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Publication Detail
Efficacy and Safety of Atacicept in Patients With Systemic Lupus Erythematosus: Results of a Twenty‐Four–Week, Multicenter, Randomized, Double‐Blind, Placebo‐Controlled, Parallel‐Arm, Phase IIb Study
  • Publication Type:
    Journal article
  • Publication Sub Type:
    Article
  • Authors:
    Merrill JT, Wallace DJ, Wax S, Kao A, Fraser PA, Chang P, Isenberg D
  • Publisher:
    Wiley-Blackwell
  • Publication date:
    01/02/2018
  • Journal:
    Arthritis and Rheumatology
  • Medium:
    Print-Electronic
  • Status:
    Published
  • Print ISSN:
    2326-5191
  • Language:
    eng
  • Addresses:
    University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Abstract
To evaluate the efficacy and safety of atacicept, an antagonist of BLyS/APRIL-mediated B cell activation, in patients with systemic lupus erythematosus (SLE).ADDRESS II was a phase IIb, multicentre study (NCT01972568). Patients with active, autoantibody-positive SLE receiving standard therapy were randomized (1:1:1) to atacicept (75 or 150 mg) or placebo for 24 weeks. The primary endpoint was the SLE responder index (SRI)-4 at Week 24.The ITT population included 306 patients. There was a trend towards improved SRI-4 response rate with atacicept 75 mg (57.8% [adjusted OR 1.78], P = 0.045) and 150 mg (53.8% [adjusted OR 1.56], P = 0.121) versus placebo (44.0%) at Week 24 (primary analysis; screening visit as baseline). In a pre-specified sensitivity analysis using study Day 1 as baseline, a significantly larger proportion of patients receiving atacicept 75 mg (55.9% [adjusted OR 1.88], P = 0.029) and 150 mg (55.8% [adjusted OR 1.96], P = 0.020) achieved SRI-4 response at Week 24 versus placebo (41%). In pre-defined subpopulations with baseline high disease activity (HDA), serologically active disease (SA), or both, statistically significant improvements in SRI-4 and SRI-6 response rates were seen with atacicept versus placebo. Severe flare risk was reduced with atacicept in both the ITT and HDA populations. The risks of serious adverse events and serious or severe infection were not increased with atacicept versus placebo.Atacicept showed evidence of efficacy in SLE, particularly in HDA and SA patients. Reductions in disease activity and severe flare were observed with atacicept treatment, along with an acceptable safety profile. This article is protected by copyright. All rights reserved.
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