The efficacy and safety of tocilizumab combined with disease-modifying anti-rheumatoid drugs in the treatment of active rheumatoid arthritis: a multi-center, randomized, double-blinded, placebo-controlled trial

• Published in: Chung-hua nei kʿo tsa chih Vol. 52; no. 4; p. 323
• Main Authors: Shi, Qun, Zhao, Yan, Bao, Chun-de, Li, Xing-Fu, Huang, Feng, Zhu, Ping, Li, Zhan-Guo, Gu, Jie-Ruo, Zhang, Zhi-Yi, Zhao, Dong-Bao, Zhao, Shuang-Ling, Jiang, Qiu-di, Tian, Jin, Zhang, Feng-Chun
• Format: Journal Article
• Language: Chinese
• Published: China 01.04.2013
• Subjects: Aged; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - therapeutic use; Antirheumatic Agents - adverse effects; Antirheumatic Agents - therapeutic use; Arthritis, Rheumatoid - drug therapy; Double-Blind Method; Drug Therapy, Combination; Humans; Interleukin-6; Receptors, Interleukin-6; Safety; Severity of Illness Index; Treatment Outcome
• ISSN: 0578-1426

To evaluate the efficacy and safety of human anti-interleukin-6 (IL-6) receptor antibody (tocilizumab) in combination with disease-modifying anti-rheumatoid drugs (DMARDs) for the treatment of rheumatoid arthritis (RA) patients with moderate to severe activity and inadequate response to DMARDs. The present study was a multi-center, randomized, double-blinded, placebo controlled trial. Eligible patients were randomized (tocilizumab:Placebo = 2:1) to one of two groups: tocilizumab 8 mg/kg group or placebo group. The drug was administered every 4 weeks by infusion along with stable dose of DMARDs. The primary analysis evaluated at week 24 included: the proportion of patients with American College of Rheumatology (ACR)20, ACR50 and ACR70 response; the average changes of ACR core components from baseline; the proportion of patients with disease activity score (DAS28) ≤ 3.2 and DAS28 < 2.6. Patients who completed double-blinded phase could choose to enter 24-week open-label therapy with tocilizumab 8 mg/kg infusion