Clinical efficacy and safety of methotrexate compared with leflunomide in the treatment of rheumatoid arthritis A protocol for systematic review and meta-analysis

Background: Methotrexate and leflunomide are classic treatments for rheumatoid arthritis (RA), however, which is the best choice for patients of RA is still an important question clinically, and this meta-analysis is used to systematically evaluate and compare their efficacy and safety. Methods: We searched PubMed, Cochrance Library, Embase, SinoMed, China National Knowledge Infrastructure, China Science and Technology Journal Database, WanFang Data databases. The retrieval time was from the establishment to September 7, 2021. Literature screening, data extraction, and quality assessment were performed according to the Cochrane risk of bias tool. Meta-analysis of the included studies was performed using RevMan 5.3 software and Stata 12.0 software. Results: The clinical efficacy and safety of leflunomide and methotrexate are evaluated by American College of Rheumatology (ACR)20/50/70, DAS28, total effective rate, adverse reaction rate, morning stiffness, swollen joint count, tender joint count, erythrocyte sedimentation rate, C-reactive protein, and rheumatoid factor. Conclusion: The results of this meta-analysis will provide reliable evidence clinical efficacy and safety for RA. More high-quality randomized controlled trials are still needed to provide more reliable evidence for the treatment of RA. PROSPERO number: CRD42021270980