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
Autor: | Praveen Jadhav, Patnala Ashok Kumar, Liyakat Ali Gauri, Sanjeev K. Mendiratta, Uma Kumar, Girishchandra Bartakke, Vikram Haridas, Reena Sharma, Dinesh Jain, Rajendrakumar H. Jani, Rajiv Gupta, Girish Bhatia, Gaurav Rathi |
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Rok vydání: | 2015 |
Předmět: |
Adult
Male musculoskeletal diseases medicine.medical_specialty Time Factors Injections Subcutaneous India Severity of Illness Index Arthritis Rheumatoid 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Double-Blind Method Rheumatology Internal medicine medicine Clinical endpoint Adalimumab Humans In patient Prospective Studies skin and connective tissue diseases Adverse effect Biosimilar Pharmaceuticals 030203 arthritis & rheumatology business.industry Remission Induction Biosimilar Middle Aged medicine.disease Surgery C-Reactive Protein Treatment Outcome Therapeutic Equivalency Tolerability Antirheumatic Agents Rheumatoid arthritis Female business Biomarkers medicine.drug |
Zdroj: | International Journal of Rheumatic Diseases. 19:1157-1168 |
ISSN: | 1756-185X 1756-1841 |
Popis: | 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. |
Databáze: | OpenAIRE |
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