A prospective, randomized, double-blind, multicentre, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC-3197) and adalimumab (Humira) in patients with rheumatoid arthritis

Rajendrakumar H Jani, Rajiv Gupta, Girish Bhatia, Gaurav Rathi, Patnala Ashok Kumar, Reena Sharma, Uma Kumar, Liyakat A Gauri, Praveen Jadhav, Girishchandra Bartakke, Vikram Haridas, Dinesh Jain, Sanjeev K Mendiratta, Rajendrakumar H Jani, Rajiv Gupta, Girish Bhatia, Gaurav Rathi, Patnala Ashok Kumar, Reena Sharma, Uma Kumar, Liyakat A Gauri, Praveen Jadhav, Girishchandra Bartakke, Vikram Haridas, Dinesh Jain, Sanjeev K Mendiratta

Abstract

Aim: In this study, efficacy, tolerability and safety of biosimilar adalimumab (Exemptia; Zydus Cadila) was compared with reference adalimumab (Humira; AbbVie) in patients with moderate to severe rheumatoid arthritis (RA).

Method: In this multicentre, prospective, randomized, double-blind, active controlled parallel arm study, 120 patients with moderate to severe RA were given 40 mg of either test adalimumab (Exemptia) or reference adalimumab (Humira) by subcutaneous route every other week for 12 weeks. The primary endpoint was proportion of responders in two tretament groups by American College of Rheumatology 20 (ACR20) at week 12. The secondary endpoints were change in Disease Activity Score of 28 joints - C-reactive protein (DAS28-CRP) and proportion of patients with an ACR50 and ACR70 response in two treatment groups at week 12. Safety outcomes were also assessed.

Results: After 12 weeks, patients treated every other week with test adalimumab (Zydus Cadila) had statistically similar response rates as compared to reference adalimumab (AbbVie): ACR20 (82% vs. 79.2%; P > 0.7); ACR50 (46%, vs. 43.4%; P > 0.7); ACR70 (14% vs. 15.1%; P > 0.8). The change in DAS28-CRP score was -2.1 ± 1.09 and -2.1 ± 1.21, in test and reference products, respectively. It was statistically significant compared to baseline, but not significantly different between the two products. Three serious adverse events and no death was reported during the study. Both adalimumab preparations were safe and well tolerated in this study.

Conclusion: The results demonstrated biosimilarity with respect to efficacy, tolerability and safety of test adalimumab (Exemptia) and reference adalimumab (Humira) in patients with moderate to severe RA.

Keywords: Exemptia; Humira; Zydus; adalimumab; biosimilar; rheumatoid arthritis.

© 2015 The Authors. International Journal of Rheumatic Diseases published by Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

Figures

Figure 1
Figure 1
Consolidated Standards for Reporting Trials (CONSORT) 2010 flow diagram.

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