COMPARISON OF AZATHIOPRINE, METHOTREXATE, AND THE COMBINATION OF THE 2 IN THE TREATMENT OF RHEUMATOID-ARTHRITIS - A 48-WEEK CONTROLLED CLINICAL-TRIAL WITH RADIOLOGIC OUTCOME ASSESSMENT

Objective. To assess the relative efficacy of methotrexate (MTX), azat hioprine (AZA), and their combination in the treatment of rheumatoid a rthritis (RA) in a double-blind, prospective, multicenter, controlled trial. Methods. Two hundred nine patients with active RA were treated with escalating doses of MTX (5-15 mg/week), AZA (50-150 mg/day), or c ombination (5 mg MTX/week plus 50 mg AZA/day-7,5 mg MTX/week plus 100 mg AZA/day), with opportunity to increase the dosage at 6-week interva ls. The patients were evaluated for significant clinical and laborator y improvement and assessed for radiologic progression at 48 weeks. Res ults. One hundred ten patients remained on the initial, randomly assig ned therapeutic regimen, The percentage of patients who were responder s, defined as those who had 30% or greater improvement in at least 3 o f 4 variables, was 38% for the combination treatment, 26% for AZA, and 45% for MTX (P = 0.06), A trend toward decreased radiologic progressi on was seen in the MTX-treated patients, Termination of treatment due to adverse experience occurred more frequently with combination and AZ A treatments than with MTX treatment, Lack of effectiveness, adverse g astrointestinal effects, and liver enzyme elevation were the most freq uent causes of treatment discontinuation. Conclusion. This study estab lishes that the combination of MTX and AZA in the dosages utilized is not associated with more toxicity than treatment with single agents; h owever, enhanced efficacy is also not seen, There is a trend toward de creased radiologic progression in patients treated with MTX.