Objective: To determine the efficacy and safety of the combination of leflunomide and methotrexate for the treatment of patients with active rheumatoid arthritis (RA) in an open, non‐comparative, multicentre trial.
Methods: Seventy‐four patients with active RA were enrolled to receive concomitantly leflunomide (no loading dose, 10
Results: Sixty‐five patients completed 20 weeks of treatment, and 71.6% were responders based on the ACR20 criteria. After 20 weeks, the mean changes were −16.3 for tender joint count, −12.0 for swollen joint count, −44.0 for physician global assessment, −34.3 for patient global assessment, −22.7 for erythrocyte sedimentation rate, and −0.65 for the Health Assessment Questionnaire score. Adverse events occurred in 40.5% of the patients, and were considered serious in four patients who discontinued therapy. Abnormal liver function was noted for 16 patients (21.6%). Two of these patients were withdrawn from the study; after discontinuing the medication, their liver function recovered fully. Conclusion: The combination of leflunomide and methotrexate was effective and well tolerated in the treatment of active RA patients. This combination may be a useful option as an initial treatment for active RA before starting biological agents.