Genovese MC, Kinnman N, de La Bourdonnaye G et al. Arthritis Rheum 2011;63:1793–803.
This article reported a Phase II study of atacicept in patients with rheumatoid arthritis who had failed tumor necrosis factor antagonist therapy. The efficacy, safety, and biological activity of three doses of atacicept were described.
B cells might contribute to the pathogenesis of rheumatoid arthritis (RA), possibly via producing pro-inflammatory cytokines and presenting antigen. A proliferation-inducing ligand (APRIL) and B lymphocyte stimulator (BLyS) are important for B cell proliferation and survival. Thus, targeting these cytokines is a potential approach for new therapy. In this study, the authors describe a Phase II, double-blind, placebo-controlled study with a fusion protein of the extracellular domain of TACI (a receptor for APRIL and BAFF), and the human immunoglobulin G1 (IgG1) Fc fragment. In AUGUST I (Atacicept for Reduction of Signs and Symptoms in RA Trial), a total of 256 patients were randomized 1:1:1:1 to receive atacicept (25 mg, 75 mg, or 150 mg) or placebo twice a week for 4 weeks, then weekly for 21 weeks, followed by a 13-week treatment-free period. The efficacy endpoint was defined at week 26 by C-reactive protein (CRP) level, based on American College of Rheumatology criteria (ACR20-CRP).