Tofacitinib 5 mg twice daily in patients with rheumatoid arthritis and inadequate response to disease-modifying antirheumatic drugs: A comprehensive review of phase 3 efficacy and safety
Journal of Clinical Rheumatology Apr 03, 2019
Bird P, et al. - Tofacitinib 5 mg BID was given to 1216 cases while 681 received placebo, and 204 received adalimumab to study the effectiveness and safety for tofacitinib 5 mg BID, placebo, and adalimumab the treatment of rheumatoid arthritis (RA). Significantly higher improvement (20%, 50%, and 70%) in American College of Rheumatology response criteria (ACR20, ACR50, and ACR70, respectively) response rates, higher improvement in Health Assessment Questionnaire-Disability Index, and a greater proportion of Disease Activity Score-defined remission with tofacitinib as compared to placebo at month 3. They noted the similar frequency of adverse events (AEs), serious AEs, and discontinuations due to AEs for tofacitinib vs placebo at month 3. They observed more frequent serious infection events for tofacitinib. They found a reduction in RA signs and symptoms with an improvement in physical function with tofacitinib 5 mg BID vs placebo in subjects with incomplete response to previous disease-modifying antirheumatic drugs.
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