As single agent therapy is often ineffective in inducing disease remission and preventing irreversible joint damage in patients with aggressive RA, new treatment modalities are being investigated. In this trial we evaluated the safety, tolerability, and efficacy of a combination therapy with cylosporin A (CsA) and methotrexate (MTX) in the treatment of active, early RA. According to the study design, during the first 6 months the patients were treated with CsA and MTX in combination and then, at the end of the 6th month, they were randomised to receive either CsA or MTX for another 18 months. In this work we report the results of the first 6 months. Sixty- two patients with severe, active, and early RA were enrolled in the trial. Five of them did not even start taking the study therapy and were not included in the analysis. Seven patients discontinued the therapy before the 6th month because of adverse events. However, no serious side effect was recorded and tolerability was good in most cases. All of the indices of disease activity showed a highly significant improvement. The results of this study suggest that, over a 6-month period, combination therapy with CsA and MTX is safe, well-tolerated and effective in reducing disease activity in early RA.
|Translated title of the contribution||Combination therapy with cyclosporin A and methotrexate in early rheumatoid arthritis|
|Number of pages||8|
|Publication status||Published - 1998|
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