Dosing methods for treating autoimmune diseases using a taci-ig fusion protein such as atacicept

The technology of a medicine and a composition is applied in the application field of a TACI-Ig fusion protein such as ATACICEPT for preparing a medicine for the treatment of lupus erythematosus, and can solve problems such as renal complications, side effects, and seriousness that cannot significantly affect disease progression.

Inactive Publication Date: 2010-07-28
ZYMOGENETICS INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, high doses of steroid therapy can have serious side effects for patients
[0009] These standard treatments are often nonspecific, often with severe side effects, do not significantly affect disease progression or turn into life-threatening renal complications (lupus nephritis or LN)

Method used

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  • Dosing methods for treating autoimmune diseases using a taci-ig fusion protein such as atacicept
  • Dosing methods for treating autoimmune diseases using a taci-ig fusion protein such as atacicept
  • Dosing methods for treating autoimmune diseases using a taci-ig fusion protein such as atacicept

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] Example 1 - Subcutaneous Administration of Atacicept

[0074] This phase Ib, double-blind, placebo-controlled, dose-escalation trial included six arms (n = 8 each, except arm 5, n = 7) treated with atacicept or placebo (3:1 ratio). patient. Groups 1-4 received a single subcutaneous dose of placebo, or atacicept at 0.3, 1, 3 or 9 mg / kg. Groups 5 and 6 received 4 weekly doses of placebo, or atacicept at 1 or 3 mg / kg (see Table 1). Patients were then maintained for 6 weeks (Groups 1-4) or 9 weeks (Groups 5 and 6). Measured structures include: (i) systemic and local tolerability of atacicept; (ii) frequency of adverse events (AEs); (iii) pharmacokinetics and pharmacodynamics of atacicept, including effects on lymphocyte subsets and Effect of Ig levels; and (iv) Measurement of SLE disease activity.

[0075] Patients with mild to moderate SLE participated in the trial. The biological activity of atacicept was demonstrated by a dose-dependent reduction in immunoglobulin l...

Embodiment 2

[0089] Intravenous administration of embodiment 2-atacicept

[0090]This Phase Ib, double-blind, placebo-controlled, dose-escalation trial included 4 groups (n=6 each) of patients treated with atacicept or placebo (3:1 ratio). Groups 1-3 received a single dose of placebo, 3, 9 or 18 mg / kg of atacicept. Group 4 received two doses of placebo or 9 mg / kg atacicept, the second dose being given three weeks after the initial dose (see Table 1). Outcomes measured included: (i) systemic and local tolerability of intravenous atacicept; (ii) frequency of adverse events (AEs); (iii) pharmacokinetics and pharmacodynamics of intravenous atacicept, including effects on lymphatic Effects of cell subpopulations and Ig levels; and (iv) measurement of SLE disease activity. Subjects were evaluated at 6 weeks (Cohorts 1-3) or 9 weeks (Cohort 4); subjects in Cohorts 3 and 4 returned on study days 84 and 120 for PK and biomarker sampling . Serum PK markers were sampled as follows: (i) For single...

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Abstract

In various embodiments, the present invention provides methods, compositions, dosing, and administration schedules for treatment of autoimmune diseases, including systemic erythematosus (SLE), for example, comprising administering to a patient in need of such treatment a TACI-Ig fusion molecule such as atacicept. In one embodiment, the TACI-Ig fusion molecule is administered in amount sufficient to slow, suppress or inhibit proliferation-inducing functions of BLyS and APRIL, in particular the use of multiple administrations of the fusion molecule at relatively low dose over the course of the treatment.

Description

field of invention [0001] In various embodiments, the present invention relates to methods and compositions for treating autoimmune diseases or disorders of the immune system comprising administering a TACI-Ig fusion protein, such as atacicept, using a dosage regimen that maximally blocks Function of TNF family ligands. Background of the invention [0002] BIyS ligand / receptor family [0003] Three receptors, TACI (transmembrane activator or calcium-regulating cyclophylin ligand-responsive agent), BCMA (B-cell maturation antigen), and BAFF-R (receptor for activating B-cell factors, belonging to the TNF family), have been identified as Has specific binding affinity for two growth factors, BLyS (b-lymphocyte stimulator) and APRIL (a proliferation-inducing ligand) (Marsters et al. Curr Biol 2000; 10(13): 785-788; Thompson et al. Science 2001;293:2108-2111). TACI and BCMA bind both BLyS and APRIL, while BAFF-R seems to only bind BLyS with high affinity (Marsters et al.CurrBio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K9/00A61K38/00
CPCA61K9/0019C07K2319/00A61K38/177A61K9/06A61K47/48507A61K45/06A61K2300/00A61K47/6835A61P13/12A61P17/00A61P25/00A61P29/00A61P3/10A61P37/00A61P37/02A61P37/06A61P43/00
Inventor S·J·巴斯比J·A·格罗斯J·维斯克I·奈斯托洛夫A·穆纳夫O·帕帕索利奥蒂斯C·佩纳罗西
Owner ZYMOGENETICS INC
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