Tofacitinib versus methotrexate as the first-line disease-modifying antirheumatic drugs in the treatment of rheumatoid arthritis: An open-label randomized controlled trial.

Objective: To compare tofacitinib and methotrexate (MTX) as first-line disease-modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis (RA).

Methods: This open-label, randomized controlled, parallel-group, 3-month trial randomly assigned 100 RA patients to tofacitinib 10 mg daily (49 patients) or MTX 25 mg subcutaneously weekly (51 patients). The primary end point was low disease activity (LDA) measured with Disease Activity Score-28 with C-reactive protein (DAS28-CRP), and the secondary end point was LDA and remission measured by DAS28-erythrocyte sedimentation rate (ESR), Clinical Disease Activity Index (CDAI), and Simplified Disease Activity Index (SDAI).