patient using an auto-injector or prefilled syringe during the treatment phase.

[0160] Embodiment 13: The method according to embodiment 6, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the treatment phase.

[0161] Embodiment 14: The method according to embodiment 13, wherein about 100 mg of hum13B8-b is administered to the patient during the treatment phase.

[0162] Embodiment 15: The method according to embodiment 13, wherein about 200 mg of hum13B8-b is administered to the patient during the treatment phase.

[0163] Embodiment 16: The method according to embodiment 6, wherein a first dose of hum13B8-b is administered to the patient on week 0, a second dose of hum13B8-b is administered to the patient at about week 4, and subsequent doses of hum13B8-b are administered to the patient at about every 12 weeks thereafter during the treatment phase.

[0164] Embodiment 17: The method according to embodiment 16, wherein the first dose of hum13B8-b, the second dose of hum13B8-b, and subsequent doses of hum13B8-b are the same.

[0165] Embodiment 18: The method according to embodiment 16, wherein the first dose of hum13B8-b, the second dose of hum13B8-b, and subsequent doses of hum13B8-b are different.

[0166] Embodiment 19: The method according to embodiment 17, wherein the first dose, the second dose, and subsequent doses comprise about 100 mg of hum13B8-b.

[0167] Embodiment 20: The method according to embodiment 17, wherein the first dose, the second dose, and subsequent doses comprise about 200 mg of hum13B8-b.

[0168] Embodiment 21: The method according to embodiment 16, wherein the first dose comprises about 100 mg of hum13B8-b.

[0169] Embodiment 22: The method according to embodiment 16, wherein the second dose comprises about 100 mg of hum13B8-b.

[0170] Embodiment 23: The method according to embodiment 16, wherein the subsequent doses comprise about 100 mg of hum13B8-b.

[0171] Embodiment 24: The method according to embodiment 16, wherein the first dose comprises about 200 mg of hum13B8-b.

[0172] Embodiment 25: The method according to embodiment 16, wherein the second dose comprises about 200 mg of hum13B8-b.22Attorney Docket No.24-1507-WO

[0173] Embodiment 26: The method according to embodiment 16, wherein the subsequent doses comprise about 200 mg of hum13B8-b.

[0174] Embodiment 27: The method according to embodiment 18, wherein the first dose comprises about 100 mg of hum13B8-b, and the amount of hum13B8-b administered in the second dose and subsequent doses is different from the first dose.

[0175] Embodiment 28: The method according to embodiment 18, wherein the first dose of hum13B8-b comprises about 200 mg of hum13B8-b, and the amount of hum13B8-b administered in the second dose and subsequent doses is different from the first dose.

[0176] Embodiment 29: The method according to embodiment 2, wherein the extension phase comprises administering hum13B8-b to the patient for up to about 208 weeks.

[0177] Embodiment 30: The method according to embodiment 2, wherein the extension phase comprises administering hum13B8-b to the patient at the same interval as hum13B8-b is administered to the patient during the treatment phase.

[0178] Embodiment 31: The method according to embodiment 30, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient about every four weeks (Q4W) during the extension phase.

[0179] Embodiment 32: The method according to embodiment 31, wherein hum13B8-b is administered to the patient for at least up to about 4 weeks, for at least up to about 8 weeks, for at least up to about 12 weeks, for at least up to about 16 weeks, for at least up to about 20 weeks, for at least up to about 24 weeks, for at least up to about 28 weeks, for at least up to about 32 weeks, for at least up to about 36 weeks, for at least up to about 40 weeks, for at least up to about 44 weeks, for at least up to about 48 weeks, for at least up to about 52 weeks, for at least up to about 56 weeks, for at least up to about 60 weeks, for at least up to about 64 weeks, for at least up to about 68 weeks, for at least up to about 72 weeks, for at least up to about 76 weeks, for at least up to about 80 weeks, for at least up to about 84 weeks, for at least up to about 88 weeks, for at least up to about 92 weeks, for at least up to about 96 weeks, for at least up to about 100 weeks, for at least up to about 104 weeks, for at least up to about 108 weeks, for at least up to about 112 weeks, for at least up to about 116 weeks, for at least up to about 120 weeks, for at least up to about 124 weeks, for at least up to about 128 weeks, for at least up to about 132 weeks, for at least up to about 136 weeks, for at least up to about 140 weeks, for at least up to about 144 weeks, for at least up to about 148 weeks, for at least up to about 152 weeks, for at least up to about 156 weeks, for at least up to about 160 weeks, for at least up to about 164 weeks, for at least up to about 168 weeks, for at least up to about 172, for at least up to about 176 weeks, for at least up to about 180 weeks,23Attorney Docket No.24-1507-WOfor at least up to about 184 weeks, for at least up to about 188 weeks, for at least up to about 192 weeks, for at least up to about 196 weeks, for at least up to about 200 weeks, for at least up to about 204 weeks, or for at least up to about 208 weeks.

[0180] Embodiment 33: The method according to embodiment 31, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient about every twelve weeks (Q12W) during the extension phase.

[0181] Embodiment 34: The method according to embodiment 33, wherein hum13B8-b is administered to the patient for at least up to about 12 weeks, for at least up to about 24 weeks, for at least up to about 36 weeks, for at least up to about 48 weeks, for at least up to about 60 weeks, for at least up to about 72 weeks, for at least up to about 84 weeks, for at least up to about 96 weeks, for at least up to about 108 weeks, for at least up to about 120 weeks, for at least up to about 132 weeks, for at least up to about 144 weeks, for at least up to about 156 weeks, for at least up to about 168 weeks, for at least up to about 180 weeks, for at least up to about 192 weeks, for at least up to about 204 weeks, or for at least up to about 216 weeks.

[0182] Embodiment 35: The method according to embodiment 2, wherein hum13B8-b is administered to the patient at different time intervals during the extension phase than hum13B8-b is administered to the patient during the treatment phase.

[0183] Embodiment 36: The method according to embodiment 35, wherein hum13B8-b is administered to the patient Q4W during the treatment phase and hum13B8-b is administered to the patient Q12W during the extension phase.

[0184] Embodiment 37: The method according to embodiment 2, wherein a therapeutically effective amount of hum13B8-b is administered to the patient during the extension phase.

[0185] Embodiment 38: The method according to embodiment 37, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the extension phase.

[0186] Embodiment 39: The method according to embodiment 38, wherein about 100 mg of hum13B8-b is administered to the patient during the extension phase.

[0187] Embodiment 40: The method according to embodiment 38, wherein about 200 mg of hum13B8-b is administered to the patient during the treatment phase.

[0188] Embodiment 41: The method according to embodiment 2, wherein the dose of hum13B8-b administered to the patient during the extension phase is different than the dose of hum13B8-b administered to the patient during the treatment phase.24Attorney Docket No.24-1507-WO

[0189] Embodiment 42: The method according to embodiment 41, wherein about 200 mg of hum13B8-b is administered to the patient during the treatment phase and about 100 mg of hum13B8-b is administered to the patient during the extension phase.

[0190] Embodiment 43: The method according to embodiment 41, wherein about 200 mg hum13B8-b is administered to the patient Q4W during the treatment phase and about 100 mg hum13B8-b is administered to the patient Q12 during the extension phase.

[0191] Embodiment 44: The method according to embodiment 2, wherein the same dose of hum13B8-b is administered to the patient during the extension phase and during the treatment phase.

[0192] Embodiment 45: The method according to embodiment 44, wherein about 100 mg hum13B8-b is administered to the patient during the treatment phase and about 100 mg hum13B8-b is administered to the patient during the extension phase.

[0193] Embodiment 46: The method according to embodiment 44, wherein about 200 mg of hum13B8-b is administered to the patient during the treatment phase and about 200 mg of hum13B8-b is administered to the patient during the extension phase.

[0194] Embodiment 47: The method according to any one of embodiments 1-46, wherein the method comprises a treatment phase of up to about 52 weeks followed by an extension phase of an additional up to about 208 weeks, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the extension phase.

[0195] Embodiment 48: The method according to any one of embodiments 39-47, wherein hum13B8-b is administered to the patient subcutaneously during the extension phase.

[0196] Embodiment 49: The method according to embodiment 48, wherein hum13B8-b is administered to the patient by subcutaneous injection during the extension phase.

[0197] Embodiment 50: The method according to embodiment 48, wherein hum13B8-b is administered to the patient using an auto-injector or prefilled syringe during the extension phase.

[0198] Embodiment 51: The method according to any one of embodiments 29-39, 41-45, or 47-50, wherein administration of about 100 mg of hum13B8-b during the extension phase results in minimal or no serious adverse events (SAEs) in the patient.

[0199] Embodiment 52: The method according to any one of embodiments 29-38, 40, 41, 44, 46-51, wherein administration of about 200 mg of hum13B8-b during the extension phase results in minimal or no serious adverse events (SAEs) in the patient.25Attorney Docket No.24-1507-WO

[0200] Embodiment 53: The method according to either embodiment 51 or embodiment 52, wherein the SAEs include blood and lymphatic disorders, cardiac disorders, gastrointestinal disorders, general disorders, hepatobiliary disorders, infections and infestations, injury, poisoning and procedural complications, investigations, metabolism and nutrition disorders, musculoskeletal and connective tissue disorders, neoplasms, nervous system disorders, renal and urinary disorders, reproductive system and breast disorders, respiratory, thoracic and mediastinal disorders, surgical and medical procedures, and vascular disorders.

[0201] Embodiment 54: The method according to embodiment 53, wherein the blood or lymphatic disorder is anemia.

[0202] Embodiment 55: The method according to embodiment 53, wherein the cardiac disorder is acute myocardial infarction, cardiac failure, coronary artery stenosis, or tachycardia.

[0203] Embodiment 56: The method according to embodiment 53, wherein the gastrointestinal disorder is abdominal hernia, hemorrhagic erosive gastritis, or intestinal obstruction.

[0204] Embodiment 57: The method according to embodiment 53, wherein the general disorder is generalized oedema.

[0205] Embodiment 58: The method according to embodiment 53, wherein the hepatobiliary disorder is cholelithiasis.

[0206] Embodiment 59: The method according to embodiment 54, wherein the infection or infestation is abdominal abscess, COVID-19 pneumonia, gallbladder empyema, intestinal sepsis, septic shock, or upper respiratory tract infection.

[0207] Embodiment 60: The method according to embodiment 53, wherein the injury, poisoning, or procedural complication is craniocerebral injury, hip fracture, humerus fracture, ligament rupture, subdural hematoma, or tibia fracture.

[0208] Embodiment 61: The method according to embodiment 53, wherein the investigation is a kidney biopsy.

[0209] Embodiment 62: The method according to embodiment 53, wherein the metabolism or nutrition disorder is diabetes mellitus.

[0210] Embodiment 63: The method according to embodiment 53, wherein the musculoskeletal or connective tissue disorder is intervertebral disc disorder, lumbar spinal stenosis, osteoarthritis, or rhabdomyolysis.26Attorney Docket No.24-1507-WO

[0211] Embodiment 64: The method according to embodiment 53, wherein the neoplasm is adenocarcinoma metastatic, colorectal adenoma, invasive ductal breast carcinoma, esophageal carcinoma, or uterine leiomyoma.

[0212] Embodiment 65: The method according to embodiment 53, wherein the nervous system disorder is dizziness, metabolic encephalopathy, retinal migraine, subarachnoid hemorrhage, or tension headache.

[0213] Embodiment 66: The method according to embodiment 53, wherein the renal or urinary disorder is acute kidney injury, calculus urinary, end stage renal disease, or ureterolithiasis.

[0214] Embodiment 67: The method according to embodiment 53, wherein the reproductive system or breast disorder is hydrocele female or uterine hemorrhage.

[0215] Embodiment 68: The method according to embodiment 53, wherein the respiratory, thoracic, or mediastinal disorder is bronchitis chronic or interstitial lung disease.

[0216] Embodiment 69: The method according to embodiment 53, wherein the surgical or medical procedure is gastric bypass.

[0217] Embodiment 70: The method according to embodiment 53, wherein the vascular disorder is aortic dissection, arteriosclerosis, deep vein thrombosis, hypertension, or hypertensive crisis.

[0218] Embodiment 71: The method according to any one of embodiments 29-39, 41-45, or 47-50, wherein administration of about 100 mg of hum13B8-b during the extension phase results in minimal or no other adverse events (OAEs) in the patient.

[0219] Embodiment 72: The method according to any one of embodiments 29-38, 40, 41, 44, or 46-51, wherein administration of about 200 mg of hum13B8-b during the extension phase results in minimal or no other adverse events (OAEs) in the patient.

[0220] Embodiment 73: The method according to either embodiment 71 or embodiment 72, wherein the OAEs include one or more of blood or lymphatic system disorders, cardiac disorders, congenital, familial, or genetic disorders, ear or labyrinth disorders, endocrine disorders, eye disorders, gastrointestinal disorders, general disorders, hepatobiliary disorders, immune system disorders, infections or infestations, injuries, poisoning or procedural complications, investigations, metabolism or nutrition disorders, musculoskeletal or connective tissue disorders, neoplasms benign, malignant, or unspecified, nervous system disorders, psychiatric disorders, renal or urinary disorders, reproductive system or breast disorders, respiratory, thoracic, or mediastinal disorders, skin or subcutaneous tissue disorders, surgical or medical procedures, or vascular disorders.27Attorney Docket No.24-1507-WO

[0221] Embodiment 74: The method according to embodiment 73, wherein the blood or lymphatic system disorder is anemia, leukocytosis, leukopenia, lymphadenopathy, lymphopenia, neutropenia, or neutrophilia.

[0222] Embodiment 75: The method according to embodiment 73, wherein the cardiac disorder is acute myocardial infarction, atrial fibrillation, atrioventricular block first degree, cardiac failure, cardiac failure congestive, coronary artery stenosis, diastolic dysfunction, mitral valve incompetence, myocardial ischemia, palpitations, pericardial cyst, sinus tachycardia, tachycardia, or tricuspid valve incompetence.

[0223] Embodiment 76: The method according to embodiment 73, wherein the congenital, familial, or genetic disorder is accessory spleen, Gilbert's syndrome, or hydrocele.

[0224] Embodiment 77: The method according to embodiment 73, wherein the ear or labyrinth disorder is ear pain or vertigo.

[0225] Embodiment 78: The method according to embodiment 73, wherein the endocrine disorder is autoimmune thyroiditis, goiter, hypothyroidic goiter, hypothyroidism, or thyroid mass.

[0226] Embodiment 79: The method according to embodiment 73, wherein the eye disorder is astigmatism, blepharitis, blindness transient, cataract, cataract nuclear, diabetic retinopathy, keratitis, myopia, retinal vascular disorder, or visual acuity reduced.

[0227] Embodiment 80: The method according to embodiment 73, wherein the gastrointestinal disorder is abdominal hernia, abdominal pain, abdominal pain upper, abdominal rigidity, anal fistula, aphthous ulcer, Barrett's esophagus, chronic gastritis, coeliac artery stenosis, constipation, dental caries, diaphragmatic hernia, diarrhea, diverticulum, diverticulum intestinal, duodenitis, dyspepsia, enteritis, food poisoning, gastric ulcer, gastritis, gastritis erosive, gastrointestinal disorder, gastroesophageal reflux disease, gingival swelling, hemorrhagic erosive gastritis, hemorrhoids, hiatus hernia, intestinal metaplasia, intestinal obstruction, irritable bowel syndrome, large intestine polyp, nausea, pancreatitis chronic, rectal polyp, retained deciduous tooth, toothache, or vomiting.

[0228] Embodiment 81: The method according to embodiment 73, wherein the general disorder is asthenia, chest pain, chills, drug intolerance, fatigue, generalized oedema, influenza like illness, injection site erythema, injection site pain, injection site pruritus, injection site rash, injection site reaction, injury associated with device, oedema peripheral, pyrexia, vaccination site pain, or xerosis.

[0229] Embodiment 82: The method according to embodiment 73, wherein the hepatobiliary disorder is biliary dyskinesia, cholecystitis, cholelithiasis, cholestasis, diabetic28Attorney Docket No.24-1507-WOhepatopathy, gallbladder polyp, hepatic steatosis, hepatitis, hyperbilirubinemia, hypertransaminasaemia, non-alcoholic steatohepatitis, or steatohepatitis.

[0230] Embodiment 83: The method according to embodiment 73, wherein the immune system disorder is an allergy to an arthropod bite or allergy to plants.

[0231] Embodiment 84: The method according to embodiment 73, wherein the infection or infestation is abdominal abscess, acute sinusitis, adenovirus infection, bacteriuria, Bartholin's abscess, breast abscess, bronchitis, COVID-19, COVID-19 pneumonia, cellulitis, chronic sinusitis, conjunctivitis, coronavirus infection, cystitis, diverticulitis, erythema migraines, Escherichia infection, furuncle, gallbladder empyema, gastroenteritis, gastroenteritis viral, gastrointestinal bacterial overgrowth, gastrointestinal infection, gingivitis, helicobacter gastritis, helicobacter infection, Herpes simplex, Herpes zoster, Hordeolum, influenza, intestinal sepsis, joint abscess, laryngitis, localized infection, lower respiratory tract infection, nasopharyngitis, oral herpes, otitis externa, otitis media, periodontitis, pharyngitis, pharyngotonsillitis, pneumonia, pneumonia bacterial, pulmonary tuberculosis, pulpitis dental, purulent discharge, pyelonephritis, pyelonephritis acute, respiratory tract infection, respiratory tract infection viral, rhinitis, septic shock, sinusitis, skin infection, suspected COVID-19, tonsillitis, tooth infection, tracheitis, tracheobronchitis, upper respiratory tract infection, urinary tract infection, vaginal infection, viral infection, viral pharyngitis, viral upper respiratory tract infection, vulvovaginal mycotic infection, or wound infection.

[0232] Embodiment 85: The method according to embodiment 73, wherein the injury, poisoning, or procedural complication is second degree burns, concussion, contusion, craniocerebral injury, cuboid syndrome, epicondylitis, fall, fibula fracture, foot fracture, hand fracture, hip fracture, humerus fracture, iliotibial band syndrome, immunization reaction, joint injury, ligament rupture, ligament sprain, limb injury, meniscus injury, muscle strain, nail avulsion, post vaccination syndrome, skin abrasion, skin laceration, soft tissue injury, spinal compression fracture, subdural hematoma, synovial rupture, tendon injury, thermal burn, tibia fracture, or tooth fracture.

[0233] Embodiment 86: The method according to embodiment 73, wherein the investigation is alanine aminotransferase increased, apolipoprotein B increased, aspartate aminotransferase increased, bilirubin conjugated increased, bilirubin urine present, biopsy kidney, blood bilirubin increased, blood cholesterol increased, blood creatine phosphokinase increased, blood creatinine increased, blood glucose increased, blood pressure increased, blood triglycerides increased, blood urea increased, C-reactive protein increased, Gamma-29Attorney Docket No.24-1507-WOglutamyl transferase increased, glomerular filtration rate decreased, hematocrit decreased, hemoglobin decreased, hepatic enzyme increased, low density lipoprotein increased, lymphocyte count decreased, monocyte count decreased, neutrophil count decreased, platelet count decreased, prostatic specific antigen increased, red blood cell count decreased, transaminases increased, urinary casts, weight decreased, weight increased, or white blood cell count decreased.

[0234] Embodiment 87: The method according to embodiment 73, wherein the metabolism or nutrition disorder is cholesterosis, copper deficiency, dehydration, diabetes mellitus, diabetes mellitus inadequate control, dyslipidemia, glucose tolerance impaired, hypercholesterolemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, hyperuricemia, hypokalemia, hypomagnesaemia, hyponatremia, impaired fasting glucose, insulin resistance, obesity, type 2 diabetes mellitus, or vitamin D deficiency.

[0235] Embodiment 88: The method according to embodiment 73, wherein the musculoskeletal or connective tissue disorder is arthralgia, arthritis, back pain, bursitis, dactylitis, exostosis, fracture pain, greater trochanteric pain syndrome, intervertebral disc disorder, intervertebral disc displacement, intervertebral disc protrusion, jaw cyst, joint contracture, joint effusion, joint swelling, lumbar spinal stenosis, metatarsalgia, muscle spasms, musculoskeletal discomfort, musculoskeletal stiffness, myalgia, neck pain, osteoarthritis, osteochondrosis, osteoporosis, pain in extremity, periarthritis, periarticular disorder, plantar fasciitis, pseudoarthrosis, psoriatic arthropathy, rhabdomyolysis, rotator cuff syndrome, sacroiliitis, spinal disorder, spinal osteoarthritis, spinal pain, spinal stenosis, spondylolisthesis, synovial cyst, tendonitis, tenosynovitis, tenosynovitis stenosis, or trigger finger.

[0236] Embodiment 89: The method according to embodiment 73, wherein the neoplasm benign, malignant, or unspecified is adenocarcinoma metastatic, adrenal adenoma, anogenital warts, benign esophageal neoplasm, colorectal adenoma, hemangioma of liver, invasive ductal breast carcinoma, esophageal carcinoma, prostatic adenoma, or uterine leiomyoma.

[0237] Embodiment 90: The method according to embodiment 73, wherein the nervous system disorder is anosmia, bradykinesia, carpal tunnel syndrome, cervicobrachial syndrome, diabetic neuropathy, dizziness, encephalopathy, headache, hypoesthesia, lumbar radiculopathy, lumbosacral radiculopathy, metabolic encephalopathy, migraine, myotonia, neuralgia, neuritis, Parkinson's disease, restless legs syndrome, retinal migraine, sciatica, sensory loss, spinal cord hematoma, subarachnoid hemorrhage, syncope, or tension headache.30Attorney Docket No.24-1507-WO

[0238] Embodiment 91: The method according to embodiment 73, wherein the psychiatric disorder is adjustment disorder, affective disorder, anxiety, depression, insomnia, irritability, mixed anxiety and depressive disorder, sleep disorder, or stress.

[0239] Embodiment 92: The method according to embodiment 73, wherein the renal or urinary disorder is acute kidney injury, calculus urinary, chronic kidney disease, cystitis hemorrhagic, cystitis noninfective, end stage renal disease, glomerulonephritis chronic, hematuria, hypertonic bladder, nephrolithiasis, nephrosclerosis, pollakiuria, proteinuria, renal colic, renal cyst, stress urinary incontinence, ureterolithiasis, or urinary tract inflammation.

[0240] Embodiment 93: The method according to embodiment 73, wherein the reproductive system or breast disorder is abnormal uterine bleeding, adenomyosis, Bartholin's cyst, erectile dysfunction, hydrocele female, intermenstrual bleeding, menstruation irregular, prostatitis, prostatomegaly, uterine hemorrhage, or vaginal discharge.

[0241] Embodiment 94: The method according to embodiment 73, wherein the respiratory, thoracic, or mediastinal disorder is bronchitis chronic, cough, dysphonia, interstitial lunch disease, nasal congestion, oropharyngeal pain, respiratory failure, rhinorrhea, sinus congestion, sleep apnea syndrome, or upper respiratory tract inflammation.

[0242] Embodiment 95: The method according to embodiment 73, wherein the skin or subcutaneous tissue disorder is alopecia, angioedema, dermatitis allergic, dermatitis contact, dermatitis psoriasiform, ecchymosis, erythema, hidradenitis, pruritis, psoriasis, rash, skin exfoliation, or skin ulcer.

[0243] Embodiment 96: The method according to embodiment 73, wherein the surgical or medical procedure is gastric bypass.

[0244] Embodiment 97: The method according to embodiment 73, wherein the vascular disorder is aortic arteriosclerosis, aortic dissection, arteriosclerosis, bleeding varicose vein, blood pressure fluctuation, deep vein thrombosis, diabetic microangiopathy, essential hypertension, hypertension, hypertensive crisis, lymph stasis, peripheral venous disease, phlebitis, or thrombophlebitis.

[0245] Embodiment 98: An anti-IL-23p19 antibody hum13B8-b for use in a method of treating psoriatic arthritis in a patient in need thereof, the method comprising administering to a patient the anti-IL-23p19 antibody hum13B8-b comprising: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0246] Embodiment 99: The hum13B8-b for use of embodiment 98, wherein the use comprises a treatment phase and an extension phase.31Attorney Docket No.24-1507-WO

[0247] Embodiment 100: The hum13B8-b for use of embodiment 99, wherein the treatment phase comprises administering hum13B8-b to the patient for up to about 52 weeks.

[0248] Embodiment 101: The hum13B8-b for use of embodiment 99, wherein the treatment phase comprises administering hum13B8-b to the patient at week 0, at about week 4, and about every 12 weeks thereafter.

[0249] Embodiment 102: The hum13B8-b for use of embodiment 99, wherein the treatment phase comprises administering hum13B8-b to the patient at week 0, at about week 4, and about every 4 weeks thereafter.

[0250] Embodiment 103: The hum13B8-b for use of embodiment 99, wherein a therapeutically effective amount of hum13B8-b is administered to the patient during the treatment phase.

[0251] Embodiment 104: The hum13B8-b for use of embodiment 99, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the treatment phase.

[0252] Embodiment 105: The hum13B8-b for use of embodiment 104, wherein about 100 mg of hum13B8-b is administered to the patient during the treatment phase.

[0253] Embodiment 106: The hum13B8-b for use of embodiment 104, wherein about 200 mg of hum13B8-b is administered to the patient during the treatment phase.

[0254] Embodiment 107: The hum13B8-b for use of embodiment 103, wherein hum13B8-b is administered to the patient subcutaneously during the treatment phase.

[0255] Embodiment 108: The hum13B8-b for use of embodiment 103, wherein hum13B8-b is administered to the patient by subcutaneous injection during the treatment phase.

[0256] Embodiment 109: The hum13B8-b for use of embodiment 103, wherein hum13B8-b is administered to the patient using an auto-injector or prefilled syringe during the treatment phase.

[0257] Embodiment 110: The hum13B8-b for use of embodiment 103, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the treatment phase.

[0258] Embodiment 111: The hum13B8-b for use of embodiment 110, wherein about 100 mg of hum13B8-b is administered to the patient during the treatment phase.

[0259] Embodiment 112: The hum13B8-b for use of embodiment 110, wherein about 200 mg of hum13B8-b is administered to the patient during the treatment phase.

[0260] Embodiment 113: The hum13B8-b for use of embodiment 103, wherein a first dose of hum13B8-b is administered to the patient on week 0, a second dose of hum13B8-b is32Attorney Docket No.24-1507-WOadministered to the patient at about week 4, and subsequent doses of hum13B8-b are administered to the patient at about every 12 weeks thereafter during the treatment phase.

[0261] Embodiment 114: The hum13B8-b for use of embodiment 113, wherein the first dose of hum13B8-b, the second dose of hum13B8-b, and subsequent doses of hum13B8-b are the same.

[0262] Embodiment 115: The hum13B8-b for use of embodiment 113, wherein the first dose of hum13B8-b, the second dose of hum13B8-b, and subsequent doses of hum13B8-b are different.

[0263] Embodiment 116: The hum13B8-b for use of embodiment 114, wherein the first dose, the second dose, and subsequent doses comprise about 100 mg of hum13B8-b.

[0264] Embodiment 117: The hum13B8-b for use of embodiment 114, wherein the first dose, the second dose, and subsequent doses comprise about 200 mg of hum13B8-b.

[0265] Embodiment 118: The hum13B8-b for use of embodiment 113, wherein the first dose comprises about 100 mg of hum13B8-b.

[0266] Embodiment 119: The hum13B8-b for use of embodiment 113, wherein the second dose comprises about 100 mg of hum13B8-b.

[0267] Embodiment 120: The hum13B8-b for use of embodiment 113, wherein the subsequent doses comprise about 100 mg of hum13B8-b.

[0268] Embodiment 121: The method according to embodiment 113, wherein the first dose comprises about 200 mg of hum13B8-b.

[0269] Embodiment 122: The hum13B8-b for use of embodiment 113, wherein the second dose comprises about 200 mg of hum13B8-b.

[0270] Embodiment 123: The hum13B8-b for use of embodiment 113, wherein the subsequent doses comprise about 200 mg of hum13B8-b.

[0271] Embodiment 124: The hum13B8-b for use of embodiment 115, wherein the first dose comprises about 100 mg of hum13B8-b, and the amount of hum13B8-b administered in the second dose and subsequent doses is different from the first dose.

[0272] Embodiment 125: The hum13B8-b for use of embodiment 114, wherein the first dose of hum13B8-b comprises about 200 mg of hum13B8-b, and the amount of hum13B8-b administered in the second dose and subsequent doses is different from the first dose.

[0273] Embodiment 126: The hum13B8-b for use of embodiment 99, wherein the extension phase comprises administering hum13B8-b to the patient for up to about 208 weeks.33Attorney Docket No.24-1507-WO

[0274] Embodiment 127: The hum13B8-b for use of embodiment 99, wherein the extension phase comprises administering hum13B8-b to the patient at the same interval as hum13B8-b is administered to the patient during the treatment phase.

[0275] Embodiment 128: The hum13B8-b for use of embodiment 127, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient about every four weeks (Q4W) during the extension phase.

[0276] Embodiment 129: The hum13B8-b for use of embodiment 128, wherein hum13B8-b is administered to the patient for at least up to about 4 weeks, for at least up to about 8 weeks, for at least up to about 12 weeks, for at least up to about 16 weeks, for at least up to about 20 weeks, for at least up to about 24 weeks, for at least up to about 28 weeks, for at least up to about 32 weeks, for at least up to about 36 weeks, for at least up to about 40 weeks, for at least up to about 44 weeks, for at least up to about 48 weeks, for at least up to about 52 weeks, for at least up to about 56 weeks, for at least up to about 60 weeks, for at least up to about 64 weeks, for at least up to about 68 weeks, for at least up to about 72 weeks, for at least up to about 76 weeks, for at least up to about 80 weeks, for at least up to about 84 weeks, for at least up to about 88 weeks, for at least up to about 92 weeks, for at least up to about 96 weeks, for at least up to about 100 weeks, for at least up to about 104 weeks, for at least up to about 108 weeks, for at least up to about 112 weeks, for at least up to about 116 weeks, for at least up to about 120 weeks, for at least up to about 124 weeks, for at least up to about 128 weeks, for at least up to about 132 weeks, for at least up to about 136 weeks, for at least up to about 140 weeks, for at least up to about 144 weeks, for at least up to about 148 weeks, for at least up to about 152 weeks, for at least up to about 156 weeks, for at least up to about 160 weeks, for at least up to about 164 weeks, for at least up to about 168 weeks, for at least up to about 172, for at least up to about 176 weeks, for at least up to about 180 weeks, for at least up to about 184 weeks, for at least up to about 188 weeks, for at least up to about 192 weeks, for at least up to about 196 weeks, for at least up to about 200 weeks, for at least up to about 204 weeks, or for at least up to about 208 weeks.

[0277] Embodiment 130: The hum13B8-b for use of embodiment 128, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient about every twelve weeks (Q12W) during the extension phase.

[0278] Embodiment 131: The hum13B8-b for use of embodiment 130, wherein hum13B8-b is administered to the patient for at least up to about 12 weeks, for at least up to about 24weeks, for at least up to about 36 weeks, for at least up to about 48 weeks, for at least up to about 60 weeks, for at least up to about 72 weeks, for at least up to about 8434Attorney Docket No.24-1507-WOweeks, for at least up to about 96 weeks, for at least up to about 108 weeks, for at least up to about 120 weeks, for at least up to about 132 weeks, for at least up to about 144 weeks, for at least up to about 156 weeks, for at least up to about 168 weeks, for at least up to about 180 weeks, for at least up to about 192 weeks, for at least up to about 204 weeks, or for at least up to about 216 weeks.

[0279] Embodiment 132: The hum13B8-b for use of embodiment 99, wherein hum13B8-b is administered to the patient at different time intervals during the extension phase than hum13B8-b is administered to the patient during the treatment phase.

[0280] Embodiment 133: The hum13B8-b for use of embodiment 132, wherein hum13B8-b is administered to the patient Q4W during the treatment phase and hum13B8-b is administered to the patient Q12W during the extension phase.

[0281] Embodiment 134: The hum13B8-b for use of embodiment 99, wherein a therapeutically effective amount of hum13B8-b is administered to the patient during the extension phase.

[0282] Embodiment 135: The hum13B8-b for use of embodiment 134, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the extension phase.

[0283] Embodiment 136: The hum13B8-b for use of embodiment 135, wherein about 100 mg of hum13B8-b is administered to the patient during the extension phase.

[0284] Embodiment 137: The hum13B8-b for use of embodiment 135, wherein about 200 mg of hum13B8-b is administered to the patient during the treatment phase.

[0285] Embodiment 138: The hum13B8-b for use of embodiment 99, wherein the dose of hum13B8-b administered to the patient during the extension phase is different than the dose of hum13B8-b administered to the patient during the treatment phase.

[0286] Embodiment 139: The hum13B8-b for use of embodiment 138, wherein about 200 mg of hum13B8-b is administered to the patient during the treatment phase and about 100 mg of hum13B8-b is administered to the patient during the extension phase.

[0287] Embodiment 140: The hum13B8-b for use of embodiment 138, wherein about 200 mg hum13B8-b is administered to the patient Q4W during the treatment phase and about 100 mg hum13B8-b is administered to the patient Q12 during the extension phase.

[0288] Embodiment 141: The method according to embodiment 99, wherein the same dose of hum13B8-b is administered to the patient during the treatment phase and during the extension phase.35Attorney Docket No.24-1507-WO

[0289] Embodiment 142: The hum13B8-b for use of embodiment 141, wherein about 100 mg hum13B8-b is administered to the patient during the treatment phase and about 100 mg hum13B8-b is administered to the patient during the extension phase.

[0290] Embodiment 143: The hum13B8-b for use of embodiment 141, wherein about 200 mg of hum13B8-b is administered to the patient during the treatment phase and about 200 mg of hum13B8-b is administered to the patient during the extension phase.

[0291] Embodiment 144: The hum13B8-b for use of any one of embodiments 98-143, wherein the use comprises a treatment phase of up to about 52 weeks followed by an extension phase of an additional up to about 208 weeks, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the extension phase.

[0292] Embodiment 145: The hum13B8-b for use of any one of embodiments 136-144, wherein hum13B8-b is administered to the patient subcutaneously during the extension phase.

[0293] Embodiment 146: The hum13B8-b for use of embodiment 145, wherein hum13B8-b is administered to the patient by subcutaneous injection during the extension phase.

[0294] Embodiment 147: The hum13B8-b for use of embodiment 145, wherein hum13B8-b is administered to the patient using an auto-injector or prefilled syringe during the extension phase.

[0295] Embodiment 148: The hum13B8-b for use of any one of embodiments 126-136, 138-142, or 144-147, wherein administration of about 100 mg of hum13B8-b during the extension phase results in minimal or no serious adverse events (SAEs) in the patient.

[0296] Embodiment 149: The hum13B8-b for use of any one of embodiments 126-134, 137, 138, or 143-147, wherein administration of about 200 mg of hum13B8-b during the extension phase results in minimal or no serious adverse events (SAEs) in the patient.

[0297] Embodiment 150: The hum13B8-b for use of either embodiment 148 or embodiment 149, wherein the SAEs include blood and lymphatic disorders, cardiac disorders, gastrointestinal disorders, general disorders, hepatobiliary disorders, infections and infestations, injury, poisoning and procedural complications, investigations, metabolism and nutrition disorders, musculoskeletal and connective tissue disorders, neoplasms, nervous system disorders, renal and urinary disorders, reproductive system and breast disorders, respiratory, thoracic and mediastinal disorders, surgical and medical procedures, and vascular disorders.36Attorney Docket No.24-1507-WO

[0298] Embodiment 151: The hum13B8-b for use of embodiment 150, wherein the blood or lymphatic disorder is anemia.

[0299] Embodiment 152: The hum13B8-b for use of embodiment 150, wherein the cardiac disorder is acute myocardial infarction, cardiac failure, coronary artery stenosis, or tachycardia.

[0300] Embodiment 153: The hum13B8-b for use of embodiment 150, wherein the gastrointestinal disorder is abdominal hernia, hemorrhagic erosive gastritis, or intestinal obstruction.

[0301] Embodiment 154: The hum13B8-b for use of embodiment 150, wherein the general disorder is generalized oedema.

[0302] Embodiment 155: The hum13B8-b for use of embodiment 150, wherein the hepatobiliary disorder is cholelithiasis.

[0303] Embodiment 156: The hum13B8-b for use of embodiment 151, wherein the infection or infestation is abdominal abscess, COVID-19 pneumonia, gallbladder empyema, intestinal sepsis, septic shock, or upper respiratory tract infection.

[0304] Embodiment 157: The hum13B8-b for use of embodiment 150, wherein the injury, poisoning, or procedural complication is craniocerebral injury, hip fracture, humerus fracture, ligament rupture, subdural hematoma, or tibia fracture.

[0305] Embodiment 158: The hum13B8-b for use of embodiment 150, wherein the investigation is a kidney biopsy.

[0306] Embodiment 159: The hum13B8-b for use of embodiment 150, wherein the metabolism or nutrition disorder is diabetes mellitus.

[0307] Embodiment 160: The hum13B8-b for use of embodiment 150, wherein the musculoskeletal or connective tissue disorder is intervertebral disc disorder, lumbar spinal stenosis, osteoarthritis, or rhabdomyolysis.

[0308] Embodiment 161: The hum13B8-b for use of embodiment 150, wherein the neoplasm is adenocarcinoma metastatic, colorectal adenoma, invasive ductal breast carcinoma, esophageal carcinoma, or uterine leiomyoma.

[0309] Embodiment 162: The hum13B8-b for use of embodiment 150, wherein the nervous system disorder is dizziness, metabolic encephalopathy, retinal migraine, subarachnoid hemorrhage, or tension headache.

[0310] Embodiment 163: The hum13B8-b for use of embodiment 150, wherein the renal or urinary disorder is acute kidney injury, calculus urinary, end stage renal disease, or ureterolithiasis.37Attorney Docket No.24-1507-WO

[0311] Embodiment 164: The hum13B8-b for use of embodiment 150, wherein the reproductive system or breast disorder is hydrocele female or uterine hemorrhage.

[0312] Embodiment 165: The hum13B8-b for use of embodiment 150, wherein the respiratory, thoracic, or mediastinal disorder is bronchitis chronic or interstitial lung disease.

[0313] Embodiment 166: The hum13B8-b for use of embodiment 53, wherein the surgical or medical procedure is gastric bypass.

[0314] Embodiment 167: The hum13B8-b for use of embodiment 150, wherein the vascular disorder is aortic dissection, arteriosclerosis, deep vein thrombosis, hypertension, or hypertensive crisis.

[0315] Embodiment 168: The hum13B8-b for use of any one of embodiments 126-136, 138-142, or 144-147, wherein administration of 100 mg of hum13B8-b during the extension phase results in minimal or no other adverse events (OAEs) in the patient.

[0316] Embodiment 169: The hum13B8-b for use of any one of embodiments 126-134, 137, 138, or 143-147, wherein administration of 200 mg of hum13B8-b during the extension phase results in minimal or no other adverse events (OAEs) in the patient.

[0317] Embodiment 170: The hum13B8-b for use of either embodiment 168 or embodiment 169, wherein the OAEs include one or more of blood or lymphatic system disorders, cardiac disorders, congenital, familial, or genetic disorders, ear or labyrinth disorders, endocrine disorders, eye disorders, gastrointestinal disorders, general disorders, hepatobiliary disorders, immune system disorders, infections or infestations, injuries, poisoning or procedural complications, investigations, metabolism or nutrition disorders, musculoskeletal or connective tissue disorders, neoplasms benign, malignant, or unspecified, nervous system disorders, psychiatric disorders, renal or urinary disorders, reproductive system or breast disorders, respiratory, thoracic, or mediastinal disorders, skin or subcutaneous tissue disorders, surgical or medical procedures, or vascular disorders.

[0318] Embodiment 171: The hum13B8-b for use of embodiment 170, wherein the blood or lymphatic system disorder is anemia, leukocytosis, leukopenia, lymphadenopathy, lymphopenia, neutropenia, or neutrophilia.

[0319] Embodiment 172: The hum13B8-b for use of embodiment 170, wherein the cardiac disorder is acute myocardial infarction, atrial fibrillation, atrioventricular block first degree, cardiac failure, cardiac failure congestive, coronary artery stenosis, diastolic dysfunction, mitral valve incompetence, myocardial ischemia, palpitations, pericardial cyst, sinus tachycardia, tachycardia, or tricuspid valve incompetence.38Attorney Docket No.24-1507-WO

[0320] Embodiment 173: The hum13B8-b for use of embodiment 170, wherein the congenital, familial, or genetic disorder is accessory spleen, Gilbert's syndrome, or hydrocele.

[0321] Embodiment 174: The hum13B8-b for use of embodiment 170, wherein the ear or labyrinth disorder is ear pain or vertigo.

[0322] Embodiment 175: The hum13B8-b for use of embodiment 170, wherein the endocrine disorder is autoimmune thyroiditis, goiter, hypothyroidic goiter, hypothyroidism, or thyroid mass.

[0323] Embodiment 176: The hum13B8-b for use of embodiment 170, wherein the eye disorder is astigmatism, blepharitis, blindness transient, cataract, cataract nuclear, diabetic retinopathy, keratitis, myopia, retinal vascular disorder, or visual acuity reduced.

[0324] Embodiment 177: The hum13B8-b for use of embodiment 170, wherein the gastrointestinal disorder is abdominal hernia, abdominal pain, abdominal pain upper, abdominal rigidity, anal fistula, aphthous ulcer, Barrett's esophagus, chronic gastritis, coeliac artery stenosis, constipation, dental caries, diaphragmatic hernia, diarrhea, diverticulum, diverticulum intestinal, duodenitis, dyspepsia, enteritis, food poisoning, gastric ulcer, gastritis, gastritis erosive, gastrointestinal disorder, gastroesophageal reflux disease, gingival swelling, hemorrhagic erosive gastritis, hemorrhoids, hiatus hernia, intestinal metaplasia, intestinal obstruction, irritable bowel syndrome, large intestine polyp, nausea, pancreatitis chronic, rectal polyp, retained deciduous tooth, toothache, or vomiting.

[0325] Embodiment 178: The hum13B8-b for use of embodiment 170, wherein the general disorder is asthenia, chest pain, chills, drug intolerance, fatigue, generalized oedema, influenza like illness, injection site erythema, injection site pain, injection site pruritus, injection site rash, injection site reaction, injury associated with device, oedema peripheral, pyrexia, vaccination site pain, or xerosis.

[0326] Embodiment 179: The hum13B8-b for use of embodiment 170, wherein the hepatobiliary disorder is biliary dyskinesia, cholecystitis, cholelithiasis, cholestasis, diabetic hepatopathy, gallbladder polyp, hepatic steatosis, hepatitis, hyperbilirubinemia, hypertransaminasaemia, non-alcoholic steatohepatitis, or steatohepatitis.

[0327] Embodiment 180: The hum13B8-b for use of embodiment 170, wherein the immune system disorder is an allergy to an arthropod bite or allergy to plants.

[0328] Embodiment 181: The hum13B8-b for use of embodiment 170, wherein the infection or infestation is abdominal abscess, acute sinusitis, adenovirus infection, bacteriuria, Bartholin's abscess, breast abscess, bronchitis, COVID-19, COVID-19 pneumonia, cellulitis, chronic sinusitis, conjunctivitis, coronavirus infection, cystitis, diverticulitis, erythema39Attorney Docket No.24-1507-WOmigraines, Escherichia infection, furuncle, gallbladder empyema, gastroenteritis, gastroenteritis viral, gastrointestinal bacterial overgrowth, gastrointestinal infection, gingivitis, helicobacter gastritis, helicobacter infection, Herpes simplex, Herpes zoster, Hordeolum, influenza, intestinal sepsis, joint abscess, laryngitis, localized infection, lower respiratory tract infection, nasopharyngitis, oral herpes, otitis externa, otitis media, periodontitis, pharyngitis, pharyngotonsillitis, pneumonia, pneumonia bacterial, pulmonary tuberculosis, pulpitis dental, purulent discharge, pyelonephritis, pyelonephritis acute, respiratory tract infection, respiratory tract infection viral, rhinitis, septic shock, sinusitis, skin infection, suspected COVID-19, tonsillitis, tooth infection, tracheitis, tracheobronchitis, upper respiratory tract infection, urinary tract infection, vaginal infection, viral infection, viral pharyngitis, viral upper respiratory tract infection, vulvovaginal mycotic infection, or wound infection.

[0329] Embodiment 182: The hum13B8-b for use of embodiment 170, wherein the injury, poisoning, or procedural complication is second degree burns, concussion, contusion, craniocerebral injury, cuboid syndrome, epicondylitis, fall, fibula fracture, foot fracture, hand fracture, hip fracture, humerus fracture, iliotibial band syndrome, immunization reaction, joint injury, ligament rupture, ligament sprain, limb injury, meniscus injury, muscle strain, nail avulsion, post vaccination syndrome, skin abrasion, skin laceration, soft tissue injury, spinal compression fracture, subdural hematoma, synovial rupture, tendon injury, thermal burn, tibia fracture, or tooth fracture.

[0330] Embodiment 183: The hum13B8-b for use according to embodiment 170, wherein the investigation is alanine aminotransferase increased, apolipoprotein B increased, aspartate aminotransferase increased, bilirubin conjugated increased, bilirubin urine present, biopsy kidney, blood bilirubin increased, blood cholesterol increased, blood creatine phosphokinase increased, blood creatinine increased, blood glucose increased, blood pressure increased, blood triglycerides increased, blood urea increased, C-reactive protein increased, Gamma-glutamyl transferase increased, glomerular filtration rate decreased, hematocrit decreased, hemoglobin decreased, hepatic enzyme increased, low density lipoprotein increased, lymphocyte count decreased, monocyte count decreased, neutrophil count decreased, platelet count decreased, prostatic specific antigen increased, red blood cell count decreased, transaminases increased, urinary casts, weight decreased, weight increased, or white blood cell count decreased.

[0331] Embodiment 184: The hum13B8-b for use of embodiment 170, wherein the metabolism or nutrition disorder is cholesterosis, copper deficiency, dehydration, diabetes40Attorney Docket No.24-1507-WOmellitus, diabetes mellitus inadequate control, dyslipidemia, glucose tolerance impaired, hypercholesterolemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, hyperuricemia, hypokalemia, hypomagnesaemia, hyponatremia, impaired fasting glucose, insulin resistance, obesity, type 2 diabetes mellitus, or vitamin D deficiency.

[0332] Embodiment 185: The hum13B8-b for use of embodiment 170, wherein the musculoskeletal or connective tissue disorder is arthralgia, arthritis, back pain, bursitis, dactylitis, exostosis, fracture pain, greater trochanteric pain syndrome, intervertebral disc disorder, intervertebral disc displacement, intervertebral disc protrusion, jaw cyst, joint contracture, joint effusion, joint swelling, lumbar spinal stenosis, metatarsalgia, muscle spasms, musculoskeletal discomfort, musculoskeletal stiffness, myalgia, neck pain, osteoarthritis, osteochondrosis, osteoporosis, pain in extremity, periarthritis, periarticular disorder, plantar fasciitis, pseudoarthrosis, psoriatic arthropathy, rhabdomyolysis, rotator cuff syndrome, sacroiliitis, spinal disorder, spinal osteoarthritis, spinal pain, spinal stenosis, spondylolisthesis, synovial cyst, tendonitis, tenosynovitis, tenosynovitis stenosis, or trigger finger.

[0333] Embodiment 186: The hum13B8-b for use of embodiment 170, wherein the neoplasm benign, malignant, or unspecified is adenocarcinoma metastatic, adrenal adenoma, anogenital warts, benign esophageal neoplasm, colorectal adenoma, hemangioma of liver, invasive ductal breast carcinoma, esophageal carcinoma, prostatic adenoma, or uterine leiomyoma.

[0334] Embodiment 187: The hum13B8-b for use of embodiment 170, wherein the nervous system disorder is anosmia, bradykinesia, carpal tunnel syndrome, cervicobrachial syndrome, diabetic neuropathy, dizziness, encephalopathy, headache, hypoesthesia, lumbar radiculopathy, lumbosacral radiculopathy, metabolic encephalopathy, migraine, myotonia, neuralgia, neuritis, Parkinson's disease, restless legs syndrome, retinal migraine, sciatica, sensory loss, spinal cord hematoma, subarachnoid hemorrhage, syncope, or tension headache.

[0335] Embodiment 188: The hum13B8-b for use of embodiment 170, wherein the psychiatric disorder is adjustment disorder, affective disorder, anxiety, depression, insomnia, irritability, mixed anxiety and depressive disorder, sleep disorder, or stress.

[0336] Embodiment 189: The hum13B8-b for use of embodiment 170, wherein the renal or urinary disorder is acute kidney injury, calculus urinary, chronic kidney disease, cystitis hemorrhagic, cystitis noninfective, end stage renal disease, glomerulonephritis chronic, hematuria, hypertonic bladder, nephrolithiasis, nephrosclerosis, pollakiuria, proteinuria, renal colic, renal cyst, stress urinary incontinence, ureterolithiasis, or urinary tract inflammation.41Attorney Docket No.24-1507-WO

[0337] Embodiment 190: The hum13B8-b for use of embodiment 170, wherein the reproductive system or breast disorder is abnormal uterine bleeding, adenomyosis, Bartholin's cyst, erectile dysfunction, hydrocele female, intermenstrual bleeding, menstruation irregular, prostatitis, prostatomegaly, uterine hemorrhage, or vaginal discharge.

[0338] Embodiment 191: The hum13B8-b for use of embodiment 170, wherein the respiratory, thoracic, or mediastinal disorder is bronchitis chronic, cough, dysphonia, interstitial lunch disease, nasal congestion, oropharyngeal pain, respiratory failure, rhinorrhea, sinus congestion, sleep apnea syndrome, or upper respiratory tract inflammation.

[0339] Embodiment 192: The hum13B8-b for use of embodiment 170, wherein the skin or subcutaneous tissue disorder is alopecia, angioedema, dermatitis allergic, dermatitis contact, dermatitis psoriasiform, ecchymosis, erythema, hidradenitis, pruritis, psoriasis, rash, skin exfoliation, or skin ulcer.

[0340] Embodiment 193: The hum13B8-b for use of embodiment 170, wherein the surgical or medical procedure is gastric bypass.

[0341] Embodiment 194: The hum13B8-b for use of embodiment 170, wherein the vascular disorder is aortic arteriosclerosis, aortic dissection, arteriosclerosis, bleeding varicose vein, blood pressure fluctuation, deep vein thrombosis, diabetic microangiopathy, essential hypertension, hypertension, hypertensive crisis, lymph stasis, peripheral venous disease, phlebitis, or thrombophlebitis.

[0342] Embodiment 195: The use of an anti-IL-23p19 antibody hum13B8-b for the manufacture of a medicament for therapeutic treatment for treating psoriatic arthritis, wherein the anti-IL-23p19 antibody hum13B8-b comprises: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0343] Embodiment 196: The use of embodiment 195, wherein the medicament comprises a treatment phase and an extension phase.

[0344] Embodiment 197: The use of embodiment 196, wherein the treatment phase comprises administering the medicament to the patient for up to about 52 weeks.

[0345] Embodiment 198: The use of embodiment 196, wherein the treatment phase comprises administering the medicament to the patient at week 0, at about week 4, and about every 12 weeks thereafter.

[0346] Embodiment 199: The use of embodiment 196, wherein the treatment phase comprises administering the medicament to the patient at week 0, at about week 4, and about every 4 weeks thereafter.42Attorney Docket No.24-1507-WO

[0347] Embodiment 200: The use of embodiment 196, wherein a therapeutically effective amount of the medicament is administered to the patient during the treatment phase.

[0348] Embodiment 201: The use of embodiment 196, wherein about 100 mg or about 200 mg of the medicament is administered to the patient during the treatment phase.

[0349] Embodiment 202: The use of embodiment 201, wherein about 100 mg of the medicament is administered to the patient during the treatment phase.

[0350] Embodiment 203: The use of embodiment 201, wherein about 200 mg of the medicament is administered to the patient during the treatment phase.

[0351] Embodiment 204: The use of embodiment 200, wherein the medicament is administered to the patient subcutaneously during the treatment phase.

[0352] Embodiment 205: The use of embodiment 200, wherein the medicament is administered to the patient by subcutaneous injection during the treatment phase.

[0353] Embodiment 206: The use of embodiment 200, wherein the medicament is administered to the patient using an auto-injector or prefilled syringe during the treatment phase.

[0354] Embodiment 207: The use of embodiment 200, wherein about 100 mg or about 200 mg of the medicament is administered to the patient during the treatment phase.

[0355] Embodiment 208: The use of embodiment 207, wherein about 100 mg of the medicament is administered to the patient during the treatment phase.

[0356] Embodiment 209: The use of embodiment 207, wherein about 200 mg of the medicament is administered to the patient during the treatment phase.

[0357] Embodiment 210: The use of embodiment 200, wherein a first dose of the medicament is administered to the patient on week 0, a second dose of the medicament is administered to the patient at about week 4, and subsequent doses of the medicament are administered to the patient at about every 12 weeks thereafter during the treatment phase.

[0358] Embodiment 211: The use of embodiment 211, wherein the first dose of the medicament, the second dose of the medicament, and subsequent doses of the medicament are the same.

[0359] Embodiment 212: The use of embodiment 211, wherein the first dose of the medicament, the second dose of the medicament, and subsequent doses of the medicament are different.

[0360] Embodiment 213: The use of embodiment 211, wherein the first dose, the second dose, and subsequent doses comprise about 100 mg of the medicament.43Attorney Docket No.24-1507-WO

[0361] Embodiment 214: The use of embodiment 211, wherein the first dose, the second dose, and subsequent doses comprise about 200 mg of the medicament.

[0362] Embodiment 215: The use of embodiment 210, wherein the first dose comprises about 100 mg of the medicament.

[0363] Embodiment 216: The use of embodiment 210, wherein the second dose comprises about 100 mg of the medicament.

[0364] Embodiment 217: The use of embodiment 210, wherein the subsequent doses comprise about 100 mg of the medicament.

[0365] Embodiment 218: The use of embodiment 210, wherein the first dose comprises about 200 mg of the medicament.

[0366] Embodiment 219: The use of embodiment 210, wherein the second dose comprises about 200 mg of the medicament.

[0367] Embodiment 220: The use of embodiment 210, wherein the subsequent doses comprise about 200 mg of the medicament.

[0368] Embodiment 221: The use of embodiment 212, wherein the first dose comprises about 100 mg of the medicament, and the amount of the medicament administered in the second dose and subsequent doses is different from the first dose.

[0369] Embodiment 222: The use of embodiment 211, wherein the first dose of the medicament comprises about 200 mg of the medicament, and the amount of the medicament administered in the second dose and subsequent doses is different from the first dose.

[0370] Embodiment 223: The use of embodiment 196, wherein the extension phase comprises administering the medicament to the patient for up to about 208 weeks.

[0371] Embodiment 224: The use of embodiment 196, wherein the extension phase comprises administering the medicament to the patient at the same interval as the medicament is administered to the patient during the treatment phase.

[0372] Embodiment 225: The use of embodiment 224, wherein about 100 mg or about 200 mg of the medicament is administered to the patient about every four weeks (Q4W) during the extension phase.

[0373] Embodiment 226: The use of embodiment 225, wherein the medicament is administered to the patient for at least up to about 4 weeks, for at least up to about 8 weeks, for at least up to about 12 weeks, for at least up to about 16 weeks, for at least up to about 20 weeks, for at least up to about 24 weeks, for at least up to about 28 weeks, for at least up to about 32 weeks, for at least up to about 36 weeks, for at least up to about 40 weeks, for at least up to about 44 weeks, for at least up to about 48 weeks, for at least up to about 5244Attorney Docket No.24-1507-WOweeks, for at least up to about 56 weeks, for at least up to about 60 weeks, for at least up to about 64 weeks, for at least up to about 68 weeks, for at least up to about 72 weeks, for at least up to about 76 weeks, for at least up to about 80 weeks, for at least up to about 84 weeks, for at least up to about 88 weeks, for at least up to about 92 weeks, for at least up to about 96 weeks, for at least up to about 100 weeks, for at least up to about 104 weeks, for at least up to about 108 weeks, for at least up to about 112 weeks, for at least up to about 116 weeks, for at least up to about 120 weeks, for at least up to about 124 weeks, for at least up to about 128 weeks, for at least up to about 132 weeks, for at least up to about 136 weeks, for at least up to about 140 weeks, for at least up to about 144 weeks, for at least up to about 148 weeks, for at least up to about 152 weeks, for at least up to about 156 weeks, for at least up to about 160 weeks, for at least up to about 164 weeks, for at least up to about 168 weeks, for at least up to about 172, for at least up to about 176 weeks, for at least up to about 180 weeks, for at least up to about 184 weeks, for at least up to about 188 weeks, for at least up to about 192 weeks, for at least up to about 196 weeks, for at least up to about 200 weeks, for at least up to about 204 weeks, or for at least up to about 208 weeks.

[0374] Embodiment 227: The use of embodiment 130, wherein about 100 mg or about 200 mg of the medicament is administered to the patient about every twelve weeks (Q12W) during the extension phase.

[0375] Embodiment 228: The use of embodiment 130, wherein the medicament is administered to the patient for at least up to about 12 weeks, for at least up to about 24 weeks, for at least up to about 36 weeks, for at least up to about 48 weeks, for at least up to about 60 weeks, for at least up to about 72 weeks, for at least up to about 84 weeks, for at least up to about 96 weeks, for at least up to about 108 weeks, for at least up to about 120 weeks, for at least up to about 132 weeks, for at least up to about 144 weeks, for at least up to about 156 weeks, for at least up to about 168 weeks, for at least up to about 180 weeks, for at least up to about 192 weeks, for at least up to about 204 weeks, or for at least up to about 216 weeks.

[0376] Embodiment 229: The use of embodiment 196, wherein the medicament is administered to the patient at different time intervals during the extension phase than the medicament is administered to the patient during the treatment phase.

[0377] Embodiment 230: The use of embodiment 229, wherein the medicament is administered to the patient Q4W during the treatment phase and the medicament is administered to the patient Q12W during the extension phase.

[0378] Embodiment 231: The use of embodiment 196, wherein a therapeutically effective amount of the medicament is administered to the patient during the extension phase.45Attorney Docket No.24-1507-WO

[0379] Embodiment 232: The use of embodiment 231, wherein about 100 mg or about 200 mg of the medicament is administered to the patient during the extension phase.

[0380] Embodiment 233: The use of embodiment 232, wherein about 100 mg of the medicament is administered to the patient during the extension phase.

[0381] Embodiment 234: The use of embodiment 232, wherein about 200 mg of the medicament is administered to the patient during the treatment phase.

[0382] Embodiment 235: The use of embodiment 196, wherein the dose of the medicament administered to the patient during the extension phase is different than the dose of the medicament administered to the patient during the treatment phase.

[0383] Embodiment 236: The use of embodiment 235, wherein about 200 mg of the medicament is administered to the patient during the treatment phase and about 100 mg of the medicament is administered to the patient during the extension phase.

[0384] Embodiment 237: The use of embodiment 235, wherein about 200 mg the medicament is administered to the patient Q4W during the treatment phase and about 100 mg the medicament is administered to the patient Q12 during the extension phase.

[0385] Embodiment 238: The use of embodiment 196, wherein the same dose of the medicament is administered to the patient during the extension phase and during the treatment phase.

[0386] Embodiment 239: The use of embodiment 238, wherein about 100 mg the medicament is administered to the patient during the treatment phase and about 100 mg the medicament is administered to the patient during the extension phase.

[0387] Embodiment 240: The use of embodiment 238, wherein about 200 mg of the medicament is administered to the patient during the treatment phase and about 200 mg of the medicament is administered to the patient during the extension phase.

[0388] Embodiment 241: The use of any one of embodiments 195-240, wherein the method comprises a treatment phase of up to about 52 weeks followed by an extension phase of an additional up to about 208 weeks, wherein about 100 mg or about 200 mg of the medicament is administered to the patient during the extension phase.

[0389] Embodiment 242: The use of any one of embodiments 233-241, wherein the medicament is administered to the patient subcutaneously during the extension phase.

[0390] Embodiment 243: The use of embodiment 242, wherein the medicament is administered to the patient by subcutaneous injection during the extension phase.46Attorney Docket No.24-1507-WO

[0391] Embodiment 244: The use of embodiment 242, wherein the medicament is administered to the patient using an auto-injector or prefilled syringe during the extension phase.

[0392] Embodiment 245: The use of any one of embodiments 223-233, 235-239, or 241-244, wherein administration of about 100 mg of the medicament during the extension phase results in minimal or no serious adverse events (SAEs) in the patient.

[0393] Embodiment 246: The use of any one of embodiments 223-231, 234, 235, 238, or 240-244, wherein administration of about 200 mg the medicament during the extension phase results in minimal or no serious adverse events (SAEs) in the patient.

[0394] Embodiment 247: The use of either embodiment 245 or embodiment 246, wherein the SAEs include blood and lymphatic disorders, cardiac disorders, gastrointestinal disorders, general disorders, hepatobiliary disorders, infections and infestations, injury, poisoning and procedural complications, investigations, metabolism and nutrition disorders, musculoskeletal and connective tissue disorders, neoplasms, nervous system disorders, renal and urinary disorders, reproductive system and breast disorders, respiratory, thoracic and mediastinal disorders, surgical and medical procedures, and vascular disorders.

[0395] Embodiment 248: The use of embodiment 247, wherein the blood or lymphatic disorder is anemia.

[0396] Embodiment 249: The use of embodiment 247, wherein the cardiac disorder is acute myocardial infarction, cardiac failure, coronary artery stenosis, or tachycardia.

[0397] Embodiment 250: The use of embodiment 247, wherein the gastrointestinal disorder is abdominal hernia, hemorrhagic erosive gastritis, or intestinal obstruction.

[0398] Embodiment 251: The use of embodiment 247, wherein the general disorder is generalized oedema.

[0399] Embodiment 252: The use of embodiment 247, wherein the hepatobiliary disorder is cholelithiasis.

[0400] Embodiment 253: The use of embodiment 247, wherein the infection or infestation is abdominal abscess, COVID-19 pneumonia, gallbladder empyema, intestinal sepsis, septic shock, or upper respiratory tract infection.

[0401] Embodiment 254: The use of embodiment 247, wherein the injury, poisoning, or procedural complication is craniocerebral injury, hip fracture, humerus fracture, ligament rupture, subdural hematoma, or tibia fracture.

[0402] Embodiment 255: The use of embodiment 247, wherein the investigation is a kidney biopsy.47Attorney Docket No.24-1507-WO

[0403] Embodiment 256: The use of embodiment 247, wherein the metabolism or nutrition disorder is diabetes mellitus.

[0404] Embodiment 257: The use of embodiment 247, wherein the musculoskeletal or connective tissue disorder is intervertebral disc disorder, lumbar spinal stenosis, osteoarthritis, or rhabdomyolysis.

[0405] Embodiment 258: The use of embodiment 247, wherein the neoplasm is adenocarcinoma metastatic, colorectal adenoma, invasive ductal breast carcinoma, esophageal carcinoma, or uterine leiomyoma.

[0406] Embodiment 259: The use of embodiment 247, wherein the nervous system disorder is dizziness, metabolic encephalopathy, retinal migraine, subarachnoid hemorrhage, or tension headache.

[0407] Embodiment 260: The use of embodiment 247, wherein the renal or urinary disorder is acute kidney injury, calculus urinary, end stage renal disease, or ureterolithiasis.

[0408] Embodiment 261: The use of embodiment 247, wherein the reproductive system or breast disorder is hydrocele female or uterine hemorrhage.

[0409] Embodiment 262: The use of embodiment 247, wherein the respiratory, thoracic, or mediastinal disorder is bronchitis chronic or interstitial lung disease.

[0410] Embodiment 263: The use of embodiment 247, wherein the surgical or medical procedure is gastric bypass.

[0411] Embodiment 264: The use of embodiment 247, wherein the vascular disorder is aortic dissection, arteriosclerosis, deep vein thrombosis, hypertension, or hypertensive crisis.

[0412] Embodiment 265: The use of any one of embodiments 223-233, 235-239, or 241-244, wherein administration of about 100 mg of the medicament during the extension phase results in minimal or no other adverse events (OAEs) in the patient.

[0413] Embodiment 266: The use of any one of embodiments 223-231, 234, 235, 238, or 240-244, wherein administration of about 200 mg of the medicament during the extension phase results in minimal or no other adverse events (OAEs) in the patient.

[0414] Embodiment 267: The use of either embodiment 265 or embodiment 266, wherein the OAEs include one or more of blood or lymphatic system disorders, cardiac disorders, congenital, familial, or genetic disorders, ear or labyrinth disorders, endocrine disorders, eye disorders, gastrointestinal disorders, general disorders, hepatobiliary disorders, immune system disorders, infections or infestations, injuries, poisoning or procedural complications, investigations, metabolism or nutrition disorders, musculoskeletal or connective tissue disorders, neoplasms benign, malignant, or unspecified, nervous system48Attorney Docket No.24-1507-WOdisorders, psychiatric disorders, renal or urinary disorders, reproductive system or breast disorders, respiratory, thoracic, or mediastinal disorders, skin or subcutaneous tissue disorders, surgical or medical procedures, or vascular disorders.

[0415] Embodiment 268: The use of embodiment 267, wherein the blood or lymphatic system disorder is anemia, leukocytosis, leukopenia, lymphadenopathy, lymphopenia, neutropenia, or neutrophilia.

[0416] Embodiment 269: The use of embodiment 267, wherein the cardiac disorder is acute myocardial infarction, atrial fibrillation, atrioventricular block first degree, cardiac failure, cardiac failure congestive, coronary artery stenosis, diastolic dysfunction, mitral valve incompetence, myocardial ischemia, palpitations, pericardial cyst, sinus tachycardia, tachycardia, or tricuspid valve incompetence.

[0417] Embodiment 270: The use of embodiment 267, wherein the congenital, familial, or genetic disorder is accessory spleen, Gilbert's syndrome, or hydrocele.

[0418] Embodiment 271: The use of embodiment 267, wherein the ear or labyrinth disorder is ear pain or vertigo.

[0419] Embodiment 272: The use of embodiment 267, wherein the endocrine disorder is autoimmune thyroiditis, goiter, hypothyroidic goiter, hypothyroidism, or thyroid mass.

[0420] Embodiment 273: The use of embodiment 267, wherein the eye disorder is astigmatism, blepharitis, blindness transient, cataract, cataract nuclear, diabetic retinopathy, keratitis, myopia, retinal vascular disorder, or visual acuity reduced.

[0421] Embodiment 274: The use of embodiment 267, wherein the gastrointestinal disorder is abdominal hernia, abdominal pain, abdominal pain upper, abdominal rigidity, anal fistula, aphthous ulcer, Barrett's esophagus, chronic gastritis, coeliac artery stenosis, constipation, dental caries, diaphragmatic hernia, diarrhea, diverticulum, diverticulum intestinal, duodenitis, dyspepsia, enteritis, food poisoning, gastric ulcer, gastritis, gastritis erosive, gastrointestinal disorder, gastroesophageal reflux disease, gingival swelling, hemorrhagic erosive gastritis, hemorrhoids, hiatus hernia, intestinal metaplasia, intestinal obstruction, irritable bowel syndrome, large intestine polyp, nausea, pancreatitis chronic, rectal polyp, retained deciduous tooth, toothache, or vomiting.

[0422] Embodiment 275: The use of embodiment 267, wherein the general disorder is asthenia, chest pain, chills, drug intolerance, fatigue, generalized oedema, influenza like illness, injection site erythema, injection site pain, injection site pruritus, injection site rash, injection site reaction, injury associated with device, oedema peripheral, pyrexia, vaccination site pain, or xerosis.49Attorney Docket No.24-1507-WO

[0423] Embodiment 276: The use of embodiment 267, wherein the hepatobiliary disorder is biliary dyskinesia, cholecystitis, cholelithiasis, cholestasis, diabetic hepatopathy, gallbladder polyp, hepatic steatosis, hepatitis, hyperbilirubinemia, hypertransaminasaemia, non-alcoholic steatohepatitis, or steatohepatitis.

[0424] Embodiment 277: The use of embodiment 267, wherein the immune system disorder is an allergy to an arthropod bite or allergy to plants.

[0425] Embodiment 278: The use of embodiment 267, wherein the infection or infestation is abdominal abscess, acute sinusitis, adenovirus infection, bacteriuria, Bartholin's abscess, breast abscess, bronchitis, COVID-19, COVID-19 pneumonia, cellulitis, chronic sinusitis, conjunctivitis, coronavirus infection, cystitis, diverticulitis, erythema migraines, Escherichia infection, furuncle, gallbladder empyema, gastroenteritis, gastroenteritis viral, gastrointestinal bacterial overgrowth, gastrointestinal infection, gingivitis, helicobacter gastritis, helicobacter infection, Herpes simplex, Herpes zoster, Hordeolum, influenza, intestinal sepsis, joint abscess, laryngitis, localized infection, lower respiratory tract infection, nasopharyngitis, oral herpes, otitis externa, otitis media, periodontitis, pharyngitis, pharyngotonsillitis, pneumonia, pneumonia bacterial, pulmonary tuberculosis, pulpitis dental, purulent discharge, pyelonephritis, pyelonephritis acute, respiratory tract infection, respiratory tract infection viral, rhinitis, septic shock, sinusitis, skin infection, suspected COVID-19, tonsillitis, tooth infection, tracheitis, tracheobronchitis, upper respiratory tract infection, urinary tract infection, vaginal infection, viral infection, viral pharyngitis, viral upper respiratory tract infection, vulvovaginal mycotic infection, or wound infection.

[0426] Embodiment 279: The use of embodiment 267, wherein the injury, poisoning, or procedural complication is second degree burns, concussion, contusion, craniocerebral injury, cuboid syndrome, epicondylitis, fall, fibula fracture, foot fracture, hand fracture, hip fracture, humerus fracture, iliotibial band syndrome, immunization reaction, joint injury, ligament rupture, ligament sprain, limb injury, meniscus injury, muscle strain, nail avulsion, post vaccination syndrome, skin abrasion, skin laceration, soft tissue injury, spinal compression fracture, subdural hematoma, synovial rupture, tendon injury, thermal burn, tibia fracture, or tooth fracture.

[0427] Embodiment 280: The use of embodiment 267, wherein the investigation is alanine aminotransferase increased, apolipoprotein B increased, aspartate aminotransferase increased, bilirubin conjugated increased, bilirubin urine present, biopsy kidney, blood bilirubin increased, blood cholesterol increased, blood creatine phosphokinase increased, blood creatinine increased, blood glucose increased, blood pressure increased, blood50Attorney Docket No.24-1507-WOtriglycerides increased, blood urea increased, C-reactive protein increased, Gamma-glutamyl transferase increased, glomerular filtration rate decreased, hematocrit decreased, hemoglobin decreased, hepatic enzyme increased, low density lipoprotein increased, lymphocyte count decreased, monocyte count decreased, neutrophil count decreased, platelet count decreased, prostatic specific antigen increased, red blood cell count decreased, transaminases increased, urinary casts, weight decreased, weight increased, or white blood cell count decreased.

[0428] Embodiment 281: The use of embodiment 267, wherein the metabolism or nutrition disorder is cholesterosis, copper deficiency, dehydration, diabetes mellitus, diabetes mellitus inadequate control, dyslipidemia, glucose tolerance impaired, hypercholesterolemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, hyperuricemia, hypokalemia, hypomagnesaemia, hyponatremia, impaired fasting glucose, insulin resistance, obesity, type 2 diabetes mellitus, or vitamin D deficiency.

[0429] Embodiment 282: The use of embodiment 267, wherein the musculoskeletal or connective tissue disorder is arthralgia, arthritis, back pain, bursitis, dactylitis, exostosis, fracture pain, greater trochanteric pain syndrome, intervertebral disc disorder, intervertebral disc displacement, intervertebral disc protrusion, jaw cyst, joint contracture, joint effusion, joint swelling, lumbar spinal stenosis, metatarsalgia, muscle spasms, musculoskeletal discomfort, musculoskeletal stiffness, myalgia, neck pain, osteoarthritis, osteochondrosis, osteoporosis, pain in extremity, periarthritis, periarticular disorder, plantar fasciitis, pseudoarthrosis, psoriatic arthropathy, rhabdomyolysis, rotator cuff syndrome, sacroiliitis, spinal disorder, spinal osteoarthritis, spinal pain, spinal stenosis, spondylolisthesis, synovial cyst, tendonitis, tenosynovitis, tenosynovitis stenosis, or trigger finger.

[0430] Embodiment 283: The use of embodiment 267, wherein the neoplasm benign, malignant, or unspecified is adenocarcinoma metastatic, adrenal adenoma, anogenital warts, benign esophageal neoplasm, colorectal adenoma, hemangioma of liver, invasive ductal breast carcinoma, esophageal carcinoma, prostatic adenoma, or uterine leiomyoma.

[0431] Embodiment 284: The use of embodiment 267, wherein the nervous system disorder is anosmia, bradykinesia, carpal tunnel syndrome, cervicobrachial syndrome, diabetic neuropathy, dizziness, encephalopathy, headache, hypoesthesia, lumbar radiculopathy, lumbosacral radiculopathy, metabolic encephalopathy, migraine, myotonia, neuralgia, neuritis, Parkinson's disease, restless legs syndrome, retinal migraine, sciatica, sensory loss, spinal cord hematoma, subarachnoid hemorrhage, syncope, or tension headache.51Attorney Docket No.24-1507-WO

[0432] Embodiment 285: The use of embodiment 267, wherein the psychiatric disorder is adjustment disorder, affective disorder, anxiety, depression, insomnia, irritability, mixed anxiety and depressive disorder, sleep disorder, or stress.

[0433] Embodiment 286: The use of embodiment 267, wherein the renal or urinary disorder is acute kidney injury, calculus urinary, chronic kidney disease, cystitis hemorrhagic, cystitis noninfective, end stage renal disease, glomerulonephritis chronic, hematuria, hypertonic bladder, nephrolithiasis, nephrosclerosis, pollakiuria, proteinuria, renal colic, renal cyst, stress urinary incontinence, ureterolithiasis, or urinary tract inflammation.

[0434] Embodiment 287: The use of embodiment 267, wherein the reproductive system or breast disorder is abnormal uterine bleeding, adenomyosis, Bartholin's cyst, erectile dysfunction, hydrocele female, intermenstrual bleeding, menstruation irregular, prostatitis, prostatomegaly, uterine hemorrhage, or vaginal discharge.

[0435] Embodiment 288: The use of embodiment 267, wherein the respiratory, thoracic, or mediastinal disorder is bronchitis chronic, cough, dysphonia, interstitial lunch disease, nasal congestion, oropharyngeal pain, respiratory failure, rhinorrhea, sinus congestion, sleep apnea syndrome, or upper respiratory tract inflammation.

[0436] Embodiment 289: The use of embodiment 267, wherein the skin or subcutaneous tissue disorder is alopecia, angioedema, dermatitis allergic, dermatitis contact, dermatitis psoriasiform, ecchymosis, erythema, hidradenitis, pruritis, psoriasis, rash, skin exfoliation, or skin ulcer.

[0437] Embodiment 290: The use of embodiment 267, wherein the surgical or medical procedure is gastric bypass.

[0438] Embodiment 291: The use of embodiment 267, wherein the vascular disorder is aortic arteriosclerosis, aortic dissection, arteriosclerosis, bleeding varicose vein, blood pressure fluctuation, deep vein thrombosis, diabetic microangiopathy, essential hypertension, hypertension, hypertensive crisis, lymph stasis, peripheral venous disease, phlebitis, or thrombophlebitis.

[0439] Embodiment 292: A pharmaceutical composition comprising an anti-IL-23p19 antibody hum13B8-b for use in the treatment of psoriatic arthritis in a patient in need thereof, wherein the anti-IL-23p19 antibody hum13B8-b comprises: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.

[0440] Embodiment 293: The pharmaceutical composition of embodiment 292, wherein the pharmaceutical composition is administered in a treatment phase and an extension phase.52Attorney Docket No.24-1507-WO

[0441] Embodiment 294: The pharmaceutical composition of embodiment 293, wherein the pharmaceutical composition is administered to the patient for up to about 52 weeks during the treatment phase.

[0442] Embodiment 295: The pharmaceutical composition of embodiment 293, wherein the pharmaceutical composition is administered to the patient at week 0, at about week 4, and about every 12 weeks thereafter during the treatment phase.

[0443] Embodiment 296: The pharmaceutical composition of embodiment 293, wherein the pharmaceutical composition is administered to the patient at week 0, at about week 4, and about every 4 weeks thereafter during the treatment phase.

[0444] Embodiment 297: The pharmaceutical composition of embodiment 293, wherein a therapeutically effective amount of the pharmaceutical composition is administered to the patient during the treatment phase.

[0445] Embodiment 298: The pharmaceutical composition of embodiment 293, wherein a dose of the pharmaceutical composition comprising about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the treatment phase.

[0446] Embodiment 299: The pharmaceutical composition of embodiment 298, wherein the dose of the pharmaceutical composition comprises about 100 mg of hum13B8-b.

[0447] Embodiment 300: The pharmaceutical composition of embodiment 298, wherein the dose of the pharmaceutical composition comprises about 200 mg of hum13B8-b.

[0448] Embodiment 301: The pharmaceutical composition of embodiment 297, wherein the pharmaceutical composition is administered to the patient subcutaneously.

[0449] Embodiment 302: The pharmaceutical composition of embodiment 297, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection.

[0450] Embodiment 303: The pharmaceutical composition of embodiment 297, wherein the pharmaceutical composition is administered to the patient using an auto-injector or prefilled syringe.

[0451] Embodiment 304: The pharmaceutical composition of embodiment 297, wherein a dose of the pharmaceutical composition comprising about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the treatment phase.

[0452] Embodiment 305: The pharmaceutical composition of embodiment 304, wherein the dose of the pharmaceutical composition comprises about 100 mg of hum13B8-b.

[0453] Embodiment 306: The pharmaceutical composition of embodiment 304, wherein the dose of the pharmaceutical composition comprises about 200 mg of hum13B8-b.53Attorney Docket No.24-1507-WO

[0454] Embodiment 307: The pharmaceutical composition of embodiment 297, wherein a first dose of the pharmaceutical composition is administered to the patient on week 0, a second dose of the pharmaceutical composition is administered to the patient at about week 4, and subsequent doses of the pharmaceutical composition are administered to the patient at about every 12 weeks thereafter during the treatment phase.

[0455] Embodiment 308: The pharmaceutical composition of embodiment 307, wherein the first dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and subsequent doses of the pharmaceutical composition are the same.

[0456] Embodiment 309: The pharmaceutical composition of embodiment 307, wherein the first dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and subsequent doses of the pharmaceutical composition are different.

[0457] Embodiment 310: The pharmaceutical composition of embodiment 308, wherein the first dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and subsequent doses of the pharmaceutical composition comprise about 100 mg of hum13B8-b.

[0458] Embodiment 311: The pharmaceutical composition of embodiment 308, wherein the first dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and subsequent doses of the pharmaceutical composition comprise about 200 mg of hum13B8-b.

[0459] Embodiment 312: The pharmaceutical composition of embodiment 307, wherein the first dose of the pharmaceutical composition comprises about 100 mg of hum13B8-b.

[0460] Embodiment 313: The pharmaceutical composition of embodiment 307, wherein the second dose of the pharmaceutical composition comprises about 100 mg of hum13B8-b.

[0461] Embodiment 314: The pharmaceutical composition of embodiment 307, wherein the subsequent doses of the pharmaceutical composition comprise about 100 mg of hum13B8-b.

[0462] Embodiment 315: The pharmaceutical composition of embodiment 307, wherein the first dose of the pharmaceutical composition comprises about 200 mg of hum13B8-b.

[0463] Embodiment 316: The pharmaceutical composition of embodiment 307, wherein the second dose of the pharmaceutical composition comprises about 200 mg of hum13B8-b.

[0464] Embodiment 317: The pharmaceutical composition of embodiment 307, wherein the subsequent doses of the pharmaceutical composition comprise about 200 mg of hum13B8-b.54Attorney Docket No.24-1507-WO

[0465] Embodiment 318: The pharmaceutical composition of embodiment 309, wherein the first dose of the pharmaceutical composition comprises about 100 mg of hum13B8-b, and the amount of hum13B8-b administered in the second dose of the pharmaceutical composition and subsequent doses of the pharmaceutical composition is different from the first dose.

[0466] Embodiment 319: The pharmaceutical composition of embodiment 309, wherein the first dose of the pharmaceutical composition comprises about 200 mg of hum13B8-b, and the amount of hum13B8-b administered in the second dose of the pharmaceutical composition and subsequent doses of the pharmaceutical composition is different from the first dose.

[0467] Embodiment 320: The pharmaceutical composition of embodiment 293, wherein the pharmaceutical composition is administered to the patient for up to about 208 weeks during the extension phase.

[0468] Embodiment 321: The pharmaceutical composition of embodiment 293, wherein the pharmaceutical composition is administered to the patient during the extension phase at the same interval as the pharmaceutical composition is administered to the patient during the treatment phase.

[0469] Embodiment 322: The pharmaceutical composition of embodiment 321, wherein a dose of the pharmaceutical composition comprising about 100 mg or about 200 mg of hum13B8-b is administered to the patient about every four weeks (Q4W) during the extension phase.

[0470] Embodiment 323: The pharmaceutical composition of embodiment 322, wherein a dose of the pharmaceutical composition is administered to the patient for at least up to about 4 weeks, for at least up to about 8 weeks, for at least up to about 12 weeks, for at least up to about 16 weeks, for at least up to about 20 weeks, for at least up to about 24 weeks, for at least up to about 28 weeks, for at least up to about 32 weeks, for at least up to about 36 weeks, for at least up to about 40 weeks, for at least up to about 44 weeks, for at least up to about 48 weeks, for at least up to about 52 weeks, for at least up to about 56 weeks, for at least up to about 60 weeks, for at least up to about 64 weeks, for at least up to about 68 weeks, for at least up to about 72 weeks, for at least up to about 76 weeks, for at least up to about 80 weeks, for at least up to about 84 weeks, for at least up to about 88 weeks, for at least up to about 92 weeks, for at least up to about 96 weeks, for at least up to about 100 weeks, for at least up to about 104 weeks, for at least up to about 108 weeks, for at least up to about 112 weeks, for at least up to about 116 weeks, for at least up to about 120 weeks, for at55Attorney Docket No.24-1507-WOleast up to about 124 weeks, for at least up to about 128 weeks, for at least up to about 132 weeks, for at least up to about 136 weeks, for at least up to about 140 weeks, for at least up to about 144 weeks, for at least up to about 148 weeks, for at least up to about 152 weeks, for at least up to about 156 weeks, for at least up to about 160 weeks, for at least up to about 164 weeks, for at least up to about 168 weeks, for at least up to about 172, for at least up to about 176 weeks, for at least up to about 180 weeks, for at least up to about 184 weeks, for at least up to about 188 weeks, for at least up to about 192 weeks, for at least up to about 196 weeks, for at least up to about 200 weeks, for at least up to about 204 weeks, or for at least up to about 208 weeks.

[0471] Embodiment 324: The pharmaceutical composition of embodiment 322, wherein a dose of the pharmaceutical composition comprising about 100 mg or about 200 mg of hum13B8-b is administered to the patient about every twelve weeks (Q12W) during the extension phase.

[0472] Embodiment 325: The pharmaceutical composition of embodiment 324, wherein a dose of the pharmaceutical composition is administered to the patient for at least up to about 12 weeks, for at least up to about 24weeks, for at least up to about 36 weeks, for at least up to about 48 weeks, for at least up to about 60 weeks, for at least up to about 72 weeks, for at least up to about 84 weeks, for at least up to about 96 weeks, for at least up to about 108 weeks, for at least up to about 120 weeks, for at least up to about 132 weeks, for at least up to about 144 weeks, for at least up to about 156 weeks, for at least up to about 168 weeks, for at least up to about 180 weeks, for at least up to about 192 weeks, for at least up to about 204 weeks, or for at least up to about 216 weeks.

[0473] Embodiment 326: The pharmaceutical composition of embodiment 325, wherein the pharmaceutical composition is administered to the patient during the extension phase at different time intervals than the time intervals the pharmaceutical composition is administered to the patient during the treatment phase.

[0474] Embodiment 327: The pharmaceutical composition of embodiment 326, wherein the pharmaceutical composition is administered to the patient Q4W during the treatment phase and the pharmaceutical composition is administered to the patient Q12W during the extension phase.

[0475] Embodiment 328: The pharmaceutical composition of embodiment 293, wherein a therapeutically effective amount of the pharmaceutical composition is administered to the patient during the extension phase.56Attorney Docket No.24-1507-WO

[0476] Embodiment 329: The pharmaceutical composition of embodiment 328, wherein a dose of the pharmaceutical composition comprising about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the extension phase.

[0477] Embodiment 330: The pharmaceutical composition of embodiment 329, wherein the dose of the pharmaceutical composition comprises about 100 mg of hum13B8-b.

[0478] Embodiment 331: The pharmaceutical composition of embodiment 329, wherein the dose of the pharmaceutical composition comprises about 200 mg of hum13B8-b.

[0479] Embodiment 332: The pharmaceutical composition of embodiment 293, wherein the dose of the pharmaceutical composition administered to the patient during the extension phase is different than the dose of the pharmaceutical composition administered to the patient during the treatment phase.

[0480] Embodiment 333: The pharmaceutical composition of embodiment 332, wherein a dose of the pharmaceutical composition comprising about 200 mg of hum13B8-b is administered to the patient during the treatment phase and a dose of the pharmaceutical composition comprising about 100 mg of hum13B8-b is administered to the patient during the extension phase.

[0481] Embodiment 334: The pharmaceutical composition of embodiment 332, wherein a dose of the pharmaceutical composition comprising about 200 mg hum13B8-b is administered to the patient Q4W during the treatment phase and a dose of the pharmaceutical composition comprising about 100 mg hum13B8-b is administered to the patient Q12W during the extension phase.

[0482] Embodiment 335: The pharmaceutical composition of embodiment 293, wherein the dose of the pharmaceutical composition administered to the patient during the treatment phase and the dose of the pharmaceutical composition administered to the patient during the extension phase are the same.

[0483] Embodiment 336: The pharmaceutical composition of embodiment 335, wherein a dose of the pharmaceutical composition comprising about 100 mg hum13B8-b is administered to the patient during the treatment phase and a dose of the pharmaceutical composition comprising about 100 mg hum13B8-b is administered to the patient during the extension phase.

[0484] Embodiment 337: The pharmaceutical composition of embodiment 335, wherein a dose of the pharmaceutical composition comprising about 200 mg of hum13B8-b is administered to the patient during the treatment phase and a dose of the pharmaceutical57Attorney Docket No.24-1507-WOcomposition comprising about 200 mg of hum13B8-b is administered to the patient during the extension phase.

[0485] Embodiment 338: The pharmaceutical composition of any one of embodiments 292-337, wherein the pharmaceutical composition is administered to the patient for up to about 52 weeks during the treatment phase and the pharmaceutical composition is administered to the patient for an additional up to about 208 weeks during the extension phase, and wherein a dose of the pharmaceutical composition comprising about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the extension phase.

[0486] Embodiment 339: The pharmaceutical composition of any one of embodiments 330-338, wherein the pharmaceutical composition is administered to the patient subcutaneously during the extension phase.

[0487] Embodiment 340: The pharmaceutical composition of embodiment 339, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection.

[0488] Embodiment 341: The pharmaceutical composition of embodiment 339, wherein the pharmaceutical composition is administered to the patient using an auto-injector or prefilled syringe.

[0489] Embodiment 342: The pharmaceutical composition of any one of embodiments 320-330, 332-336, or 338-341, wherein administration of one or more doses of the pharmaceutical composition comprising about 100 mg of hum13B8-b during the extension phase results in minimal or no serious adverse events (SAEs) in the patient.

[0490] Embodiment 343: The pharmaceutical composition of any one of embodiments 320-329, 331, 332, 335, or 337-342, wherein administration of one or more doses of the pharmaceutical composition comprising about 200 mg of hum13B8-b during the extension phase results in minimal or no serious adverse events (SAEs) in the patient.

[0491] Embodiment 344: The pharmaceutical composition of either embodiment 342 or embodiment 343, wherein the SAEs include blood and lymphatic disorders, cardiac disorders, gastrointestinal disorders, general disorders, hepatobiliary disorders, infections and infestations, injury, poisoning and procedural complications, investigations, metabolism and nutrition disorders, musculoskeletal and connective tissue disorders, neoplasms, nervous system disorders, renal and urinary disorders, reproductive system and breast disorders, respiratory, thoracic and mediastinal disorders, surgical and medical procedures, and vascular disorders.

[0492] Embodiment 345: The pharmaceutical composition of embodiment 344, wherein the blood or lymphatic disorder is anemia.58Attorney Docket No.24-1507-WO

[0493] Embodiment 346: The pharmaceutical composition of embodiment 344, wherein the cardiac disorder is acute myocardial infarction, cardiac failure, coronary artery stenosis, or tachycardia.

[0494] Embodiment 347: The pharmaceutical composition of embodiment 344, wherein the gastrointestinal disorder is abdominal hernia, hemorrhagic erosive gastritis, or intestinal obstruction.

[0495] Embodiment 348: The pharmaceutical composition of embodiment 344, wherein the general disorder is generalized oedema.

[0496] Embodiment 349: The pharmaceutical composition of embodiment 344, wherein the hepatobiliary disorder is cholelithiasis.

[0497] Embodiment 350: The pharmaceutical composition of embodiment 344, wherein the infection or infestation is abdominal abscess, COVID-19 pneumonia, gallbladder empyema, intestinal sepsis, septic shock, or upper respiratory tract infection.

[0498] Embodiment 351: The pharmaceutical composition of embodiment 344, wherein the injury, poisoning, or procedural complication is craniocerebral injury, hip fracture, humerus fracture, ligament rupture, subdural hematoma, or tibia fracture.

[0499] Embodiment 352: The pharmaceutical composition of embodiment 344, wherein the investigation is a kidney biopsy.

[0500] Embodiment 353: The pharmaceutical composition of embodiment 344, wherein the metabolism or nutrition disorder is diabetes mellitus.

[0501] Embodiment 354: The pharmaceutical composition of embodiment 344, wherein the musculoskeletal or connective tissue disorder is intervertebral disc disorder, lumbar spinal stenosis, osteoarthritis, or rhabdomyolysis.

[0502] Embodiment 355: The pharmaceutical composition of embodiment 344, wherein the neoplasm is adenocarcinoma metastatic, colorectal adenoma, invasive ductal breast carcinoma, esophageal carcinoma, or uterine leiomyoma.

[0503] Embodiment 356: The pharmaceutical composition of embodiment 344, wherein the nervous system disorder is dizziness, metabolic encephalopathy, retinal migraine, subarachnoid hemorrhage, or tension headache.

[0504] Embodiment 357: The pharmaceutical composition of embodiment 344, wherein the renal or urinary disorder is acute kidney injury, calculus urinary, end stage renal disease, or ureterolithiasis.

[0505] Embodiment 358: The pharmaceutical composition of embodiment 344, wherein the reproductive system or breast disorder is hydrocele female or uterine hemorrhage.59Attorney Docket No.24-1507-WO

[0506] Embodiment 359: The pharmaceutical composition of embodiment 344, wherein the respiratory, thoracic, or mediastinal disorder is bronchitis chronic or interstitial lung disease.

[0507] Embodiment 360: The pharmaceutical composition of embodiment 344, wherein the surgical or medical procedure is gastric bypass.

[0508] Embodiment 361: The pharmaceutical composition of embodiment 344, wherein the vascular disorder is aortic dissection, arteriosclerosis, deep vein thrombosis, hypertension, or hypertensive crisis.

[0509] Embodiment 362: The pharmaceutical composition of any one of embodiments 320-330, 332-336, or 338-341, wherein administration of a dose of the pharmaceutical composition comprising about 100 mg of hum13B8-b during the extension phase results in minimal or no other adverse events (OAEs) in the patient.

[0510] Embodiment 363: The pharmaceutical composition of any one of embodiments 320-329, 331, 332, 335, or 337-342, wherein administration of a dose of the pharmaceutical composition comprising about 200 mg of hum13B8-b during the extension phase results in minimal or no other adverse events (OAEs) in the patient.

[0511] Embodiment 364: The pharmaceutical composition of either embodiment 362 or embodiment 363, wherein the OAEs include one or more of blood or lymphatic system disorders, cardiac disorders, congenital, familial, or genetic disorders, ear or labyrinth disorders, endocrine disorders, eye disorders, gastrointestinal disorders, general disorders, hepatobiliary disorders, immune system disorders, infections or infestations, injuries, poisoning or procedural complications, investigations, metabolism or nutrition disorders, musculoskeletal or connective tissue disorders, neoplasms benign, malignant, or unspecified, nervous system disorders, psychiatric disorders, renal or urinary disorders, reproductive system or breast disorders, respiratory, thoracic, or mediastinal disorders, skin or subcutaneous tissue disorders, surgical or medical procedures, or vascular disorders.

[0512] Embodiment 365: The pharmaceutical composition of embodiment 364, wherein the blood or lymphatic system disorder is anemia, leukocytosis, leukopenia, lymphadenopathy, lymphopenia, neutropenia, or neutrophilia.

[0513] Embodiment 366: The pharmaceutical composition of embodiment 364, wherein the cardiac disorder is acute myocardial infarction, atrial fibrillation, atrioventricular block first degree, cardiac failure, cardiac failure congestive, coronary artery stenosis, diastolic dysfunction, mitral valve incompetence, myocardial ischemia, palpitations, pericardial cyst, sinus tachycardia, tachycardia, or tricuspid valve incompetence.60Attorney Docket No.24-1507-WO

[0514] Embodiment 367: The pharmaceutical composition of embodiment 364, wherein the congenital, familial, or genetic disorder is accessory spleen, Gilbert's syndrome, or hydrocele.

[0515] Embodiment 368: The pharmaceutical composition of embodiment 364, wherein the ear or labyrinth disorder is ear pain or vertigo.

[0516] Embodiment 369: The pharmaceutical composition of embodiment 364, wherein the endocrine disorder is autoimmune thyroiditis, goiter, hypothyroidic goiter, hypothyroidism, or thyroid mass.

[0517] Embodiment 370: The pharmaceutical composition of embodiment 364, wherein the eye disorder is astigmatism, blepharitis, blindness transient, cataract, cataract nuclear, diabetic retinopathy, keratitis, myopia, retinal vascular disorder, or visual acuity reduced.

[0518] Embodiment 371: The pharmaceutical composition of embodiment 364, wherein the gastrointestinal disorder is abdominal hernia, abdominal pain, abdominal pain upper, abdominal rigidity, anal fistula, aphthous ulcer, Barrett's esophagus, chronic gastritis, coeliac artery stenosis, constipation, dental caries, diaphragmatic hernia, diarrhea, diverticulum, diverticulum intestinal, duodenitis, dyspepsia, enteritis, food poisoning, gastric ulcer, gastritis, gastritis erosive, gastrointestinal disorder, gastroesophageal reflux disease, gingival swelling, hemorrhagic erosive gastritis, hemorrhoids, hiatus hernia, intestinal metaplasia, intestinal obstruction, irritable bowel syndrome, large intestine polyp, nausea, pancreatitis chronic, rectal polyp, retained deciduous tooth, toothache, or vomiting.

[0519] Embodiment 372: The pharmaceutical composition of embodiment 364, wherein the general disorder is asthenia, chest pain, chills, drug intolerance, fatigue, generalized oedema, influenza like illness, injection site erythema, injection site pain, injection site pruritus, injection site rash, injection site reaction, injury associated with device, oedema peripheral, pyrexia, vaccination site pain, or xerosis.

[0520] Embodiment 373: The pharmaceutical composition of embodiment 364, wherein the hepatobiliary disorder is biliary dyskinesia, cholecystitis, cholelithiasis, cholestasis, diabetic hepatopathy, gallbladder polyp, hepatic steatosis, hepatitis, hyperbilirubinemia, hypertransaminasaemia, non-alcoholic steatohepatitis, or steatohepatitis.

[0521] Embodiment 374: The pharmaceutical composition of embodiment 364, wherein the immune system disorder is an allergy to an arthropod bite or allergy to plants.

[0522] Embodiment 375: The pharmaceutical composition of embodiment 364, wherein the infection or infestation is abdominal abscess, acute sinusitis, adenovirus infection, bacteriuria, Bartholin's abscess, breast abscess, bronchitis, COVID-19, COVID-1961Attorney Docket No.24-1507-WOpneumonia, cellulitis, chronic sinusitis, conjunctivitis, coronavirus infection, cystitis, diverticulitis, erythema migraines, Escherichia infection, furuncle, gallbladder empyema, gastroenteritis, gastroenteritis viral, gastrointestinal bacterial overgrowth, gastrointestinal infection, gingivitis, helicobacter gastritis, helicobacter infection, Herpes simplex, Herpes zoster, Hordeolum, influenza, intestinal sepsis, joint abscess, laryngitis, localized infection, lower respiratory tract infection, nasopharyngitis, oral herpes, otitis externa, otitis media, periodontitis, pharyngitis, pharyngotonsillitis, pneumonia, pneumonia bacterial, pulmonary tuberculosis, pulpitis dental, purulent discharge, pyelonephritis, pyelonephritis acute, respiratory tract infection, respiratory tract infection viral, rhinitis, septic shock, sinusitis, skin infection, suspected COVID-19, tonsillitis, tooth infection, tracheitis, tracheobronchitis, upper respiratory tract infection, urinary tract infection, vaginal infection, viral infection, viral pharyngitis, viral upper respiratory tract infection, vulvovaginal mycotic infection, or wound infection.

[0523] Embodiment 376: The pharmaceutical composition of embodiment 364, wherein the injury, poisoning, or procedural complication is second degree burns, concussion, contusion, craniocerebral injury, cuboid syndrome, epicondylitis, fall, fibula fracture, foot fracture, hand fracture, hip fracture, humerus fracture, iliotibial band syndrome, immunization reaction, joint injury, ligament rupture, ligament sprain, limb injury, meniscus injury, muscle strain, nail avulsion, post vaccination syndrome, skin abrasion, skin laceration, soft tissue injury, spinal compression fracture, subdural hematoma, synovial rupture, tendon injury, thermal burn, tibia fracture, or tooth fracture.

[0524] Embodiment 377: The pharmaceutical composition of embodiment 364, wherein the investigation is alanine aminotransferase increased, apolipoprotein B increased, aspartate aminotransferase increased, bilirubin conjugated increased, bilirubin urine present, biopsy kidney, blood bilirubin increased, blood cholesterol increased, blood creatine phosphokinase increased, blood creatinine increased, blood glucose increased, blood pressure increased, blood triglycerides increased, blood urea increased, C-reactive protein increased, Gamma-glutamyl transferase increased, glomerular filtration rate decreased, hematocrit decreased, hemoglobin decreased, hepatic enzyme increased, low density lipoprotein increased, lymphocyte count decreased, monocyte count decreased, neutrophil count decreased, platelet count decreased, prostatic specific antigen increased, red blood cell count decreased, transaminases increased, urinary casts, weight decreased, weight increased, or white blood cell count decreased.62Attorney Docket No.24-1507-WO

[0525] Embodiment 378: The pharmaceutical composition of embodiment 364, wherein the metabolism or nutrition disorder is cholesterosis, copper deficiency, dehydration, diabetes mellitus, diabetes mellitus inadequate control, dyslipidemia, glucose tolerance impaired, hypercholesterolemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, hyperuricemia, hypokalemia, hypomagnesaemia, hyponatremia, impaired fasting glucose, insulin resistance, obesity, type 2 diabetes mellitus, or vitamin D deficiency.

[0526] Embodiment 379: The pharmaceutical composition of embodiment 364, wherein the musculoskeletal or connective tissue disorder is arthralgia, arthritis, back pain, bursitis, dactylitis, exostosis, fracture pain, greater trochanteric pain syndrome, intervertebral disc disorder, intervertebral disc displacement, intervertebral disc protrusion, jaw cyst, joint contracture, joint effusion, joint swelling, lumbar spinal stenosis, metatarsalgia, muscle spasms, musculoskeletal discomfort, musculoskeletal stiffness, myalgia, neck pain, osteoarthritis, osteochondrosis, osteoporosis, pain in extremity, periarthritis, periarticular disorder, plantar fasciitis, pseudoarthrosis, psoriatic arthropathy, rhabdomyolysis, rotator cuff syndrome, sacroiliitis, spinal disorder, spinal osteoarthritis, spinal pain, spinal stenosis, spondylolisthesis, synovial cyst, tendonitis, tenosynovitis, tenosynovitis stenosis, or trigger finger.

[0527] Embodiment 380: The pharmaceutical composition of embodiment 364, wherein the neoplasm benign, malignant, or unspecified is adenocarcinoma metastatic, adrenal adenoma, anogenital warts, benign esophageal neoplasm, colorectal adenoma, hemangioma of liver, invasive ductal breast carcinoma, esophageal carcinoma, prostatic adenoma, or uterine leiomyoma.

[0528] Embodiment 381: The pharmaceutical composition of embodiment 364, wherein the nervous system disorder is anosmia, bradykinesia, carpal tunnel syndrome, cervicobrachial syndrome, diabetic neuropathy, dizziness, encephalopathy, headache, hypoesthesia, lumbar radiculopathy, lumbosacral radiculopathy, metabolic encephalopathy, migraine, myotonia, neuralgia, neuritis, Parkinson's disease, restless legs syndrome, retinal migraine, sciatica, sensory loss, spinal cord hematoma, subarachnoid hemorrhage, syncope, or tension headache.

[0529] Embodiment 382: The pharmaceutical composition of embodiment 364, wherein the psychiatric disorder is adjustment disorder, affective disorder, anxiety, depression, insomnia, irritability, mixed anxiety and depressive disorder, sleep disorder, or stress.

[0530] Embodiment 383: The pharmaceutical composition of embodiment 364, wherein the renal or urinary disorder is acute kidney injury, calculus urinary, chronic kidney disease,63Attorney Docket No.24-1507-WOcystitis hemorrhagic, cystitis noninfective, end stage renal disease, glomerulonephritis chronic, hematuria, hypertonic bladder, nephrolithiasis, nephrosclerosis, pollakiuria, proteinuria, renal colic, renal cyst, stress urinary incontinence, ureterolithiasis, or urinary tract inflammation.

[0531] Embodiment 384: The pharmaceutical composition of embodiment 364, wherein the reproductive system or breast disorder is abnormal uterine bleeding, adenomyosis, Bartholin's cyst, erectile dysfunction, hydrocele female, intermenstrual bleeding, menstruation irregular, prostatitis, prostatomegaly, uterine hemorrhage, or vaginal discharge.

[0532] Embodiment 385: The pharmaceutical composition of embodiment 364, wherein the respiratory, thoracic, or mediastinal disorder is bronchitis chronic, cough, dysphonia, interstitial lunch disease, nasal congestion, oropharyngeal pain, respiratory failure, rhinorrhea, sinus congestion, sleep apnea syndrome, or upper respiratory tract inflammation.

[0533] Embodiment 386: The pharmaceutical composition of embodiment 364, wherein the skin or subcutaneous tissue disorder is alopecia, angioedema, dermatitis allergic, dermatitis contact, dermatitis psoriasiform, ecchymosis, erythema, hidradenitis, pruritis, psoriasis, rash, skin exfoliation, or skin ulcer.

[0534] Embodiment 387: The pharmaceutical composition of embodiment 364, wherein the surgical or medical procedure is gastric bypass.

[0535] Embodiment 388: The pharmaceutical composition of embodiment 364, wherein the vascular disorder is aortic arteriosclerosis, aortic dissection, arteriosclerosis, bleeding varicose vein, blood pressure fluctuation, deep vein thrombosis, diabetic microangiopathy, essential hypertension, hypertension, hypertensive crisis, lymph stasis, peripheral venous disease, phlebitis, or thrombophlebitis.EXAMPLESExample 1: Serious Adverse Events for Subjects Receiving 200 mg Q4W, 200 mg Q12W, and 100 mg Q12WTable 1. Overall Serious Adverse EventsSerious adverse events (SAE) Tildrakizumab Tildrakizumab Tildrakizumab 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Total subjects affected by SAE-subjects affected / exposed 3 / 5 (60.00%) 2 / 22 (9.09%) 7 / 49 (14.29%) -number of deaths (all causes) 0 1 0 -number of deaths resultingfrom adverse events64Attorney Docket No.24-1507-WOTable 2. Neoplasms (Benign, Malignant, and Unspecified), Including Cysts and Polyps Serious adverse events Tildrakizumab Tildrakizumab Tildrakizumab 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Adenocarcinoma metastaticSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Colorectal adenomaSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Invasive ductal breast carcinomaSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Oesophageal carcinomaSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Uterine leiomyomaSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%)Table 3. Vascular DisordersSerious adverse events Tildrakizumab Tildrakizumab Tildrakizumab 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Aortic dissectionsubjects affected / exposed 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) Occurrences causally related to 0 / 0 0 / 1 0 / 0 treatment / allDeaths causally related to 0 / 0 0 / 1 0 / 0 treatment / allArteriosclerosisSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) Occurrences causally related to 0 / 0 0 / 0 0 / 1 treatment / allDeaths causally related to 0 / 0 0 / 0 0 / 0 treatment / allDeep vein thrombosisSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) HypertensionSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Hypertensive crisisSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) Occurrences causally related to 0 / 0 0 / 0 0 / 1 treatment / allDeaths causally related to 0 / 0 0 / 0 0 / 0 treatment / allTable 4. Surgical and Medical ProceduresSerious adverse events Tildrakizumab Tildrakizumab Tildrakizumab 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Gastric bypasssubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposed65Attorney Docket No.24-1507-WOTable 5. General Disorders and Administration Site ConditionsSerious adverse events Tildrakizumab Tildrakizumab Tildrakizumab 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Generalized Oedemasubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Table 6. Reproductive System and Breast DisordersSerious adverse events Tildrakizumab Tildrakizumab Tildrakizumab 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Hydrocele femalesubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Uterine hemorrhagesubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Table 7. Respiratory, Thoracic, and Mediastinal DisordersSerious adverse events Tildrakizumab Tildrakizumab Tildrakizumab 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Bronchitis chronicsubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedInterstitial lung diseaseSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) Occurrences causally related to 0 / 0 0 / 0 0 / 1 treatment / allDeaths causally related to 0 / 0 0 / 0 0 / 0 treatment / allTable 8. InvestigationsSerious adverse events Tildrakizumab Tildrakizumab Tildrakizumab 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Biopsy kidneysubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Table 9. Injury, Poisoning and Procedural ComplicationsSerious adverse events Tildrakizumab Tildrakizumab Tildrakizumab 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Craniocerebral injurysubjects affected / exposed 1 / 5 (20.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Occurrences causally related to 0 / 1 0 / 0 0 / 0 treatment / allDeaths causally related to 0 / 0 0 / 0 0 / 0 treatment / allHip fractureSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Humerus fractureSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Ligament ruptureSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Subdural hematoma66Attorney Docket No.24-1507-WOSubjects affected / exposed 1 / 5 (20.00%) 0 / 22 (0.00%) 1 / 49 (0.00%) Occurrences causally related to 0 / 1 0 / 0 0 / 0 treatment / allDeaths causally related to 0 / 0 0 / 0 0 / 0 treatment / allTibia fractureSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Table 10. Cardiac DisordersSerious adverse events Tildrakizumab Tildrakizumab Tildrakizumab 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Acute myocardial infarctionsubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Cardiac failureSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Coronary artery stenosisSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) Occurrences causally related to 0 / 0 0 / 0 0 / 1 treatment / allDeaths causally related to 0 / 0 0 / 0 0 / 0 treatment / allTachycardiaSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Table 11. Nervous System DisordersSerious adverse events Tildrakizumab Tildrakizumab Tildrakizumab 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Dizzinesssubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Metabolic encephalopathySubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) Occurrences causally related to 0 / 0 0 / 0 0 / 2 treatment / allDeaths causally related to 0 / 0 0 / 0 0 / 0 treatment / allRetinal MigraineSubjects affected / exposed 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) Occurrences causally related to 0 / 0 0 / 1 0 / 0 treatment / allDeaths causally related to 0 / 0 0 / 0 0 / 0 treatment / allSubarachnoid hemorrhageSubjects affected / exposed 1 / 5 (20.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Occurrences causally related to 0 / 1 0 / 0 0 / 0 treatment / allDeaths causally related to 0 / 0 0 / 0 0 / 0 treatment / allTension headacheSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%)67Attorney Docket No.24-1507-WOTable 12. Blood and Lymphatic System DisordersSerious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W AnemiaSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) Occurrences causally related to 0 / 0 0 / 0 0 / 1 treatment / allDeaths causally related to 0 / 0 0 / 0 0 / 0 treatment / allTable 13. Gastrointestinal DisordersSerious adverse events Tildrakizumab Tildrakizumab Tildrakizumab 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Abdominal herniasubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Hemorrhagic erosive gastritisSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Intestinal obstructionSubjects affected / exposed 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) Table 14. Hepatobiliary DisordersSerious adverse events Tildrakizumab Tildrakizumab Tildrakizumab200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Cholelithiasissubjects affected 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) / exposedTable 15. Renal and Urinary DisordersSerious adverse events Tildrakizumab Tildrakizumab Tildrakizumab 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Acute kidney injurySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences causally 0 / 0 0 / 0 0 / 2related to treatment / allDeaths causally related 0 / 0 0 / 0 0 / 0to treatment / allCalculus urinarySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedEnd stage renal diseaseSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedUreterolithiasisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposed68Attorney Docket No.24-1507-WOTable 16. Musculoskeletal and Connective Tissue DisordersSerious adverse events Tildrakizumab Tildrakizumab Tildrakizumab 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Intervertebral discdisordersubjects affected 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) / exposedLumbar spinal stenosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences causally 0 / 0 0 / 0 0 / 1 related to treatment / allDeaths causally related 0 / 0 0 / 0 0 / 0 to treatment / allOsteoarthritisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 2 / 49 (4.08%) affected / exposedOccurrences causally 0 / 0 0 / 0 0 / 2 related to treatment / allDeaths causally related 0 / 0 0 / 0 0 / 0 to treatment / allRhabdomyolysisSubjects 0 / 5 (20.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedOccurrences causally 0 / 0 0 / 0 0 / 0 related to treatment / allDeaths causally related 0 / 0 0 / 0 0 / 0 to treatment / allTable 17. Infections and InfestationsSerious adverse events Tildrakizumab Tildrakizumab Tildrakizumab 200 mg, Q4W 200 mg, Q12Ws 100 mg, Q12W Abdominal abscesssubjects affected 1 / 5 (20.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) / exposedOccurrences causally 1 / 1 0 / 0 0 / 0 related to treatment / allDeaths causally related 0 / 0 0 / 0 0 / 0 to treatment / allCOVID-19 pneumoniaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedGallbladder empyemaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedIntestinal sepsisSubjects 0 / 5 (20.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposed69Attorney Docket No.24-1507-WOOccurrences causally 0 / 0 0 / 0 1 / 2 related to treatment / allDeaths causally related 0 / 0 0 / 0 0 / 0 to treatment / allSeptic shockSubjects 0 / 5 (20.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences causally 0 / 0 0 / 0 1 / 1 related to treatment / allDeaths causally related 0 / 0 0 / 0 0 / 0 to treatment / allUpper respiratory tract infectionSubjects 0 / 5 (20.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences causally 0 / 0 0 / 0 0 / 1related to treatment / allDeaths causally related 0 / 0 0 / 0 0 / 0to treatment / allTable 18. Metabolism and Nutrition DisordersSerious adverse events Tildrakizumab Tildrakizumab Tildrakizumab 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Diabetes mellitusSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences causally 0 / 0 0 / 0 0 / 1 related to treatment / allDeaths causally related 0 / 0 0 / 0 0 / 0 to treatment / allExample 2: Serious Adverse Events for Subjects Initially Receiving 200 mg Q4W to 100 mg Q12W or 200 mg Q12W to 100 mg Q12WTable 19. Overall Serious EventsSerious adverse events Tildra 200 mg, Q4Wswitched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W Total subjects affected by serious adverse eventsSubjects 3 / 54 (5.56%) 25 / 151 (16.56%) affected / exposedNumber of deaths 0 1(all causes)Table 20. Neoplasms (Benign, Malignant, and Unspecified), Including Cysts and Polyps Serious adverse events Tildra 200 mg, Q4W switched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W Adenocarcinoma metastatic70Attorney Docket No.24-1507-WOSubjects 0 / 54 (0.00%) 1 / 151 (0.66%) affected / exposedOccurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related 0 / 0 0 / 1to treatment / allColorectal adenomaSubjects 0 / 54 (0.00%) 1 / 151 (0.66%) affected / exposedOccurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related 0 / 0 0 / 0to treatment / allInvasive ductal breast carcinomaSubjects 0 / 54 (0.00%) 1 / 151 (0.66%) affected / exposedOccurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related 0 / 0 0 / 0to treatment / allOesophageal carcinomaSubjects 0 / 54 (0.00%) 0 / 151 (0.00%) affected / exposedUterine leiomyomaSubjects 1 / 54 (1.85%) 0 / 151 (0.00%) affected / exposedOccurrences causally 0 / 1 0 / 0related to treatment / allDeaths causally related 0 / 0 0 / 0to treatment / allTable 21. Vascular DisordersSerious adverse events Tildra 200 mg, Q4W switched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W Aortic dissectionSubjects 0 / 54 (0.00%) 0 / 151 (0.00%) affected / exposedArteriosclerosisSubjects 0 / 54 (0.00%) 0 / 151 (0.00%) affected / exposedDeep vein thrombosisSubjects 0 / 54 (0.00%) 2 / 151 (1.32%) affected / exposedOccurrences causally 0 / 0 0 / 2related to treatment / allDeaths causally related 0 / 0 0 / 0to treatment / allHypertension71Attorney Docket No.24-1507-WOSubjects 0 / 54 (0.00%) 2 / 151 (1.32%) affected / exposedOccurrences causally 0 / 0 0 / 2related to treatment / allDeaths causally related 0 / 0 0 / 0to treatment / allHypertensive crisisSubjects 0 / 54 (0.00%) 0 / 151 (0.00%) affected / exposedTable 22. Surgical and Medical ProceduresSerious adverse events Tildra 200 mg, Q4W switched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W Gastric bypassSubjects 0 / 54 (0.00%) 1 / 151 (0.66%) affected / exposedOccurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0treatment / allTable 23. General Disorders and AdministrationSerious adverse events Tildra 200 mg, Q4W switched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W Generalized OedemaSubjects 0 / 54 (0.00%) 1 / 151 (0.66%) affected / exposedOccurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allTable 24. Reproductive System and Breast DisordersSerious adverse events Tildra 200 mg, Q4W switched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W Hydrocele femaleSubjects 0 / 54 (0.00%) 1 / 151 (0.66%) affected / exposedOccurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allUterine hemorrhageSubjects 1 / 54 (1.85%) 0 / 151 (0.00%) affected / exposedOccurrences causally 0 / 1 0 / 0related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / all72Attorney Docket No.24-1507-WOTable 25. Respiratory, Thoracic, and Mediastinal DisordersSerious adverse events Tildra 200 mg, Q4W switched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W Bronchitis chronicSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences causally 0 / 1 0 / 0related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allInterstitial lung diseaseSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Table 26. InvestigationsSerious adverse events Tildra 200 mg, Q4W switched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W Biopsy kidneySubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allTable 27. Injury, Poisoning, and Procedural ComplicationsSerious adverse events Tildra 200 mg, Q4W switched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W Craniocerebral injurySubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Hip fractureSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allHumerus fractureSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allLigament ruptureSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allSubdural hematomaSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Tibia fracture73Attorney Docket No.24-1507-WOSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0treatment / allTable 28. Cardiac DisordersSerious adverse events Tildra 200 mg, Q4W switched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W Acute myocardialinfarctionSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences causally 0 / 0 0 / 2related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allCardiac failureSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allCoronary artery stenosisSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) TachycardiaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allTable 29. Nervous System DisordersSerious adverse events Tildra 200 mg, Q4W switched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W DizzinessSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allMetabolic encephalopathySubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Retinal migraineSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) SubarachnoidhemorrhageSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Tension headacheSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%)74Attorney Docket No.24-1507-WOOccurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allTable 30. Blood and Lymphatic System DisordersSerious adverse events Tildra 200 mg, Q4W switched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W AnemiaSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Table 31. Gastrointestinal DisordersSerious adverse events Tildra 200 mg, Q4W switched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W Abdominal herniaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allHemorrhagic erosive gastritisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allIntestinal obstructionSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allTable 32. Hepatobiliary DisordersSerious adverse events Tildra 200 mg, Q4W switched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W Abdominal herniaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allTable 33. Renal and Urinary DisordersSerious adverse events Tildra 200 mg, Q4W switched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W Acute kidney injurySubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Calculus urinary75Attorney Docket No.24-1507-WOSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allEnd stage renal diseaseSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allUreterolithiasisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allTable 34. Musculoskeletal and Connective Tissue DisordersSerious adverse events Tildra 200 mg, Q4W switched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W Intervertebral disc disorderSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allLumbar spinal stenosisSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) OsteoarthritisSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) RhabdomyolysisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allTable 35. Infections and InfestationsSerious adverse events Tildra 200 mg, Q4W switched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W Abdominal AbscessSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) COVID-19 pneumoniaSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences causally 0 / 0 0 / 2related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / all76Attorney Docket No.24-1507-WOGallbladder empyemaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences causally 0 / 0 0 / 1related to treatment / allDeaths causally related to 0 / 0 0 / 0 treatment / allIntestinal sepsisSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Septic shockSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Upper respiratory tract infectionSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Table 36. Metabolism and Nutrition DisordersSerious adverse events Tildra 200 mg, Q4W switched Tildra 200 mg, Q12W switched to Tildra 100 mg, Q12W to Tildra 100 mg, Q12W Diabetes mellitusSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%)Example 3: Non-Serious Adverse Events for Subjects Receiving 200 mg Q4W, 200 mg Q12W, or 100 mg Q12WTable 37. Overall Non-Serious Adverse EventsNon-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Total Subjects affected by non-serious adverse eventsSubjects affected / exposed 5 / 5 (100.00%) 14 / 22 (63.64%) 36 / 49 (73.47%) Table 38. Neoplasms (benign, malignant and unspecified), including cysts and polyps Non-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Adenocarcinoma metastaticSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedAdrenal adenomaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Anogenital wartsSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedBenign oesophageal neoplasmSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Colorectal adenomaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposed77Attorney Docket No.24-1507-WOHemangioma of liverSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedInvasive ductal breast carcinomaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedOesophageal carcinomaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Prostatic adenomaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedUterine leiomyomaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Table 39. Vascular DisordersNon-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Aortic arteriosclerosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedAortic dissectionSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 ArteriosclerosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Bleeding varicose veinSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedBlood pressure fluctuationSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedDeep vein thrombosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedDiabetic microangiopathySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Essential hypertensionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHypertension78Attorney Docket No.24-1507-WOSubjects 2 / 5 (40.00%) 0 / 22 (0.00%) 2 / 49 (4.08%) affected / exposedOccurrences (all) 3 0 2 Hypertensive crisisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 LymphostasisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPeripheral venous diseaseSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPhlebitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedThrombophlebitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTable 40. Surgical and Medical ProceduresNon-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Gastric bypassSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTable 41. General Disorders and Administration Site ConditionsNon-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W AstheniaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Chest painSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedChillsSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedDrug intoleranceSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedFatigueSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 1 1 Generalized oedema79Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedInfluenza like illnessSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 2 / 49 (4.08%) affected / exposedOccurrences (all) 0 0 2 Injection site erythemaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Injection site painSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Injection site pruritusSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Injection site rashSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedInjection site reactionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedInjury associated with deviceSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Oedema peripheralSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 PyrexiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 3 / 49 (6.12%) affected / exposedOccurrences (all) 0 0 3 Vaccination site painSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 XerosisSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 Table 42. Immune System DisordersNon-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Allergy to an arthropod bite80Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedAllergy to plantsSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTable 43. Reproductive System and Breast DisordersNon-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Abnormal uterine bleedingSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedAdenomyosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedBartholin's cystSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedErectile dysfunctionSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 Hydrocele femaleSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedIntermenstrualbleedingSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedMenstruation irregularSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedProstatitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedProstatomegalySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedUterine hemorrhageSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedVaginal dischargeSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTable 44. Respiratory, Thoracic, and Mediastinal DisordersNon-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Bronchitis chronic81Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedCoughSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 DysphoniaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedInterstitial lung diseaseSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Nasal congestionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedOropharyngeal painSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Respiratory failureSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedRhinorrheaSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 Sinus congestionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedSleep apnea syndromeSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedUpper respiratory tract inflammationSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedDermatitis allergicSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedDermatitis contactSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedDermatitis psoriasiformSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 182Attorney Docket No.24-1507-WOTable 45. Psychiatric DisordersNon-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W AdjustmentdisorderSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedAffective disorderSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedAnxietySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 2 / 49 (4.08%) affected / exposedOccurrences (all) 0 0 2 DepressionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedInsomniaSubjects 0 / 5 (0.00%) 2 / 22 (9.09%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 2 0 IrritabilitySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedMixed anxiety anddepressive disorderSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedSleep disorderSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedStressSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTable 46. InvestigationsNon-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Alanine aminotransferase increasedSubjects 1 / 5 (20.00%) 0 / 22 (0.00%) 2 / 49 (4.08%) affected / exposedOccurrences (all) 1 0 4 Apolipoprotein BincreasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedBilirubin urine presentSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposed83Attorney Docket No.24-1507-WOOccurrences (all) 0 1 0 Biopsy kidneySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedBlood bilirubin increasedSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 1 1 Blood cholesterol increasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedBlood creatine phosphokinase increasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 2 / 49 (4.08%) affected / exposedOccurrences (all) 0 0 3 Blood creatinine increasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Blood glucose increasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 2 / 49 (4.08%) affected / exposedOccurrences (all) 0 0 3 Blood pressure increasedSubjects 1 / 5 (20.00%) 0 / 22 (0.00%) 3 / 49 (6.12%) affected / exposedOccurrences (all) 1 0 3 Blood triglycerides increasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedBlood urea increasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedC-reactive protein increasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Gamma-glutamyltransferase increasedSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 1 1 Glomerular filtration rate decreasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHematocrit decreasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Hemoglobin decreased84Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 3 Hepatic enzyme increasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Low density lipoprotein increasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedLymphocyte count decreasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Monocyte count decreasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Neutrophil count decreasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPlatelet countdecreasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Prostatic specific antigen increasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedRed blood cell count decreasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 2 Transaminases increasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Urinary castsSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedWeight decreasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedWeight increasedSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 White blood cell count decreased85Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Table 47. Injury, Poisoning, and Procedural ComplicationsNon-serious Tildrakizumab Tildrakizumab Tildrakizumab adverse events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Burns second degreeSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 ConcussionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedContusionSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 1 1 Craniocerebral injurySubjects 1 / 5 (20.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 1 0 0 Cuboid syndromeSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedEpicondylitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 FallSubjects 0 / 5 (0.00%) 2 / 22 (9.09%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 2 1 Fibula fractureSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedFoot fractureSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHand fractureSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHip fractureSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHumerus fractureSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedIliotibial band syndrome86Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 Immunization reactionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedJoint injurySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedLigament ruptureSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedLigament sprainSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedLimb injurySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedMeniscus injurySubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 Muscle strainSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedNail avulsionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPost vaccinationsyndromeSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedSkin abrasionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedSkin lacerationSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 Soft tissue injurySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedSpinal compression fractureSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedSubdural hematomaSubjects 1 / 5 (20.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposed87Attorney Docket No.24-1507-WOOccurrences (all) 1 0 0 Synovial ruptureSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTendon injurySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedThermal burnSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTibia fractureSubjects 1 / 5 (20.00%) 0 / 5 (0.00%) 0 / 22 (0.00%) affected / exposedOccurrences (all) 1 0 0 Tooth fractureSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedAspartate aminotransferase increasedSubjects 1 / 5 (20.00%) 1 / 22 (4.55%) 2 / 49 (4.08%) affected / exposedOccurrences (all) 1 2 3 Bilirubin conjugated increasedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTable 48. Congenital, Familial and Genetic DisordersNon-serious Tildrakizumab Tildrakizumab Tildrakizumab adverse events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Accessory spleenSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedGilberts syndromeSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHydroceleSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTable 49. Cardiac DisordersNon-serious Tildrakizumab Tildrakizumab Tildrakizumab adverse events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Atrial fibrillationSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Atrioventricularblock first degreeSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposed88Attorney Docket No.24-1507-WOAcute myocardial infarctionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedCardiac failureSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedCardiac failure congestiveSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedCoronary artery stenosisSubjects 0 / 5 (00.00%) 0 / 22 (0.00%) 1 / 49 (2.04 %) affected / exposedOccurrences (all) 0 0 2 Diastolic dysfunctionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedMitral valve incompetenceSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedMyocardial ischemiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPalpitationsSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPericardial cystSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedSinus tachycardiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTachycardiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTricuspid valve incompetenceSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTable 50. Nervous System DisordersNon-serious Tildrakizumab Tildrakizumab Tildrakizumab adverse events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W AnosmiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedBradykinesiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedCarpal tunnel syndrome89Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedCervicobrachial syndromeSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedDiabetic neuropathySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 DizzinessSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedEncephalopathySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 HeadacheSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 3 / 49 (6.12%) affected / exposedOccurrences (all) 0 0 3 HypoaesthesiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedLumbarradiculopathySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedLumbosacral radiculopathySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedMetabolic encephalopathySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 2 MigraineSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 MyotoniaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedNeuralgiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedNeuritisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedParkinson's disease90Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedRestless legs syndromeSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 2 / 49 (4.08%) affected / exposedOccurrences (all) 0 0 2 SciaticaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Sensory lossSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedSpinal cord hematomaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedSubarachnoid hemorrhageSubjects 1 / 5 (20.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 1 0 0 SyncopeSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTension headacheSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedRetinal migraineSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 3 0 Table 51. Blood and Lymphatic System DisordersNon-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W AnaemiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 3 LeukocytosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedLeukopeniaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedLymphadenopathySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedLymphopenia91Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedNeutropeniaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 NeutrophiliaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTable 52. Ear and Labyrinth DisordersNon-serious Tildrakizumab Tildrakizumab Tildrakizumab adverse events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W NeutropeniaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedNeutropeniaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTable 53. Eye DisordersNon-serious Tildrakizumab Tildrakizumab Tildrakizumab adverse events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W AstigmatismSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedBlepharitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedBlindness transientSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 2 0 CataractSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Cataract nuclearSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedDiabetic retinopathySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 KeratitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedMyopia92Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedRetinal vascular disorderSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedVisual acuity reducedSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTable 54. Gastrointestinal DisordersNon-serious Tildrakizumab Tildrakizumab Tildrakizumab adverse events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Abdominal herniaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedAbdominal painSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 4 / 49 (8.16%) affected / exposedOccurrences (all) 0 0 4 Abdominal pain upperSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedAbdominal rigiditySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedAnal fistulaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedAphthous ulcerSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedBarrett's oesophagusSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Chronic gastritisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Coeliac artery stenosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 ConstipationSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedDental cariesSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 3 / 49 (6.12%) affected / exposed93Attorney Docket No.24-1507-WOOccurrences (all) 0 0 3 Diaphragmatic herniaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedDiarrhoeaSubjects 0 / 5 (0.00%) 4 / 22 (18.18%) 3 / 49 (6.12%) affected / exposedOccurrences (all) 0 6 5 DiverticulumSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedDiverticulum intestinalSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedDuodenitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedDyspepsiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedEnteritisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedFood poisoningSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedGastric ulcerSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedGastritisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Gastritis erosiveSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedGastrointestinal disorderSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Gastroesophageal reflux diseaseSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedGingival swellingSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHemorrhagic erosive gastritisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposed94Attorney Docket No.24-1507-WOHaemorrhoidsSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHiatus herniaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Intestinal metaplasiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Intestinal obstructionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedIrritable bowel syndromeSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedLarge intestine polypSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 2 / 49 (4.08%) affected / exposedOccurrences (all) 0 0 3 NauseaSubjects 1 / 5 (20.00%) 2 / 22 (9.09%) 2 / 49 (4.08%) affected / exposedOccurrences (all) 1 2 2 Pancreatitis chronicSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Rectal polypSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Retained deciduous toothSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedToothacheSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedVomitingSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 2 / 49 (4.08%) affected / exposedOccurrences (all) 0 0 2 Table 55. Hepatobiliary DisordersNon-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Biliary dyskinesia95Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedCholecystitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedCholelithiasisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 CholestasisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedDiabetichepatopathySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Gallbladder polypSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHepatic steatosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 HepatitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 HyperbilirubinaemiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 HypertransaminasaemiaSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 Non-alcoholic steatohepatitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 SteatohepatitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTable 56. Skin and Subcutaneous Tissue DisordersNon-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Alopecia96Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedAngioedemaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedEcchymosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 ErythemaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHidradenitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPruritusSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 PsoriasisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 2 RashSubjects 0 / 5 (0.00%) 2 / 22 (9.09%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 2 0 Skin exfoliationSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 Skin ulcerSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Table 57. Renal and Urinary DisordersNon-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Acute kidney injurySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 2 Calculus urinarySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Chronic kidney disease97Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedCystitis hemorrhagicSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedCystitis noninfectiveSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedEnd stage renal diseaseSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedGlomerulonephritis chronicSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHaematuriaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHypertonic bladderSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 NephrolithiasisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 NephrosclerosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPollakiuriaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedProteinuriaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedRenal colicSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedRenal cystSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedStress urinaryincontinenceSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedUreterolithiasisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedUrinary tract inflammation98Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedEcchymosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTable 58. Endocrine DisordersNon-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Autoimmune thyroiditisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 GoitreSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Hypothyroidic goiterSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHypothyroidismSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Thyroid massSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTable 59. Musculoskeletal and Connective Tissue DisordersNon-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W ArthralgiaSubjects 0 / 5 (0.00%) 3 / 22 (13.64%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 3 1 ArthritisSubjects 0 / 5 (0.00%) 2 / 22 (9.09%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 2 1 Back painSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 4 / 49 (8.16%) affected / exposedOccurrences (all) 0 0 5 BursitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedDactylitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposed99Attorney Docket No.24-1507-WOExostosisSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 Fracture painSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedGreater trochanteric pain syndromeSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 Intervertebral disc disorderSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedIntervertebral disc displacementSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedIntervertebral disc protrusionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedJaw cystSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedJoint contractureSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedJoint effusionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Joint swellingSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedLumbar spinal stenosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 2 MetatarsalgiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedMuscle spasmsSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 Musculoskeletal discomfortSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedMusculoskeletal stiffness100Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedMyalgiaSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 2 / 49 (4.08%) affected / exposedOccurrences (all) 0 1 2 Neck painSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 OsteoarthritisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 2 / 49 (4.08%) affected / exposedOccurrences (all) 0 0 3 OsteochondrosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedOsteoporosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPain in extremitySubjects 0 / 5 (0.00%) 2 / 22 (9.09%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 2 0 PeriarthritisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPeriarticular disorderSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPlantar fasciitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPseudarthrosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPsoriaticarthropathySubjects 0 / 5 (0.00%) 2 / 22 (9.09%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 3 2 RhabdomyolysisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedRotator cuff syndromeSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedSacroiliitis101Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 Spinal disorderSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedSpinal osteoarthritisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedSpinal painSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Spinal stenosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 SpondylolisthesisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedSynovial cystSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTendonitisSubjects 0 / 5 (0.00%) 2 / 22 (9.09%) 2 / 49 (4.08%) affected / exposedOccurrences (all) 0 2 2 TenosynovitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTenosynovitis stenosansSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTrigger fingerSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTable 60. Infections and InfestationsNon-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W Abdominal abscessSubjects 1 / 5 (20.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 1 0 0 Acute sinusitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedAdenovirus infection102Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedBacteriuriaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedBartholin's abscessSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedBreast abscessSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedBronchitisSubjects 0 / 5 (0.00%) 2 / 22 (9.09%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 2 1 COVID-19Subjects 0 / 5 (0.00%) 0 / 22 (0.00%) 3 / 49 (6.12%) affected / exposedOccurrences (all) 0 0 3 COVID-19 pneumoniaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedCellulitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedChronic sinusitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedConjunctivitisSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 Coronavirus infectionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 CystitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedDiverticulitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedErythema migransSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Escherichia infectionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposed103Attorney Docket No.24-1507-WOFuruncleSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedGallbladderempyemaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedGastroenteritisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedGastroenteritis viralSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedGastrointestinal bacterial overgrowthSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedGastrointestinal infectionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedGingivitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Helicobacter gastritisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHelicobacter infectionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHerpes simplexSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHerpes zosterSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHordeolumSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedInfluenzaSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 1 1 Intestinal sepsisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 2 Joint abscessSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposed104Attorney Docket No.24-1507-WOOccurrences (all) 0 0 1 LaryngitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedLocalised infectionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedLower respiratory tract infectionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedNasopharyngitisSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 7 / 49 (14.29%) affected / exposedOccurrences (all) 0 1 8 Oral herpesSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedOtitis externaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedOtitis mediaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPeriodontitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 PharyngitisSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 PharyngotonsillitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPneumoniaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPneumonia bacterialSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPulmonary tuberculosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPulpitis dentalSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPurulent dischargeSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposed105Attorney Docket No.24-1507-WOPyelonephritisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedPyelonephritis acuteSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedRespiratory tract infectionSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 Respiratory tract infection viralSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 3 / 49 (6.12%) affected / exposedOccurrences (all) 0 0 3 RhinitisSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 Septic shockSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 SinusitisSubjects 0 / 5 (0.00%) 2 / 22 (9.09%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 2 0 Skin infectionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedSuspected COVID-19Subjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTonsillitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTooth infectionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTracheitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTracheobronchitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedUpper respiratory tract infectionSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 7 / 49 (14.29%) affected / exposedOccurrences (all) 0 1 8 Urinary tract infection106Attorney Docket No.24-1507-WOSubjects 1 / 5 (20.00%) 1 / 22 (4.55%) 2 / 49 (4.08%) affected / exposedOccurrences (all) 1 3 3 Vaginal infectionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedViral infectionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedViral pharyngitisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedViral upper respiratory tract infectionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedVulvovaginal mycotic infectionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedWound infectionSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedTable 61. Metabolism and Nutrition DisordersNon-serious adverse Tildrakizumab Tildrakizumab Tildrakizumab events 200 mg, Q4W 200 mg, Q12W 100 mg, Q12W CholesterosisSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedCopper deficiencySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedDehydrationSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 2 / 49 (4.08%) affected / exposedOccurrences (all) 0 0 2 Diabetes mellitusSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 2 / 49 (4.08%) affected / exposedOccurrences (all) 0 0 2 Diabetes mellitus inadequate controlSubjects 0 / 5 (0.00%) 1 / 22 (4.55%) 0 / 49 (0.00%) affected / exposedOccurrences (all) 0 1 0 DyslipidaemiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Glucose tolerance impaired107Attorney Docket No.24-1507-WOSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHyperglycaemiaSubjects 1 / 5 (20.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 1 0 1 HyperlipidaemiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 HypertriglyceridemiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHyperuricaemiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 HypokalaemiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHypomagnesaemiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedHyponatraemiaSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedImpaired fasting glucoseSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedInsulin resistanceSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 0 / 49 (0.00%) affected / exposedObesitySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1 Type 2 diabetes mellitusSubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 2 Vitamin D deficiencySubjects 0 / 5 (0.00%) 0 / 22 (0.00%) 1 / 49 (2.04%) affected / exposedOccurrences (all) 0 0 1Example 4: Non-Serious Adverse Events for Subjects Initially Receiving 200 mg Q4W to 100 mg Q12W or 200 mg Q12W to 100 mg Q12W108Attorney Docket No.24-1507-WOTable 62. Overall Non-Serious Adverse EventsNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg, Q12W Q12WTotal subjects affected bynon-serious adverse events 44 / 54 (81.48%) 125 / 151 (82.78%) Subjects affected / exposedTable 63. Neoplasms (Benign, Malignant, and Unspecified), Including Cysts and Polyps Non-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg, Q12W Q12w Adenocarcinoma metastaticSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Adrenal adenomaSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Anogenital wartsSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2Benign oesophageal neoplasmSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Occurrences (all) 0 0 Colorectal adenomaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Haemangioma of liverSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Invasive ductal breast carcinomaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Oesophageal carcinomaSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Occurrences (all) 0 0 Prostatic adenomaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Uterine leiomyomaSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0109Attorney Docket No.24-1507-WOTable 64. Vascular DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg, Q12W Q12WAortic arteriosclerosisSubjects affected / exposed 1 / 54 (1.85%) 2 / 151 (1.32%) Occurrences (all) 1 2 Aortic dissectionSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) ArteriosclerosisSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Bleeding varicose veinSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1Blood pressure fluctuationSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0Deep vein thrombosisSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2 Diabetic microangiopathySubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Essential hypertensionSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 HypertensionSubjects affected / exposed 5 / 54 (9.26%) 10 / 151 (6.62%) Occurrences (all) 6 12 Hypertensive crisisSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) LymphostasisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Peripheral venous diseaseSubjects affected / exposed 1 / 54 (1.85%) 2 / 151 (1.32%) Occurrences (all) 1 2 PhlebitisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 ThrombophlebitisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1Table 65. Surgical and Medical ProceduresNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W Gastric bypass110Attorney Docket No.24-1507-WOSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1Table 66. General Disorders and Administration Site ConditionsNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12 AstheniaSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2 Chest painSubjects affected / exposed 1 / 54 (1.85%) 2 / 151 (1.32%) Occurrences (all) 1 3 ChillsSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 1 1Drug intoleranceSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 FatigueSubjects affected / exposed 0 / 54 (0.00%) 4 / 151 (2.65%) Occurrences (all) 0 4 Generalised OedemaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Influenza like illnessSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Injection site erythemaSubjects affected / exposed 2 / 54 (3.70%) 1 / 151 (0.66%) Occurrences (all) 10 1 Injection site painSubjects affected / exposed 1 / 54 (1.85%) 2 / 151 (1.32%) Occurrences (all) 1 2 Injection site pruritisSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 2 0 Injection site rashSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Injection site reactionSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1Injury associated with deviceSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Oedema peripheralSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2 Pyrexia111Attorney Docket No.24-1507-WOSubjects affected / exposed 4 / 54 (7.41%) 4 / 151 (2.65%) Occurrences (all) 5 5 Vaccination site painSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) XerosisSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Table 67. Immune System DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W Allergy to arthropod biteSubjects affected / exposed 0 / 54 (0.00%) 3 / 151 (1.99%) Occurrences (all) 0 3 Allergy to plantsSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1Table 68. Reproductive System and Breast DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W Abnormal uterine bleedingSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 2 AdenomyosisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Bartholin's cystSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Erectile dysfunctionSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Hydrocele femaleSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Intermenstrual bleedingSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Menstruation irregularSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) ProstatitisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 ProstatomegalySubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Uterine haemorrhage112Attorney Docket No.24-1507-WOSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Vaginal dischargeSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1Table 69. Respiratory, Thoracic and Mediastinal DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W Bronchitis chronicSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 CoughSubjects affected / exposed 1 / 54 (1.85%) 2 / 151 (1.32%) Occurrences (all) 1 3 DysphoniaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Interstitial lung diseaseSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Nasal congestionSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Oropharyngeal painSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Respiratory failSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 RhinorrhoeaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1Sinus congestionSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0Sleep apnoea syndromeSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Upper respiratory tract inflammationSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Dermatitis allergicSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 1 1 Dermatitis contactSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1113Attorney Docket No.24-1507-WODermatitis psoriasiformSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Table 70. Psychiatric DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W Adjustment disorderSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Affective disorderSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 AnxietySubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 1 1 DepressionSubjects affected / exposed 0 / 54 (0.00%) 3 / 151 (1.99%) Occurrences (all) 0 3 InsomniaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 2 IrritabilitySubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Mixed anxiety and depressive disorderSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0Sleep disorderSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1StressSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1Table 71. InvestigationsNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W Alanine aminotransferaseincreasedSubjects affected / exposed 2 / 54 (3.70%) 3 / 151 (1.99%) Occurrences (all) 2 3 Apolipoprotein B increasedSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Bilirubin urine presentSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Biopsy kidney114Attorney Docket No.24-1507-WOSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Blood bilirubin increasedSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Blood cholesterol increasedSubjects affected / exposed 2 / 54 (3.70%) 3 / 151 (1.99%) Occurrences (all) 2 3 Blood creatine phosphokinase increasedSubjects affected / exposed 1 / 54 (1.85%) 3 / 151 (1.99%) Occurrences (all) 1 3 Blood creatinine increasedSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 1 1 Blood glucose increasedSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Blood pressure increasedSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 3 Blood triglycerides increasedSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 3 Blood urea increasedSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 C-reactive protein increasedSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Gamma-glutamyltransferase increasedSubjects affected / exposed 1 / 54 (1.85%) 5 / 151 (3.31%) Occurrences (all) 1 6 Glomerular filtration rate decreasedSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Haematocrit decreasedSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Haemoglobin decreasedSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Hepatic enzyme increasedSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Low density lipoprotein increasedSubjects affected / exposed 1 / 54 (1.85%) 3 / 151 (1.99%) Occurrences (all) 1 4 Lymphocyte count decreasedSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Monocyte count decreasedSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Neutrophil count decreased115Attorney Docket No.24-1507-WOSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Platelet count decreasedSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Prostatic specific antigen increasedSubjects affected / exposed 2 / 54 (3.70%) 0 / 151 (0.00%) Occurrences (all) 2 0Red blood cell count decreasedSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Transaminases increasedSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Urinary castsSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Weight decreasedSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Weight increasedSubjects affected / exposed 3 / 54 (5.56%) 7 / 151 (4.64%) Occurrences (all) 3 7 White blood cell count decreasedSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0Table 72. Injury, Poisoning, and Procedural ComplicationsNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W Burns second degreeSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) ConcussionSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 ContusionSubjects affected / exposed 0 / 54 (0.00%) 3 / 151 (1.99%) Occurrences (all) 0 3 Craniocerebral injurySubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Cuboid syndromeSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 EpicondylitisSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) FallSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Fibula fractureSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%)116Attorney Docket No.24-1507-WOOccurrences (all) 0 1 Foot fractureSubjects affected / exposed 0 / 54 (0.00%) 3 / 151 (1.99%) Occurrences (all) 0 3 Hand fractureSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 1 1 Hip fractureSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Humerus fractureSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Iliotibial band syndromeSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Immunisation reactionSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 1 1 Joint injurySubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Ligament ruptureSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2 Ligament sprainSubjects affected / exposed 2 / 54 (3.70%) 4 / 151 (2.65%) Occurrences (all) 2 4 Limb injurySubjects affected / exposed 1 / 54 (1.85%) 2 / 151 (1.32%) Occurrences (all) 1 2 Meniscus injurySubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2 Muscle strainSubjects affected / exposed 0 / 54 (0.00%) 3 / 151 (1.99%) Occurrences (all) 0 3 Nail avulsionSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Post vaccination syndromeSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 2 Skin abrasionSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2 Skin lacerationSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Soft tissue injury117Attorney Docket No.24-1507-WOSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Spinal compression fractureSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Subdural haematomaSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Synovial ruptureSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Tendon injurySubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Thermal burnSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2Tibia fractureSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 2Tooth fractureSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Aspartate aminotransferase increasedSubjects affected / exposed 1 / 54 (1.85%) 3 / 151 (1.99%) Occurrences (all) 1 3 Bilirubin conjugated increasedSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Table 73. Congenital, Familial, and Genetic DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W Accessory SpleenSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Gilbert's SyndromeSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 HydroceleSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1Table 74. Cardiac DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W Atrial fibrillationSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%)118Attorney Docket No.24-1507-WOAtrioventricular block firstdegreeSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 1 1Acute myocardial infarctionSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2 Cardiac failureSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Cardiac failure congestiveSubjects affected / exposed 2 / 54 (3.70%) 1 / 151 (0.66%) Occurrences (all) 2 1 Coronary artery stenosisSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Diastolic dysfunctionSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Mitral valve incompetenceSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2 Myocardial ischaemiaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 PalpitationsSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Pericardial cystSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0Sinus tachycardiaSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 TachycardiaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 2 Tricuspid valveincompetenceSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1Table 75. Nervous System DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W AnosmiaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1119Attorney Docket No.24-1507-WOBradykinesiaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Carpal tunnel syndromeSubjects affected / exposed 1 / 54 (1.85%) 2 / 151 (1.32%) Occurrences (all) 1 2 Cervicobrachial syndromeSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Diabetic neuropathySubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 DizzinessSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2 EncephalopathySubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) HeadacheSubjects affected / exposed 4 / 54 (7.41%) 13 / 151 (8.61%) Occurrences (all) 6 37 HypoaesthesiaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Lumbar radiculopathySubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Lumbosacral radiculopathySubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Metabolic encephalopathySubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) MigraineSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 MyotoniaSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 NeuralgiaSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 NeuritisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Parkinson's diseaseSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Restless legs syndromeSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%)120Attorney Docket No.24-1507-WOSciaticaSubjects affected / exposed 1 / 54 (1.85%) 4 / 151 (2.65%) Occurrences (all) 1 5 Sensory lossSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Spinal cord haematomaSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Subarachnoid hemorrhageSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) SyncopeSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Tension headacheSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2 Retinal migraineSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Table 76. Blood and Lymphatic System DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W AnaemiaSubjects affected / exposed 0 / 54 (0.00%) 3 / 151 (1.99%) Occurrences (all) 0 3 LeukocytosisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 LeukopeniaSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2 LymphadenopathySubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 LymphopeniaSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2 NeutropeniaSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 3 NeutrophiliaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1121Attorney Docket No.24-1507-WOTable 77. Ear and Labyrinth DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12WEar painSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 VertigoSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 1 1Table 78. Eye DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W AstigmatismSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 BlepharitisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Blindness transientSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) CataractSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2 Cataract nuclearSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Diabetic retinopathySubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) KeratitisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 MyopiaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Retinal vascular disorderSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Visual acuity reducedSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1Table 79. Gastrointestinal DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W Abdominal hernia122Attorney Docket No.24-1507-WOSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Abdominal painSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 1 1 Abdominal pain upperSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Abdominal rigiditySubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 2 Anal fistulaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Aphthous ulcerSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Barrett's oesophagusSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Chronic gastritisSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 1 1 Coeliac artery stenosisSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) ConstipationSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Dental cariesSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 1 1 Diaphragmatic herniaSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 DiarrhoeaSubjects affected / exposed 4 / 54 (7.41%) 6 / 151 (3.97%) Occurrences (all) 5 8 DiverticulumSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Diverticulum intestinalSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 DuodenitisSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 DyspepsiaSubjects affected / exposed 2 / 54 (3.70%) 0 / 151 (0.00%)123Attorney Docket No.24-1507-WOOccurrences (all) 3 0 EnteritisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Food poisoningSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Gastric ulcerSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 GastritisSubjects affected / exposed 1 / 54 (1.85%) 2 / 151 (1.32%) Occurrences (all) 1 2 Gastritis erosiveSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Gastrointestinal disorderSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Gastroesophageal reflux diseaseSubjects affected / exposed 2 / 54 (3.70%) 0 / 151 (0.00%) Occurrences (all) 2 0 Gingival swellingSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Hemorrhagic erosive gastritisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 2 HaemorrhoidsSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2 Hiatus herniaSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Intestinal metaplasiaSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Intestinal obstructionSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Irritable bowel syndromeSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 2 Large intestine polypSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 NauseaSubjects affected / exposed 0 / 54 (0.00%) 6 / 151 (3.97%) Occurrences (all) 0 16 Pancreatitis chronic124Attorney Docket No.24-1507-WOSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Rectal polypSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Retained deciduous toothSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 ToothacheSubjects affected / exposed 1 / 54 (1.85%) 3 / 151 (1.99%) Occurrences (all) 3 5 VomitingSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0Table 80. Hepatobiliary DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W Biliary dyskinesiaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 CholecystitisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 3 CholelithiasisSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 2 0 CholestasisSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Diabetic hepatopathySubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Gallbladder polypSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2 Hepatic steatosisSubjects affected / exposed 0 / 54 (0.00%) 3 / 151 (1.99%) Occurrences (all) 0 3 HepatitisSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) HyperbilirubinaemiaSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2 HypertransaminasaemiaSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Non-alcoholic steatohepatitisSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Steatohepatitis125Attorney Docket No.24-1507-WOSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0Table 81. Skin and Subcutaneous Tissue DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W AlopeciaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 AngioedemaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 EcchymosisSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Occurrences (all) 0 0 ErythemaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 HidradenitisSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 PruritisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 PsoriasisSubjects affected / exposed 0 / 54 (0.00%) 5 / 151 (3.31%) Occurrences (all) 0 5RashSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2Skin exfoliationSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Occurrences (all) 0 0Skin ulcerSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0Table 82. Renal and Urinary DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W Acute kidney injurySubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Calculus urinarySubjects affected / exposed 0 / 54 (0.00%) 3 / 151 (1.99%) Occurrences (all) 0 5 Chronic kidney disease126Attorney Docket No.24-1507-WOSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Cystitis haemorrhagicSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Cystitis noninfectiveSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 1 1 End stage renal diseaseSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 2 Glomerulonephritis chronicSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 HaematuriaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Hypertonic bladderSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) NephrolithiasisSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 NephrosclerosisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 PollakiuriaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 ProteinuriaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Renal colicSubjects affected / exposed 0 / 54 (0.00%) 3 / 151 (1.99%) Occurrences (all) 0 3 Renal cystSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 1 1 Stress urinary incontinenceSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 UreterolithiasisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Urinary tract inflammationSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0127Attorney Docket No.24-1507-WOTable 83. Endocrine DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W Autoimmune thyroiditisSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) GoitreSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Hypothyroidic goitreSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 HypothyroidismSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Thyroid massSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1Table 84. Musculoskeletal and Connective Tissue DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W ArthralgiaSubjects affected / exposed 1 / 54 (1.85%) 6 / 151 (3.97%) Occurrences (all) 1 7 ArthritisSubjects affected / exposed 1 / 54 (1.85%) 2 / 151 (1.32%) Occurrences (all) 1 2Back painSubjects affected / exposed 2 / 54 (3.70%) 6 / 151 (3.97%) Occurrences (all) 2 9 BursitisSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 4 DactylitisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 ExostosisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Fracture painSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Greater trochanteric pain syndromeSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Intervertebral disc disorderSubjects affected / exposed 1 / 54 (1.85%) 2 / 151 (1.32%)128Attorney Docket No.24-1507-WOOccurrences (all) 1 3 Intervertebral disc displacementSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1Intervertebral disc protrusionSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 1 1 Jaw cystSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Joint contractureSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Joint effusionSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 3 Joint swellingSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Lumbar spinal stenosisSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) MetatarsalgiaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Muscle spasmsSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Musculoskeletal discomfortSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Musculoskeletal stiffnessSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 MyalgiaSubjects affected / exposed 2 / 54 (3.70%) 2 / 151 (1.32%) Occurrences (all) 3 2 Neck painSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 OsteoarthritisSubjects affected / exposed 2 / 54 (3.70%) 2 / 151 (1.32%) Occurrences (all) 4 2 OsteochondrosisSubjects affected / exposed 2 / 54 (3.70%) 1 / 151 (0.66%) Occurrences (all) 2 2 OsteoporosisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Pain in extremity129Attorney Docket No.24-1507-WOSubjects affected / exposed 1 / 54 (1.85%) 2 / 151 (1.32%) Occurrences (all) 1 3 PeriarthritisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Periarticular disorderSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Plantar fasciitisSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 1 1 PseudarthrosisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Psoriatic arthropathySubjects affected / exposed 1 / 54 (1.85%) 9 / 151 (5.96%) Occurrences (all) 1 17 RhabdomyolysisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Rotator cuff syndromeSubjects affected / exposed 1 / 54 (1.85%) 2 / 151 (1.32%) Occurrences (all) 1 2 SacroiliitisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Spinal disorderSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Spinal osteoarthritisSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Spinal painSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Spinal stenosisSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) SpondylolisthesisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Synovial cystSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 TendonitisSubjects affected / exposed 2 / 54 (3.70%) 0 / 151 (0.00%) Occurrences (all) 2 0 TenosynovitisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1130Attorney Docket No.24-1507-WOTenosynovitis stenosansSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 2 1 Trigger fingerSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1Table 85. Infections and InfestationsNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W Abdominal abscessSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Acute sinusitisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Adenovirus infectionSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 BacteriuriaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Bartholin's abscessSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Breast abscessSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 BronchitisSubjects affected / exposed 2 / 54 (3.70%) 1 / 151 (0.66%) Occurrences (all) 2 1 COVID-19Subjects affected / exposed 11 / 54 (20.37%) 25 / 151 (16.56%) Occurrences (all) 12 29 COVID-19 pneumoniaSubjects affected / exposed 0 / 54 (0.00%) 3 / 151 (1.99%) Occurrences (all) 0 3 CellulitisSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Chronic sinusitisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 ConjunctivitisSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 2 1 Coronavirus infectionSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%)131Attorney Docket No.24-1507-WOOccurrences (all) 0 1 CystitisSubjects affected / exposed 0 / 54 (0.00%) 3 / 151 (1.99%) Occurrences (all) 0 3 DiverticulitisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Erythema migransSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Escherichia infectionSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 FuruncleSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Gallbladder empyemaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 GastroenteritisSubjects affected / exposed 1 / 54 (1.85%) 3 / 151 (1.99%) Occurrences (all) 1 3 Gastroenteritis viralSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 1 1 Gastrointestinal bacterial overgrowthSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Gastrointestinal infectionSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 GingivitisSubjects affected / exposed 0 / 54 (0.00%) 2 / 151 (1.32%) Occurrences (all) 0 2 Helicobacter gastritisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Helicobacter infectionSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%) Occurrences (all) 1 1 Herpes simplexSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Herpes zosterSubjects affected / exposed 2 / 54 (3.70%) 0 / 151 (0.00%) Occurrences (all) 2 0 HordeolumSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1132Attorney Docket No.24-1507-WOInfluenzaSubjects affected / exposed 1 / 54 (1.85%) 4 / 151 (2.65%) Occurrences (all) 1 6 Intestinal sepsisSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Joint abscessSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) LaryngitisSubjects affected / exposed 2 / 54 (3.70%) 0 / 151 (0.00%) Occurrences (all) 2 0 Localised infectionSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Lower respiratory tract infectionSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 NasopharyngitisSubjects affected / exposed 8 / 54 (14.81%) 21 / 151 (13.91%) Occurrences (all) 14 36 Oral herpesSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Otitis externaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Otitis mediaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 PeriodontitisSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 PharyngitisSubjects affected / exposed 2 / 54 (3.70%) 9 / 151 (5.96%) Occurrences (all) 3 9 PharyngotonsillitisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 PneumoniaSubjects affected / exposed 0 / 54 (0.00%) 4 / 151 (2.65%) Occurrences (all) 0 4 Pneumonia bacterialSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Pulmonary tuberculosisSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Pulpitis dentalSubjects affected / exposed 1 / 54 (1.85%) 1 / 151 (0.66%)133Attorney Docket No.24-1507-WOOccurrences (all) 1 1 Purulent dischargeSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 PyelonephritisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Pyelonephritis acuteSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Respiratory tract infectionSubjects affected / exposed 2 / 54 (3.70%) 2 / 151 (1.32%) Occurrences (all) 3 2 Respiratory tract infection viralSubjects affected / exposed 1 / 54 (1.85%) 2 / 151 (1.32%) Occurrences (all) 2 2 RhinitisSubjects affected / exposed 1 / 54 (1.85%) 13 / 151 (8.61%) Occurrences (all) 1 17 Septic shockSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) SinusitisSubjects affected / exposed 2 / 54 (3.70%) 4 / 151 (2.65%) Occurrences (all) 2 4 Skin infectionSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Suspected COVID-19Subjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 TonsillitisSubjects affected / exposed 1 / 54 (1.85%) 2 / 151 (1.32%) Occurrences (all) 1 2 Tooth infectionSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 TracheitisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 TracheobronchitisSubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0 Upper respiratory tractinfectionSubjects affected / exposed 9 / 54 (16.67%) 13 / 151 (8.61%) Occurrences (all) 14 14 Urinary tract infectionSubjects affected / exposed 3 / 54 (5.56%) 18 / 151 (11.92%)134Attorney Docket No.24-1507-WOOccurrences (all) 4 24 Vaginal infectionSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1Viral infectionSubjects affected / exposed 1 / 54 (1.85%) 2 / 151 (1.32%) Occurrences (all) 1 4Viral pharyngitisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1Viral upper respiratorytract infectionSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Vulvovaginal mycoticinfectionSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Wound infectionSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1Table 86. Metabolism and Nutrition DisordersNon-serious adverse events Tildra 200 mg, Q4W Tildra 200 mg, Q12W switched to Tildra 100 mg, switched to Tildra 100 mg,Q12W Q12W CholesterosisSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Copper deficiencySubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 DehydrationSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) Diabetes mellitusSubjects affected / exposed 2 / 54 (3.70%) 2 / 151 (1.32%) Occurrences (all) 2 2 Diabetes mellitusinadequate controlSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 4 DyslipidaemiaSubjects affected / exposed 0 / 54 (0.00%) 4 / 151 (2.65%) Occurrences (all) 0 4 Glucose tolerance impairedSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Hypercholesterolaemia135Attorney Docket No.24-1507-WOSubjects affected / exposed 1 / 54 (1.85%) 6 / 151 (3.97%) Occurrences (all) 1 6 HyperglycaemiaSubjects affected / exposed 1 / 54 (1.85%) 2 / 151 (1.32%) Occurrences (all) 1 2 HyperlipidaemiaSubjects affected / exposed 1 / 54 (1.85%) 3 / 151 (1.99%) Occurrences (all) 1 3 HypertriglyceridaemiaSubjects affected / exposed 0 / 54 (0.00%) 4 / 151 (2.65%) Occurrences (all) 0 5 HyperuricaemiaSubjects affected / exposed 0 / 54 (0.00%) 0 / 151 (0.00%) HypokalaemiaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 HypomagnesaemiaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 HyponatraemiaSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Impaired fasting glucoseSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 Insulin resistanceSubjects affected / exposed 0 / 54 (0.00%) 1 / 151 (0.66%) Occurrences (all) 0 1 ObesitySubjects affected / exposed 3 / 54 (5.56%) 3 / 151 (1.99%) Occurrences (all) 3 3 Type 2 diabetes mellitusSubjects affected / exposed 1 / 54 (1.85%) 6 / 151 (3.97%) Occurrences (all) 1 6 Vitamin D deficiencySubjects affected / exposed 1 / 54 (1.85%) 0 / 151 (0.00%) Occurrences (all) 1 0136

Claims

Attorney Docket No.24-1507-WOWHAT IS CLAIMED IS:Claim 1: A pharmaceutical composition comprising an anti-IL-23p19 antibody hum13B8-b for use in the treatment of psoriatic arthritis in a patient in need thereof, wherein the anti-IL-23p19 antibody hum13B8-b comprises:(i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and(ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.Claim 2: The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is administered in a treatment phase and an extension phase.Claim 3: The pharmaceutical composition of claim 2, wherein the pharmaceutical composition is administered to the patient for up to about 52 weeks during the treatment phase.Claim 4: The pharmaceutical composition of claim 2, wherein the pharmaceutical composition is administered to the patient at week 0, at about week 4, and about every 12 weeks thereafter during the treatment phase.Claim 5: The pharmaceutical composition of claim 2, wherein the pharmaceutical composition is administered to the patient at week 0, at about week 4, and about every 4 weeks thereafter during the treatment phase.Claim 6: The pharmaceutical composition of claim 2, wherein a therapeutically effective amount of the pharmaceutical composition is administered to the patient during the treatment phase.Claim 7: The pharmaceutical composition of claim 2, wherein a dose of the pharmaceutical composition comprising about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the treatment phase.137Attorney Docket No.24-1507-WOClaim 8: The pharmaceutical composition of claim 7, wherein the dose of the pharmaceutical composition comprises about 100 mg of hum13B8-b.Claim 9: The pharmaceutical composition of claim 7, wherein the dose of the pharmaceutical composition comprises about 200 mg of hum13B8-b.Claim 10: The pharmaceutical composition of claim 6, wherein the pharmaceutical composition is administered to the patient subcutaneously.Claim 11: The pharmaceutical composition of claim 6, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection.Claim 12: The pharmaceutical composition of claim 6, wherein the pharmaceutical composition is administered to the patient using an auto-injector or prefilled syringe.Claim 13: The pharmaceutical composition of claim 6, wherein a dose of the pharmaceutical composition comprising about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the treatment phase.Claim 14: The pharmaceutical composition of claim 13, wherein the dose of the pharmaceutical composition comprises about 100 mg of hum13B8-b.Claim 15: The pharmaceutical composition of claim 13, wherein the dose of the pharmaceutical composition comprises about 200 mg of hum13B8-b.Claim 16: The pharmaceutical composition of claim 6, wherein a first dose of the pharmaceutical composition is administered to the patient on week 0, a second dose of the pharmaceutical composition is administered to the patient at about week 4, and subsequent doses of the pharmaceutical composition are administered to the patient at about every 12 weeks thereafter during the treatment phase.Claim 17: The pharmaceutical composition of claim 16, wherein the first dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and subsequent doses of the pharmaceutical composition are the same.138Attorney Docket No.24-1507-WOClaim 18: The pharmaceutical composition of claim 16, wherein the first dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and subsequent doses of the pharmaceutical composition are different.Claim 19: The pharmaceutical composition of claim 17, wherein the first dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and subsequent doses of the pharmaceutical composition comprise about 100 mg of hum13B8-b.Claim 20: The pharmaceutical composition of claim 17, wherein the first dose of the pharmaceutical composition, the second dose of the pharmaceutical composition, and subsequent doses of the pharmaceutical composition comprise about 200 mg of hum13B8-b.Claim 21: The pharmaceutical composition of claim 16, wherein the first dose of the pharmaceutical composition comprises about 100 mg of hum13B8-b.Claim 22: The pharmaceutical composition of claim 16, wherein the second dose of the pharmaceutical composition comprises about 100 mg of hum13B8-b.Claim 23: The pharmaceutical composition of claim 16, wherein the subsequent doses of the pharmaceutical composition comprise about 100 mg of hum13B8-b.Claim 24: The pharmaceutical composition of claim 16, wherein the first dose of the pharmaceutical composition comprises about 200 mg of hum13B8-b.Claim 25: The pharmaceutical composition of claim 16, wherein the second dose of the pharmaceutical composition comprises about 200 mg of hum13B8-b.Claim 26: The pharmaceutical composition of claim 16, wherein the subsequent doses of the pharmaceutical composition comprise about 200 mg of hum13B8-b.Claim 27: The pharmaceutical composition of claim 18, wherein the first dose of the pharmaceutical composition comprises about 100 mg of hum13B8-b, and the amount of139Attorney Docket No.24-1507-WOhum13B8-b administered in the second dose of the pharmaceutical composition and subsequent doses of the pharmaceutical composition is different from the first dose.Claim 28: The pharmaceutical composition of claim 18, wherein the first dose of the pharmaceutical composition comprises about 200 mg of hum13B8-b, and the amount of hum13B8-b administered in the second dose of the pharmaceutical composition and subsequent doses of the pharmaceutical composition is different from the first dose.Claim 29: The pharmaceutical composition of claim 2, wherein the pharmaceutical composition is administered to the patient for up to about 208 weeks during the extension phase.Claim 30: The pharmaceutical composition of claim 2, wherein the pharmaceutical composition is administered to the patient during the extension phase at the same interval as the pharmaceutical composition is administered to the patient during the treatment phase.Claim 31: The pharmaceutical composition of claim 30, wherein a dose of the pharmaceutical composition comprising about 100 mg or about 200 mg of hum13B8-b is administered to the patient about every four weeks (Q4W) during the extension phase.Claim 32: The pharmaceutical composition of claim 31, wherein a dose of the pharmaceutical composition is administered to the patient for at least up to about 4 weeks, for at least up to about 8 weeks, for at least up to about 12 weeks, for at least up to about 16 weeks, for at least up to about 20 weeks, for at least up to about 24 weeks, for at least up to about 28 weeks, for at least up to about 32 weeks, for at least up to about 36 weeks, for at least up to about 40 weeks, for at least up to about 44 weeks, for at least up to about 48 weeks, for at least up to about 52 weeks, for at least up to about 56 weeks, for at least up to about 60 weeks, for at least up to about 64 weeks, for at least up to about 68 weeks, for at least up to about 72 weeks, for at least up to about 76 weeks, for at least up to about 80 weeks, for at least up to about 84 weeks, for at least up to about 88 weeks, for at least up to about 92 weeks, for at least up to about 96 weeks, for at least up to about 100 weeks, for at least up to about 104 weeks, for at least up to about 108 weeks, for at least up to about 112 weeks, for at least up to about 116 weeks, for at least up to about 120 weeks, for at least up to about 124 weeks, for at least up to about 128 weeks, for at least up to about 132 weeks, for at140Attorney Docket No.24-1507-WOleast up to about 136 weeks, for at least up to about 140 weeks, for at least up to about 144 weeks, for at least up to about 148 weeks, for at least up to about 152 weeks, for at least up to about 156 weeks, for at least up to about 160 weeks, for at least up to about 164 weeks, for at least up to about 168 weeks, for at least up to about 172, for at least up to about 176 weeks, for at least up to about 180 weeks, for at least up to about 184 weeks, for at least up to about 188 weeks, for at least up to about 192 weeks, for at least up to about 196 weeks, for at least up to about 200 weeks, for at least up to about 204 weeks, or for at least up to about 208 weeks.Claim 33: The pharmaceutical composition of claim 31, wherein a dose of the pharmaceutical composition comprising about 100 mg or about 200 mg of hum13B8-b is administered to the patient about every twelve weeks (Q12W) during the extension phase.Claim 34: The pharmaceutical composition of claim 33, wherein a dose of the pharmaceutical composition is administered to the patient for at least up to about 12 weeks, for at least up to about 24weeks, for at least up to about 36 weeks, for at least up to about 48 weeks, for at least up to about 60 weeks, for at least up to about 72 weeks, for at least up to about 84 weeks, for at least up to about 96 weeks, for at least up to about 108 weeks, for at least up to about 120 weeks, for at least up to about 132 weeks, for at least up to about 144 weeks, for at least up to about 156 weeks, for at least up to about 168 weeks, for at least up to about 180 weeks, for at least up to about 192 weeks, for at least up to about 204 weeks, or for at least up to about 216 weeks.Claim 35: The pharmaceutical composition of claim 34, wherein the pharmaceutical composition is administered to the patient during the extension phase at different time intervals than the time intervals the pharmaceutical composition is administered to the patient during the treatment phase.Claim 36: The pharmaceutical composition of claim 35, wherein the pharmaceutical composition is administered to the patient Q4W during the treatment phase and the pharmaceutical composition is administered to the patient Q12W during the extension phase.141Attorney Docket No.24-1507-WOClaim 37: The pharmaceutical composition of claim 2, wherein a therapeutically effective amount of the pharmaceutical composition is administered to the patient during the extension phase.Claim 38: The pharmaceutical composition of claim 37, wherein a dose of the pharmaceutical composition comprising about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the extension phase.Claim 39: The pharmaceutical composition of claim 38, wherein the dose of the pharmaceutical composition comprises about 100 mg of hum13B8-b.Claim 40: The pharmaceutical composition of claim 38, wherein the dose of the pharmaceutical composition comprises about 200 mg of hum13B8-b.Claim 41: The pharmaceutical composition of claim 2, wherein the dose of the pharmaceutical composition administered to the patient during the extension phase is different than the dose of the pharmaceutical composition administered to the patient during the treatment phase.Claim 42: The pharmaceutical composition of claim 41, wherein a dose of the pharmaceutical composition comprising about 200 mg of hum13B8-b is administered to the patient during the treatment phase and a dose of the pharmaceutical composition comprising about 100 mg of hum13B8-b is administered to the patient during the extension phase.Claim 43: The pharmaceutical composition of claim 41, wherein a dose of the pharmaceutical composition comprising about 200 mg hum13B8-b is administered to the patient Q4W during the treatment phase and a dose of the pharmaceutical composition comprising about 100 mg hum13B8-b is administered to the patient Q12W during the extension phase.Claim 44: The pharmaceutical composition of claim 2, wherein the dose of the pharmaceutical composition administered to the patient during the treatment phase and the dose of the pharmaceutical composition administered to the patient during the extension phase are the same.142Attorney Docket No.24-1507-WOClaim 45: The pharmaceutical composition of claim 44, wherein a dose of the pharmaceutical composition comprising about 100 mg hum13B8-b is administered to the patient during the treatment phase and a dose of the pharmaceutical composition comprising about 100 mg hum13B8-b is administered to the patient during the extension phase.Claim 46: The pharmaceutical composition of claim 44, wherein a dose of the pharmaceutical composition comprising about 200 mg of hum13B8-b is administered to the patient during the treatment phase and a dose of the pharmaceutical composition comprising about 200 mg of hum13B8-b is administered to the patient during the extension phase.Claim 47: The pharmaceutical composition of any one of claims 1-46, wherein the pharmaceutical composition is administered to the patient for up to about 52 weeks during the treatment phase and the pharmaceutical composition is administered to the patient for an additional up to about 208 weeks during the extension phase, and wherein a dose of the pharmaceutical composition comprising about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the extension phase.Claim 48: The pharmaceutical composition of any one of claims 39-47, wherein the pharmaceutical composition is administered to the patient subcutaneously during the extension phase.Claim 49: The pharmaceutical composition of claim 48, wherein the pharmaceutical composition is administered to the patient by subcutaneous injection.Claim 50: The pharmaceutical composition of claim 48, wherein the pharmaceutical composition is administered to the patient using an auto-injector or prefilled syringe.Claim 51: The pharmaceutical composition of any one of claims 29-39, 41-45, or 47-50, wherein administration of one or more doses of the pharmaceutical composition comprising about 100 mg of hum13B8-b during the extension phase results in minimal or no serious adverse events (SAEs) in the patient.143Attorney Docket No.24-1507-WOClaim 52: The pharmaceutical composition of any one of claims 29-38, 40, 41, 44, 46-51, wherein administration of one or more doses of the pharmaceutical composition comprising about 200 mg of hum13B8-b during the extension phase results in minimal or no serious adverse events (SAEs) in the patient.Claim 53: The pharmaceutical composition of either claim 51 or claim 52, wherein the SAEs include blood and lymphatic disorders, cardiac disorders, gastrointestinal disorders, general disorders, hepatobiliary disorders, infections and infestations, injury, poisoning and procedural complications, investigations, metabolism and nutrition disorders, musculoskeletal and connective tissue disorders, neoplasms, nervous system disorders, renal and urinary disorders, reproductive system and breast disorders, respiratory, thoracic and mediastinal disorders, surgical and medical procedures, and vascular disorders.Claim 54: The pharmaceutical composition of claim 53, wherein the blood or lymphatic disorder is anemia.Claim 55: The pharmaceutical composition of claim 53, wherein the cardiac disorder is acute myocardial infarction, cardiac failure, coronary artery stenosis, or tachycardia.Claim 56: The pharmaceutical composition of claim 53, wherein the gastrointestinal disorder is abdominal hernia, hemorrhagic erosive gastritis, or intestinal obstruction.Claim 57: The pharmaceutical composition of claim 53, wherein the general disorder is generalized oedema.Claim 58: The pharmaceutical composition of claim 53, wherein the hepatobiliary disorder is cholelithiasis.Claim 59: The pharmaceutical composition of claim 53, wherein the infection or infestation is abdominal abscess, COVID-19 pneumonia, gallbladder empyema, intestinal sepsis, septic shock, or upper respiratory tract infection.144Attorney Docket No.24-1507-WOClaim 60: The pharmaceutical composition of claim 53, wherein the injury, poisoning, or procedural complication is craniocerebral injury, hip fracture, humerus fracture, ligament rupture, subdural hematoma, or tibia fracture.Claim 61: The pharmaceutical composition of claim 53, wherein the investigation is a kidney biopsy.Claim 62: The pharmaceutical composition of claim 53, wherein the metabolism or nutrition disorder is diabetes mellitus.Claim 63: The pharmaceutical composition of claim 53, wherein the musculoskeletal or connective tissue disorder is intervertebral disc disorder, lumbar spinal stenosis, osteoarthritis, or rhabdomyolysis.Claim 64: The pharmaceutical composition of claim 53, wherein the neoplasm is adenocarcinoma metastatic, colorectal adenoma, invasive ductal breast carcinoma, esophageal carcinoma, or uterine leiomyoma.Claim 65: The pharmaceutical composition of claim 53, wherein the nervous system disorder is dizziness, metabolic encephalopathy, retinal migraine, subarachnoid hemorrhage, or tension headache.Claim 66: The pharmaceutical composition of claim 53, wherein the renal or urinary disorder is acute kidney injury, calculus urinary, end stage renal disease, or ureterolithiasis.Claim 67: The pharmaceutical composition of claim 53, wherein the reproductive system or breast disorder is hydrocele female or uterine hemorrhage.Claim 68: The pharmaceutical composition of claim 53, wherein the respiratory, thoracic, or mediastinal disorder is bronchitis chronic or interstitial lung disease.Claim 69: The pharmaceutical composition of claim 53, wherein the surgical or medical procedure is gastric bypass.145Attorney Docket No.24-1507-WOClaim 70: The pharmaceutical composition of claim 53, wherein the vascular disorder is aortic dissection, arteriosclerosis, deep vein thrombosis, hypertension, or hypertensive crisis.Claim 71: The pharmaceutical composition of any one of claims 29-39, 41-45, or 47-50, wherein administration of a dose of the pharmaceutical composition comprising about 100 mg of hum13B8-b during the extension phase results in minimal or no other adverse events (OAEs) in the patient.Claim 72: The pharmaceutical composition of any one of claims 29-38, 40, 41, 44, or 46-51, wherein administration of a dose of the pharmaceutical composition comprising about 200 mg of hum13B8-b during the extension phase results in minimal or no other adverse events (OAEs) in the patient.Claim 73: The pharmaceutical composition of either claim 71 or claim 72, wherein the OAEs include one or more of blood or lymphatic system disorders, cardiac disorders, congenital, familial, or genetic disorders, ear or labyrinth disorders, endocrine disorders, eye disorders, gastrointestinal disorders, general disorders, hepatobiliary disorders, immune system disorders, infections or infestations, injuries, poisoning or procedural complications, investigations, metabolism or nutrition disorders, musculoskeletal or connective tissue disorders, neoplasms benign, malignant, or unspecified, nervous system disorders, psychiatric disorders, renal or urinary disorders, reproductive system or breast disorders, respiratory, thoracic, or mediastinal disorders, skin or subcutaneous tissue disorders, surgical or medical procedures, or vascular disorders.Claim 74: The pharmaceutical composition of claim 73, wherein the blood or lymphatic system disorder is anemia, leukocytosis, leukopenia, lymphadenopathy, lymphopenia, neutropenia, or neutrophilia.Claim 75: The pharmaceutical composition of claim 73, wherein the cardiac disorder is acute myocardial infarction, atrial fibrillation, atrioventricular block first degree, cardiac failure, cardiac failure congestive, coronary artery stenosis, diastolic dysfunction, mitral valve incompetence, myocardial ischemia, palpitations, pericardial cyst, sinus tachycardia, tachycardia, or tricuspid valve incompetence.146Attorney Docket No.24-1507-WOClaim 76: The pharmaceutical composition of claim 73, wherein the congenital, familial, or genetic disorder is accessory spleen, Gilbert's syndrome, or hydrocele.Claim 77: The pharmaceutical composition of claim 73, wherein the ear or labyrinth disorder is ear pain or vertigo.Claim 78: The pharmaceutical composition of claim 73, wherein the endocrine disorder is autoimmune thyroiditis, goiter, hypothyroidic goiter, hypothyroidism, or thyroid mass.Claim 79: The pharmaceutical composition of claim 73, wherein the eye disorder is astigmatism, blepharitis, blindness transient, cataract, cataract nuclear, diabetic retinopathy, keratitis, myopia, retinal vascular disorder, or visual acuity reduced.Claim 80: The pharmaceutical composition of claim 73, wherein the gastrointestinal disorder is abdominal hernia, abdominal pain, abdominal pain upper, abdominal rigidity, anal fistula, aphthous ulcer, Barrett's esophagus, chronic gastritis, coeliac artery stenosis, constipation, dental caries, diaphragmatic hernia, diarrhea, diverticulum, diverticulum intestinal, duodenitis, dyspepsia, enteritis, food poisoning, gastric ulcer, gastritis, gastritis erosive, gastrointestinal disorder, gastroesophageal reflux disease, gingival swelling, hemorrhagic erosive gastritis, hemorrhoids, hiatus hernia, intestinal metaplasia, intestinal obstruction, irritable bowel syndrome, large intestine polyp, nausea, pancreatitis chronic, rectal polyp, retained deciduous tooth, toothache, or vomiting.Claim 81: The pharmaceutical composition of claim 73, wherein the general disorder is asthenia, chest pain, chills, drug intolerance, fatigue, generalized oedema, influenza like illness, injection site erythema, injection site pain, injection site pruritus, injection site rash, injection site reaction, injury associated with device, oedema peripheral, pyrexia, vaccination site pain, or xerosis.Claim 82: The pharmaceutical composition of claim 73, wherein the hepatobiliary disorder is biliary dyskinesia, cholecystitis, cholelithiasis, cholestasis, diabetic hepatopathy, gallbladder polyp, hepatic steatosis, hepatitis, hyperbilirubinemia, hypertransaminasaemia, non-alcoholic steatohepatitis, or steatohepatitis.147Attorney Docket No.24-1507-WOClaim 83: The pharmaceutical composition of claim 73 wherein the immune system disorder is an allergy to an arthropod bite or allergy to plants.Claim 84: The pharmaceutical composition of claim 73, wherein the infection or infestation is abdominal abscess, acute sinusitis, adenovirus infection, bacteriuria, Bartholin's abscess, breast abscess, bronchitis, COVID-19, COVID-19 pneumonia, cellulitis, chronic sinusitis, conjunctivitis, coronavirus infection, cystitis, diverticulitis, erythema migraines, Escherichia infection, furuncle, gallbladder empyema, gastroenteritis, gastroenteritis viral, gastrointestinal bacterial overgrowth, gastrointestinal infection, gingivitis, helicobacter gastritis, helicobacter infection, Herpes simplex, Herpes zoster, Hordeolum, influenza, intestinal sepsis, joint abscess, laryngitis, localized infection, lower respiratory tract infection, nasopharyngitis, oral herpes, otitis externa, otitis media, periodontitis, pharyngitis, pharyngotonsillitis, pneumonia, pneumonia bacterial, pulmonary tuberculosis, pulpitis dental, purulent discharge, pyelonephritis, pyelonephritis acute, respiratory tract infection, respiratory tract infection viral, rhinitis, septic shock, sinusitis, skin infection, suspected COVID-19, tonsillitis, tooth infection, tracheitis, tracheobronchitis, upper respiratory tract infection, urinary tract infection, vaginal infection, viral infection, viral pharyngitis, viral upper respiratory tract infection, vulvovaginal mycotic infection, or wound infection.Claim 85: The pharmaceutical composition of claim 73, wherein the injury, poisoning, or procedural complication is second degree burns, concussion, contusion, craniocerebral injury, cuboid syndrome, epicondylitis, fall, fibula fracture, foot fracture, hand fracture, hip fracture, humerus fracture, iliotibial band syndrome, immunization reaction, joint injury, ligament rupture, ligament sprain, limb injury, meniscus injury, muscle strain, nail avulsion, post vaccination syndrome, skin abrasion, skin laceration, soft tissue injury, spinal compression fracture, subdural hematoma, synovial rupture, tendon injury, thermal burn, tibia fracture, or tooth fracture.Claim 86: The pharmaceutical composition of claim 73, wherein the investigation is alanine aminotransferase increased, apolipoprotein B increased, aspartate aminotransferase increased, bilirubin conjugated increased, bilirubin urine present, biopsy kidney, blood bilirubin increased, blood cholesterol increased, blood creatine phosphokinase increased, blood creatinine increased, blood glucose increased, blood pressure increased, blood triglycerides increased, blood urea increased, C-reactive protein increased, Gamma-glutamyl148Attorney Docket No.24-1507-WOtransferase increased, glomerular filtration rate decreased, hematocrit decreased, hemoglobin decreased, hepatic enzyme increased, low density lipoprotein increased, lymphocyte count decreased, monocyte count decreased, neutrophil count decreased, platelet count decreased, prostatic specific antigen increased, red blood cell count decreased, transaminases increased, urinary casts, weight decreased, weight increased, or white blood cell count decreased.Claim 87: The pharmaceutical composition of claim 73, wherein the metabolism or nutrition disorder is cholesterosis, copper deficiency, dehydration, diabetes mellitus, diabetes mellitus inadequate control, dyslipidemia, glucose tolerance impaired, hypercholesterolemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, hyperuricemia, hypokalemia, hypomagnesaemia, hyponatremia, impaired fasting glucose, insulin resistance, obesity, type 2 diabetes mellitus, or vitamin D deficiency.Claim 88: The pharmaceutical composition of claim 73, wherein the musculoskeletal or connective tissue disorder is arthralgia, arthritis, back pain, bursitis, dactylitis, exostosis, fracture pain, greater trochanteric pain syndrome, intervertebral disc disorder, intervertebral disc displacement, intervertebral disc protrusion, jaw cyst, joint contracture, joint effusion, joint swelling, lumbar spinal stenosis, metatarsalgia, muscle spasms, musculoskeletal discomfort, musculoskeletal stiffness, myalgia, neck pain, osteoarthritis, osteochondrosis, osteoporosis, pain in extremity, periarthritis, periarticular disorder, plantar fasciitis, pseudoarthrosis, psoriatic arthropathy, rhabdomyolysis, rotator cuff syndrome, sacroiliitis, spinal disorder, spinal osteoarthritis, spinal pain, spinal stenosis, spondylolisthesis, synovial cyst, tendonitis, tenosynovitis, tenosynovitis stenosis, or trigger finger.Claim 89: The pharmaceutical composition of claim 73, wherein the neoplasm benign, malignant, or unspecified is adenocarcinoma metastatic, adrenal adenoma, anogenital warts, benign esophageal neoplasm, colorectal adenoma, hemangioma of liver, invasive ductal breast carcinoma, esophageal carcinoma, prostatic adenoma, or uterine leiomyoma.Claim 90: The pharmaceutical composition of claim 73, wherein the nervous system disorder is anosmia, bradykinesia, carpal tunnel syndrome, cervicobrachial syndrome, diabetic neuropathy, dizziness, encephalopathy, headache, hypoesthesia, lumbar radiculopathy, lumbosacral radiculopathy, metabolic encephalopathy, migraine, myotonia,149Attorney Docket No.24-1507-WOneuralgia, neuritis, Parkinson's disease, restless legs syndrome, retinal migraine, sciatica, sensory loss, spinal cord hematoma, subarachnoid hemorrhage, syncope, or tension headache.Claim 91: The pharmaceutical composition of claim 73, wherein the psychiatric disorder is adjustment disorder, affective disorder, anxiety, depression, insomnia, irritability, mixed anxiety and depressive disorder, sleep disorder, or stress.Claim 92: The pharmaceutical composition of claim 73, wherein the renal or urinary disorder is acute kidney injury, calculus urinary, chronic kidney disease, cystitis hemorrhagic, cystitis noninfective, end stage renal disease, glomerulonephritis chronic, hematuria, hypertonic bladder, nephrolithiasis, nephrosclerosis, pollakiuria, proteinuria, renal colic, renal cyst, stress urinary incontinence, ureterolithiasis, or urinary tract inflammation.Claim 93: The pharmaceutical composition of claim 73, wherein the reproductive system or breast disorder is abnormal uterine bleeding, adenomyosis, Bartholin's cyst, erectile dysfunction, hydrocele female, intermenstrual bleeding, menstruation irregular, prostatitis, prostatomegaly, uterine hemorrhage, or vaginal discharge.Claim 94: The pharmaceutical composition of claim 73, wherein the respiratory, thoracic, or mediastinal disorder is bronchitis chronic, cough, dysphonia, interstitial lunch disease, nasal congestion, oropharyngeal pain, respiratory failure, rhinorrhea, sinus congestion, sleep apnea syndrome, or upper respiratory tract inflammation.Claim 95: The pharmaceutical composition of claim 73, wherein the skin or subcutaneous tissue disorder is alopecia, angioedema, dermatitis allergic, dermatitis contact, dermatitis psoriasiform, ecchymosis, erythema, hidradenitis, pruritis, psoriasis, rash, skin exfoliation, or skin ulcer.Claim 96: The pharmaceutical composition of claim 73, wherein the surgical or medical procedure is gastric bypass.Claim 97: The pharmaceutical composition of claim 73, wherein the vascular disorder is aortic arteriosclerosis, aortic dissection, arteriosclerosis, bleeding varicose vein, blood pressure fluctuation, deep vein thrombosis, diabetic microangiopathy, essential hypertension,150Attorney Docket No.24-1507-WOhypertension, hypertensive crisis, lymph stasis, peripheral venous disease, phlebitis, or thrombophlebitis.Claim 98: A method of treating psoriatic arthritis, the method comprising administering an anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein the anti-IL-23p19 antibody hum13B8-b comprises:(i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1, and(ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.Claim 99: The method of claim 98, wherein the method comprises a treatment phase and an extension phase.Claim 100: The method of claim 99, wherein the treatment phase comprises administering hum13B8-b to the patient for up to about 52 weeks.Claim 101: The method of claim 99, wherein the treatment phase comprises administering hum13B8-b to the patient at week 0, at about week 4, and about every 12 weeks thereafter.Claim 102 The method of claim 99, wherein the treatment phase comprises administering hum13B8-b to the patient at week 0, at about week 4, and about every 4 weeks thereafter.Claim 103: The method of claim 99, wherein a therapeutically effective amount of hum13B8-b is administered to the patient during the treatment phase.Claim 104: The method of claim 99, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the treatment phase.Claim 105: The method of claim 104, wherein about 100 mg of hum13B8-b is administered to the patient during the treatment phase.Claim 106: The method of claim 104 wherein about 200 mg of hum13B8-b is administered to the patient during the treatment phase.151Attorney Docket No.24-1507-WOClaim 107: The method of claim 103, wherein hum13B8-b is administered to the patient subcutaneously.Claim 108: The method of claim 103, wherein hum13B8-b is administered to the patient by subcutaneous injection.Claim 109: The method of claim 103, wherein hum13B8-b is administered to the patient using an auto-injector or prefilled syringe.Claim 110: The method of claim 103, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the treatment phase.Claim 111: The method of claim 110, wherein about 100 mg of hum13B8-b is administered to the patient.Claim 112: The method of claim 110, wherein about 200 mg of hum13B8-b is administered to the patient.Claim 113: The method of claim 103, wherein a first dose of hum13B8-b is administered to the patient on week 0, a second dose of hum13B8-b is administered to the patient at about week 4, and subsequent doses of hum13B8-b are administered to the patient at about every 12 weeks thereafter during the treatment phase.Claim 114: The method of claim 113, wherein the first dose of hum13B8-b, the second dose of hum13B8-b, and subsequent doses of hum13B8-b are the same.Claim 115: The method of claim 113, wherein the first dose of hum13B8-b, the second dose of hum13B8-b, and subsequent doses of hum13B8-b are different.Claim 116: The method of claim 114, wherein the first dose, the second dose, and subsequent doses comprise about 100 mg of hum13B8-b.152Attorney Docket No.24-1507-WOClaim 117: The method of claim 114, wherein the first dose, the second dose, and subsequent doses comprise about 200 mg of hum13B8-b.Claim 118: The method of claim 113, wherein the first dose comprises about 100 mg of hum13B8-b.Claim 119: The method of claim 113, wherein the second dose comprises about 100 mg of hum13B8-b.Claim 120 The method of claim 113, wherein the subsequent doses comprise about 100 mg of hum13B8-b.Claim 121: The method of claim 113, wherein the first dose comprises about 200 mg of hum13B8-b.Claim 122: The method of claim 113, wherein the second dose comprises about 200 mg of hum13B8-b.Claim 123: The method of claim 113, wherein the subsequent doses comprise about 200 mg of hum13B8-b.Claim 124: The method of claim 115, wherein the first dose comprises about 100 mg of hum13B8-b, and the amount of hum13B8-b administered in the second dose and subsequent doses is different from the first dose.Claim 125: The method of claim 115, wherein the first dose of hum13B8-b comprises about 200 mg of hum13B8-b, and the amount of hum13B8-b administered in the second dose and subsequent doses is different from the first dose.Claim 126: The method of claim 99, wherein the extension phase comprises administering hum13B8-b to the patient for up to about 208 weeks.153Attorney Docket No.24-1507-WOClaim 127: The method of claim 99, wherein the extension phase comprises administering hum13B8-b to the patient at the same interval as hum13B8-b is administered to the patient during the treatment phase.Claim 128: The method of claim 127, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient about every four weeks (Q4W) during the extension phase.Claim 129: The method of claim 128, wherein hum13B8-b is administered to the patient for at least up to about 4 weeks, for at least up to about 8 weeks, for at least up to about 12 weeks, for at least up to about 16 weeks, for at least up to about 20 weeks, for at least up to about 24 weeks, for at least up to about 28 weeks, for at least up to about 32 weeks, for at least up to about 36 weeks, for at least up to about 40 weeks, for at least up to about 44 weeks, for at least up to about 48 weeks, for at least up to about 52 weeks, for at least up to about 56 weeks, for at least up to about 60 weeks, for at least up to about 64 weeks, for at least up to about 68 weeks, for at least up to about 72 weeks, for at least up to about 76 weeks, for at least up to about 80 weeks, for at least up to about 84 weeks, for at least up to about 88 weeks, for at least up to about 92 weeks, for at least up to about 96 weeks, for at least up to about 100 weeks, for at least up to about 104 weeks, for at least up to about 108 weeks, for at least up to about 112 weeks, for at least up to about 116 weeks, for at least up to about 120 weeks, for at least up to about 124 weeks, for at least up to about 128 weeks, for at least up to about 132 weeks, for at least up to about 136 weeks, for at least up to about 140 weeks, for at least up to about 144 weeks, for at least up to about 148 weeks, for at least up to about 152 weeks, for at least up to about 156 weeks, for at least up to about 160 weeks, for at least up to about 164 weeks, for at least up to about 168 weeks, for at least up to about 172, for at least up to about 176 weeks, for at least up to about 180 weeks, for at least up to about 184 weeks, for at least up to about 188 weeks, for at least up to about 192 weeks, for at least up to about 196 weeks, for at least up to about 200 weeks, for at least up to about 204 weeks, or for at least up to about 208 weeks.Claim 130: The method of claim 128, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient about every twelve weeks (Q12W) during the extension phase.154Attorney Docket No.24-1507-WOClaim 131: The method of claim 130, wherein hum13B8-b is administered to the patient for at least up to about 12 weeks, for at least up to about 24 weeks, for at least up to about 36 weeks, for at least up to about 48 weeks, for at least up to about 60 weeks, for at least up to about 72 weeks, for at least up to about 84 weeks, for at least up to about 96 weeks, for at least up to about 108 weeks, for at least up to about 120 weeks, for at least up to about 132 weeks, for at least up to about 144 weeks, for at least up to about 156 weeks, for at least up to about 168 weeks, for at least up to about 180 weeks, for at least up to about 192 weeks, for at least up to about 204 weeks, or for at least up to about 216 weeks.Claim 132: The method of claim 99, wherein hum13B8-b is administered to the patient at different time intervals during the extension phase than the time intervals hum13B8-b is administered to the patient during the treatment phase.Claim 133: The method of claim 132, wherein hum13B8-b is administered to the patient Q4W during the treatment phase and hum13B8-b is administered to the patient Q12W during the extension phase.Claim 134: The method of claim 99, wherein a therapeutically effective amount of hum13B8-b is administered to the patient during the extension phase.Claim 135: The method of claim 134, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the extension phase.Claim 136: The method of claim 135, wherein about 100 mg of hum13B8-b is administered to the patient.Claim 137: The method of claim 135, wherein about 200 mg of hum13B8-b is administered to the patient.Claim 138: The method of claim 99, wherein the dose of hum13B8-b administered to the patient during the extension phase is different than the dose of hum13B8-b administered to the patient during the treatment phase.155Attorney Docket No.24-1507-WOClaim 139: The method of claim 138, wherein about 200 mg of hum13B8-b is administered to the patient during the treatment phase and about 100 mg of hum13B8-b is administered to the patient during the extension phase.Claim 140: The method of claim 138, wherein about 200 mg hum13B8-b is administered to the patient Q4W during the treatment phase and about 100 mg hum13B8-b is administered to the patient Q12W during the extension phase.Claim 141: The method of claim 99, wherein the same dose of hum13B8-b is administered to the patient during the extension phase and during the treatment phase.Claim 142: The method of claim 141, wherein about 100 mg hum13B8-b is administered to the patient during the treatment phase and about 100 mg hum13B8-b is administered to the patient during the extension phase.Claim 143: The method of claim 141, wherein about 200 mg of hum13B8-b is administered to the patient during the treatment phase and about 200 mg of hum13B8-b is administered to the patient during the extension phase.Claim 144: The method of any one of claims 98-143, wherein the method comprises a treatment phase of up to about 52 weeks followed by an extension phase of an additional up to about 208 weeks, wherein about 100 mg or about 200 mg of hum13B8-b is administered to the patient during the extension phase.Claim 145: The method of any one of claims 134-144, wherein hum13B8-b is administered to the patient subcutaneously during the extension phase.Claim 146: The method of claim 145, wherein hum13B8-b is administered to the patient by subcutaneous injection.Claim 147: The method of claim 145, wherein hum13B8-b is administered to the patient using an auto-injector or prefilled syringe.156Attorney Docket No.24-1507-WOClaim 148: The method of any one of claims 126-136, 138-142, or 144-147, wherein administration of about 100 mg of hum13B8-b during the extension phase results in minimal or no serious adverse events (SAEs) in the patient.Claim 149: The method of to any one of claims 126-134, 137, 138, 141, or 143-147, wherein administration of about 200 mg of hum13B8-b during the extension phase results in minimal or no serious adverse events (SAEs) in the patient.Claim 150: The method of either claim 148 or claim 149, wherein the SAEs include one or more of blood and or lymphatic disorders, cardiac disorders, gastrointestinal disorders, general disorders, hepatobiliary disorders, infections or infestations, injuries, poisoning or procedural complications, investigations, metabolism or nutrition disorders, musculoskeletal or connective tissue disorders, neoplasms, nervous system disorders, renal or urinary disorders, reproductive system or breast disorders, respiratory, thoracic, or mediastinal disorders, surgical or medical procedures, and / or vascular disorders.Claim 151: The method of claim 150, wherein the blood or lymphatic disorder is anemia.Claim 152: The method of claim 150, wherein the cardiac disorder is acute myocardial infarction, cardiac failure, coronary artery stenosis, or tachycardia.Claim 153: The method of claim 150, wherein the gastrointestinal disorder is abdominal hernia, hemorrhagic erosive gastritis, or intestinal obstruction.Claim 154: The method of claim 150, wherein the general disorder is generalized oedema.Claim 155: The method of claim 150, wherein the hepatobiliary disorder is cholelithiasis.Claim 156: The method of claim 150, wherein the infection or infestation is abdominal abscess, COVID-19 pneumonia, gallbladder empyema, intestinal sepsis, septic shock, or upper respiratory tract infection.157Attorney Docket No.24-1507-WOClaim 157: The method of claim 150, wherein the injury, poisoning, or procedural complication is craniocerebral injury, hip fracture, humerus fracture, ligament rupture, subdural hematoma, or tibia fracture.Claim 158: The method of claim 150, wherein the investigation is a kidney biopsy.Claim 159: The method of claim 150, wherein the metabolism or nutrition disorder is diabetes mellitus.Claim 160: The method of claim 150, wherein the musculoskeletal or connective tissue disorder is intervertebral disc disorder, lumbar spinal stenosis, osteoarthritis, or rhabdomyolysis.Claim 161: The method of claim 150, wherein the neoplasm is adenocarcinoma metastatic, colorectal adenoma, invasive ductal breast carcinoma, esophageal carcinoma, or uterine leiomyoma.Claim 162: The method of claim 150, wherein the nervous system disorder is dizziness, metabolic encephalopathy, retinal migraine, subarachnoid hemorrhage, or tension headache.Claim 163: The method of claim 150, wherein the renal or urinary disorder is acute kidney injury, calculus urinary, end stage renal disease, or ureterolithiasis.Claim 164: The method of claim 150, wherein the reproductive system or breast disorder is hydrocele female or uterine hemorrhage.Claim 165: The method of claim 150, wherein the respiratory, thoracic, or mediastinal disorder is bronchitis chronic or interstitial lung disease.Claim 166: The method of claim 150, wherein the surgical or medical procedure is gastric bypass.Claim 167: The method of claim 150, wherein the vascular disorder is aortic dissection, arteriosclerosis, deep vein thrombosis, hypertension, or hypertensive crisis.158Attorney Docket No.24-1507-WOClaim 168: The method of any one of claims 126-136, 138-142, or 144-147, wherein administration of about 100 mg of hum13B8-b during the extension phase results in minimal or no other adverse events (OAEs) in the patient.Claim 169: The method of any one of claims 126-134, 137, 138, 141, or 143-147, wherein administration of about 200 mg of hum13B8-b during the extension phase results in minimal or no other adverse events (OAEs) in the patientClaim 170: The method of either claim 168 or claim 169, wherein the OAEs include one or more of blood or lymphatic system disorders, cardiac disorders, congenital, familial, or genetic disorders, ear or labyrinth disorders, endocrine disorders, eye disorders, gastrointestinal disorders, general disorders, hepatobiliary disorders, immune system disorders, infections or infestations, injuries, poisoning or procedural complications, investigations, metabolism or nutrition disorders, musculoskeletal or connective tissue disorders, neoplasms benign, malignant, or unspecified, nervous system disorders, psychiatric disorders, renal or urinary disorders, reproductive system or breast disorders, respiratory, thoracic, or mediastinal disorders, skin or subcutaneous tissue disorders, surgical or medical procedures, or vascular disorders.Claim 171: The method of claim 170, wherein the blood or lymphatic system disorder is anemia, leukocytosis, leukopenia, lymphadenopathy, lymphopenia, neutropenia, or neutrophilia.Claim 172: The method of claim 170, wherein the cardiac disorder is acute myocardial infarction, atrial fibrillation, atrioventricular block first degree, cardiac failure, cardiac failure congestive, coronary artery stenosis, diastolic dysfunction, mitral valve incompetence, myocardial ischemia, palpitations, pericardial cyst, sinus tachycardia, tachycardia, or tricuspid valve incompetence.Claim 173: The method of claim 170, wherein the congenital, familial, or genetic disorder is accessory spleen, Gilbert's syndrome, or hydrocele.159Attorney Docket No.24-1507-WOClaim 174: The method of claim 170, wherein the ear or labyrinth disorder is ear pain or vertigo.Claim 175: The method of claim 170, wherein the endocrine disorder is autoimmune thyroiditis, goiter, hypothyroidic goiter, hypothyroidism, or thyroid mass.Claim 176: The method of claim 170, wherein the eye disorder is astigmatism, blepharitis, blindness transient, cataract, cataract nuclear, diabetic retinopathy, keratitis, myopia, retinal vascular disorder, or visual acuity reduced.Claim 177: The method of claim 170, wherein the gastrointestinal disorder is abdominal hernia, abdominal pain, abdominal pain upper, abdominal rigidity, anal fistula, aphthous ulcer, Barrett's esophagus, chronic gastritis, coeliac artery stenosis, constipation, dental caries, diaphragmatic hernia, diarrhea, diverticulum, diverticulum intestinal, duodenitis, dyspepsia, enteritis, food poisoning, gastric ulcer, gastritis, gastritis erosive, gastrointestinal disorder, gastroesophageal reflux disease, gingival swelling, hemorrhagic erosive gastritis, hemorrhoids, hiatus hernia, intestinal metaplasia, intestinal obstruction, irritable bowel syndrome, large intestine polyp, nausea, pancreatitis chronic, rectal polyp, retained deciduous tooth, toothache, or vomiting.Claim 178: The method of claim 170, wherein the general disorder is asthenia, chest pain, chills, drug intolerance, fatigue, generalized oedema, influenza like illness, injection site erythema, injection site pain, injection site pruritus, injection site rash, injection site reaction, injury associated with device, oedema peripheral, pyrexia, vaccination site pain, or xerosis.Claim 179: The method of claim 170, wherein the hepatobiliary disorder is biliary dyskinesia, cholecystitis, cholelithiasis, cholestasis, diabetic hepatopathy, gallbladder polyp, hepatic steatosis, hepatitis, hyperbilirubinemia, hypertransaminasaemia, non-alcoholic steatohepatitis, or steatohepatitis.Claim 180: The method of claim 170, wherein the immune system disorder is an allergy to an arthropod bite or allergy to plants.160Attorney Docket No.24-1507-WOClaim 181: The method of claim 170, wherein the infection or infestation is abdominal abscess, acute sinusitis, adenovirus infection, bacteriuria, Bartholin's abscess, breast abscess, bronchitis, COVID-19, COVID-19 pneumonia, cellulitis, chronic sinusitis, conjunctivitis, coronavirus infection, cystitis, diverticulitis, erythema migraines, Escherichia infection, furuncle, gallbladder empyema, gastroenteritis, gastroenteritis viral, gastrointestinal bacterial overgrowth, gastrointestinal infection, gingivitis, helicobacter gastritis, helicobacter infection, Herpes simplex, Herpes zoster, Hordeolum, influenza, intestinal sepsis, joint abscess, laryngitis, localized infection, lower respiratory tract infection, nasopharyngitis, oral herpes, otitis externa, otitis media, periodontitis, pharyngitis, pharyngotonsillitis, pneumonia, pneumonia bacterial, pulmonary tuberculosis, pulpitis dental, purulent discharge, pyelonephritis, pyelonephritis acute, respiratory tract infection, respiratory tract infection viral, rhinitis, septic shock, sinusitis, skin infection, suspected COVID-19, tonsillitis, tooth infection, tracheitis, tracheobronchitis, upper respiratory tract infection, urinary tract infection, vaginal infection, viral infection, viral pharyngitis, viral upper respiratory tract infection, vulvovaginal mycotic infection, or wound infection.Claim 182: The method of claim 170, wherein the injury, poisoning, or procedural complication is second degree burns, concussion, contusion, craniocerebral injury, cuboid syndrome, epicondylitis, fall, fibula fracture, foot fracture, hand fracture, hip fracture, humerus fracture, iliotibial band syndrome, immunization reaction, joint injury, ligament rupture, ligament sprain, limb injury, meniscus injury, muscle strain, nail avulsion, post vaccination syndrome, skin abrasion, skin laceration, soft tissue injury, spinal compression fracture, subdural hematoma, synovial rupture, tendon injury, thermal burn, tibia fracture, or tooth fracture.Claim 183: The method of claim 170, wherein the investigation is alanine aminotransferase increased, apolipoprotein B increased, aspartate aminotransferase increased, bilirubin conjugated increased, bilirubin urine present, biopsy kidney, blood bilirubin increased, blood cholesterol increased, blood creatine phosphokinase increased, blood creatinine increased, blood glucose increased, blood pressure increased, blood triglycerides increased, blood urea increased, C-reactive protein increased, Gamma-glutamyl transferase increased, glomerular filtration rate decreased, hematocrit decreased, hemoglobin decreased, hepatic enzyme increased, low density lipoprotein increased, lymphocyte count decreased, monocyte count decreased, neutrophil count decreased, platelet count decreased, prostatic161Attorney Docket No.24-1507-WOspecific antigen increased, red blood cell count decreased, transaminases increased, urinary casts, weight decreased, weight increased, or white blood cell count decreased.Claim 184: The method of claim 170, wherein the metabolism or nutrition disorder is cholesterosis, copper deficiency, dehydration, diabetes mellitus, diabetes mellitus inadequate control, dyslipidemia, glucose tolerance impaired, hypercholesterolemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, hyperuricemia, hypokalemia, hypomagnesaemia, hyponatremia, impaired fasting glucose, insulin resistance, obesity, type 2 diabetes mellitus, or vitamin D deficiency.Claim 185: The method of claim 170, wherein the musculoskeletal or connective tissue disorder is arthralgia, arthritis, back pain, bursitis, dactylitis, exostosis, fracture pain, greater trochanteric pain syndrome, intervertebral disc disorder, intervertebral disc displacement, intervertebral disc protrusion, jaw cyst, joint contracture, joint effusion, joint swelling, lumbar spinal stenosis, metatarsalgia, muscle spasms, musculoskeletal discomfort, musculoskeletal stiffness, myalgia, neck pain, osteoarthritis, osteochondrosis, osteoporosis, pain in extremity, periarthritis, periarticular disorder, plantar fasciitis, pseudoarthrosis, psoriatic arthropathy, rhabdomyolysis, rotator cuff syndrome, sacroiliitis, spinal disorder, spinal osteoarthritis, spinal pain, spinal stenosis, spondylolisthesis, synovial cyst, tendonitis, tenosynovitis, tenosynovitis stenosis, or trigger finger.Claim 186: The method of claim 170, wherein the neoplasm benign, malignant, or unspecified is adenocarcinoma metastatic, adrenal adenoma, anogenital warts, benign esophageal neoplasm, colorectal adenoma, hemangioma of liver, invasive ductal breast carcinoma, esophageal carcinoma, prostatic adenoma, or uterine leiomyoma.Claim 187: The method of claim 170, wherein the nervous system disorder is anosmia, bradykinesia, carpal tunnel syndrome, cervicobrachial syndrome, diabetic neuropathy, dizziness, encephalopathy, headache, hypoesthesia, lumbar radiculopathy, lumbosacral radiculopathy, metabolic encephalopathy, migraine, myotonia, neuralgia, neuritis, Parkinson's disease, restless legs syndrome, retinal migraine, sciatica, sensory loss, spinal cord hematoma, subarachnoid hemorrhage, syncope, or tension headache.162Attorney Docket No.24-1507-WOClaim 188: The method of claim 170, wherein the psychiatric disorder is adjustment disorder, affective disorder, anxiety, depression, insomnia, irritability, mixed anxiety and depressive disorder, sleep disorder, or stress.Claim 189: The method of claim 170, wherein the renal or urinary disorder is acute kidney injury, calculus urinary, chronic kidney disease, cystitis hemorrhagic, cystitis noninfective, end stage renal disease, glomerulonephritis chronic, hematuria, hypertonic bladder, nephrolithiasis, nephrosclerosis, pollakiuria, proteinuria, renal colic, renal cyst, stress urinary incontinence, ureterolithiasis, or urinary tract inflammation.Claim 190: The method of claim 170, wherein the reproductive system or breast disorder is abnormal uterine bleeding, adenomyosis, Bartholin's cyst, erectile dysfunction, hydrocele female, intermenstrual bleeding, menstruation irregular, prostatitis, prostatomegaly, uterine hemorrhage, or vaginal discharge.Claim 191: The method of claim 170, wherein the respiratory, thoracic, or mediastinal disorder is bronchitis chronic, cough, dysphonia, interstitial lunch disease, nasal congestion, oropharyngeal pain, respiratory failure, rhinorrhea, sinus congestion, sleep apnea syndrome, or upper respiratory tract inflammation.Claim 192: The method of claim 170, wherein the skin or subcutaneous tissue disorder is alopecia, angioedema, dermatitis allergic, dermatitis contact, dermatitis psoriasiform, ecchymosis, erythema, hidradenitis, pruritis, psoriasis, rash, skin exfoliation, or skin ulcer.Claim 193: The method of claim 170, wherein the surgical or medical procedure is gastric bypass.Claim 194: The method of claim 170, wherein the vascular disorder is aortic arteriosclerosis, aortic dissection, arteriosclerosis, bleeding varicose vein, blood pressure fluctuation, deep vein thrombosis, diabetic microangiopathy, essential hypertension, hypertension, hypertensive crisis, lymph stasis, peripheral venous disease, phlebitis, or thrombophlebitis.163