A clinical study of CPH 82 vs methotrexate in early rheumatoid arthritis

Objectives. The objectives of this study were to evaluate the therapeutic e fficacy of CPH 82 in comparison with methotrexate (MTX) in adult patients w ith early, active rheumatoid arthritis (RA) and to compare the tolerance an d safety profiles of the two drugs. Methods. The study was a 24-week, double-blind, randomized study in 10 cent res of 100 patients with active RA, with a disease duration of less than 2 yr at the start of treatment, which consisted of either CPH 82 300 mg/day o r MTX 10 mg/week. The six primary effect variables were: number of swollen joints, Ritchie's articular index, patient's pain score, patient's global s core, Health Assessment Questionnaire (HAQ) and C-reactive protein (CRP). E rythrocyte sedimentation rate (ESR), physician's global score and the effic acy according to the European League Against Rheumatism (EULAR) and America n College of Rheumatology (ACR) response criteria were also analysed. Results. There was a significant improvement for both drugs in all variable s. Significant differences between the drugs in favour of MTX were found on ly in patient's pain score, CRP and ESR. By the EULAR criteria, 76% and 86% were judged to be responders in the CPM 82 and MTX groups: respectively. B y the ACR criteria, the corresponding figures were 58% and 64%. The most co mmon side-effects were gastrointestinal, which were similar in both gl-sups . The numbers of treatment failures due to adverse events were two with CPH 82 and 14 with MTX. Conclusions. The clinical effect of CPI-I 82 in this study was comparable t o that of MTX at a dose of 10 mg/week. Both drugs reduced acute-phase react ants, MTX more effectively than CPN 82. The safety profile of CPH 82 was mo n favourable than that of MTX without folic acid supplementation.