Objective: The objective of the research project was to evaluate the effect of combined therapy with methotrexate and cyclosporin A in active rheumatoid arthritis refractory to previous monotherapy with methotrexate, and to evaluate the incidence of undesirable effects of this treatment. Method: The investigated group comprised 37 patients with rheumatoid arthritis who were treated for at least three months with methotrexate, at least 10 mg/week, with an unsatisfactory effect. These patients were given in addition to the mentioned treatment cyclosporin, initial dose 2.5 mg/kg, gradually increasing up to 5 mg/day. The authors evaluated the trend of some parameters (erythro- cyte sedimentation rate, CRP, articular index, HAQ questionnaire) during six months treatment and investigated also the development of possible side effects. After completion of the study a complete check-up examination after another six months was made and the further development of the disease and treatment was described in some patients. Results: In all investigated parameters there was a significant drop as compared with values at the onset of treatment (p < 0.01). During treatment 25 manifestations of undesirable therapeutic effects were recorded, incl. in particular hypertension, nephrotoxicity mild hepatopathy, gastrointestinal complaints and infections. In five patients it was therefore necessary to stop treatment prematurely, in the remainder these complications were managed by common therapy. Conclusion: The results provided evidence of a very good effect of combined treatment with cyclosporin A and methotrexate. Undesirable effects of this treatment which developed during therapy were in the majority controlled by common therapy and as a rule did not lead to early termination of treatment.

        Key words: rheumatoid arthritis, DMARDs, cyclosporin A, methotrexate