Long-term methotrexate (MTX) combination therapy versus MTX alone for active rheumatoid arthritis

In 37 patients with active rheumatoid arthritis (RA) responding insufficiently to a diseasemodifying anti-rheumatic drug (DMARD), we compared the safety and efficacy of methotrexate (MTX) used alone (MTX-only group) with MTX used in combination (combined-treatment group). Patients were assigned randomly to 5 years of treatment with MTX alone (initial dose, 7.5 mg/week) or with MTX (initial dose, 5 mg/week) plus their previous DMARD continued at half dosage. After 3 years of therapy, the combined-treatment group showed significantly better sustained response of the Lansbury index, erythrocyte sedimentation rate and C-reactive protein than the MTX-only group. Ten patients withdrew because of adverse drug effects, with a somewhat higher frequency in the combined-treatment group (six of 19, 32%) than in the MTX-only group (four of 18,22%) difference not significant). One patient in each group withdrew because of insufficient response to therapy. We found that combining the original drug with MTX in previously intractable RA cases resulted in at least additive efficacy.