Subcutaneous Tocilizumab Versus Placebo in ... - Wiley Online Library
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Subcutaneous Tocilizumab Versus Placebo in Combination With Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis ALAN KIVITZ,1 EWA OLECH,2 MICHAEL BOROFSKY,3 BEATRIZ M. ZAZUETA,4 ˜ O C. RADOMINSKI,6 JOAN T. MERRILL,7 LUCY ROWELL,8 FEDERICO NAVARRO-SARABIA,5 SEBASTIA 8 9 CLARE NASMYTH-MILLER, MIN BAO, STEPHEN WRIGHT,8 AND JANET E. POPE10 Objective. The efficacy and safety of subcutaneous tocilizumab (TCZ-SC) versus subcutaneous placebo (PBO-SC) was evaluated in patients with rheumatoid arthritis who had an inadequate response to disease-modifying antirheumatic drugs in the BREVACTA study. Methods. Patients (n ⴝ 656) were randomized 2:1 to receive TCZ-SC 162 mg every other week or PBO-SC every other week for 24 weeks; 20% previously received anti–tumor necrosis factor treatment. Escape therapy with TCZ-SC 162 mg weekly was offered from week 12 for inadequate response. The primary end point was the American College of Rheumatology 20% improvement (ACR20) response at week 24. The key secondary outcomes were radiographic progression and safety. Results. TCZ-SC was superior to PBO-SC for ACR20 response at week 24 (60.9% versus 31.5%; P < 0.0001). All secondary end points showed TCZ-SC to be superior to PBO-SC, including ACR50 and ACR70 response (40% and 20% for TCZ-SC, respectively, and 12% and 5% for PBO-SC, respectively; P < 0.0001 for both) and Disease Activity Score in 28 joints (DAS28) remission (DAS28
