Tofacitinib plus methotrexate versus tofacitinib monotherapy in rheumatoid arthritis: A comprehensive evidence synthesis and critical analysis.

Abstract

Objective: To compare the benefits of Tofacitinib with Methotrexate vs Tofacitinib alone with respect to efficacy and safety over a period of 6 months. Study Design: Randomized Controlled Trial. Setting: Outpatient Department of Rheumatology, Madinah Teaching Hospital, Faisalabad. Period: 01^st August,2025 to 31^st Jan,2026. Methods: Consisted of 60 people enrolled as per the inclusion criteria (ACR/EULAR 2010 Criteria), after getting approval from the ethics review committee. Individuals segregated into two groups: Group A received Tofacitinib alone, whereas Group B received Tofacitinib with Methotrexate. DAS28-ESR, along with ESR and CRP, was used as an assessment tool for response, both at baseline and at 6 months. Results: Both the arms showed improvement in disease activity, however there were better results in the combination arm than with monotherapy (−2.3 ± 0.6 vs −1.6 ± 0.5; p < 0.001). Remission and reduction of disease activity was observed in the combination group with the occurrence of more adverse effects in the same group. Conclusion: Tofacitinib with Methotrexate provides better efficacy for disease control as compared to Tofacitinib alone. This consolidates the prior belief that Methotrexate is the anchor drug in the management of RA.