Safety and efficacy of newer biologics DMARDs in the management of rheumatoid arthritis: A systematic review

新型生物制剂DMARDs治疗类风湿性关节炎的安全性和有效性:系统评价

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Abstract

OBJECTIVE: To analyze the safety and efficacy of certain biologics DMARDs (Adalimumab, Baricitinib, Pefacitinib and Sirukumab) either used alone or as a combination with MTX for management of rheumatoid arthritis. METHOD: We conducted a systematic literature review on various phase 3 Randomized controlled trails, double blind, placebo controlled, parallel group clinical trials for 52 weeks from 2017 to 2019 conforming to the Preferred Reporting Items for Systematic reviews and Meta-Analysis guidelines. The primary efficacy endpoints were American College of Rheumatology 20 response rate improvement criteria, other secondary endpoints were American College of Rheumatology 50/70 response rates, Health Assessment Questionnaire Disability Index, Disease Activity Score-28 for rheumatoid arthritis with Erythrocyte Sedimentation Rate/C Reactive Protein and Radiographic outcomes. RESULTS: Finally, four studies were included for qualitative synthesis in which we observed improvement in ACR 20 response rate was found in the newer agents study group. SB5 (72.4%) at week 24, Baricitinib (70%) at week 12, Pefacitinib 100 mg and 150 mg (57.7% & 74.5%) at week 12 and Sirukumab 50 mg and 100 mg (55% & 54%) at week 16 respectively. ACR 50 and ACR 70 response rate at different point in time was also found to be higher in the study group which indicates their efficacy. CONCLUSION: In this systematic review, we observed an improvement in ACR 20 response rate and other secondary efficacy outcomes with an acceptable safety margin. From the evidence of RCTs, we have identified that newer therapeutic agents has beneficial effects when compared to existing therapy.

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