Treating spondyloarthritic and psoriatic conditions with upadacitinib

Abstract

To provide methods for treating various spondyloarthritic and psoriatic conditions.SOLUTION: Provided are methods for treating various spondyloarthritic and psoriatic conditions, including types of axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), and psoriasis (PsO), by a JAK1 inhibitor, upadacitinib free base or a pharmaceutically acceptable salt thereof. In various aspects, methods for treating active non-radiographic axSpA (nr-axSpA), methods for treating active ankylosing spondylitis (AS), methods for treating active psoriatic arthritis (PsA), and methods for treating active psoriasis (PsO) are provided.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 032,042, filed May 29, 2020; U.S. Provisional Patent Application No. 62 / 968,849, filed January 31, 2020; U.S. Provisional Patent Application No. 62 / 927,548, filed October 29, 2019; and U.S. Provisional Patent Application No. 62 / 908,163, filed September 30, 2019, all of which are incorporated by reference in their entireties. [Background technology]

[0002] Axial spondyloarthritis (axSpA) encompasses diverse inflammatory involvement of the axial skeleton. Based on the International Society for the Assessment of Spondyloarthritis (ASAS) axSpA criteria, the disease can be further divided into two radiographic categories: ankylosing spondylitis (AS) and an "early" form of axial SpA, termed non-radiographic axial spondyloarthritis (nr-axSpA). Patients with nr-axSpA and AS share common epidemiological, genetic, and clinical disease characteristics, including those related to disease activity, as well as similar responses to treatment. See, e.g., Poddubnyy and Sieper, Curr Opin Rheumatol. (2014) 26:377-383.

[0003] According to international treatment recommendations, nonsteroidal anti-inflammatory drugs (NSAIDs) are the first-line treatment for axSpA. See, for example, van der Heijde D et al., Ann Rheum Dis. (2017) 76:978-991; Ward et al., Arthritis Rheumatol. (2016) 68:282-298. After failure of two NSAIDs administered for up to four weeks, biologic disease-modifying antirheumatic drugs (bDMARDs) are the next recommended treatment option. In axSpA, conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and long-term corticosteroids are ineffective and therefore not recommended for the treatment of axial symptoms. See, for example, van der Heijde D et al., Ann Rheum Dis. (2017) 76:978-991. Furthermore, only approximately 45%–50% of patients demonstrate an International Society for the Assessment of Spondyloarthritis (ASAS40) response, and only approximately 15%–20% achieve remission in bionaïve patients, with response rates even lower in axSpA, which has shown an inadequate response to bDMARDs. See, for example, Sieper and Poddubnyy, Lancet (2017) 390:73–84; Sieper et al., Ann Rheum Dis. (2017) 76:571–592; Rudwaleit et al., Arthritis Res Ther. (2010) 12:R117; Deodhar et al., Arthritis Rheumatol. (2019) 71:599–611. To date, with the exception of NSAIDs, no oral targeted therapy has been approved for the treatment of ankylosing spondylitis (AS) or axSpA that does not meet radiographic criteria.

[0004] Psoriatic arthritis (PsA) is a chronic systemic inflammatory disease classified as a subtype of spondyloarthritis (SpA) and is characterized by the association of arthritis and psoriasis. The course of PsA is typically characterized by cycles of inflammation and remission. Left untreated, patients with PsA may experience persistent inflammation, progressive joint damage, disability, and reduced life expectancy. Initial treatment for musculoskeletal symptoms consists of local injections of nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids, while topical therapy is used for the initial treatment of psoriasis. In patients for whom these treatments are neither effective nor toxic, systemic therapy with nonbiologic disease-modifying antirheumatic drugs (nonbiologic DMARDs) (e.g., methotrexate [MTX], leflunomide [LEF], sulfasalazine [SSZ]) and cyclosporine A is recommended, followed by anti-tumor necrosis factor (TNF) therapy in patients with an inadequate response. In addition, other biologic therapies (e.g., IL-12 / 23 or IL-17 inhibitors) are also recommended in certain PsA patients instead of anti-TNF inhibitors. See, for example, Gossec et al., Ann Rheum Dis. (2016) 75:499-510; Coates et al., Arthritis Rheumatol. (2016) 68:1060-71. However, despite the beneficial results achieved with currently available biologic agents, approximately 40% of patients do not achieve at least a 20% improvement in their American College of Rheumatology (ACR) score, and only 58%-61% of PsA patients receiving these agents achieve clinical remission one year after treatment, with only approximately 43% achieving sustained remission for at least one year. For example, Gossec et al., Ann Rheum Dis.(2016)75:499-510;Alamanos et al.,J Rheumatol.(2003)30:2641-2644;Savolainen et al.,J Rheumatol.(2003)30:2460-8;Sandborn,Dig See Dis. (2010) 28:536-42; Saber et al., Arthritis Res Therapy (2010) 12: R94; Perrotta et al., J Rheumatol. (2016) 43:350-5. [Prior art documents]

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[0005]

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[0006] Therefore, there remains a clear medical need for additional therapeutic options for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), and psoriasis (PsO), including PsO as a cutaneous manifestation of PsA. [Means for solving the problem]

[0007] The present disclosure addresses the above needs and provides methods for treating axial spondyloarthritis (axSpA), including non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), and methods for treating psoriasis (PsO), including psoriatic arthritis (PsA) and PsO as a cutaneous manifestation of PsA.

[0008] Embodiments 1-77 set forth below illustrate particular aspects of the methods described herein.

[0009] Embodiment 1: In certain aspects, provided are methods for treating active ankylosing spondylitis (AS) in a subject in need thereof, comprising orally administering to the subject once daily for at least 14 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof in an amount sufficient to deliver the equivalent of 15 mg of upadacitinib free base, wherein the subject achieves an International Society for Spondyloarthritis Assessment 40 (ASAS40) response within 14 weeks of administration of the first dose.

[0010] Embodiment 2: The method of embodiment 1, wherein when the method is used to treat a population of subjects, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of the subjects in the treated population achieve an ASAS40 response within 14 weeks of administration of the first dose. In certain embodiments of the method of embodiment 1, when the method is used to treat a population of subjects, a statistically significant portion of the subjects in the treated population achieve an ASAS40 response within 14 weeks of administration of the first dose.

[0011] Embodiment 3: A subject or subjects in the treated population who have active AS at baseline receive, within 14 weeks of administering the first dose: Improvement from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS); b. Improvement from baseline in magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score for the spine (MRI-Spine SPARCC); c.ASAS partial remission (PR); d.Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) response; e. Improvement from baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI); f.ASDAS Low Disease Activity (LDA); g.ASDAS inactive disease (ID); h. Significant improvement in ASDAS (MI); and i. Clinically important improvement on ASDAS (CII) 3. The method of embodiment 1 or 2, further achieving at least one result selected from the group consisting of:

[0012] In certain embodiments of the method of Embodiment 1 or 2, when the method is used to treat a population of subjects, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of the subjects in the treated population achieve at least one of these outcomes within 14 weeks of administration of the first dose. In other embodiments of the method of Embodiment 1 or 2, when the method is used to treat a population of subjects, a statistically significant portion of the subjects in the treated population achieve at least one of these outcomes within 14 weeks of administration of the first dose.

[0013] Embodiment 4: The method of embodiment 3, wherein the subject or subjects in said treated population with active AS at baseline further achieve each outcome within 14 weeks of administration of the first dose.

[0014] Embodiment 5: The method of any one of embodiments 1-4, wherein the subject or subjects in said treated population meet the 1984 Revised New York Criteria for Ankylosing Spondylitis at baseline.

[0015] Embodiment 6: The method of any one of embodiments 1 to 5, wherein the subject or subjects in said treated population meet the 2009 ASAS classification criteria at baseline.

[0016] Embodiment 7: A subject or subjects in the treated population, at baseline, a.Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4; b. Ankylosing Spondylitis Disease Activity Score (ASDAS) of 2.1 or greater; and c. Patient assessment of total back pain on a numerical rating scale of 0 to 10 (total back pain score) of 4 or greater The method of any one of embodiments 1 to 6, wherein the method satisfies at least one criterion selected from the group consisting of:

[0017] Embodiment 8: The method of any one of embodiments 1-7, wherein the subject or subjects in said treated population are biological disease-modifying antirheumatic drug (bDMARD) naive at baseline.

[0018] Embodiment 9: The method of any one of embodiments 1-7, wherein the subject or subjects in the treated population have an inadequate response to or intolerance to biological disease-modifying antirheumatic drugs (bDMARDs) at baseline.

[0019] Embodiment 10: The method of embodiment 9, wherein prior to administration of the first dose, the subject or subjects in the treated population have been administered a bDMARD and have discontinued use of the bDMARD due to intolerance or lack of efficacy.

[0020] Embodiment 11: The method of embodiment 10, wherein the bDMARD is a tumor necrosis factor (TNF) inhibitor or an interleukin (IL)-17 inhibitor.

[0021] Embodiment 12: The method of any one of embodiments 1 to 11, wherein the subject or subjects in the treated population have, at baseline, an inadequate response to or intolerance to at least two NSAIDs, intolerance to NSAIDS, and / or a contraindication to NSAIDs.

[0022] Embodiment 13: In another aspect, provided is a method for treating active non-radiographic axial spondyloarthritis in a subject in need thereof, comprising orally administering to the subject once daily for at least 14 weeks an amount of upadacitinib free base or a pharmaceutically acceptable salt thereof sufficient to deliver 15 mg of upadacitinib free base equivalent, wherein the subject achieves an ASAS 40 response within 14 weeks of administering the first dose. In certain embodiments, when the method is used to treat a population of subjects, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of subjects in the treated population achieve an ASAS 40 response within 14 weeks of administering the first dose. In certain embodiments, a statistically significant portion of subjects in the treated population achieve an ASAS 40 response within 14 weeks of administering the first dose.

[0023] Embodiment 14: In yet another aspect, a method of treating axial spondyloarthritis that does not meet radiographic criteria for activity in a subject in need thereof is provided, comprising orally administering to the subject one dose of upadacitinib free base or a pharmaceutically acceptable salt thereof once daily for at least 52 weeks, in an amount sufficient to deliver the equivalent of 15 mg of upadacitinib free base, wherein the subject achieves an ASAS 40 response within 52 weeks of administering the first dose. In certain embodiments, when the method is used to treat a population of subjects, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of the subjects in the treated population achieve an ASAS 40 response within 52 weeks of administering the first dose. In certain embodiments, a statistically significant portion of the subjects in the treated population achieve an ASAS 40 response within 52 weeks of administering the first dose.

[0024] Embodiment 15: The method of embodiment 13 or 14, wherein the subject or subjects in the treated population meet the 2009 ASAS classification criteria for axial spondyloarthritis but do not meet the radiological criteria of the 1984 revised New York criteria for ankylosing spondylitis at baseline.

[0025] Embodiment 16: A subject or subjects in the treated population has, at baseline, a.Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4; b. Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥ 2.1; c. Patient assessment of total back pain on a 0-10 numeric rating scale (total back pain score) of 4 or greater; and d. i. Objective signs of active inflammation on MRI of the sacroiliac (SI) joints, and ii. High-sensitivity C-reactive protein > upper limit of normal (ULN) objective signs of inflammatory activity selected from the group consisting of 15. The method of embodiment 13 or 14, wherein the method satisfies at least one criterion selected from the group consisting of:

[0026] Embodiment 17: The method of any one of embodiments 13 to 16, wherein the subject or subjects in said treated population are bDMARD-naive at baseline.

[0027] Embodiment 18: The method of any one of embodiments 13 to 16, wherein the subject or subjects in said treated population have an inadequate response to or intolerance to a bDMARD at baseline.

[0028] Embodiment 19: The method of embodiment 18, wherein prior to administration of the first dose, the subject or subjects in the treated population have received one bDMARD and have discontinued use of the bDMARD due to intolerance or lack of efficacy.

[0029] Embodiment 20: The method of embodiment 19, wherein the bDMARD is a tumor necrosis factor (TNF) inhibitor or an interleukin (IL)-17 inhibitor.

[0030] Embodiment 21: The method of any one of embodiments 13 to 20, wherein the subject or subjects in the treated population have an inadequate response or intolerance to at least two NSAIDs, intolerance to NSAIDS, and / or contraindications to NSAIDs at baseline.

[0031] Embodiment 22: A subject or subjects in the treated population receives, within 14 weeks of receiving a first dose: Improvement from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS); b. Improvement from baseline in the Magnetic Resonance Imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score for the SI joint (MRI-SI joint SPARCC); c.ASAS partial remission (PR); d.Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response; e. Improvement from baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI); f. Improvement from baseline in ankylosing spondylitis quality of life (ASQoL); g. Improvement from baseline in ASAS Health Index (HI); h. Improvement from baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES); and i. Linear Bath Ankylosing Spondylitis Mobility Index (BASMI) lin ) improvement from baseline 22. The method of any one of embodiments 13-21, which achieves at least one additional result selected from the group consisting of:

[0032] In certain embodiments of the method of any one of Embodiments 13-21, when the method is used to treat a population of subjects, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of the subjects in the treated population achieve at least one outcome within 14 weeks of the first administration. In certain embodiments of the method of any one of Embodiments 13-21, when the method is used to treat a population of subjects, a statistically significant portion of the subjects in the treated population achieve at least one outcome within 14 weeks of administration of the first dose.

[0033] Embodiment 23: In yet another aspect, there is provided a method of treating active psoriatic arthritis (PsA) in a subject in need thereof, comprising orally administering to the subject once daily for at least 12 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof in an amount sufficient to deliver the equivalent of 15 mg of upadacitinib free base, wherein the subject achieves an American College of Rheumatology 20% (ACR20) response within 12 weeks of administration of the first dose.

[0034] Embodiment 24: In yet another aspect, there is provided a method of treating active psoriatic arthritis (PsA) in a subject in need thereof, comprising orally administering to the subject once daily for at least 12 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof in an amount sufficient to deliver 30 mg of upadacitinib free base equivalent, wherein the subject achieves an American College of Rheumatology 20% (ACR20) response within 12 weeks of administration of the first dose.

[0035] Embodiment 25: The method of embodiment 23 or 24, wherein when the method is used to treat a population of subjects, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of the subjects in the treated population achieve an ACR20 response within 12 weeks of administration of the first dose. In other embodiments of the method of embodiment 23 or 24, when the method is used to treat a population of subjects, a statistically significant portion of the subjects in the treated population achieve an ACR20 response within 12 weeks of administration of the first dose.

[0036] Embodiment 26: A subject or subjects in the treated population who have active PsA at baseline: Improvement from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) within 12 weeks of the first dose; b. A static psoriasis physician global assessment (sIGA) of 0 or 1 and achieving at least a 2-point improvement from baseline within 16 weeks of the first dose (for subjects with a baseline sIGA of 2 or greater); c. Achieving a PASI (Psoriasis Area and Severity Index) 75 response within 16 weeks of the first dose (for subjects with psoriasis ≥ 3% BSA at baseline); d. Improvement from baseline in Sharp / van der Heijdes score (SHS) within 24 weeks of first dose administration; e. Achieving minimal disease activity (MDA) within 24 weeks of first dose administration; f. An improvement from baseline in Leeds Enthesitis Index (LEI) within 24 weeks of receiving the first dose, preferably, the improvement is the resolution of enthesitis (LEI=0) within 24 weeks of receiving the first dose (in subjects with enthesitis present at baseline (LEI>0)); g. Achieving an ACR20 response within 12 weeks of the first dose (non-inferiority of upadacitinib to adalimumab); h. Improvement from baseline on the 36-item Short Form Health Survey (SF-36) within 12 weeks of first dose administration; and i. Improvement from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire within 12 weeks of the first dose 26. The method of any one of embodiments 23 to 25, further achieving at least one result selected from the group consisting of:

[0037] In certain embodiments, when the methods of Embodiments 23-25 ​​are used to treat a population of subjects, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of the subjects in the treated population achieve at least one outcome within 14 weeks of administering the first dose. In other embodiments, when the methods of Embodiments 23-25 ​​are used to treat a population of subjects, a statistically significant portion of the subjects in the treated population achieve at least one outcome within 14 weeks of administering the first dose.

[0038] Embodiment 27: The method of embodiment 26, wherein the subject or subjects in said treated population who have active PsA at baseline further achieve each outcome.

[0039] Embodiment 28: A subject or subjects in the treated population who have active PsA at baseline: ACR20 response within 12 weeks of first dose administration and superiority to adalimumab (40 mg every other week); and b. An improvement from baseline in the Leeds Dactylitis Index (LDI) within 24 weeks of administration of the first dose, preferably the improvement being the disappearance of dactylitis (LDI=0) within 24 weeks of administration of the first dose (in subjects with dactylitis present at baseline (LDI>0)). 28. The method of any of embodiments 23-27, further achieving at least one result selected from the group consisting of:

[0040] In certain embodiments of embodiment 28, when the method is used to treat a population of subjects, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of the subjects in the treated population achieve at least one outcome within 14 weeks of administering the first dose. In other embodiments of embodiment 28, when the method is used to treat a population of subjects, a statistically significant portion of the subjects in the treated population achieve at least one outcome within 14 weeks of administering the first dose.

[0041] Embodiment 29: The method of embodiment 28, wherein a subject or subjects in said treated population with active PsA further achieve an ACR20 response and superiority to adalimumab (40 mg every other week) within 12 weeks of receiving the first dose. In certain embodiments of embodiment 29, a statistically significant proportion of subjects in the treated population achieve an ACR20 response and superiority to adalimumab within 12 weeks of receiving the first dose. In certain embodiments of embodiment 29, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of subjects in the treated population achieve an ACR20 response and superiority to adalimumab within 12 weeks of receiving the first dose.

[0042] Embodiment 30: The method of embodiment 29, wherein a subject or subjects in the treated population with active PsA are orally administered once daily for at least 12 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof sufficient to deliver the equivalent of 30 mg of upadacitinib free base.

[0043] Embodiment 31: The method of any one of embodiments 23-30, wherein a subject or subjects in the treated population achieve an ACR50 response (ACR50) within 12 weeks of administration of the first dose. In certain embodiments of embodiment 31, a statistically significant proportion of subjects in the treated population achieve an ACR50 response within 12 weeks of administration of the first dose. In certain embodiments of embodiment 31, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of subjects in the treated population achieve an ACR50 response within 12 weeks of administration of the first dose.

[0044] Embodiment 32: The method of any one of embodiments 23-30, wherein a subject or subjects in the treated population achieve an ACR70 response (ACR70) within 12 weeks of administration of the first dose. In certain embodiments of embodiment 32, a statistically significant proportion of subjects in the treated population achieve an ACR70 response within 12 weeks of administration of the first dose. In certain embodiments of embodiment 32, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of subjects in the treated population achieve an ACR70 response within 12 weeks of administration of the first dose.

[0045] Embodiment 33: The method of any one of embodiments 23-32, wherein the subject or subjects in said treated population meet Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at baseline.

[0046] Embodiment 34: The method of any one of embodiments 23 to 33, wherein the subject or subjects in the treated population have at baseline at least one criterion selected from the group consisting of 3 or more tender joints (based on a 68-joint count) and 3 or more swollen joints (based on a 66-joint count).

[0047] Embodiment 35: The method of embodiment 34, wherein the subject or subjects in said treated population have 5 or more tender joints (based on a 68-joint count) and 5 or more swollen joints (based on a 66-joint count) at baseline.

[0048] Embodiment 36: The method of any one of embodiments 23 to 35, wherein the subject or subjects in the treated population have, at baseline, at least one criterion selected from the group consisting of one or more erosions on x-ray as determined by central imaging review, and hs-CRP > laboratory-defined upper limit of normal (ULN).

[0049] Embodiment 37: The method of any one of embodiments 23-36, wherein the subject or subjects in said treated population have a diagnosis of active plaque psoriasis or said subject has a documented history of plaque psoriasis at baseline.

[0050] Embodiment 38: The method of any one of embodiments 23 to 36, wherein the subject or subjects in the treated population have an inadequate response to or intolerance to at least one biological disease-modifying antirheumatic drug (bDMARD) at baseline.

[0051] Embodiment 39: The method of embodiment 38, wherein the subject or subjects in said treated population have discontinued all bDMARDs prior to administration of the first dose.

[0052] Embodiment 40: The method of any one of embodiments 23 to 36, wherein the subject or subjects in the treated population have, at baseline, an inadequate response to or intolerance to prior or concurrent treatment with at least one non-biologic DMARD, or intolerance to or a contraindication to a non-biologic DMARD.

[0053] Embodiment 41: The method of any one of embodiments 23 to 40, wherein the subject or subjects in the treated population have moderate to severe active psoriatic arthritis at baseline.

[0054] Embodiment 42: In yet another aspect, there is provided a method of treating active psoriasis in a subject in need thereof, comprising orally administering to the subject once daily for at least 16 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof sufficient to deliver the equivalent of 15 mg of upadacitinib free base, wherein the subject achieves a Psoriasis Area Severity Index (PASI) 75 response within 16 weeks of administration of the first dose.

[0055] Embodiment 43: In yet another aspect, there is provided a method of treating active psoriasis in a subject in need thereof, comprising orally administering to the subject once daily for at least 16 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof sufficient to deliver 30 mg of upadacitinib free base equivalent, wherein the subject achieves a Psoriasis Area Severity Index (PASI) 75 response within 16 weeks of administration of the first dose.

[0056] Embodiment 44: The method of embodiment 42 or 43, wherein when the method is used to treat a population of subjects, a portion of the subjects in the treated population achieve a PASI 75 response within 16 weeks of receiving the first dose. In certain embodiments of embodiment 44, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of the subjects in the treated population achieve a PASI 75 response within 16 weeks of receiving the first dose. In other embodiments of embodiment 44, a statistically significant portion of the subjects in the treated population achieve a PASI 75 response within 16 weeks of receiving the first dose.

[0057] Embodiment 45: The method of any one of embodiments 1 to 44 or 46 to 77, wherein the subject is an adult subject, or the subjects in the treated population are adult subjects.

[0058] Embodiment 46: The method of any one of embodiments 1-12, wherein the ASAS40 response is maintained or improved beyond week 14 by continuing to administer the daily dose. In one aspect, the ASAS40 response is maintained or improved through week 64.

[0059] Embodiment 47: The method of any one of embodiments 1 to 12, wherein the subject or subjects in the treated population further achieve an ASAS 40 within 2 weeks of administration of the first dose.

[0060] Embodiment 48: The method of any one of embodiments 1 to 12, wherein the subject or subjects in the treated population further achieve an ASAS40 within 2 weeks of administering the first dose, and wherein said ASAS40 is maintained or improved at week 14 or beyond by continuing to administer daily doses.

[0061] Embodiment 49: In another aspect, provided is a method of treating active ankylosing spondylitis in a subject in need thereof, comprising orally administering to the subject once daily for at least 14 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof sufficient to deliver the equivalent of 15 mg of upadacitinib free base, wherein the subject achieves ASAS partial response (PR), ASDAS low disease activity (LDA), ASDAS inactive disease (ID), ASDAS major improvement (MI), and / or ASDAS clinically important improvement (CII) within 14 weeks of administration of the first dose.

[0062] Embodiment 50: The method of embodiment 49, wherein when the method is used to treat a population of subjects, a portion of the subjects in the treated population achieve ASAS partial response (PR), ASDAS low disease activity (LDA), ASDAS inactive disease (ID), ASDAS major improvement (MI), and / or ASDAS clinically important improvement (CII) within 14 weeks of receiving the first dose. In certain embodiments of embodiment 50, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of the subjects in the treated population achieve ASAS partial response (PR), ASDAS low disease activity (LDA), ASDAS inactive disease (ID), ASDAS major improvement (MI), and / or ASDAS clinically important improvement (CII) within 14 weeks of receiving the first dose. In certain embodiments of embodiment 50, a statistically significant proportion of subjects in the treated population achieve ASAS partial response (PR), ASDAS low disease activity (LDA), ASDAS inactive disease (ID), ASDAS major improvement (MI), and / or ASDAS clinically important improvement (CII) within 14 weeks of administration of the first dose.

[0063] Embodiment 51: The method of embodiment 49 or 50, wherein the subject or subjects in said treated population further achieve each outcome within 14 weeks of administration of the first dose.

[0064] Embodiment 52: The method of any one of embodiments 49-51, wherein the subject or subjects in the treated population meet the 1984 Revised New York Criteria for Ankylosing Spondylitis at baseline.

[0065] Embodiment 53: The method of any one of embodiments 49 to 51, wherein the subject or subjects in the treated population meet the 2009 ASAS classification criteria at baseline.

[0066] Embodiment 54: A subject or subjects in the treated population has, at baseline, a.Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4; b. Ankylosing Spondylitis Disease Activity Score (ASDAS) of 2.1 or greater; and c. Patient assessment of total back pain on a numerical rating scale of 0 to 10 (total back pain score) of 4 or greater 54. The method of any one of embodiments 49 to 53, wherein the method satisfies at least one criterion selected from the group consisting of:

[0067] Embodiment 55: The method of any one of embodiments 49-54, wherein the subject or subjects in said treated population are biological disease-modifying antirheumatic drug (bDMARD) naive at baseline.

[0068] Embodiment 56: The method of any one of embodiments 49-55, wherein the subject or subjects in the treated population have an inadequate response to or intolerance to biological disease-modifying antirheumatic drugs (bDMARDs) at baseline.

[0069] Embodiment 57: The method of embodiment 56, wherein prior to administration of the first dose, the subject or subjects in the population have received one bDMARD and have discontinued use of the bDMARD due to intolerance or lack of efficacy.

[0070] Embodiment 58: The method of embodiment 57, wherein the bDMARD is a tumor necrosis factor (TNF) inhibitor or an interleukin (IL)-17 inhibitor.

[0071] Embodiment 59: The method of any one of embodiments 49 to 58, wherein the subject or subjects in the population have, at baseline, an inadequate response to or intolerance to at least two NSAIDs, intolerance to NSAIDS, and / or a contraindication to NSAIDs.

[0072] Embodiment 60: The method of any one of embodiments 49-59, wherein ASAS partial response (PR), ASDAS low disease activity (LDA), ASDAS inactive disease (ID), ASDAS major improvement (MI), and / or ASDAS clinically important improvement (CII) is maintained or improved from week 14 onwards by continuing administration of the daily dose.

[0073] Embodiment 61: The method of any one of embodiments 49-60, wherein a subject or subjects in said treated population further achieve ASAS partial response (PR), ASDAS low disease activity (LDA), ASDAS inactive disease (ID), ASDAS major improvement (MI), and / or ASDAS clinically important improvement (CII) within 2 weeks of administration of the first dose. In a particular embodiment of embodiment 61, a statistically significant portion of subjects in the treated population achieve ASAS partial response (PR), ASDAS low disease activity (LDA), ASDAS inactive disease (ID), ASDAS major improvement (MI), and / or ASDAS clinically important improvement (CII) within 2 weeks of administration of the first dose. In certain embodiments of embodiment 61, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of subjects in the treated population achieve ASAS partial response (PR), ASDAS low disease activity (LDA), ASDAS inactive disease (ID), ASDAS major improvement (MI), and / or ASDAS clinically important improvement (CII) within 2 weeks of administration of the first dose.

[0074] Embodiment 62: The method of any one of embodiments 23 to 41, wherein the ACR score is maintained or improved from week 12 onwards by continuing to administer the daily dose.

[0075] Embodiment 63: The method of any one of embodiments 23 to 41 or 62, wherein the subject or subjects in said treated population further achieve ACR20 within 2 weeks of administration of the first dose.

[0076] Embodiment 64: The method of any one of embodiments 42-44, wherein the subject or subjects in the treated population achieve a Psoriasis Area Severity Index (PASI) 90 response within 16 weeks of administration of the first dose.

[0077] Embodiment 65: The method of any one of embodiments 42-44 or 64, wherein the PASI response is maintained or improved beyond week 16 by continuing to administer the daily dose.

[0078] Embodiment 66: In another aspect, there is provided a method of treating active psoriatic arthritis in a subject in need thereof, comprising orally administering to the subject once daily for at least 24 weeks an amount of upadacitinib free base, or a pharmaceutically acceptable form thereof, sufficient to deliver the equivalent of 15 mg of upadacitinib free base, wherein the subject achieves minimal disease activity (MDA) within 24 weeks of administration of the first dose.

[0079] Embodiment 67: In another aspect, there is provided a method of treating active psoriatic arthritis in a subject in need thereof, comprising orally administering to the subject once daily for at least 24 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof sufficient to deliver the equivalent of 30 mg of upadacitinib free base, wherein the subject achieves minimal disease activity (MDA) within 24 weeks of administration of the first dose.

[0080] Embodiment 68: The method of embodiment 66 or 67, wherein when the method is used to treat a population of subjects, a portion of the subjects in the treated population achieve minimal disease activity (MDA) within 24 weeks of administration of the first dose. In certain embodiments of embodiment 68, a statistically significant portion of the subjects in the treated population achieve minimal disease activity (MDA) within 24 weeks of administration of the first dose. In certain embodiments of embodiment 68, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of the subjects in the treated population achieve minimal disease activity (MDA) within 24 weeks of administration of the first dose.

[0081] Embodiment 69: The method of any one of embodiments 66-68, wherein a subject or subjects in the treated population further achieves a Psoriasis Area and Severity Index (PASI) response selected from a PASI 75 response, a PASI 90 response, and a PASI 100 response within 16 weeks of administration of the first dose, and wherein the PASI response is maintained or improved beyond week 16 with continued administration of the daily dose. In certain embodiments of embodiment 69, a statistically significant proportion of subjects in the treated population achieve a PASI 75 response, a PASI 90 response, and a PASI 100 response within 16 weeks of administration of the first dose. In certain embodiments of embodiment 69, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of subjects in the treated population achieve a PASI 75 response, a PASI 90 response, and a PASI 100 response within 16 weeks of administration of the first dose.

[0082] Embodiment 70: The method of any one of embodiments 23-42, wherein a subject or subjects in the treated population achieve a Psoriasis Area Severity Index (PASI) 75 response within 16 weeks of receiving the first dose. In certain embodiments of embodiment 70, a statistically significant proportion of subjects in the treated population achieve a PASI 75 response within 16 weeks of receiving the first dose. In certain embodiments of embodiment 70, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of subjects in the treated population achieve a PASI 75 response within 16 weeks of receiving the first dose.

[0083] Embodiment 71: The method of any one of embodiments 23-42 or 70, wherein the subject or subjects in the treated population achieve a Psoriasis Area Severity Index (PASI) 90 response within 16 weeks of administration of the first dose.

[0084] Embodiment 72: The method of any one of embodiments 23-42 or 70-71, wherein the subject or subjects in the treated population achieve a Psoriasis Area Severity Index (PASI) 100 response within 16 weeks of administration of the first dose.

[0085] Embodiment 73: In another aspect, there is provided a method of treating active psoriatic arthritis in a subject in need thereof, comprising orally administering to the subject once daily for at least 16 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof in an amount sufficient to deliver the equivalent of 15 mg of upadacitinib free base, wherein the subject achieves a Psoriasis Area Severity Index (PASI) 75 response within 16 weeks of administration of the first dose.

[0086] Embodiment 74: In another aspect, there is provided a method of treating active psoriatic arthritis in a subject in need thereof, comprising orally administering to the subject once daily for at least 16 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof sufficient to deliver 30 mg of upadacitinib free base equivalent, wherein the subject achieves a Psoriasis Area Severity Index (PASI) 75 response within 16 weeks of administration of the first dose.

[0087] Embodiment 75: The method of embodiment 73 or 74, wherein, when the method is used to treat a population of subjects, some subjects in the treated population achieve a PASI 75 response within 16 weeks of administering the first dose. In certain embodiments of embodiment 75, a statistically significant portion of the subjects in the treated population achieve a PASI 75 response within 16 weeks of administering the first dose. In certain embodiments of embodiment 75, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, or at least 45% of the subjects in the treated population achieve a PASI 75 response within 16 weeks of administering the first dose.

[0088] Embodiment 76: The method of any one of embodiments 73 to 75, wherein the subject or subjects in the treated population achieve a Psoriasis Area Severity Index (PASI) 90 response within 16 weeks of administration of the first dose.

[0089] Embodiment 77: The method of any one of embodiments 73 to 76, wherein the subject or subjects in the treated population achieve a Psoriasis Area Severity Index (PASI) 100 response within 16 weeks of administration of the first dose. [Brief explanation of the drawings]

[0090] [Figure 1] Diagram depicting the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS1) clinical trial design. An asterisk (*) indicates that radiographs were taken during the screening period. ASAS40 = International Spondyloarthritis Assessment Society 40% response. MRI = Magnetic Resonance Imaging. QD = Once daily. SI = Sacroiliac joint. [Figure 2]This diagram depicts the multiplicity-controlled analysis used in the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS1) clinical trial using the Hochberg method. An asterisk (*) indicates that the result was statistically significant in the multiplicity-controlled analysis; otherwise, a nominal p-value is shown. Multiplicity-controlled endpoints are tested sequentially, with an initial assigned α of 0.05. Statistical significance (p<0.05) can be claimed for a lower endpoint only if the previous endpoint in the procedure meets the requirements for statistical significance. The ASAS HI can only be assessed if all endpoints tested by the Hochberg method are statistically significant. The Hochberg method tests all endpoints using an α assigned according to the magnitude of the nominal p-value, starting from the highest value. If an endpoint is rejected, all endpoints with smaller p-values ​​are also rejected. If an endpoint fails, the procedure proceeds to the next endpoint. ASAS = International Society for Spondyloarthritis Assessment. ASAS40 = ASAS 40% Response. ASAS HI = ASAS Health Index. ASAS PR = ASAS partial remission. ASDAS = Ankylosing Spondylitis Disease Activity Score. ASQoL = Ankylosing Spondylitis Quality of Life. BASDAI50 = 50% improvement from baseline in the Bath Ankylosing Spondylitis Disease Activity Index. BASFI = Bath Ankylosing Spondylitis Functional Index. BASMI = Bath Ankylosing Spondylitis Mobility Index. MASES = Maastricht Ankylosing Spondylitis Enthesitis Score. MRI = Magnetic Resonance Imaging. QD = Once daily. SPARCC = Canadian Spondyloarthritis Research Consortium. WPAI = Work Productivity and Activity Impairment. [Figure 3A]Figures 3A and 3B depict week 14 results of the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS1) clinical trial for the primary clinical efficacy endpoint and the time course of the primary endpoint through week 64, respectively. Figure 3A depicts ASAS20, ASAS40, ASAS PR, and BASDAI50 responses at week 14; Figure 3B depicts change from baseline in SPARCC MRI spine and SI joint scores at week 14; and Figure 3C depicts other multi-control primary secondary efficacy endpoints at week 14. These results demonstrate that the study met its endpoints, with a statistically significantly higher number of patients receiving upadacitinib free base than those receiving placebo achieving an ASAS40 response at Week 14 (48 / 93 [51.6%] vs. 24 / 94 [25.5%]; p=0.0003), for a treatment difference (95% CI) of 26.1% (12.6-39.5%). All endpoints were multiply controlled except for ASAS20 and SPARCC MRI SI joint. Multiply controlled secondary endpoints were tested sequentially and included ASDAS, SPARCC MRI spine, Hochberg-tested endpoints (BASDAI50, ASQoL, ASAS PR, BASFI, BASMI, MASES, and WPAI), and ASAS HI. In Figures 3L-3N, an asterisk (***) indicates P<0.001, an asterisk (**) indicates P<0.01, and an asterisk (*) indicates P<0.05. For other figures, an asterisk (*) indicates statistical significance in multiplicity-controlled analyses; otherwise, nominal p-values ​​are shown. After multiplicity adjustment, the changes from baseline to week 14 in ASDAS (Figure 3C), SPARCC MRI Spine (Figure 3B), and BASFI (Figure 3C), as well as the proportion of patients achieving BASDAI50 (Figure 3A) and ASAS PR (Figure 3A), were statistically significant for upadacitinib free base versus placebo.Figures 3D–3K depict the time course of ASAS40 (Figure 3D), ASAS20 (Figure 3E), ASAS partial response (PR) (Figure 3F), BASDAI50 response (Figure 3G), ASDAS inactive disease (ID) (Figure 3H), ASDAS low disease activity (LDA) (Figure 3I), ASDAS major improvement (MI) (Figure 3J), and ASDAS clinically important improvement (CII) (Figure 3K) through Week 64. At Week 14, the placebo group was rescued and administered upadacitinib 15 mg free base (placebo → upadacitinib 15 mg QD). Patients who switched from placebo to upadacitinib at Week 14 demonstrated similar efficacy responses compared with patients who continued upadacitinib free base from Day 0. These data suggest that upadacitinib 15 mg QD achieves efficacy at Week 14 and maintains or even improves efficacy through Week 64, addressing an unmet need for patients with AS (even those with non-radiographic axial spondyloarthritis (nr-axSpA)), particularly those with active disease who are not adequately responsive to NSAIDs. A significantly higher proportion of patients receiving upadacitinib compared with placebo achieved reductions in Patient Pain Assessment (Pt Pain) of 30% or more as early as Week 2 (Figure 3L), 50% or more (Figure 3M), and 70% or more as early as Week 4 (Figure 3N), and the achieved efficacy was maintained thereafter. Patients who switched from placebo to open-label upadacitinib at Week 14 generally achieved the same level of pain relief as patients originally randomized to upadacitinib from Week 14 onward. MASES assessments included patients with enthesitis at baseline, WPAI assessments included currently enrolled patients, and SPARCC MRI assessments included populations pre-specified in the statistical analysis plan (baseline included MRI data within 3 days of the first dose of study medication, and week 14 included MRI data up to the first dose of phase 2 study medication). ASAS20 = International Society for Spondyloarthritis Assessment 20 Response. ASAS40 = International Society for Spondyloarthritis Assessment 40 Response. ASQoL = Ankylosing Spondylitis Quality of Life Score. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI50 = 50% improvement from baseline in Barth Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BASMI = Barth Ankylosing Spondylitis Mobility Index.HI = Health Index. MASES = Maastricht Ankylosing Spondylitis Enthesitis Score. MRI = Magnetic Resonance Imaging. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. AO = Observed. PR = Partial Response. QD = Once Daily. SI = Sacroiliac. SPARCC = Canadian Spondyloarthritis Research Consortium. WPAI = Work Productivity and Activity Impairment. [Figure 3B]Figures 3A and 3B depict week 14 results of the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS1) clinical trial for the primary clinical efficacy endpoint and the time course of the primary endpoint through week 64, respectively. Figure 3A depicts ASAS20, ASAS40, ASAS PR, and BASDAI50 responses at week 14; Figure 3B depicts change from baseline in SPARCC MRI spine and SI joint scores at week 14; and Figure 3C depicts other multi-control primary secondary efficacy endpoints at week 14. These results demonstrate that the study met its endpoints, with a statistically significantly higher number of patients receiving upadacitinib free base than those receiving placebo achieving an ASAS40 response at Week 14 (48 / 93 [51.6%] vs. 24 / 94 [25.5%]; p=0.0003), for a treatment difference (95% CI) of 26.1% (12.6-39.5%). All endpoints were multiply controlled except for ASAS20 and SPARCC MRI SI joint. Multiply controlled secondary endpoints were tested sequentially and included ASDAS, SPARCC MRI spine, Hochberg-tested endpoints (BASDAI50, ASQoL, ASAS PR, BASFI, BASMI, MASES, and WPAI), and ASAS HI. In Figures 3L-3N, an asterisk (***) indicates P<0.001, an asterisk (**) indicates P<0.01, and an asterisk (*) indicates P<0.05. For other figures, an asterisk (*) indicates statistical significance in multiplicity-controlled analyses; otherwise, nominal p-values ​​are shown. After multiplicity adjustment, the changes from baseline to week 14 in ASDAS (Figure 3C), SPARCC MRI Spine (Figure 3B), and BASFI (Figure 3C), as well as the proportion of patients achieving BASDAI50 (Figure 3A) and ASAS PR (Figure 3A), were statistically significant for upadacitinib free base versus placebo.Figures 3D–3K depict the time course of ASAS40 (Figure 3D), ASAS20 (Figure 3E), ASAS partial response (PR) (Figure 3F), BASDAI50 response (Figure 3G), ASDAS inactive disease (ID) (Figure 3H), ASDAS low disease activity (LDA) (Figure 3I), ASDAS major improvement (MI) (Figure 3J), and ASDAS clinically important improvement (CII) (Figure 3K) through Week 64. At Week 14, the placebo group was rescued and administered upadacitinib 15 mg free base (placebo → upadacitinib 15 mg QD). Patients who switched from placebo to upadacitinib at Week 14 demonstrated similar efficacy responses compared with patients who continued upadacitinib free base from Day 0. These data suggest that upadacitinib 15 mg QD achieves efficacy at Week 14 and maintains or even improves efficacy through Week 64, addressing an unmet need for patients with AS (even those with non-radiographic axial spondyloarthritis (nr-axSpA)), particularly those with active disease who are not adequately responsive to NSAIDs. A significantly higher proportion of patients receiving upadacitinib compared with placebo experienced reductions in Patient Pain Assessment (Pt Pain) of 30% or greater as early as Week 2 (Figure 3L), 50% or greater (Figure 3M), and 70% or greater as early as Week 4 (Figure 3N), with the efficacy achieved subsequently maintained. Patients who switched from placebo to open-label upadacitinib at Week 14 generally achieved the same level of pain relief as patients originally randomized to upadacitinib from Week 14 onward. MASES assessments included patients with enthesitis at baseline, WPAI assessments included currently enrolled patients, and SPARCC MRI assessments included populations pre-specified in the statistical analysis plan (baseline included MRI data within 3 days of the first dose of study medication, and week 14 included MRI data up to the first dose of phase 2 study medication). ASAS20 = International Society for Spondyloarthritis Assessment 20 Response. ASAS40 = International Society for Spondyloarthritis Assessment 40 Response. ASQoL = Ankylosing Spondylitis Quality of Life Score. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI50 = 50% improvement from baseline in Barth Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BASMI = Barth Ankylosing Spondylitis Mobility Index.HI = Health Index. MASES = Maastricht Ankylosing Spondylitis Enthesitis Score. MRI = Magnetic Resonance Imaging. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. AO = Observed. PR = Partial Response. QD = Once Daily. SI = Sacroiliac. SPARCC = Canadian Spondyloarthritis Research Consortium. WPAI = Work Productivity and Activity Impairment. [Figure 3C]Figures 3A and 3B depict week 14 results of the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS1) clinical trial for the primary clinical efficacy endpoint and the time course of the primary endpoint through week 64, respectively. Figure 3A depicts ASAS20, ASAS40, ASAS PR, and BASDAI50 responses at week 14; Figure 3B depicts change from baseline in SPARCC MRI spine and SI joint scores at week 14; and Figure 3C depicts other multi-control primary secondary efficacy endpoints at week 14. These results demonstrate that the study met its endpoints, with a statistically significantly higher number of patients receiving upadacitinib free base than those receiving placebo achieving an ASAS40 response at Week 14 (48 / 93 [51.6%] vs. 24 / 94 [25.5%]; p=0.0003), for a treatment difference (95% CI) of 26.1% (12.6-39.5%). All endpoints were multiply controlled except for ASAS20 and SPARCC MRI SI joint. Multiply controlled secondary endpoints were tested sequentially and included ASDAS, SPARCC MRI spine, Hochberg-tested endpoints (BASDAI50, ASQoL, ASAS PR, BASFI, BASMI, MASES, and WPAI), and ASAS HI. In Figures 3L-3N, an asterisk (***) indicates P<0.001, an asterisk (**) indicates P<0.01, and an asterisk (*) indicates P<0.05. For other figures, an asterisk (*) indicates statistical significance in multiplicity-controlled analyses; otherwise, nominal p-values ​​are shown. After multiplicity adjustment, the changes from baseline to week 14 in ASDAS (Figure 3C), SPARCC MRI Spine (Figure 3B), and BASFI (Figure 3C), as well as the proportion of patients achieving BASDAI50 (Figure 3A) and ASAS PR (Figure 3A), were statistically significant for upadacitinib free base versus placebo.Figures 3D–3K depict the time course of ASAS40 (Figure 3D), ASAS20 (Figure 3E), ASAS partial response (PR) (Figure 3F), BASDAI50 response (Figure 3G), ASDAS inactive disease (ID) (Figure 3H), ASDAS low disease activity (LDA) (Figure 3I), ASDAS major improvement (MI) (Figure 3J), and ASDAS clinically important improvement (CII) (Figure 3K) through Week 64. At Week 14, the placebo group was rescued and administered upadacitinib 15 mg free base (placebo → upadacitinib 15 mg QD). Patients who switched from placebo to upadacitinib at Week 14 demonstrated similar efficacy responses compared with patients who continued upadacitinib free base from Day 0. These data suggest that upadacitinib 15 mg QD achieves efficacy at Week 14 and maintains or even improves efficacy through Week 64, addressing an unmet need for patients with AS (even those with non-radiographic axial spondyloarthritis (nr-axSpA)), particularly those with active disease who are not adequately responsive to NSAIDs. A significantly higher proportion of patients receiving upadacitinib compared with placebo experienced reductions in Patient Pain Assessment (Pt Pain) of 30% or greater as early as Week 2 (Figure 3L), 50% or greater (Figure 3M), and 70% or greater as early as Week 4 (Figure 3N), with the efficacy achieved subsequently maintained. Patients who switched from placebo to open-label upadacitinib at Week 14 generally achieved the same level of pain relief as patients originally randomized to upadacitinib from Week 14 onward. MASES assessments included patients with enthesitis at baseline, WPAI assessments included currently enrolled patients, and SPARCC MRI assessments included populations pre-specified in the statistical analysis plan (baseline included MRI data within 3 days of the first dose of study medication, and week 14 included MRI data up to the first dose of phase 2 study medication). ASAS20 = International Society for Spondyloarthritis Assessment 20 Response. ASAS40 = International Society for Spondyloarthritis Assessment 40 Response. ASQoL = Ankylosing Spondylitis Quality of Life Score. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI50 = 50% improvement from baseline in Barth Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BASMI = Barth Ankylosing Spondylitis Mobility Index.HI = Health Index. MASES = Maastricht Ankylosing Spondylitis Enthesitis Score. MRI = Magnetic Resonance Imaging. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. AO = Observed. PR = Partial Response. QD = Once Daily. SI = Sacroiliac. SPARCC = Canadian Spondyloarthritis Research Consortium. WPAI = Work Productivity and Activity Impairment. [Figure 3D]Figures 3A and 3B depict week 14 results of the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS1) clinical trial for the primary clinical efficacy endpoint and the time course of the primary endpoint through week 64, respectively. Figure 3A depicts ASAS20, ASAS40, ASAS PR, and BASDAI50 responses at week 14; Figure 3B depicts change from baseline in SPARCC MRI spine and SI joint scores at week 14; and Figure 3C depicts other multi-control primary secondary efficacy endpoints at week 14. These results demonstrate that the study met its endpoints, with a statistically significantly higher number of patients receiving upadacitinib free base than those receiving placebo achieving an ASAS40 response at Week 14 (48 / 93 [51.6%] vs. 24 / 94 [25.5%]; p=0.0003), for a treatment difference (95% CI) of 26.1% (12.6-39.5%). All endpoints were multiply controlled except for ASAS20 and SPARCC MRI SI joint. Multiply controlled secondary endpoints were tested sequentially and included ASDAS, SPARCC MRI spine, Hochberg-tested endpoints (BASDAI50, ASQoL, ASAS PR, BASFI, BASMI, MASES, and WPAI), and ASAS HI. In Figures 3L-3N, an asterisk (***) indicates P<0.001, an asterisk (**) indicates P<0.01, and an asterisk (*) indicates P<0.05. For other figures, an asterisk (*) indicates statistical significance in multiplicity-controlled analyses; otherwise, nominal p-values ​​are shown. After multiplicity adjustment, the changes from baseline to week 14 in ASDAS (Figure 3C), SPARCC MRI Spine (Figure 3B), and BASFI (Figure 3C), as well as the proportion of patients achieving BASDAI50 (Figure 3A) and ASAS PR (Figure 3A), were statistically significant for upadacitinib free base versus placebo.Figures 3D–3K depict the time course of ASAS40 (Figure 3D), ASAS20 (Figure 3E), ASAS partial response (PR) (Figure 3F), BASDAI50 response (Figure 3G), ASDAS inactive disease (ID) (Figure 3H), ASDAS low disease activity (LDA) (Figure 3I), ASDAS major improvement (MI) (Figure 3J), and ASDAS clinically important improvement (CII) (Figure 3K) through Week 64. At Week 14, the placebo group was rescued and administered upadacitinib 15 mg free base (placebo → upadacitinib 15 mg QD). Patients who switched from placebo to upadacitinib at Week 14 demonstrated similar efficacy responses compared with patients who continued upadacitinib free base from Day 0. These data suggest that upadacitinib 15 mg QD achieves efficacy at Week 14 and maintains or even improves efficacy through Week 64, addressing an unmet need for patients with AS (even those with non-radiographic axial spondyloarthritis (nr-axSpA)), particularly those with active disease who are not adequately responsive to NSAIDs. A significantly higher proportion of patients receiving upadacitinib compared with placebo experienced reductions in Patient Pain Assessment (Pt Pain) of 30% or greater as early as Week 2 (Figure 3L), 50% or greater (Figure 3M), and 70% or greater as early as Week 4 (Figure 3N), with the efficacy achieved subsequently maintained. Patients who switched from placebo to open-label upadacitinib at Week 14 generally achieved the same level of pain relief as patients originally randomized to upadacitinib from Week 14 onward. MASES assessments included patients with enthesitis at baseline, WPAI assessments included currently enrolled patients, and SPARCC MRI assessments included populations pre-specified in the statistical analysis plan (baseline included MRI data within 3 days of the first dose of study medication, and week 14 included MRI data up to the first dose of phase 2 study medication). ASAS20 = International Society for Spondyloarthritis Assessment 20 Response. ASAS40 = International Society for Spondyloarthritis Assessment 40 Response. ASQoL = Ankylosing Spondylitis Quality of Life Score. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI50 = 50% improvement from baseline in Barth Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BASMI = Barth Ankylosing Spondylitis Mobility Index.HI = Health Index. MASES = Maastricht Ankylosing Spondylitis Enthesitis Score. MRI = Magnetic Resonance Imaging. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. AO = Observed. PR = Partial Response. QD = Once Daily. SI = Sacroiliac. SPARCC = Canadian Spondyloarthritis Research Consortium. WPAI = Work Productivity and Activity Impairment. [Figure 3E]Figures 3A and 3B depict week 14 results of the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS1) clinical trial for the primary clinical efficacy endpoint and the time course of the primary endpoint through week 64, respectively. Figure 3A depicts ASAS20, ASAS40, ASAS PR, and BASDAI50 responses at week 14; Figure 3B depicts change from baseline in SPARCC MRI spine and SI joint scores at week 14; and Figure 3C depicts other multi-control primary secondary efficacy endpoints at week 14. These results demonstrate that the study met its endpoints, with a statistically significantly higher number of patients receiving upadacitinib free base than those receiving placebo achieving an ASAS40 response at Week 14 (48 / 93 [51.6%] vs. 24 / 94 [25.5%]; p=0.0003), for a treatment difference (95% CI) of 26.1% (12.6-39.5%). All endpoints were multiply controlled except for ASAS20 and SPARCC MRI SI joint. Multiply controlled secondary endpoints were tested sequentially and included ASDAS, SPARCC MRI spine, Hochberg-tested endpoints (BASDAI50, ASQoL, ASAS PR, BASFI, BASMI, MASES, and WPAI), and ASAS HI. In Figures 3L-3N, an asterisk (***) indicates P<0.001, an asterisk (**) indicates P<0.01, and an asterisk (*) indicates P<0.05. For other figures, an asterisk (*) indicates statistical significance in multiplicity-controlled analyses; otherwise, nominal p-values ​​are shown. After multiplicity adjustment, the changes from baseline to week 14 in ASDAS (Figure 3C), SPARCC MRI Spine (Figure 3B), and BASFI (Figure 3C), as well as the proportion of patients achieving BASDAI50 (Figure 3A) and ASAS PR (Figure 3A), were statistically significant for upadacitinib free base versus placebo.Figures 3D–3K depict the time course of ASAS40 (Figure 3D), ASAS20 (Figure 3E), ASAS partial response (PR) (Figure 3F), BASDAI50 response (Figure 3G), ASDAS inactive disease (ID) (Figure 3H), ASDAS low disease activity (LDA) (Figure 3I), ASDAS major improvement (MI) (Figure 3J), and ASDAS clinically important improvement (CII) (Figure 3K) through Week 64. At Week 14, the placebo group was rescued and administered upadacitinib 15 mg free base (placebo → upadacitinib 15 mg QD). Patients who switched from placebo to upadacitinib at Week 14 demonstrated similar efficacy responses compared with patients who continued upadacitinib free base from Day 0. These data suggest that upadacitinib 15 mg QD achieves efficacy at Week 14 and maintains or even improves efficacy through Week 64, addressing an unmet need for patients with AS (even those with non-radiographic axial spondyloarthritis (nr-axSpA)), particularly those with active disease who are not adequately responsive to NSAIDs. A significantly higher proportion of patients receiving upadacitinib compared with placebo experienced reductions in Patient Pain Assessment (Pt Pain) of 30% or greater as early as Week 2 (Figure 3L), 50% or greater (Figure 3M), and 70% or greater as early as Week 4 (Figure 3N), with the efficacy achieved subsequently maintained. Patients who switched from placebo to open-label upadacitinib at Week 14 generally achieved the same level of pain relief as patients originally randomized to upadacitinib from Week 14 onward. MASES assessments included patients with enthesitis at baseline, WPAI assessments included currently enrolled patients, and SPARCC MRI assessments included populations pre-specified in the statistical analysis plan (baseline included MRI data within 3 days of the first dose of study medication, and week 14 included MRI data up to the first dose of phase 2 study medication). ASAS20 = International Society for Spondyloarthritis Assessment 20 Response. ASAS40 = International Society for Spondyloarthritis Assessment 40 Response. ASQoL = Ankylosing Spondylitis Quality of Life Score. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI50 = 50% improvement from baseline in Barth Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BASMI = Barth Ankylosing Spondylitis Mobility Index.HI = Health Index. MASES = Maastricht Ankylosing Spondylitis Enthesitis Score. MRI = Magnetic Resonance Imaging. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. AO = Observed. PR = Partial Response. QD = Once Daily. SI = Sacroiliac. SPARCC = Canadian Spondyloarthritis Research Consortium. WPAI = Work Productivity and Activity Impairment. [Figure 3F]Figures 3A and 3B depict week 14 results of the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS1) clinical trial for the primary clinical efficacy endpoint and the time course of the primary endpoint through week 64, respectively. Figure 3A depicts ASAS20, ASAS40, ASAS PR, and BASDAI50 responses at week 14; Figure 3B depicts change from baseline in SPARCC MRI spine and SI joint scores at week 14; and Figure 3C depicts other multi-control primary secondary efficacy endpoints at week 14. These results demonstrate that the study met its endpoints, with a statistically significantly higher number of patients receiving upadacitinib free base than those receiving placebo achieving an ASAS40 response at Week 14 (48 / 93 [51.6%] vs. 24 / 94 [25.5%]; p=0.0003), for a treatment difference (95% CI) of 26.1% (12.6-39.5%). All endpoints were multiply controlled except for ASAS20 and SPARCC MRI SI joint. Multiply controlled secondary endpoints were tested sequentially and included ASDAS, SPARCC MRI spine, Hochberg-tested endpoints (BASDAI50, ASQoL, ASAS PR, BASFI, BASMI, MASES, and WPAI), and ASAS HI. In Figures 3L-3N, an asterisk (***) indicates P<0.001, an asterisk (**) indicates P<0.01, and an asterisk (*) indicates P<0.05. For other figures, an asterisk (*) indicates statistical significance in multiplicity-controlled analyses; otherwise, nominal p-values ​​are shown. After multiplicity adjustment, the changes from baseline to week 14 in ASDAS (Figure 3C), SPARCC MRI Spine (Figure 3B), and BASFI (Figure 3C), as well as the proportion of patients achieving BASDAI50 (Figure 3A) and ASAS PR (Figure 3A), were statistically significant for upadacitinib free base versus placebo.Figures 3D–3K depict the time course of ASAS40 (Figure 3D), ASAS20 (Figure 3E), ASAS partial response (PR) (Figure 3F), BASDAI50 response (Figure 3G), ASDAS inactive disease (ID) (Figure 3H), ASDAS low disease activity (LDA) (Figure 3I), ASDAS major improvement (MI) (Figure 3J), and ASDAS clinically important improvement (CII) (Figure 3K) through Week 64. At Week 14, the placebo group was rescued and administered upadacitinib 15 mg free base (placebo → upadacitinib 15 mg QD). Patients who switched from placebo to upadacitinib at Week 14 demonstrated similar efficacy responses compared with patients who continued upadacitinib free base from Day 0. These data suggest that upadacitinib 15 mg QD achieves efficacy at Week 14 and maintains or even improves efficacy through Week 64, addressing an unmet need for patients with AS (even those with non-radiographic axial spondyloarthritis (nr-axSpA)), particularly those with active disease who are not adequately responsive to NSAIDs. A significantly higher proportion of patients receiving upadacitinib compared with placebo achieved reductions in Patient Pain Assessment (Pt Pain) of 30% or more as early as Week 2 (Figure 3L), 50% or more (Figure 3M), and 70% or more as early as Week 4 (Figure 3N), and the achieved efficacy was maintained thereafter. Patients who switched from placebo to open-label upadacitinib at Week 14 generally achieved the same level of pain relief as patients originally randomized to upadacitinib from Week 14 onward. MASES assessments included patients with enthesitis at baseline, WPAI assessments included currently enrolled patients, and SPARCC MRI assessments included populations pre-specified in the statistical analysis plan (baseline included MRI data within 3 days of the first dose of study medication, and week 14 included MRI data up to the first dose of phase 2 study medication). ASAS20 = International Society for Spondyloarthritis Assessment 20 Response. ASAS40 = International Society for Spondyloarthritis Assessment 40 Response. ASQoL = Ankylosing Spondylitis Quality of Life Score. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI50 = 50% improvement from baseline in Barth Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BASMI = Barth Ankylosing Spondylitis Mobility Index.HI = Health Index. MASES = Maastricht Ankylosing Spondylitis Enthesitis Score. MRI = Magnetic Resonance Imaging. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. AO = Observed. PR = Partial Response. QD = Once Daily. SI = Sacroiliac. SPARCC = Canadian Spondyloarthritis Research Consortium. WPAI = Work Productivity and Activity Impairment. [Figure 3G]Figures 3A and 3B depict week 14 results of the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS1) clinical trial for the primary clinical efficacy endpoint and the time course of the primary endpoint through week 64, respectively. Figure 3A depicts ASAS20, ASAS40, ASAS PR, and BASDAI50 responses at week 14; Figure 3B depicts change from baseline in SPARCC MRI spine and SI joint scores at week 14; and Figure 3C depicts other multi-control primary secondary efficacy endpoints at week 14. These results demonstrate that the study met its endpoints, with a statistically significantly higher number of patients receiving upadacitinib free base than those receiving placebo achieving an ASAS40 response at Week 14 (48 / 93 [51.6%] vs. 24 / 94 [25.5%]; p=0.0003), for a treatment difference (95% CI) of 26.1% (12.6-39.5%). All endpoints were multiply controlled except for ASAS20 and SPARCC MRI SI joint. Multiply controlled secondary endpoints were tested sequentially and included ASDAS, SPARCC MRI spine, Hochberg-tested endpoints (BASDAI50, ASQoL, ASAS PR, BASFI, BASMI, MASES, and WPAI), and ASAS HI. In Figures 3L-3N, an asterisk (***) indicates P<0.001, an asterisk (**) indicates P<0.01, and an asterisk (*) indicates P<0.05. For other figures, an asterisk (*) indicates statistical significance in multiplicity-controlled analyses; otherwise, nominal p-values ​​are shown. After multiplicity adjustment, the changes from baseline to week 14 in ASDAS (Figure 3C), SPARCC MRI Spine (Figure 3B), and BASFI (Figure 3C), as well as the proportion of patients achieving BASDAI50 (Figure 3A) and ASAS PR (Figure 3A), were statistically significant for upadacitinib free base versus placebo.Figures 3D–3K depict the time course of ASAS40 (Figure 3D), ASAS20 (Figure 3E), ASAS partial response (PR) (Figure 3F), BASDAI50 response (Figure 3G), ASDAS inactive disease (ID) (Figure 3H), ASDAS low disease activity (LDA) (Figure 3I), ASDAS major improvement (MI) (Figure 3J), and ASDAS clinically important improvement (CII) (Figure 3K) through Week 64. At Week 14, the placebo group was rescued and administered upadacitinib 15 mg free base (placebo → upadacitinib 15 mg QD). Patients who switched from placebo to upadacitinib at Week 14 demonstrated similar efficacy responses compared with patients who continued upadacitinib free base from Day 0. These data suggest that upadacitinib 15 mg QD achieves efficacy at Week 14 and maintains or even improves efficacy through Week 64, addressing an unmet need for patients with AS (even those with non-radiographic axial spondyloarthritis (nr-axSpA)), particularly those with active disease who are not adequately responsive to NSAIDs. A significantly higher proportion of patients receiving upadacitinib compared with placebo achieved reductions in Patient Pain Assessment (Pt Pain) of 30% or more as early as Week 2 (Figure 3L), 50% or more (Figure 3M), and 70% or more as early as Week 4 (Figure 3N), and the achieved efficacy was maintained thereafter. Patients who switched from placebo to open-label upadacitinib at Week 14 generally achieved the same level of pain relief as patients originally randomized to upadacitinib from Week 14 onward. MASES assessments included patients with enthesitis at baseline, WPAI assessments included currently enrolled patients, and SPARCC MRI assessments included populations pre-specified in the statistical analysis plan (baseline included MRI data within 3 days of the first dose of study medication, and week 14 included MRI data up to the first dose of phase 2 study medication). ASAS20 = International Society for Spondyloarthritis Assessment 20 Response. ASAS40 = International Society for Spondyloarthritis Assessment 40 Response. ASQoL = Ankylosing Spondylitis Quality of Life Score. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI50 = 50% improvement from baseline in Barth Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BASMI = Barth Ankylosing Spondylitis Mobility Index.HI = Health Index. MASES = Maastricht Ankylosing Spondylitis Enthesitis Score. MRI = Magnetic Resonance Imaging. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. AO = Observed. PR = Partial Response. QD = Once Daily. SI = Sacroiliac. SPARCC = Canadian Spondyloarthritis Research Consortium. WPAI = Work Productivity and Activity Impairment. [Figure 3H]Figures 3A and 3B depict week 14 results of the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS1) clinical trial for the primary clinical efficacy endpoint and the time course of the primary endpoint through week 64, respectively. Figure 3A depicts ASAS20, ASAS40, ASAS PR, and BASDAI50 responses at week 14; Figure 3B depicts change from baseline in SPARCC MRI spine and SI joint scores at week 14; and Figure 3C depicts other multi-control primary secondary efficacy endpoints at week 14. These results demonstrate that the study met its endpoints, with a statistically significantly higher number of patients receiving upadacitinib free base than those receiving placebo achieving an ASAS40 response at Week 14 (48 / 93 [51.6%] vs. 24 / 94 [25.5%]; p=0.0003), for a treatment difference (95% CI) of 26.1% (12.6-39.5%). All endpoints were multiply controlled except for ASAS20 and SPARCC MRI SI joint. Multiply controlled secondary endpoints were tested sequentially and included ASDAS, SPARCC MRI spine, Hochberg-tested endpoints (BASDAI50, ASQoL, ASAS PR, BASFI, BASMI, MASES, and WPAI), and ASAS HI. In Figures 3L-3N, an asterisk (***) indicates P<0.001, an asterisk (**) indicates P<0.01, and an asterisk (*) indicates P<0.05. For other figures, an asterisk (*) indicates statistical significance in multiplicity-controlled analyses; otherwise, nominal p-values ​​are shown. After multiplicity adjustment, the changes from baseline to week 14 in ASDAS (Figure 3C), SPARCC MRI Spine (Figure 3B), and BASFI (Figure 3C), as well as the proportion of patients achieving BASDAI50 (Figure 3A) and ASAS PR (Figure 3A), were statistically significant for upadacitinib free base versus placebo.Figures 3D–3K depict the time course of ASAS40 (Figure 3D), ASAS20 (Figure 3E), ASAS partial response (PR) (Figure 3F), BASDAI50 response (Figure 3G), ASDAS inactive disease (ID) (Figure 3H), ASDAS low disease activity (LDA) (Figure 3I), ASDAS major improvement (MI) (Figure 3J), and ASDAS clinically important improvement (CII) (Figure 3K) through Week 64. At Week 14, the placebo group was rescued and administered upadacitinib 15 mg free base (placebo → upadacitinib 15 mg QD). Patients who switched from placebo to upadacitinib at Week 14 demonstrated similar efficacy responses compared with patients who continued upadacitinib free base from Day 0. These data suggest that upadacitinib 15 mg QD achieves efficacy at Week 14 and maintains or even improves efficacy through Week 64, addressing an unmet need for patients with AS (even those with non-radiographic axial spondyloarthritis (nr-axSpA)), particularly those with active disease who are not adequately responsive to NSAIDs. A significantly higher proportion of patients receiving upadacitinib compared with placebo achieved reductions in Patient Pain Assessment (Pt Pain) of 30% or more as early as Week 2 (Figure 3L), 50% or more (Figure 3M), and 70% or more as early as Week 4 (Figure 3N), and the achieved efficacy was maintained thereafter. Patients who switched from placebo to open-label upadacitinib at Week 14 generally achieved the same level of pain relief as patients originally randomized to upadacitinib from Week 14 onward. MASES assessments included patients with enthesitis at baseline, WPAI assessments included currently enrolled patients, and SPARCC MRI assessments included populations pre-specified in the statistical analysis plan (baseline included MRI data within 3 days of the first dose of study medication, and week 14 included MRI data up to the first dose of phase 2 study medication). ASAS20 = International Society for Spondyloarthritis Assessment 20 Response. ASAS40 = International Society for Spondyloarthritis Assessment 40 Response. ASQoL = Ankylosing Spondylitis Quality of Life Score. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI50 = 50% improvement from baseline in Barth Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BASMI = Barth Ankylosing Spondylitis Mobility Index.HI = Health Index. MASES = Maastricht Ankylosing Spondylitis Enthesitis Score. MRI = Magnetic Resonance Imaging. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. AO = Observed. PR = Partial Response. QD = Once Daily. SI = Sacroiliac. SPARCC = Canadian Spondyloarthritis Research Consortium. WPAI = Work Productivity and Activity Impairment. [Figure 3I]Figures 3A and 3B depict week 14 results of the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS1) clinical trial for the primary clinical efficacy endpoint and the time course of the primary endpoint through week 64, respectively. Figure 3A depicts ASAS20, ASAS40, ASAS PR, and BASDAI50 responses at week 14; Figure 3B depicts change from baseline in SPARCC MRI spine and SI joint scores at week 14; and Figure 3C depicts other multi-control primary secondary efficacy endpoints at week 14. These results demonstrate that the study met its endpoints, with a statistically significantly higher number of patients receiving upadacitinib free base than those receiving placebo achieving an ASAS40 response at Week 14 (48 / 93 [51.6%] vs. 24 / 94 [25.5%]; p=0.0003), for a treatment difference (95% CI) of 26.1% (12.6-39.5%). All endpoints were multiply controlled except for ASAS20 and SPARCC MRI SI joint. Multiply controlled secondary endpoints were tested sequentially and included ASDAS, SPARCC MRI spine, Hochberg-tested endpoints (BASDAI50, ASQoL, ASAS PR, BASFI, BASMI, MASES, and WPAI), and ASAS HI. In Figures 3L-3N, an asterisk (***) indicates P<0.001, an asterisk (**) indicates P<0.01, and an asterisk (*) indicates P<0.05. For other figures, an asterisk (*) indicates statistical significance in multiplicity-controlled analyses; otherwise, nominal p-values ​​are shown. After multiplicity adjustment, the changes from baseline to week 14 in ASDAS (Figure 3C), SPARCC MRI Spine (Figure 3B), and BASFI (Figure 3C), as well as the proportion of patients achieving BASDAI50 (Figure 3A) and ASAS PR (Figure 3A), were statistically significant for upadacitinib free base versus placebo.Figures 3D–3K depict the time course of ASAS40 (Figure 3D), ASAS20 (Figure 3E), ASAS partial response (PR) (Figure 3F), BASDAI50 response (Figure 3G), ASDAS inactive disease (ID) (Figure 3H), ASDAS low disease activity (LDA) (Figure 3I), ASDAS major improvement (MI) (Figure 3J), and ASDAS clinically important improvement (CII) (Figure 3K) through Week 64. At Week 14, the placebo group was rescued and administered upadacitinib 15 mg free base (placebo → upadacitinib 15 mg QD). Patients who switched from placebo to upadacitinib at Week 14 demonstrated similar efficacy responses compared with patients who continued upadacitinib free base from Day 0. These data suggest that upadacitinib 15 mg QD achieves efficacy at Week 14 and maintains or even improves efficacy through Week 64, addressing an unmet need for patients with AS (even those with non-radiographic axial spondyloarthritis (nr-axSpA)), particularly those with active disease who are not adequately responsive to NSAIDs. A significantly higher proportion of patients receiving upadacitinib compared with placebo achieved reductions in Patient Pain Assessment (Pt Pain) of 30% or more as early as Week 2 (Figure 3L), 50% or more (Figure 3M), and 70% or more as early as Week 4 (Figure 3N), and the achieved efficacy was maintained thereafter. Patients who switched from placebo to open-label upadacitinib at Week 14 generally achieved the same level of pain relief as patients originally randomized to upadacitinib from Week 14 onward. MASES assessments included patients with enthesitis at baseline, WPAI assessments included currently enrolled patients, and SPARCC MRI assessments included populations pre-specified in the statistical analysis plan (baseline included MRI data within 3 days of the first dose of study medication, and week 14 included MRI data up to the first dose of phase 2 study medication). ASAS20 = International Society for Spondyloarthritis Assessment 20 Response. ASAS40 = International Society for Spondyloarthritis Assessment 40 Response. ASQoL = Ankylosing Spondylitis Quality of Life Score. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI50 = 50% improvement from baseline in Barth Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BASMI = Barth Ankylosing Spondylitis Mobility Index.HI = Health Index. MASES = Maastricht Ankylosing Spondylitis Enthesitis Score. MRI = Magnetic Resonance Imaging. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. AO = Observed. PR = Partial Response. QD = Once Daily. SI = Sacroiliac. SPARCC = Canadian Spondyloarthritis Research Consortium. WPAI = Work Productivity and Activity Impairment. [Figure 3J]Figures 3A and 3B depict week 14 results of the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS1) clinical trial for the primary clinical efficacy endpoint and the time course of the primary endpoint through week 64, respectively. Figure 3A depicts ASAS20, ASAS40, ASAS PR, and BASDAI50 responses at week 14; Figure 3B depicts change from baseline in SPARCC MRI spine and SI joint scores at week 14; and Figure 3C depicts other multi-control primary secondary efficacy endpoints at week 14. These results demonstrate that the study met its endpoints, with a statistically significantly higher number of patients receiving upadacitinib free base than those receiving placebo achieving an ASAS40 response at Week 14 (48 / 93 [51.6%] vs. 24 / 94 [25.5%]; p=0.0003), for a treatment difference (95% CI) of 26.1% (12.6-39.5%). All endpoints were multiply controlled except for ASAS20 and SPARCC MRI SI joint. Multiply controlled secondary endpoints were tested sequentially and included ASDAS, SPARCC MRI spine, Hochberg-tested endpoints (BASDAI50, ASQoL, ASAS PR, BASFI, BASMI, MASES, and WPAI), and ASAS HI. In Figures 3L-3N, an asterisk (***) indicates P<0.001, an asterisk (**) indicates P<0.01, and an asterisk (*) indicates P<0.05. For other figures, an asterisk (*) indicates statistical significance in multiplicity-controlled analyses; otherwise, nominal p-values ​​are shown. After multiplicity adjustment, the changes from baseline to week 14 in ASDAS (Figure 3C), SPARCC MRI Spine (Figure 3B), and BASFI (Figure 3C), as well as the proportion of patients achieving BASDAI50 (Figure 3A) and ASAS PR (Figure 3A), were statistically significant for upadacitinib free base versus placebo.Figures 3D–3K depict the time course of ASAS40 (Figure 3D), ASAS20 (Figure 3E), ASAS partial response (PR) (Figure 3F), BASDAI50 response (Figure 3G), ASDAS inactive disease (ID) (Figure 3H), ASDAS low disease activity (LDA) (Figure 3I), ASDAS major improvement (MI) (Figure 3J), and ASDAS clinically important improvement (CII) (Figure 3K) through Week 64. At Week 14, the placebo group was rescued and administered upadacitinib 15 mg free base (placebo → upadacitinib 15 mg QD). Patients who switched from placebo to upadacitinib at Week 14 demonstrated similar efficacy responses compared with patients who continued upadacitinib free base from Day 0. These data suggest that upadacitinib 15 mg QD achieves efficacy at Week 14 and maintains or even improves efficacy through Week 64, addressing an unmet need for patients with AS (even those with non-radiographic axial spondyloarthritis (nr-axSpA)), particularly those with active disease who are not adequately responsive to NSAIDs. A significantly higher proportion of patients receiving upadacitinib compared with placebo experienced reductions in Patient Pain Assessment (Pt Pain) of 30% or greater as early as Week 2 (Figure 3L), 50% or greater (Figure 3M), and 70% or greater as early as Week 4 (Figure 3N), with the efficacy achieved subsequently maintained. Patients who switched from placebo to open-label upadacitinib at Week 14 generally achieved the same level of pain relief as patients originally randomized to upadacitinib from Week 14 onward. MASES assessments included patients with enthesitis at baseline, WPAI assessments included currently enrolled patients, and SPARCC MRI assessments included populations pre-specified in the statistical analysis plan (baseline included MRI data within 3 days of the first dose of study medication, and week 14 included MRI data up to the first dose of phase 2 study medication). ASAS20 = International Society for Spondyloarthritis Assessment 20 Response. ASAS40 = International Society for Spondyloarthritis Assessment 40 Response. ASQoL = Ankylosing Spondylitis Quality of Life Score. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI50 = 50% improvement from baseline in Barth Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BASMI = Barth Ankylosing Spondylitis Mobility Index.HI = Health Index. MASES = Maastricht Ankylosing Spondylitis Enthesitis Score. MRI = Magnetic Resonance Imaging. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. AO = Observed. PR = Partial Response. QD = Once Daily. SI = Sacroiliac. SPARCC = Canadian Spondyloarthritis Research Consortium. WPAI = Work Productivity and Activity Impairment. [Figure 3K]Figures 3A and 3B depict week 14 results of the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS1) clinical trial for the primary clinical efficacy endpoint and the time course of the primary endpoint through week 64, respectively. Figure 3A depicts ASAS20, ASAS40, ASAS PR, and BASDAI50 responses at week 14; Figure 3B depicts change from baseline in SPARCC MRI spine and SI joint scores at week 14; and Figure 3C depicts other multi-control primary secondary efficacy endpoints at week 14. These results demonstrate that the study met its endpoints, with a statistically significantly higher number of patients receiving upadacitinib free base than those receiving placebo achieving an ASAS40 response at Week 14 (48 / 93 [51.6%] vs. 24 / 94 [25.5%]; p=0.0003), for a treatment difference (95% CI) of 26.1% (12.6-39.5%). All endpoints were multiply controlled except for ASAS20 and SPARCC MRI SI joint. Multiply controlled secondary endpoints were tested sequentially and included ASDAS, SPARCC MRI spine, Hochberg-tested endpoints (BASDAI50, ASQoL, ASAS PR, BASFI, BASMI, MASES, and WPAI), and ASAS HI. In Figures 3L-3N, an asterisk (***) indicates P<0.001, an asterisk (**) indicates P<0.01, and an asterisk (*) indicates P<0.05. For other figures, an asterisk (*) indicates statistical significance in multiplicity-controlled analyses; otherwise, nominal p-values ​​are shown. After multiplicity adjustment, the changes from baseline to week 14 in ASDAS (Figure 3C), SPARCC MRI Spine (Figure 3B), and BASFI (Figure 3C), as well as the proportion of patients achieving BASDAI50 (Figure 3A) and ASAS PR (Figure 3A), were statistically significant for upadacitinib free base versus placebo.Figures 3D–3K depict the time course of ASAS40 (Figure 3D), ASAS20 (Figure 3E), ASAS partial response (PR) (Figure 3F), BASDAI50 response (Figure 3G), ASDAS inactive disease (ID) (Figure 3H), ASDAS low disease activity (LDA) (Figure 3I), ASDAS major improvement (MI) (Figure 3J), and ASDAS clinically important improvement (CII) (Figure 3K) through Week 64. At Week 14, the placebo group was rescued and administered upadacitinib 15 mg free base (placebo → upadacitinib 15 mg QD). Patients who switched from placebo to upadacitinib at Week 14 demonstrated similar efficacy responses compared with patients who continued upadacitinib free base from Day 0. These data suggest that upadacitinib 15 mg QD achieves efficacy at Week 14 and maintains or even improves efficacy through Week 64, addressing an unmet need for patients with AS (even those with non-radiographic axial spondyloarthritis (nr-axSpA)), particularly those with active disease who are not adequately responsive to NSAIDs. A significantly higher proportion of patients receiving upadacitinib compared with placebo achieved reductions in Patient Pain Assessment (Pt Pain) of 30% or more as early as Week 2 (Figure 3L), 50% or more (Figure 3M), and 70% or more as early as Week 4 (Figure 3N), and the achieved efficacy was maintained thereafter. Patients who switched from placebo to open-label upadacitinib at Week 14 generally achieved the same level of pain relief as patients originally randomized to upadacitinib from Week 14 onward. MASES assessments included patients with enthesitis at baseline, WPAI assessments included currently enrolled patients, and SPARCC MRI assessments included populations pre-specified in the statistical analysis plan (baseline included MRI data within 3 days of the first dose of study medication, and week 14 included MRI data up to the first dose of phase 2 study medication). ASAS20 = International Society for Spondyloarthritis Assessment 20 Response. ASAS40 = International Society for Spondyloarthritis Assessment 40 Response. ASQoL = Ankylosing Spondylitis Quality of Life Score. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI50 = 50% improvement from baseline in Barth Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BASMI = Barth Ankylosing Spondylitis Mobility Index.HI = Health Index. MASES = Maastricht Ankylosing Spondylitis Enthesitis Score. MRI = Magnetic Resonance Imaging. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. AO = Observed. PR = Partial Response. QD = Once Daily. SI = Sacroiliac. SPARCC = Canadian Spondyloarthritis Research Consortium. WPAI = Work Productivity and Activity Impairment. [Figure 3L]Figures 3A and 3B depict week 14 results of the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS1) clinical trial for the primary clinical efficacy endpoint and the time course of the primary endpoint through week 64, respectively. Figure 3A depicts ASAS20, ASAS40, ASAS PR, and BASDAI50 responses at week 14; Figure 3B depicts change from baseline in SPARCC MRI spine and SI joint scores at week 14; and Figure 3C depicts other multi-control primary secondary efficacy endpoints at week 14. These results demonstrate that the study met its endpoints, with a statistically significantly higher number of patients receiving upadacitinib free base than those receiving placebo achieving an ASAS40 response at Week 14 (48 / 93 [51.6%] vs. 24 / 94 [25.5%]; p=0.0003), for a treatment difference (95% CI) of 26.1% (12.6-39.5%). All endpoints were multiply controlled except for ASAS20 and SPARCC MRI SI joint. Multiply controlled secondary endpoints were tested sequentially and included ASDAS, SPARCC MRI spine, Hochberg-tested endpoints (BASDAI50, ASQoL, ASAS PR, BASFI, BASMI, MASES, and WPAI), and ASAS HI. In Figures 3L-3N, an asterisk (***) indicates P<0.001, an asterisk (**) indicates P<0.01, and an asterisk (*) indicates P<0.05. For other figures, an asterisk (*) indicates statistical significance in multiplicity-controlled analyses; otherwise, nominal p-values ​​are shown. After multiplicity adjustment, the changes from baseline to week 14 in ASDAS (Figure 3C), SPARCC MRI Spine (Figure 3B), and BASFI (Figure 3C), as well as the proportion of patients achieving BASDAI50 (Figure 3A) and ASAS PR (Figure 3A), were statistically significant for upadacitinib free base versus placebo.Figures 3D–3K depict the time course of ASAS40 (Figure 3D), ASAS20 (Figure 3E), ASAS partial response (PR) (Figure 3F), BASDAI50 response (Figure 3G), ASDAS inactive disease (ID) (Figure 3H), ASDAS low disease activity (LDA) (Figure 3I), ASDAS major improvement (MI) (Figure 3J), and ASDAS clinically important improvement (CII) (Figure 3K) through Week 64. At Week 14, the placebo group was rescued and administered upadacitinib 15 mg free base (placebo → upadacitinib 15 mg QD). Patients who switched from placebo to upadacitinib at Week 14 demonstrated similar efficacy responses compared with patients who continued upadacitinib free base from Day 0. These data suggest that upadacitinib 15 mg QD achieves efficacy at Week 14 and maintains or even improves efficacy through Week 64, addressing an unmet need for patients with AS (even those with non-radiographic axial spondyloarthritis (nr-axSpA)), particularly those with active disease who are not adequately responsive to NSAIDs. A significantly higher proportion of patients receiving upadacitinib compared with placebo experienced reductions in Patient Pain Assessment (Pt Pain) of 30% or greater as early as Week 2 (Figure 3L), 50% or greater (Figure 3M), and 70% or greater as early as Week 4 (Figure 3N), with the efficacy achieved subsequently maintained. Patients who switched from placebo to open-label upadacitinib at Week 14 generally achieved the same level of pain relief as patients originally randomized to upadacitinib from Week 14 onward. MASES assessments included patients with enthesitis at baseline, WPAI assessments included currently enrolled patients, and SPARCC MRI assessments included populations pre-specified in the statistical analysis plan (baseline included MRI data within 3 days of the first dose of study medication, and week 14 included MRI data up to the first dose of phase 2 study medication). ASAS20 = International Society for Spondyloarthritis Assessment 20 Response. ASAS40 = International Society for Spondyloarthritis Assessment 40 Response. ASQoL = Ankylosing Spondylitis Quality of Life Score. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI50 = 50% improvement from baseline in Barth Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BASMI = Barth Ankylosing Spondylitis Mobility Index.HI = Health Index. MASES = Maastricht Ankylosing Spondylitis Enthesitis Score. MRI = Magnetic Resonance Imaging. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. AO = Observed. PR = Partial Response. QD = Once Daily. SI = Sacroiliac. SPARCC = Canadian Spondyloarthritis Research Consortium. WPAI = Work Productivity and Activity Impairment. [Figure 3M]Figures 3A and 3B depict week 14 results of the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS1) clinical trial for the primary clinical efficacy endpoint and the time course of the primary endpoint through week 64, respectively. Figure 3A depicts ASAS20, ASAS40, ASAS PR, and BASDAI50 responses at week 14; Figure 3B depicts change from baseline in SPARCC MRI spine and SI joint scores at week 14; and Figure 3C depicts other multi-control primary secondary efficacy endpoints at week 14. These results demonstrate that the study met its endpoints, with a statistically significantly higher number of patients receiving upadacitinib free base than those receiving placebo achieving an ASAS40 response at Week 14 (48 / 93 [51.6%] vs. 24 / 94 [25.5%]; p=0.0003), for a treatment difference (95% CI) of 26.1% (12.6-39.5%). All endpoints were multiply controlled except for ASAS20 and SPARCC MRI SI joint. Multiply controlled secondary endpoints were tested sequentially and included ASDAS, SPARCC MRI spine, Hochberg-tested endpoints (BASDAI50, ASQoL, ASAS PR, BASFI, BASMI, MASES, and WPAI), and ASAS HI. In Figures 3L-3N, an asterisk (***) indicates P<0.001, an asterisk (**) indicates P<0.01, and an asterisk (*) indicates P<0.05. For other figures, an asterisk (*) indicates statistical significance in multiplicity-controlled analyses; otherwise, nominal p-values ​​are shown. After multiplicity adjustment, the changes from baseline to week 14 in ASDAS (Figure 3C), SPARCC MRI Spine (Figure 3B), and BASFI (Figure 3C), as well as the proportion of patients achieving BASDAI50 (Figure 3A) and ASAS PR (Figure 3A), were statistically significant for upadacitinib free base versus placebo.Figures 3D–3K depict the time course of ASAS40 (Figure 3D), ASAS20 (Figure 3E), ASAS partial response (PR) (Figure 3F), BASDAI50 response (Figure 3G), ASDAS inactive disease (ID) (Figure 3H), ASDAS low disease activity (LDA) (Figure 3I), ASDAS major improvement (MI) (Figure 3J), and ASDAS clinically important improvement (CII) (Figure 3K) through Week 64. At Week 14, the placebo group was rescued and administered upadacitinib 15 mg free base (placebo → upadacitinib 15 mg QD). Patients who switched from placebo to upadacitinib at Week 14 demonstrated similar efficacy responses compared with patients who continued upadacitinib free base from Day 0. These data suggest that upadacitinib 15 mg QD achieves efficacy at Week 14 and maintains or even improves efficacy through Week 64, addressing an unmet need for patients with AS (even those with non-radiographic axial spondyloarthritis (nr-axSpA)), particularly those with active disease who are not adequately responsive to NSAIDs. A significantly higher proportion of patients receiving upadacitinib compared with placebo experienced reductions in Patient Pain Assessment (Pt Pain) of 30% or greater as early as Week 2 (Figure 3L), 50% or greater (Figure 3M), and 70% or greater as early as Week 4 (Figure 3N), with the efficacy achieved subsequently maintained. Patients who switched from placebo to open-label upadacitinib at Week 14 generally achieved the same level of pain relief as patients originally randomized to upadacitinib from Week 14 onward. MASES assessments included patients with enthesitis at baseline, WPAI assessments included currently enrolled patients, and SPARCC MRI assessments included populations pre-specified in the statistical analysis plan (baseline included MRI data within 3 days of the first dose of study medication, and week 14 included MRI data up to the first dose of phase 2 study medication). ASAS20 = International Society for Spondyloarthritis Assessment 20 Response. ASAS40 = International Society for Spondyloarthritis Assessment 40 Response. ASQoL = Ankylosing Spondylitis Quality of Life Score. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI50 = 50% improvement from baseline in Barth Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BASMI = Barth Ankylosing Spondylitis Mobility Index.HI = Health Index. MASES = Maastricht Ankylosing Spondylitis Enthesitis Score. MRI = Magnetic Resonance Imaging. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. AO = Observed. PR = Partial Response. QD = Once Daily. SI = Sacroiliac. SPARCC = Canadian Spondyloarthritis Research Consortium. WPAI = Work Productivity and Activity Impairment. [Figure 3N]Figures 3A and 3B depict week 14 results of the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS1) clinical trial for the primary clinical efficacy endpoint and the time course of the primary endpoint through week 64, respectively. Figure 3A depicts ASAS20, ASAS40, ASAS PR, and BASDAI50 responses at week 14; Figure 3B depicts change from baseline in SPARCC MRI spine and SI joint scores at week 14; and Figure 3C depicts other multi-control primary secondary efficacy endpoints at week 14. These results demonstrate that the study met its endpoints, with a statistically significantly higher number of patients receiving upadacitinib free base than those receiving placebo achieving an ASAS40 response at Week 14 (48 / 93 [51.6%] vs. 24 / 94 [25.5%]; p=0.0003), for a treatment difference (95% CI) of 26.1% (12.6-39.5%). All endpoints were multiply controlled except for ASAS20 and SPARCC MRI SI joint. Multiply controlled secondary endpoints were tested sequentially and included ASDAS, SPARCC MRI spine, Hochberg-tested endpoints (BASDAI50, ASQoL, ASAS PR, BASFI, BASMI, MASES, and WPAI), and ASAS HI. In Figures 3L-3N, an asterisk (***) indicates P<0.001, an asterisk (**) indicates P<0.01, and an asterisk (*) indicates P<0.05. For other figures, an asterisk (*) indicates statistical significance in multiplicity-controlled analyses; otherwise, nominal p-values ​​are shown. After multiplicity adjustment, the changes from baseline to week 14 in ASDAS (Figure 3C), SPARCC MRI Spine (Figure 3B), and BASFI (Figure 3C), as well as the proportion of patients achieving BASDAI50 (Figure 3A) and ASAS PR (Figure 3A), were statistically significant for upadacitinib free base versus placebo.Figures 3D–3K depict the time course of ASAS40 (Figure 3D), ASAS20 (Figure 3E), ASAS partial response (PR) (Figure 3F), BASDAI50 response (Figure 3G), ASDAS inactive disease (ID) (Figure 3H), ASDAS low disease activity (LDA) (Figure 3I), ASDAS major improvement (MI) (Figure 3J), and ASDAS clinically important improvement (CII) (Figure 3K) through Week 64. At Week 14, the placebo group was rescued and administered upadacitinib 15 mg free base (placebo → upadacitinib 15 mg QD). Patients who switched from placebo to upadacitinib at Week 14 demonstrated similar efficacy responses compared with patients who continued upadacitinib free base from Day 0. These data suggest that upadacitinib 15 mg QD achieves efficacy at Week 14 and maintains or even improves efficacy through Week 64, addressing an unmet need for patients with AS (even those with non-radiographic axial spondyloarthritis (nr-axSpA)), particularly those with active disease who are not adequately responsive to NSAIDs. A significantly higher proportion of patients receiving upadacitinib compared with placebo experienced reductions in Patient Pain Assessment (Pt Pain) of 30% or greater as early as Week 2 (Figure 3L), 50% or greater (Figure 3M), and 70% or greater as early as Week 4 (Figure 3N), with the efficacy achieved subsequently maintained. Patients who switched from placebo to open-label upadacitinib at Week 14 generally achieved the same level of pain relief as patients originally randomized to upadacitinib from Week 14 onward. MASES assessments included patients with enthesitis at baseline, WPAI assessments included currently enrolled patients, and SPARCC MRI assessments included populations pre-specified in the statistical analysis plan (baseline included MRI data within 3 days of the first dose of study medication, and week 14 included MRI data up to the first dose of phase 2 study medication). ASAS20 = International Society for Spondyloarthritis Assessment 20 Response. ASAS40 = International Society for Spondyloarthritis Assessment 40 Response. ASQoL = Ankylosing Spondylitis Quality of Life Score. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI50 = 50% improvement from baseline in Barth Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BASMI = Barth Ankylosing Spondylitis Mobility Index.HI = Health Index. MASES = Maastricht Ankylosing Spondylitis Enthesitis Score. MRI = Magnetic Resonance Imaging. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. AO = Observed. PR = Partial Response. QD = Once Daily. SI = Sacroiliac. SPARCC = Canadian Spondyloarthritis Research Consortium. WPAI = Work Productivity and Activity Impairment. [Figure 4A] Figures depict data for ASAS domains (ASAS40, PtGA, back pain, BASFI, and inflammation) measured at weeks 2, 4, 8, 12, and 14 in the Phase 2 / 3 ankylosing spondylitis (SELECT-AXIS1) clinical trial. Significant differences between upadacitinib free base and placebo were observed as early as the first post-baseline visit (week 2) in the ASAS40 (Figure 4A) and mean changes for each of its four individual domains (Figures 4B-4E). These differences were maintained consistently through week 14, where statistical significance was achieved in a multiplicity-controlled analysis. Back pain is defined on a numeric rating scale (0-10) based on the following question: "How much back pain have you experienced at any time during the past week?" Inflammation is defined as the mean of questions 5 and 6 of the BASDAI. BASDAI = Bath Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BL = Baseline. LSM = Least Squares Mean. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. PtGA = Patient Global Assessment of Disease Activity. QD = Once Daily. [Figure 4B]Figures depict data for ASAS domains (ASAS40, PtGA, back pain, BASFI, and inflammation) measured at weeks 2, 4, 8, 12, and 14 in the Phase 2 / 3 ankylosing spondylitis (SELECT-AXIS1) clinical trial. Significant differences between upadacitinib free base and placebo were observed as early as the first post-baseline visit (week 2) in the ASAS40 (Figure 4A) and mean changes for each of its four individual domains (Figures 4B-4E). These differences were maintained consistently through week 14, where statistical significance was achieved in a multiplicity-controlled analysis. Back pain is defined on a numeric rating scale (0-10) based on the following question: "How much back pain have you experienced at any time during the past week?" Inflammation is defined as the mean of questions 5 and 6 of the BASDAI. BASDAI = Bath Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BL = Baseline. LSM = Least Squares Mean. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. PtGA = Patient Global Assessment of Disease Activity. QD = Once Daily. [Figure 4C] Figures depict data for ASAS domains (ASAS40, PtGA, back pain, BASFI, and inflammation) measured at weeks 2, 4, 8, 12, and 14 in the Phase 2 / 3 ankylosing spondylitis (SELECT-AXIS1) clinical trial. Significant differences between upadacitinib free base and placebo were observed as early as the first post-baseline visit (week 2) in the ASAS40 (Figure 4A) and mean changes for each of its four individual domains (Figures 4B-4E). These differences were maintained consistently through week 14, where statistical significance was achieved in a multiplicity-controlled analysis. Back pain is defined on a numeric rating scale (0-10) based on the following question: "How much back pain have you experienced at any time during the past week?" Inflammation is defined as the mean of questions 5 and 6 of the BASDAI. BASDAI = Bath Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BL = Baseline. LSM = Least Squares Mean. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. PtGA = Patient Global Assessment of Disease Activity. QD = Once Daily. [Figure 4D]Figures depict data for ASAS domains (ASAS40, PtGA, back pain, BASFI, and inflammation) measured at weeks 2, 4, 8, 12, and 14 in the Phase 2 / 3 ankylosing spondylitis (SELECT-AXIS1) clinical trial. Significant differences between upadacitinib free base and placebo were observed as early as the first post-baseline visit (week 2) in the ASAS40 (Figure 4A) and mean changes for each of its four individual domains (Figures 4B-4E). These differences were maintained consistently through week 14, where statistical significance was achieved in a multiplicity-controlled analysis. Back pain is defined on a numeric rating scale (0-10) based on the following question: "How much back pain have you experienced at any time during the past week?" Inflammation is defined as the mean of questions 5 and 6 of the BASDAI. BASDAI = Bath Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BL = Baseline. LSM = Least Squares Mean. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. PtGA = Patient Global Assessment of Disease Activity. QD = Once Daily. [Figure 4E] Figures depict data for ASAS domains (ASAS40, PtGA, back pain, BASFI, and inflammation) measured at weeks 2, 4, 8, 12, and 14 in the Phase 2 / 3 ankylosing spondylitis (SELECT-AXIS1) clinical trial. Significant differences between upadacitinib free base and placebo were observed as early as the first post-baseline visit (week 2) in the ASAS40 (Figure 4A) and mean changes for each of its four individual domains (Figures 4B-4E). These differences were maintained consistently through week 14, where statistical significance was achieved in a multiplicity-controlled analysis. Back pain is defined on a numeric rating scale (0-10) based on the following question: "How much back pain have you experienced at any time during the past week?" Inflammation is defined as the mean of questions 5 and 6 of the BASDAI. BASDAI = Bath Ankylosing Spondylitis Disease Activity Index. BASFI = Barth Ankylosing Spondylitis Functional Index. BL = Baseline. LSM = Least Squares Mean. MMRM = Mixed Model for Repeated Measures. NRI = Non-Responder Imputation. PtGA = Patient Global Assessment of Disease Activity. QD = Once Daily. [Figure 5]Figure 1 depicts the pre-specified supplemental SPARCC MRI analysis of the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS1) clinical trial. The SPARCC MRI assessment population was pre-specified in the statistical analysis plan (baseline included MRI data within 3 days after the first dose of study medication, and Week 14 included MRI data up to the first dose of Phase 2 study medication). The supplemental SPARCC MRI analysis included all MRI data collected at the nominal baseline and Week 14 visits and confirmed the results of the primary SPARCC MRI analysis at both the spine and SI joint. MMRM = mixed model for repeated measures. MRI = magnetic resonance imaging. QD = once daily. SI = sacroiliac joint. SPARCC = Canadian Spondyloarthritis Research Consortium. [Figure 6A] Figure 6 depicts cumulative probability plots of the change in SPARCC scores described in Figure 5 for Phase 2 / 3 ankylosing spondylitis (SELECT-AXIS1), showing that SPARCC MRI spine and SI joint scores improved more in patients receiving upadacitinib compared to placebo from baseline to Week 14. Results from the primary MRI analysis (Figures 6A-6B) and supplemental MRI analyses (Figures 6B-6C) were consistent. [Figure 6B] Figure 6 depicts cumulative probability plots of the change in SPARCC scores described in Figure 5 for Phase 2 / 3 ankylosing spondylitis (SELECT-AXIS1), showing that SPARCC MRI spine and SI joint scores improved more in patients receiving upadacitinib compared to placebo from baseline to Week 14. Results from the primary MRI analysis (Figures 6A-6B) and supplemental MRI analyses (Figures 6B-6C) were consistent. [Figure 6C]Figure 6 depicts cumulative probability plots of the change in SPARCC scores described in Figure 5 for Phase 2 / 3 ankylosing spondylitis (SELECT-AXIS1), showing that SPARCC MRI spine and SI joint scores improved more in patients receiving upadacitinib compared to placebo from baseline to Week 14. Results from the primary MRI analysis (Figures 6A-6B) and supplemental MRI analyses (Figures 6B-6C) were consistent. [Figure 6D] Figure 6 depicts cumulative probability plots of the change in SPARCC scores described in Figure 5 for Phase 2 / 3 ankylosing spondylitis (SELECT-AXIS1), showing that SPARCC MRI spine and SI joint scores improved more in patients receiving upadacitinib compared to placebo from baseline to Week 14. Results from the primary MRI analysis (Figures 6A-6B) and supplemental MRI analyses (Figures 6B-6C) were consistent. [Figure 7A] Figures depict the percentage of patients achieving ASDAS LDA, ASDAS ID, ASDAS CII, and ASDAS MI at week 14 in the Phase 2 / 3 ankylosing spondylitis (SELECT-AXIS1) clinical trial (Figure 7A), the change from baseline in mean ASDAS over time (Figure 7B), and the change from baseline in ASDAS MI over time (Figure 7C). The proportion of patients achieving ASDAS LDA, ASDAS ID, ASDAS CII, and ASDAS MI was greater with upadacitinib free base versus placebo at week 14 (nominal p<0.0001) (Figure 7A). ASDAS = Ankylosing Spondylitis Disease Activity Score. BL = Baseline. CII = Clinically Important Improvement (≥1·1 point decrease from baseline). ID = Inactive Disease (score <1·3). LDA = Low Disease Activity (<2.1). MI = Large Improvement (≥ ≥ point decrease from baseline). MMRM = mixed models for repeated measures. NRI = non-responder imputation. QD = once daily. [Figure 7B]Figures depict the percentage of patients achieving ASDAS LDA, ASDAS ID, ASDAS CII, and ASDAS MI at week 14 in the Phase 2 / 3 ankylosing spondylitis (SELECT-AXIS1) clinical trial (Figure 7A), the change from baseline in mean ASDAS over time (Figure 7B), and the change from baseline in ASDAS MI over time (Figure 7C). The proportion of patients achieving ASDAS LDA, ASDAS ID, ASDAS CII, and ASDAS MI was greater with upadacitinib free base versus placebo at week 14 (nominal p<0.0001) (Figure 7A). ASDAS = Ankylosing Spondylitis Disease Activity Score. BL = Baseline. CII = Clinically Important Improvement (≥1·1 point decrease from baseline). ID = Inactive Disease (score <1·3). LDA = Low Disease Activity (<2.1). MI = Large Improvement (≥ ≥ point decrease from baseline). MMRM = mixed models for repeated measures. NRI = non-responder imputation. QD = once daily. [Figure 7C] Figures depict the percentage of patients achieving ASDAS LDA, ASDAS ID, ASDAS CII, and ASDAS MI at week 14 in the Phase 2 / 3 ankylosing spondylitis (SELECT-AXIS1) clinical trial (Figure 7A), the change from baseline in mean ASDAS over time (Figure 7B), and the change from baseline in ASDAS MI over time (Figure 7C). The proportion of patients achieving ASDAS LDA, ASDAS ID, ASDAS CII, and ASDAS MI was greater with upadacitinib free base versus placebo at week 14 (nominal p<0.0001) (Figure 7A). ASDAS = Ankylosing Spondylitis Disease Activity Score. BL = Baseline. CII = Clinically Important Improvement (≥1·1 point decrease from baseline). ID = Inactive Disease (score <1·3). LDA = Low Disease Activity (<2.1). MI = Large Improvement (≥ ≥ point decrease from baseline). MMRM = mixed models for repeated measures. NRI = non-responder imputation. QD = once daily. [Figure 8A]Figures depict least squares mean (LSM) change from baseline in individual ASDAS components over time in the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS 1) clinical trial. Improvements in mean ASDAS (Figure 7B) and individual ASDAS components (Figures 8A-8D) were observed as early as week 2 with upadacitinib free base, with continued improvement through week 14. Spinal pain = BASDAI question 2. Peripheral pain / swelling = BASDAI question 3. Duration of morning stiffness = BASDAI question 6. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI = Barth Ankylosing Spondylitis Disease Activity Index. BL = baseline. hsCRP = high-sensitivity C-reactive protein. MMRM = mixed model for repeated measures. PtGA = Patient Global Assessment of Disease Activity. QD = once daily. [Figure 8B] Figures depict least squares mean (LSM) change from baseline in individual ASDAS components over time in the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS 1) clinical trial. Improvements in mean ASDAS (Figure 7B) and individual ASDAS components (Figures 8A-8D) were observed as early as week 2 with upadacitinib free base, with continued improvement through week 14. Spinal pain = BASDAI question 2. Peripheral pain / swelling = BASDAI question 3. Duration of morning stiffness = BASDAI question 6. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI = Barth Ankylosing Spondylitis Disease Activity Index. BL = baseline. hsCRP = high-sensitivity C-reactive protein. MMRM = mixed model for repeated measures. PtGA = Patient Global Assessment of Disease Activity. QD = once daily. [Figure 8C]Figures depict least squares mean (LSM) change from baseline in individual ASDAS components over time in the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS 1) clinical trial. Improvements in mean ASDAS (Figure 7B) and individual ASDAS components (Figures 8A-8D) were observed as early as week 2 with upadacitinib free base, with continued improvement through week 14. Spinal pain = BASDAI question 2. Peripheral pain / swelling = BASDAI question 3. Duration of morning stiffness = BASDAI question 6. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI = Barth Ankylosing Spondylitis Disease Activity Index. BL = baseline. hsCRP = high-sensitivity C-reactive protein. MMRM = mixed model for repeated measures. PtGA = Patient Global Assessment of Disease Activity. QD = once daily. [Figure 8D] Figures depict least squares mean (LSM) change from baseline in individual ASDAS components over time in the Phase 2 / 3 Ankylosing Spondylitis (SELECT-AXIS 1) clinical trial. Improvements in mean ASDAS (Figure 7B) and individual ASDAS components (Figures 8A-8D) were observed as early as week 2 with upadacitinib free base, with continued improvement through week 14. Spinal pain = BASDAI question 2. Peripheral pain / swelling = BASDAI question 3. Duration of morning stiffness = BASDAI question 6. ASDAS = Ankylosing Spondylitis Disease Activity Score. BASDAI = Barth Ankylosing Spondylitis Disease Activity Index. BL = baseline. hsCRP = high-sensitivity C-reactive protein. MMRM = mixed model for repeated measures. PtGA = Patient Global Assessment of Disease Activity. QD = once daily. [Figure 9] FIG. 1 depicts the phase 3 study design for the treatment of AS and nr-AxSpA subjects. AS = ankylosing spondylitis; ASAS = International Spondyloarthritis Evaluation Society; bDMARD-IR = biologic disease-modifying antirheumatic drug inadequate responder; EMA = European Medicines Agency; FDA = Food and Drug Administration; MRI = magnetic resonance imaging; nr-axSpA = axial spondyloarthritis not meeting radiographic criteria; QD = once daily; SI = sacroiliac joint; UPA = upadacitinib free base. [Figure 10]Figure 3 depicts the phase 3 study design for SELECT-PsA1 in subjects with active PsA and a prior inadequate response to at least one non-biologic DMARD (PsA DMARD-IR). a. All subjects will undergo hand and foot x-rays at screening, Weeks 24, 56, 104, and 152. b. At Week 16, subjects classified as non-responders (defined as not achieving at least a 20% improvement in either or both tender joint counts (TJC) and swollen joint counts (SJC) at both Weeks 12 and 16) will be offered rescue therapy. c. At Week 24, all placebo subjects, regardless of response, will be switched to upadacitinib free base 15 mg QD or 30 mg QD (1:1 ratio). [Figure 11A] Figure 11A depicts a graphical depiction of the testing procedures for the phase 3 SELECT-PsA1 (PsA DMARD-IR) trial for the primary endpoint (ACR20 response at week 12) and ranked secondary endpoints. The overall type I error rate was controlled at the two-sided 0.05 level (including 0.0001 alpha at the interim analysis for futility). Figure 11A, Part 1, describes the testing procedures for the adequately powered ranked secondary endpoints of PsA symptoms and radiographic progression. Figure 11B, Part 2, describes the testing procedures for additional ranked secondary endpoints, such as testing for superiority over adalimumab. Part 2 endpoints will be tested only after all Part 1 endpoints have achieved statistical significance. [Figure 11B]Figure 11A depicts a graphical depiction of the testing procedures for the phase 3 SELECT-PsA1 (PsA DMARD-IR) trial for the primary endpoint (ACR20 response at week 12) and ranked secondary endpoints. The overall type I error rate was controlled at the two-sided 0.05 level (including 0.0001 alpha at the interim analysis for futility). Figure 11A, Part 1, describes the testing procedures for the adequately powered ranked secondary endpoints of PsA symptoms and radiographic progression. Figure 11B, Part 2, describes the testing procedures for additional ranked secondary endpoints, such as testing for superiority over adalimumab. Part 2 endpoints will be tested only after all Part 1 endpoints have achieved statistical significance. [Figure 12A]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12B]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12C]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12D]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12E]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12F]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12G]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12H]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12I]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12J]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12K]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12L]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12M]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12N]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12O]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12P]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12Q]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12R]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12S]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12T]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12U]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12V]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12W]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12X]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12Y]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12Z]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12AA]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12BB]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12CC]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12DD]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 12EE]Figures 12A and 12B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA1 (PsA DMARD-IR) Phase 3 clinical trial. Figure 12A depicts the time course of ACR20 response and associated 95% confidence intervals (CIs) through Week 24. Response rates (%) with 95% CIs are provided by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base; ADA = adalimumab; QD = once daily; EOW = every other week. Symbols: ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferiority upadacitinib vs. adalimumab. Other key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 12B); patients achieving an ACR70 response (Figure 12C); patients achieving minimal disease activity (MDA) (Figure 12D); patients achieving non-inferiority of upadacitinib vs. adalimumab in ACR20 at week 12 (Figure 12E); patients achieving LS mean change from baseline at week 24 in core components of the ACR criteria: tender joint count (TJC68 ) (Figure 12F), swollen joint count (SJC66) (Figure 12G), physician global assessment of disease activity (PhGA) (Figure 12H), patient global assessment of disease activity (PtGA) (Figure 12I), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 12J), and high-sensitivity C-reactive protein (hs-CRP) (Figure 12K); psoriasis area and severity index (PASI) at 24 weeks. The proportion of patients achieving PASI 75 (Figure 12L), PASI 90 (Figure 12M), and PASI 100 (Figure 12N), assessed after week 16, allowed patients to use concomitant treatment, as determined by the investigator, specifically for psoriasis; the proportion of patients achieving static Physician's Global Assessment (sIGA) over 24 weeks (Figure 12O); change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) at 24 weeks (Figure 12P); Health Assessment Questionnaire Disability Index (HAQ-DI) (Figure 12Q) and SF-36 Physical Component Summary Score (PCS is one of two summary scores calculated from the eight SF-36 domains).A linear algorithm was applied to calculate the PCS with a normative mean value of 50, with higher scores indicating better outcomes. Patients achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue) (Figure 12S); and a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 12T), morning stiffness severity (BASDAI question 5) (Figure 12U), and morning stiffness duration (BASDAI question 6) (Figure 12V). Percentage of patients with enthesitis loss at 24 weeks by the Leeds Enthesitis Index (LEI) (Figure 12W), the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 12X), and dactylitis resolution by the Leeds Dactylitis Index (LDI) (Figure 12Y); patients who achieved change from baseline in radiographic endpoint (mTSS = modified total Sharpe / van der Heijdes score, JSN = joint space narrowing score) at week 24 (Figure 12Z); and no radiographic progression of mTSS at week 24. These include the proportion of patients with a mTSS of 0.0 or less (Figure 12AA) and a mTSS of 0.5 or less (Figure 12BB). A significantly higher proportion of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater and a 50% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, with the efficacy achieved being maintained thereafter (see Figures 12CC and 12DD). A significantly higher proportion of patients receiving upadacitinib free base versus placebo achieved a 70% or greater reduction in Pt Pain as early as week 2 (30 mg QD upadacitinib) or as early as week 4 (15 mg QD upadacitinib), with the efficacy achieved being maintained thereafter (see Figure 12EE).Symbols: *, statistically significant at the 0.05 level (UPA 15 mg QD); ζ, statistically significant at the 0.05 level (UPA 30 mg QD); #, statistically significant at the 0.05 level (ADA 40 mg EOW); ***, P<0.001 for upadacitinib vs. placebo; ###, P<0.001 for upadacitinib vs. adalimumab; ζζζ, P<0.001 for non-inferior upadacitinib vs. adalimumab; PBO=placebo; ADA=adalimumab; UPA=upadacitinib free base; EOW=every other week; QD=once daily; CI=confidence interval. [Figure 13] Figure 1 shows the phase 3 study design for SELECT-PSA2 in subjects with active PsA and a prior inadequate response to at least one bDMARD (PsA bDMARD-IR). a. At Week 16, subjects classified as non-responders (defined as not achieving at least a 20% improvement in either or both tender joint counts (TJC) and swollen joint counts (SJC) at both Weeks 12 and 16) will be offered rescue therapy. b. At Week 24, all placebo subjects will be switched to upadacitinib free base 15 mg QD or 30 mg QD (1:1 ratio), regardless of response. [Figure 14A]Figures 14A and 14B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA2 (PsA bDMARD-IR) Phase 3 clinical trial. Figure 14A depicts the time course to Week 24 for the primary endpoint ACR20. % response rates with 95% CI are shown by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base. Symbols: * = p < 0.05 for upadacitinib 15 mg QD vs. placebo; # = p < 0.05 for upadacitinib 30 mg QD vs. placebo; † = significant in multiplicity-controlled analysis.Additional key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 14B); patients achieving an ACR70 response (Figure 14C); proportion of patients achieving minimal disease activity (MDA) over 24 weeks (Figure 14D); patients achieving a change from baseline in the Leeds Enthesitis Index (LEI) (Figure 14E); patients achieving enthesitis resolution (LEI=0) (Figure 14F); proportion of patients who were enthesitis-free over 24 weeks by the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 14G); Patients who achieved a change from baseline in the LDI (Figure 14H); patients who achieved resolution of dactylitis (LDI=0) (Figure 14I); proportion of patients who achieved Psoriasis Area and Severity Index PASI75 (Figure 14J), PASI90 (Figure 14K), and PASI100 responses (Figure 14L) over 24 weeks; patients who achieved a change from baseline in Disease Activity in Psoriatic Arthritis (DAPSA) score (Figure 14M); patients who achieved a change from baseline over 24 weeks in the core components of the ACR criteria: number of tender joints (TJC68) (Figure 14N), swollen joint count (SJC66) (Figure 14O), physician global assessment of disease activity (PhGA) (Figure 14P), patient global assessment of disease activity (PtGA) (Figure 14Q), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 14R), high-sensitivity C-reactive protein (hs-CRP) (Figure 14S); proportion of patients achieving static physician global assessment (sIGA) 0 / 1 at 24 weeks (Figure 14T); self-assessment of psoriasis symptoms (SAPS). Patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14U); patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14V); patients who achieved a change from baseline at 24 weeks in the SF-36 Physical Dimension Summary (Figure 14W); and patients who achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue).) (Figure 14X); patients who achieved a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 14Y); patients who achieved a change from baseline at 24 weeks in morning stiffness severity (BASDAI question 5) (Figure 14Z); and patients who achieved a change from baseline at 24 weeks in morning stiffness duration (BASDAI question 6) (Figure 14AA). Significantly higher proportions of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater, 50% or greater, and 70% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, and the achieved efficacy was maintained thereafter (see Figures 14BB-14DD). UPA = upadacitinib; PBO = placebo; QD = once daily; NRI = non-responder complement. [Figure 14B]Figures 14A and 14B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA2 (PsA bDMARD-IR) Phase 3 clinical trial. Figure 14A depicts the time course to Week 24 for the primary endpoint ACR20. % response rates with 95% CI are shown by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base. Symbols: * = p < 0.05 for upadacitinib 15 mg QD vs. placebo; # = p < 0.05 for upadacitinib 30 mg QD vs. placebo; † = significant in multiplicity-controlled analysis.Additional key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 14B); patients achieving an ACR70 response (Figure 14C); proportion of patients achieving minimal disease activity (MDA) over 24 weeks (Figure 14D); patients achieving a change from baseline in the Leeds Enthesitis Index (LEI) (Figure 14E); patients achieving enthesitis resolution (LEI=0) (Figure 14F); proportion of patients who were enthesitis-free over 24 weeks by the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 14G); Patients who achieved a change from baseline in the LDI (Figure 14H); patients who achieved resolution of dactylitis (LDI=0) (Figure 14I); proportion of patients who achieved Psoriasis Area and Severity Index PASI75 (Figure 14J), PASI90 (Figure 14K), and PASI100 responses (Figure 14L) over 24 weeks; patients who achieved a change from baseline in Disease Activity in Psoriatic Arthritis (DAPSA) score (Figure 14M); patients who achieved a change from baseline over 24 weeks in the core components of the ACR criteria: number of tender joints (TJC68) (Figure 14N), swollen joint count (SJC66) (Figure 14O), physician global assessment of disease activity (PhGA) (Figure 14P), patient global assessment of disease activity (PtGA) (Figure 14Q), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 14R), high-sensitivity C-reactive protein (hs-CRP) (Figure 14S); proportion of patients achieving static physician global assessment (sIGA) 0 / 1 at 24 weeks (Figure 14T); self-assessment of psoriasis symptoms (SAPS). Patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14U); patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14V); patients who achieved a change from baseline at 24 weeks in the SF-36 Physical Dimension Summary (Figure 14W); and patients who achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue).) (Figure 14X); patients who achieved a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 14Y); patients who achieved a change from baseline at 24 weeks in morning stiffness severity (BASDAI question 5) (Figure 14Z); and patients who achieved a change from baseline at 24 weeks in morning stiffness duration (BASDAI question 6) (Figure 14AA). Significantly higher proportions of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater, 50% or greater, and 70% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, and the achieved efficacy was maintained thereafter (see Figures 14BB-14DD). UPA = upadacitinib; PBO = placebo; QD = once daily; NRI = non-responder complement. [Figure 14C]Figures 14A and 14B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA2 (PsA bDMARD-IR) Phase 3 clinical trial. Figure 14A depicts the time course to Week 24 for the primary endpoint ACR20. % response rates with 95% CI are shown by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base. Symbols: * = p < 0.05 for upadacitinib 15 mg QD vs. placebo; # = p < 0.05 for upadacitinib 30 mg QD vs. placebo; † = significant in multiplicity-controlled analysis.Additional key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 14B); patients achieving an ACR70 response (Figure 14C); proportion of patients achieving minimal disease activity (MDA) over 24 weeks (Figure 14D); patients achieving a change from baseline in the Leeds Enthesitis Index (LEI) (Figure 14E); patients achieving enthesitis resolution (LEI=0) (Figure 14F); proportion of patients who were enthesitis-free over 24 weeks by the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 14G); Patients who achieved a change from baseline in the LDI (Figure 14H); patients who achieved resolution of dactylitis (LDI=0) (Figure 14I); proportion of patients who achieved Psoriasis Area and Severity Index PASI75 (Figure 14J), PASI90 (Figure 14K), and PASI100 responses (Figure 14L) over 24 weeks; patients who achieved a change from baseline in Disease Activity in Psoriatic Arthritis (DAPSA) score (Figure 14M); patients who achieved a change from baseline over 24 weeks in the core components of the ACR criteria: number of tender joints (TJC68) (Figure 14N), swollen joint count (SJC66) (Figure 14O), physician global assessment of disease activity (PhGA) (Figure 14P), patient global assessment of disease activity (PtGA) (Figure 14Q), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 14R), high-sensitivity C-reactive protein (hs-CRP) (Figure 14S); proportion of patients achieving static physician global assessment (sIGA) 0 / 1 at 24 weeks (Figure 14T); self-assessment of psoriasis symptoms (SAPS). Patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14U); patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14V); patients who achieved a change from baseline at 24 weeks in the SF-36 Physical Dimension Summary (Figure 14W); and patients who achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue).) (Figure 14X); patients who achieved a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 14Y); patients who achieved a change from baseline at 24 weeks in morning stiffness severity (BASDAI question 5) (Figure 14Z); and patients who achieved a change from baseline at 24 weeks in morning stiffness duration (BASDAI question 6) (Figure 14AA). Significantly higher proportions of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater, 50% or greater, and 70% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, and the achieved efficacy was maintained thereafter (see Figures 14BB-14DD). UPA = upadacitinib; PBO = placebo; QD = once daily; NRI = non-responder complement. [Figure 14D]Figures 14A and 14B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA2 (PsA bDMARD-IR) Phase 3 clinical trial. Figure 14A depicts the time course to Week 24 for the primary endpoint ACR20. % response rates with 95% CI are shown by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base. Symbols: * = p < 0.05 for upadacitinib 15 mg QD vs. placebo; # = p < 0.05 for upadacitinib 30 mg QD vs. placebo; † = significant in multiplicity-controlled analysis.Additional key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 14B); patients achieving an ACR70 response (Figure 14C); proportion of patients achieving minimal disease activity (MDA) over 24 weeks (Figure 14D); patients achieving a change from baseline in the Leeds Enthesitis Index (LEI) (Figure 14E); patients achieving enthesitis resolution (LEI=0) (Figure 14F); proportion of patients who were enthesitis-free over 24 weeks by the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 14G); Patients who achieved a change from baseline in the LDI (Figure 14H); patients who achieved resolution of dactylitis (LDI=0) (Figure 14I); proportion of patients who achieved Psoriasis Area and Severity Index PASI75 (Figure 14J), PASI90 (Figure 14K), and PASI100 responses (Figure 14L) over 24 weeks; patients who achieved a change from baseline in Disease Activity in Psoriatic Arthritis (DAPSA) score (Figure 14M); patients who achieved a change from baseline over 24 weeks in the core components of the ACR criteria: number of tender joints (TJC68) (Figure 14N), swollen joint count (SJC66) (Figure 14O), physician global assessment of disease activity (PhGA) (Figure 14P), patient global assessment of disease activity (PtGA) (Figure 14Q), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 14R), high-sensitivity C-reactive protein (hs-CRP) (Figure 14S); proportion of patients achieving static physician global assessment (sIGA) 0 / 1 at 24 weeks (Figure 14T); self-assessment of psoriasis symptoms (SAPS). Patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14U); patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14V); patients who achieved a change from baseline at 24 weeks in the SF-36 Physical Dimension Summary (Figure 14W); and patients who achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue).) (Figure 14X); patients who achieved a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 14Y); patients who achieved a change from baseline at 24 weeks in morning stiffness severity (BASDAI question 5) (Figure 14Z); and patients who achieved a change from baseline at 24 weeks in morning stiffness duration (BASDAI question 6) (Figure 14AA). Significantly higher proportions of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater, 50% or greater, and 70% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, and the achieved efficacy was maintained thereafter (see Figures 14BB-14DD). UPA = upadacitinib; PBO = placebo; QD = once daily; NRI = non-responder complement. [Figure 14E]Figures 14A and 14B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA2 (PsA bDMARD-IR) Phase 3 clinical trial. Figure 14A depicts the time course to Week 24 for the primary endpoint ACR20. % response rates with 95% CI are shown by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base. Symbols: * = p < 0.05 for upadacitinib 15 mg QD vs. placebo; # = p < 0.05 for upadacitinib 30 mg QD vs. placebo; † = significant in multiplicity-controlled analysis.Additional key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 14B); patients achieving an ACR70 response (Figure 14C); proportion of patients achieving minimal disease activity (MDA) over 24 weeks (Figure 14D); patients achieving a change from baseline in the Leeds Enthesitis Index (LEI) (Figure 14E); patients achieving enthesitis resolution (LEI=0) (Figure 14F); proportion of patients who were enthesitis-free over 24 weeks by the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 14G); Patients who achieved a change from baseline in the LDI (Figure 14H); patients who achieved resolution of dactylitis (LDI=0) (Figure 14I); proportion of patients who achieved Psoriasis Area and Severity Index PASI75 (Figure 14J), PASI90 (Figure 14K), and PASI100 responses (Figure 14L) over 24 weeks; patients who achieved a change from baseline in Disease Activity in Psoriatic Arthritis (DAPSA) score (Figure 14M); patients who achieved a change from baseline over 24 weeks in the core components of the ACR criteria: number of tender joints (TJC68) (Figure 14N), swollen joint count (SJC66) (Figure 14O), physician global assessment of disease activity (PhGA) (Figure 14P), patient global assessment of disease activity (PtGA) (Figure 14Q), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 14R), high-sensitivity C-reactive protein (hs-CRP) (Figure 14S); proportion of patients achieving static physician global assessment (sIGA) 0 / 1 at 24 weeks (Figure 14T); self-assessment of psoriasis symptoms (SAPS). Patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14U); patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14V); patients who achieved a change from baseline at 24 weeks in the SF-36 Physical Dimension Summary (Figure 14W); and patients who achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue).) (Figure 14X); patients who achieved a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 14Y); patients who achieved a change from baseline at 24 weeks in morning stiffness severity (BASDAI question 5) (Figure 14Z); and patients who achieved a change from baseline at 24 weeks in morning stiffness duration (BASDAI question 6) (Figure 14AA). Significantly higher proportions of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater, 50% or greater, and 70% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, and the achieved efficacy was maintained thereafter (see Figures 14BB-14DD). UPA = upadacitinib; PBO = placebo; QD = once daily; NRI = non-responder complement. [Figure 14F]Figures 14A and 14B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA2 (PsA bDMARD-IR) Phase 3 clinical trial. Figure 14A depicts the time course to Week 24 for the primary endpoint ACR20. % response rates with 95% CI are shown by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base. Symbols: * = p < 0.05 for upadacitinib 15 mg QD vs. placebo; # = p < 0.05 for upadacitinib 30 mg QD vs. placebo; † = significant in multiplicity-controlled analysis.Additional key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 14B); patients achieving an ACR70 response (Figure 14C); proportion of patients achieving minimal disease activity (MDA) over 24 weeks (Figure 14D); patients achieving a change from baseline in the Leeds Enthesitis Index (LEI) (Figure 14E); patients achieving enthesitis resolution (LEI=0) (Figure 14F); proportion of patients who were enthesitis-free over 24 weeks by the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 14G); Patients who achieved a change from baseline in the LDI (Figure 14H); patients who achieved resolution of dactylitis (LDI=0) (Figure 14I); proportion of patients who achieved Psoriasis Area and Severity Index PASI75 (Figure 14J), PASI90 (Figure 14K), and PASI100 responses (Figure 14L) over 24 weeks; patients who achieved a change from baseline in Disease Activity in Psoriatic Arthritis (DAPSA) score (Figure 14M); patients who achieved a change from baseline over 24 weeks in the core components of the ACR criteria: number of tender joints (TJC68) (Figure 14N), swollen joint count (SJC66) (Figure 14O), physician global assessment of disease activity (PhGA) (Figure 14P), patient global assessment of disease activity (PtGA) (Figure 14Q), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 14R), high-sensitivity C-reactive protein (hs-CRP) (Figure 14S); proportion of patients achieving static physician global assessment (sIGA) 0 / 1 at 24 weeks (Figure 14T); self-assessment of psoriasis symptoms (SAPS). Patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14U); patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14V); patients who achieved a change from baseline at 24 weeks in the SF-36 Physical Dimension Summary (Figure 14W); and patients who achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue).) (Figure 14X); patients who achieved a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 14Y); patients who achieved a change from baseline at 24 weeks in morning stiffness severity (BASDAI question 5) (Figure 14Z); and patients who achieved a change from baseline at 24 weeks in morning stiffness duration (BASDAI question 6) (Figure 14AA). Significantly higher proportions of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater, 50% or greater, and 70% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, and the achieved efficacy was maintained thereafter (see Figures 14BB-14DD). UPA = upadacitinib; PBO = placebo; QD = once daily; NRI = non-responder complement. [Figure 14G]Figures 14A and 14B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA2 (PsA bDMARD-IR) Phase 3 clinical trial. Figure 14A depicts the time course to Week 24 for the primary endpoint ACR20. % response rates with 95% CI are shown by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base. Symbols: * = p < 0.05 for upadacitinib 15 mg QD vs. placebo; # = p < 0.05 for upadacitinib 30 mg QD vs. placebo; † = significant in multiplicity-controlled analysis.Additional key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 14B); patients achieving an ACR70 response (Figure 14C); proportion of patients achieving minimal disease activity (MDA) over 24 weeks (Figure 14D); patients achieving a change from baseline in the Leeds Enthesitis Index (LEI) (Figure 14E); patients achieving enthesitis resolution (LEI=0) (Figure 14F); proportion of patients who were enthesitis-free over 24 weeks by the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 14G); Patients who achieved a change from baseline in the LDI (Figure 14H); patients who achieved resolution of dactylitis (LDI=0) (Figure 14I); proportion of patients who achieved Psoriasis Area and Severity Index PASI75 (Figure 14J), PASI90 (Figure 14K), and PASI100 responses (Figure 14L) over 24 weeks; patients who achieved a change from baseline in Disease Activity in Psoriatic Arthritis (DAPSA) score (Figure 14M); patients who achieved a change from baseline over 24 weeks in the core components of the ACR criteria: number of tender joints (TJC68) (Figure 14N), swollen joint count (SJC66) (Figure 14O), physician global assessment of disease activity (PhGA) (Figure 14P), patient global assessment of disease activity (PtGA) (Figure 14Q), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 14R), high-sensitivity C-reactive protein (hs-CRP) (Figure 14S); proportion of patients achieving static physician global assessment (sIGA) 0 / 1 at 24 weeks (Figure 14T); self-assessment of psoriasis symptoms (SAPS). Patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14U); patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14V); patients who achieved a change from baseline at 24 weeks in the SF-36 Physical Dimension Summary (Figure 14W); and patients who achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue).) (Figure 14X); patients who achieved a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 14Y); patients who achieved a change from baseline at 24 weeks in morning stiffness severity (BASDAI question 5) (Figure 14Z); and patients who achieved a change from baseline at 24 weeks in morning stiffness duration (BASDAI question 6) (Figure 14AA). Significantly higher proportions of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater, 50% or greater, and 70% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, and the achieved efficacy was maintained thereafter (see Figures 14BB-14DD). UPA = upadacitinib; PBO = placebo; QD = once daily; NRI = non-responder complement. [Figure 14H]Figures 14A and 14B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA2 (PsA bDMARD-IR) Phase 3 clinical trial. Figure 14A depicts the time course to Week 24 for the primary endpoint ACR20. % response rates with 95% CI are shown by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base. Symbols: * = p < 0.05 for upadacitinib 15 mg QD vs. placebo; # = p < 0.05 for upadacitinib 30 mg QD vs. placebo; † = significant in multiplicity-controlled analysis.Additional key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 14B); patients achieving an ACR70 response (Figure 14C); proportion of patients achieving minimal disease activity (MDA) over 24 weeks (Figure 14D); patients achieving a change from baseline in the Leeds Enthesitis Index (LEI) (Figure 14E); patients achieving enthesitis resolution (LEI=0) (Figure 14F); proportion of patients who were enthesitis-free over 24 weeks by the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 14G); Patients who achieved a change from baseline in the LDI (Figure 14H); patients who achieved resolution of dactylitis (LDI=0) (Figure 14I); proportion of patients who achieved Psoriasis Area and Severity Index PASI75 (Figure 14J), PASI90 (Figure 14K), and PASI100 responses (Figure 14L) over 24 weeks; patients who achieved a change from baseline in Disease Activity in Psoriatic Arthritis (DAPSA) score (Figure 14M); patients who achieved a change from baseline over 24 weeks in the core components of the ACR criteria: number of tender joints (TJC68) (Figure 14N), swollen joint count (SJC66) (Figure 14O), physician global assessment of disease activity (PhGA) (Figure 14P), patient global assessment of disease activity (PtGA) (Figure 14Q), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 14R), high-sensitivity C-reactive protein (hs-CRP) (Figure 14S); proportion of patients achieving static physician global assessment (sIGA) 0 / 1 at 24 weeks (Figure 14T); self-assessment of psoriasis symptoms (SAPS). Patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14U); patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14V); patients who achieved a change from baseline at 24 weeks in the SF-36 Physical Dimension Summary (Figure 14W); and patients who achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue).) (Figure 14X); patients who achieved a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 14Y); patients who achieved a change from baseline at 24 weeks in morning stiffness severity (BASDAI question 5) (Figure 14Z); and patients who achieved a change from baseline at 24 weeks in morning stiffness duration (BASDAI question 6) (Figure 14AA). Significantly higher proportions of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater, 50% or greater, and 70% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, and the achieved efficacy was maintained thereafter (see Figures 14BB-14DD). UPA = upadacitinib; PBO = placebo; QD = once daily; NRI = non-responder complement. [Figure 14I]Figures 14A and 14B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA2 (PsA bDMARD-IR) Phase 3 clinical trial. Figure 14A depicts the time course to Week 24 for the primary endpoint ACR20. % response rates with 95% CI are shown by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base. Symbols: * = p < 0.05 for upadacitinib 15 mg QD vs. placebo; # = p < 0.05 for upadacitinib 30 mg QD vs. placebo; † = significant in multiplicity-controlled analysis.Additional key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 14B); patients achieving an ACR70 response (Figure 14C); proportion of patients achieving minimal disease activity (MDA) over 24 weeks (Figure 14D); patients achieving a change from baseline in the Leeds Enthesitis Index (LEI) (Figure 14E); patients achieving enthesitis resolution (LEI=0) (Figure 14F); proportion of patients who were enthesitis-free over 24 weeks by the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 14G); Patients who achieved a change from baseline in the LDI (Figure 14H); patients who achieved resolution of dactylitis (LDI=0) (Figure 14I); proportion of patients who achieved Psoriasis Area and Severity Index PASI75 (Figure 14J), PASI90 (Figure 14K), and PASI100 responses (Figure 14L) over 24 weeks; patients who achieved a change from baseline in Disease Activity in Psoriatic Arthritis (DAPSA) score (Figure 14M); patients who achieved a change from baseline over 24 weeks in the core components of the ACR criteria: number of tender joints (TJC68) (Figure 14N), swollen joint count (SJC66) (Figure 14O), physician global assessment of disease activity (PhGA) (Figure 14P), patient global assessment of disease activity (PtGA) (Figure 14Q), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 14R), high-sensitivity C-reactive protein (hs-CRP) (Figure 14S); proportion of patients achieving static physician global assessment (sIGA) 0 / 1 at 24 weeks (Figure 14T); self-assessment of psoriasis symptoms (SAPS). Patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14U); patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14V); patients who achieved a change from baseline at 24 weeks in the SF-36 Physical Dimension Summary (Figure 14W); and patients who achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue).) (Figure 14X); patients who achieved a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 14Y); patients who achieved a change from baseline at 24 weeks in morning stiffness severity (BASDAI question 5) (Figure 14Z); and patients who achieved a change from baseline at 24 weeks in morning stiffness duration (BASDAI question 6) (Figure 14AA). Significantly higher proportions of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater, 50% or greater, and 70% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, and the achieved efficacy was maintained thereafter (see Figures 14BB-14DD). UPA = upadacitinib; PBO = placebo; QD = once daily; NRI = non-responder complement. [Figure 14J]Figures 14A and 14B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA2 (PsA bDMARD-IR) Phase 3 clinical trial. Figure 14A depicts the time course to Week 24 for the primary endpoint ACR20. % response rates with 95% CI are shown by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base. Symbols: * = p < 0.05 for upadacitinib 15 mg QD vs. placebo; # = p < 0.05 for upadacitinib 30 mg QD vs. placebo; † = significant in multiplicity-controlled analysis.Additional key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 14B); patients achieving an ACR70 response (Figure 14C); proportion of patients achieving minimal disease activity (MDA) over 24 weeks (Figure 14D); patients achieving a change from baseline in the Leeds Enthesitis Index (LEI) (Figure 14E); patients achieving enthesitis resolution (LEI=0) (Figure 14F); proportion of patients who were enthesitis-free over 24 weeks by the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 14G); Patients who achieved a change from baseline in the LDI (Figure 14H); patients who achieved resolution of dactylitis (LDI=0) (Figure 14I); proportion of patients who achieved Psoriasis Area and Severity Index PASI75 (Figure 14J), PASI90 (Figure 14K), and PASI100 responses (Figure 14L) over 24 weeks; patients who achieved a change from baseline in Disease Activity in Psoriatic Arthritis (DAPSA) score (Figure 14M); patients who achieved a change from baseline over 24 weeks in the core components of the ACR criteria: number of tender joints (TJC68) (Figure 14N), swollen joint count (SJC66) (Figure 14O), physician global assessment of disease activity (PhGA) (Figure 14P), patient global assessment of disease activity (PtGA) (Figure 14Q), pain (PtPain) (score 0 indicates "no pain" and score 10 indicates "worst possible pain") (Figure 14R), high-sensitivity C-reactive protein (hs-CRP) (Figure 14S); proportion of patients achieving static physician global assessment (sIGA) 0 / 1 at 24 weeks (Figure 14T); self-assessment of psoriasis symptoms (SAPS). Patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14U); patients who achieved a change from baseline at 24 weeks in the Health Assessment Questionnaire-Disability Index (HAQ-DI) (Figure 14V); patients who achieved a change from baseline at 24 weeks in the SF-36 Physical Dimension Summary (Figure 14W); and patients who achieved a change from baseline at 24 weeks in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue).) (Figure 14X); patients who achieved a change from baseline at 24 weeks in morning stiffness (mean of BASDAI questions 5 and 6) (Figure 14Y); patients who achieved a change from baseline at 24 weeks in morning stiffness severity (BASDAI question 5) (Figure 14Z); and patients who achieved a change from baseline at 24 weeks in morning stiffness duration (BASDAI question 6) (Figure 14AA). Significantly higher proportions of patients receiving upadacitinib free base (15 mg QD or 30 mg QD) versus placebo achieved a 30% or greater, 50% or greater, and 70% or greater reduction in Patient Global Assessment of Pain (Pt Pain) as early as week 2, and the achieved efficacy was maintained thereafter (see Figures 14BB-14DD). UPA = upadacitinib; PBO = placebo; QD = once daily; NRI = non-responder complement. [Figure 14K]Figures 14A and 14B provide a summary of the primary and key secondary efficacy results for the SELECT-PsA2 (PsA bDMARD-IR) Phase 3 clinical trial. Figure 14A depicts the time course to Week 24 for the primary endpoint ACR20. % response rates with 95% CI are shown by visit. Nominal p-values ​​<0.05 for both UPA doses vs. placebo for all visits. UPA = upadacitinib free base. Symbols: * = p < 0.05 for upadacitinib 15 mg QD vs. placebo; # = p < 0.05 for upadacitinib 30 mg QD vs. placebo; † = significant in multiplicity-controlled analysis.Additional key secondary efficacy outcomes included patients achieving an ACR50 response (Figure 14B); patients achieving an ACR70 response (Figure 14C); proportion of patients achieving minimal disease activity (MDA) over 24 weeks (Figure 14D); patients achieving a change from baseline in the Leeds Enthesitis Index (LEI) (Figure 14E); patients achieving enthesitis resolution (LEI=0) (Figure 14F); proportion of patients who were enthesitis-free over 24 weeks by the Spondyloarthritis Research Consortium of Canada (SPARCC) (Figure 14G); Patients who achieved a change from baseline in the LDI (Figure 14H); patients who achieved resolution of dactylitis (LDI=0) (Figure 14I); proportion of patients who achieved Psoriasis Area and Severity Index PASI75 (Figure 14J), PASI90 (Figure 14K), and PASI100 responses (Figure 14L) over 24 weeks; patients who achieved a change from baseline in Disease Activity in Psoriatic Arthritis (DAPSA) score (Figure 14M); patients who achieved a change from baseline over 24 weeks in the core components of the ACR criteria: number of tender joints (TJC68) (Figure 14N), swollen joint count (SJC66) (Figure 14O), physician global assessment of disease activity (PhGA) (Figure 14P), patient global assessment of disease activity (PtGA) (Figure 14Q), pain (PtPain) (score 0 indicates "no pa...

Claims

1. A method for treating active ankylosing spondylitis in a subject in need thereof, comprising orally administering to the subject once daily for at least 14 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof in an amount sufficient to deliver an equivalent amount of 15 mg of upadacitinib free base, wherein the subject achieves an International Society for Spondyloarthritis Assessment 40 (ASAS40) response within 14 weeks of administration of the first dose.

2. 10. The method of claim 1, wherein when the method is used to treat a population of subjects, at least 10% of the subjects in the treated population achieve an ASAS40 response within 14 weeks of administration of the first dose.

3. A subject or subjects in the treated population who have active AS at baseline receive, within 14 weeks of administration of the first dose: a. Improvement from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS); b. Improvement from baseline in magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score for the spine (MRI-Spine SPARCC); c. ASAS partial response (PR); d. Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) response; e. Improvement from baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI); f. ASDAS Low Disease Activity (LDA); g. ASDAS inactive disease (ID); h. Major Improvement (MI) on the ASDAS; and i. Clinically Important Improvement (CII) on the ASDAS 3. The method of claim 1 or 2, further achieving at least one result selected from the group consisting of:

4. 4. The method of claim 3, wherein the subject or subjects in the treated population further achieve each outcome within 14 weeks of administration of the first dose.

5. 5. The method of any one of claims 1 to 4, wherein the subject or subjects in the treated population meet the 1984 revised New York criteria for ankylosing spondylitis at baseline.

6. The method of any one of claims 1 to 4, wherein the subject or subjects in the treated population meet the 2009 ASAS classification criteria at baseline.

7. A subject or subjects in the treated population, at baseline, a. A Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or greater; b. Ankylosing Spondylitis Disease Activity Score (ASDAS) of 2.1 or greater; and c. Patient assessment of total back pain on a 0-10 numerical rating scale (total back pain score) of 4 or greater The method of any one of claims 1 to 6, wherein the method satisfies at least one criterion selected from the group consisting of:

8. 8. The method of any one of claims 1 to 7, wherein the subject or subjects in the treated population are biological disease-modifying antirheumatic drug (bDMARD) naive at baseline.

9. 8. The method of any one of claims 1 to 7, wherein the subject or subjects in the treated population have an inadequate response to or intolerance to biological disease-modifying antirheumatic drugs (bDMARDs) at baseline.

10. 10. The method of claim 9, wherein prior to administration of the first dose, the subject or subjects in the treated population have received one bDMARD and have discontinued use of the bDMARD due to intolerance or lack of efficacy at baseline.

11. The method of claim 10, wherein the bDMARD is a tumor necrosis factor (TNF) inhibitor or an interleukin (IL)-17 inhibitor.

12. 12. The method of any one of claims 1 to 11, wherein the subject or subjects in the treated population have, at baseline, an inadequate response or intolerance to at least two NSAIDs, intolerance to NSAIDS, and / or contraindications to NSAIDs.

13. A method for treating active axial spondyloarthritis that does not meet radiographic criteria in a subject in need of treatment, comprising orally administering to the subject once daily for at least 14 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof in an amount sufficient to deliver an equivalent amount of 15 mg of upadacitinib free base, wherein the subject achieves an ASAS 40 response within 14 weeks of administration of the first dose.

14. A method for treating active axial spondyloarthritis that does not meet radiographic criteria in a subject in need of treatment, comprising orally administering to the subject once daily for at least 52 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof in an amount sufficient to deliver an equivalent amount of 15 mg of upadacitinib free base, wherein the subject achieves an ASAS 40 response within 52 weeks of administration of the first dose.

15. 15. The method of claim 13 or 14, wherein the subject meets the 2009 ASAS classification criteria for axial spondyloarthritis but does not meet the radiological criteria of the 1984 revised New York criteria for ankylosing spondylitis at baseline.

16. The subject, at baseline, a. A Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or greater; b. Ankylosing Spondylitis Disease Activity Score (ASDAS) of 2.1 or greater; c. Patient assessment of total back pain on a 0-10 numeric rating scale (Total Back Pain Score) of 4 or greater; and d. i. Objective signs of active inflammation on MRI of the sacroiliac (SI) joints, and ii. High-sensitivity C-reactive protein > upper limit of normal (ULN) objective signs of inflammatory activity selected from the group consisting of 15. The method of claim 13 or 14, wherein the method satisfies at least one criterion selected from the group consisting of:

17. The method of any one of claims 13 to 16, wherein the subject is bDMARD-naive at baseline.

18. The method of any one of claims 13 to 16, wherein the subject has an inadequate response or intolerance to a bDMARD at baseline.

19. 20. The method of claim 18, wherein prior to administration of the first dose, the subject has received one bDMARD and discontinued use of the bDMARD due to intolerance or lack of efficacy.

20. 20. The method of claim 19, wherein the bDMARD is a tumor necrosis factor (TNF) inhibitor or an interleukin (IL)-17 inhibitor.

21. 21. The method of any one of claims 13 to 20, wherein the subject has an inadequate response or intolerance to at least two NSAIDs, intolerance to NSAIDS, and / or a contraindication to NSAIDs at baseline.

22. the subject receives, within 14 weeks of the first dose, a. Improvement from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS); b. Improvement from baseline in magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score for the SI joint (MRI-SI joint SPARCC); c. ASAS partial response (PR); d. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response; e. Improvement from baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI); f. Improvement from baseline in Ankylosing Spondylitis Quality of Life (ASQoL); g. Improvement from baseline in ASAS Health Index (HI); h. Improvement from baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MAASES); and i. Linear Bath Ankylosing Spondylitis Mobility Index (BASMI) ｌｉｎ ) improvement from baseline 22. The method of any one of claims 13 to 21, which achieves at least one additional result selected from the group consisting of:

23. A method for treating active psoriatic arthritis in a subject in need thereof, comprising orally administering to the subject once daily for at least 12 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof in an amount sufficient to deliver the equivalent of 15 mg of upadacitinib free base, wherein the subject achieves an American College of Rheumatology 20% (ACR20) response within 12 weeks of administration of the first dose.

24. A method for treating active psoriatic arthritis in a subject in need thereof, comprising orally administering to the subject once daily for at least 12 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof in an amount sufficient to deliver 30 mg of upadacitinib free base equivalent, wherein the subject achieves an American College of Rheumatology 20% (ACR20) response within 12 weeks of administration of the first dose.

25. 25. The method of claim 23 or 24, wherein when the method is used to treat a population of subjects, at least 10% of subjects in the treated population achieve an ACR20 response within 12 weeks of administration of the first dose.

26. A subject or subjects in the treated population who have active PsA at baseline: a. Improvement from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) within 12 weeks of receiving the first dose; b. Achieving at least a 2-point improvement from baseline in psoriasis physician-administered static global assessment (sIGA) of 0 or 1 within 16 weeks of the first dose (for subjects with a baseline sIGA of 2 or greater); c. Achieving a PASI (Psoriasis Area and Severity Index) 75 response within 16 weeks of the first dose (for subjects with psoriasis of ≥ 3% BSA at baseline); d. Improvement from baseline in Sharp / van der Heijdes score (SHS) within 24 weeks of first dose administration; e. Achieving MDA (minimal disease activity) within 24 weeks of first dose administration; f. An improvement from baseline in Leeds Enthesitis Index (LEI) within 24 weeks of the first dose, preferably wherein the improvement is the disappearance of enthesitis (LEI=0) within 24 weeks of the first dose (in subjects with enthesitis present at baseline (LEI>0)); g. Achieving an ACR20 response within 12 weeks of the first dose (non-inferiority of upadacitinib to adalimumab); h. Improvement from baseline in the 36-item Short Form Health Survey (SF-36) within 12 weeks of the first dose; and i. Improvement from baseline in the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) questionnaire within 12 weeks of the first dose. The method of any one of claims 23 to 25, further achieving at least one result selected from the group consisting of:

27. 27. The method of claim 26, wherein a subject or subjects in the treated population who have active PsA at baseline further achieve each outcome.

28. A subject or subjects in the treated population who have active PsA at baseline: ACR20 response within 12 weeks of first dose administration and superiority to adalimumab (40 mg every other week); and b. An improvement from baseline in the Leeds Dactylitis Index (LDI) within 24 weeks of administration of the first dose, preferably wherein the improvement is the disappearance of dactylitis (LDI=0) within 24 weeks of administration of the first dose. (For subjects with dactylitis present at baseline (LDI>0)) The method of any one of claims 23 to 27, further achieving at least one result selected from the group consisting of:

29. 29. The method of claim 28, wherein the subject or subjects in the treated population with active PsA at baseline further achieve an ACR20 response and superiority to adalimumab (40 mg every other week) within 12 weeks of administration of the first dose.

30. 30. The method of claim 29, wherein a subject or subjects in the treated population who have active PsA at baseline are orally administered a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof in an amount sufficient to deliver the equivalent of 30 mg of upadacitinib free base once daily for at least 12 weeks.

31. 31. The method of any one of claims 23-30, wherein the subject or subjects in the treated population achieve an ACR 50% response (ACR50) within 12 weeks of administration of the first dose.

32. 31. The method of any one of claims 23-30, wherein the subject or subjects in the treated population achieve an ACR 70% response (ACR70) within 12 weeks of administration of the first dose.

33. 33. The method of any one of claims 23 to 32, wherein the subject or subjects in the treated population meet Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at baseline.

34. 34. The method of any one of claims 23 to 33, wherein the subject or subjects in the treated population have at least one criterion selected from the group consisting of 3 or more tender joints (based on a 68 joint count) and 3 or more swollen joints (based on a 66 joint count) at baseline.

35. 35. The method of claim 34, wherein the subject or subjects in the treated population have 5 or more tender joints (based on a 68 joint count) and 5 or more swollen joints (based on a 66 joint count) at baseline.

36. 36. The method of any one of claims 23-35, wherein the subject or subjects in the treated population have at baseline at least one criterion selected from the group consisting of one or more erosions on radiography as determined by central imaging review, and hs-CRP > laboratory-defined upper limit of normal (ULN).

37. 37. The method of any one of claims 23 to 36, wherein the subject or subjects in the treated population have a diagnosis of active plaque psoriasis or the subject has a documented history of plaque psoriasis at baseline.

38. 37. The method of any one of claims 23 to 36, wherein the subject or subjects in the treated population have an inadequate response to or intolerance to at least one biological disease-modifying antirheumatic drug (bDMARD) at baseline.

39. 39. The method of claim 38, wherein the subject or subjects in the treated population have discontinued all bDMARDs prior to administration of the first dose.

40. 37. The method of any one of claims 23 to 36, wherein the subject or subjects in the treated population have, at baseline, an inadequate response to or intolerance to previous or concurrent treatment with at least one non-biologic DMARD, or intolerance to or contraindication to a non-biologic DMARD.

41. 41. The method of any one of claims 23 to 40, wherein the subject or subjects in the treated population have moderate to severe active psoriatic arthritis at baseline.

42. A method for treating active psoriasis in a subject in need thereof, comprising orally administering to the subject once daily for at least 16 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof sufficient to deliver the equivalent of 15 mg of upadacitinib free base, wherein the subject achieves a Psoriasis Area Severity Index (PASI) 75 response within 16 weeks of administration of the first dose.

43. A method for treating active psoriasis in a subject in need thereof, comprising orally administering to the subject once daily for at least 16 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof in an amount sufficient to deliver 30 mg of upadacitinib free base equivalent, wherein the subject achieves a Psoriasis Area Severity Index (PASI) 75 response within 16 weeks of administration of the first dose.

44. 44. The method of claim 42 or 43, wherein when the method is used to treat a population of subjects, at least 10% of the subjects in the treated population achieve a PASI 75 response within 16 weeks of administration of the first dose.

45. 78. The method of any one of claims 1 to 44 or 46 to 77, wherein the subject is an adult subject, or the subjects in the treated population are adult subjects.

46. 13. The method of any one of claims 1 to 12, wherein the ASAS40 response is maintained or improved from week 14 onwards by continuing to administer daily doses.

47. 13. The method of any one of claims 1 to 12, wherein the subject or subjects in the treated population further achieve an ASAS 40 within two weeks of administration of the first dose.

48. 13. The method of any one of claims 1 to 12, wherein the subject or subjects in the treated population further achieve an ASAS 40 within two weeks of administration of the first dose, and wherein the ASAS 40 is maintained or improved at week 14 or beyond by continuing to administer daily doses.

49. A method for treating active ankylosing spondylitis in a subject in need thereof, comprising orally administering to the subject once daily for at least 14 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof in an amount sufficient to deliver an equivalent amount of 15 mg of upadacitinib free base, wherein the subject achieves ASDAS partial response (PR), ASDAS low disease activity (LDA), ASDAS inactive disease (ID), ASDAS major improvement (MI), and / or ASDAS clinically important improvement (CII) within 14 weeks of administration of the first dose.

50. 50. The method of claim 49, wherein when the method is used to treat a population of subjects, at least 10% of subjects in the treated population achieve ASDA partial remission (PR), ASDAS low disease activity (LDA), ASDAS inactive disease (ID), ASDAS major improvement (MI), and / or ASDAS clinically important improvement (CII) within 14 weeks of administration of the first dose.

51. 51. The method of claim 49 or 50, wherein the subject or subjects in the treated population further achieve each outcome within 14 weeks of administration of the first dose.

52. 52. The method of any one of claims 49-51, wherein the subject or subjects in the treated population meet the 1984 revised New York criteria for ankylosing spondylitis at baseline.

53. 52. The method of any one of claims 49 to 51, wherein the subject or subjects in the treated population meet the 2009 ASAS classification criteria at baseline.

54. A subject or subjects in the treated population, at baseline, a. A Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or greater; b. Ankylosing Spondylitis Disease Activity Score (ASDAS) of 2.1 or greater; and c. Patient assessment of total back pain on a 0-10 numerical rating scale (total back pain score) of 4 or greater 54. The method of any one of claims 49 to 53, wherein the method satisfies at least one criterion selected from the group consisting of:

55. 55. The method of any one of claims 49-54, wherein the subject or subjects in the treated population are biological disease-modifying antirheumatic drug (bDMARD) naive at baseline.

56. 56. The method of any one of claims 49-55, wherein the subject or subjects in the treated population have an inadequate response to or intolerance to biological disease-modifying antirheumatic drugs (bDMARDs) at baseline.

57. 57. The method of claim 56, wherein prior to administration of the first dose, the subject or subjects in the treated population have received one bDMARD and discontinued use of the bDMARD due to intolerance or lack of efficacy.

58. 58. The method of claim 57, wherein the bDMARD is a tumor necrosis factor (TNF) inhibitor or an interleukin (IL)-17 inhibitor.

59. 59. The method of any one of claims 49 to 58, wherein the subject or subjects in the treated population have, at baseline, an inadequate response to or intolerance to at least two NSAIDs, intolerance to NSAIDS, and / or contraindications to NSAIDs.

60. 60. The method of any one of claims 49-59, wherein ASDASA partial response (PR), ASDAS low disease activity (LDA), ASDAS inactive disease (ID), ASDAS major improvement (MI), and / or ASDAS clinically important improvement (CII) is maintained or improved from week 14 onwards by continuing to administer the daily dose.

61. 61. The method of any one of claims 49-60, wherein the subject or subjects in the treated population further achieve ASAS partial response (PR), ASDAS low disease activity (LDA), ASDAS inactive disease (ID), ASDAS major improvement (MI), and / or ASDAS clinically important improvement (CII) within two weeks of administration of the first dose.

62. 42. The method of any one of claims 23 to 41, wherein the ACR score is maintained or improved from week 12 onwards by continuing to administer the daily dose.

63. 63. The method of any one of claims 23-41 or 62, wherein the subject or subjects in the treated population further achieve an ACR20 within two weeks of administration of the first dose.

64. 45. The method of any one of claims 42-44, wherein the subject or subjects in the treated population achieve a Psoriasis Area Severity Index (PASI) 90 response within 16 weeks of administration of the first dose.

65. 65. The method of any one of claims 42-44 or 64, wherein the PASI response is maintained or improved beyond week 16 by continuing to administer the daily dose.

66. A method for treating active psoriatic arthritis in a subject in need thereof, comprising orally administering to the subject once daily for at least 24 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof sufficient to deliver the equivalent of 15 mg of upadacitinib free base, wherein the subject achieves minimal disease activity (MDA) within 24 weeks of administration of the first dose.

67. A method for treating active psoriatic arthritis in a subject in need thereof, comprising orally administering to the subject once daily for at least 24 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof sufficient to deliver the equivalent of 30 mg of upadacitinib free base, wherein the subject achieves minimal disease activity (MDA) within 24 weeks of administration of the first dose.

68. 68. The method of claim 66 or 67, wherein when the method is used to treat a population of subjects, at least 10% of the subjects in the treated population achieve minimal disease activity (MDA) within 24 weeks of administration of the first dose.

69. 69. The method of any one of claims 66-68, wherein the subject or subjects in the treated population further achieve a Psoriasis Area and Severity Index (PASI) response selected from a PASI 75 response, a PASI 90 response, and a PASI 100 response within 16 weeks of administration of the first dose, and wherein the PASI response is maintained or improved beyond week 16 with continued administration of daily doses.

70. 43. The method of any one of claims 23-42, wherein the subject or subjects in the treated population achieve a Psoriasis Area Severity Index (PASI) 75 response within 16 weeks of administration of the first dose.

71. 71. The method of any one of claims 23-42 or 70, wherein the subject or subjects in the treated population achieve a Psoriasis Area Severity Index (PASI) 90 response within 16 weeks of administration of the first dose.

72. 72. The method of any one of claims 23-42 or 70-71, wherein the subject or subjects in the treated population achieve a Psoriasis Area Severity Index (PASI) 100 response within 16 weeks of administration of the first dose.

73. A method for treating active psoriatic arthritis in a subject in need thereof, comprising orally administering to the subject once daily for at least 16 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof in an amount sufficient to deliver the equivalent of 15 mg of upadacitinib free base, wherein the subject achieves a Psoriasis Area Severity Index (PASI) 75 response within 16 weeks of administration of the first dose.

74. A method for treating active psoriatic arthritis in a subject in need thereof, comprising orally administering to the subject once daily for at least 16 weeks a dose of upadacitinib free base or a pharmaceutically acceptable salt thereof in an amount sufficient to deliver 30 mg of upadacitinib free base equivalent, wherein the subject achieves a Psoriasis Area Severity Index (PASI) 75 response within 16 weeks of administration of the first dose.

75. 75. The method of claim 73 or 74, wherein when the method is used to treat a population of subjects, at least 10% of the subjects in the treated population achieve a PASI 75 response within 16 weeks of administration of the first dose.

76. 76. The method of any one of claims 73-75, wherein the subject or subjects in the treated population achieve a Psoriasis Area Severity Index (PASI) 90 response within 16 weeks of administration of the first dose.

77. 77. The method of any one of claims 73-76, wherein the subject or subjects in the treated population achieve a Psoriasis Area Severity Index (PASI) 100 response within 16 weeks of administration of the first dose.

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