Dose comparison of Bredinin on rheumatoid arthritis: A multicenter post-marketing surveillance study.

In order to objectively compare the efficacy and the safety of Predinin, an immunosuppressive drug, on rheumatoid arthritis at two different dosage levels of 150 mg and 300mg, we conducted a 24-week multicenter, randomized, post-marketing surveillance study.(1) Efficacy was assessed with a total of 499 cases (251 cases, 150mg/day group ; 248 cases, 300mg/day group) . No significant biases in the patients' background factors between the two groups were found.(2) The final global improvement rates for the clinical evaluations of improved or better were 21.1% and 25.5/ in the 150 mg/day group and the 300mg/day group, respectively. The improvement rates for the clinical evaluations of slightly improved and better were 45.9% in the 150mg/day group and 57.5% in the 300 mg/day group. The difference were statistically significant between the 150mg/day and 300 mg/day groups (P<0.05) .(3) Improvement in joint swelling was markedly higher in the 300mg/day group than in the 150 mg/day group. The 300 mg dose was superior to the 150mg dose in cases where a patient failed to respond to strong DMAPDs (methotre ate or salazosulfapyridine) .(4) Safety was assessed with a total of 488 cases (252 cases ; 150mg/day group ; 230 cases ; 300mg/day group) .(5) In the overall safety rating, the incidence of the adverse reactions in the 150mg/day group and the 300mg/day group was 15.5% and 27.1%, respectively. The difference was statistically significant (P<0.01) .(6) The incidence and degree of the adverse reactions were dose-dependent. The type and timing of the adverse reactions were unrelated to the dose level.