RADIOLOGIC EVIDENCE OF DISEASE MODIFICATION IN RHEUMATOID-ARTHRITIS PATIENTS TREATED WITH CYCLOSPORINE - RESULTS OF A 48-WEEK MULTICENTER STUDY COMPARING LOW-DOSE CYCLOSPORINE WITH PLACEBO

Objective. To evaluate the therapeutic efficacy of 46 weeks of treatme nt with cyclosporine (5 mg/kg/day) in patients with rheumatoid arthrit is (RA). Methods. A 48-week randomized, double-blind, placebo-controll ed, multicenter study of cyclosporine was conducted in 122 patients wi th active RA. Patients were evaluated by objective and subjective clin ical and radiologic measurements at baseline and at the end of the stu dy. Results. Statistically significant improvement and clinically impo rtant changes were seen for the number of tender joints, number of swo llen joints, pain score, duration of morning stiffness, and Lee's func tional index in the cyclosporine-treated group at the end of the study . Radiographic examination showed that cyclosporine was capable of ret arding joint destruction. In the cyclosporine-treated group, serum cre atinine levels increased by 17.5 mu moles/liter (23%) at week 24 and b y 21.8 mu moles/liter (26%) at week 48. There was no significant diffe rence in mean serum creatinine levels in patients treated with cyclosp orine alone and those treated with cyclosporine plus nonsteroidal anti inflammatory drugs. Five patients had to be treated with antihypertens ive drugs, and 2 patients were withdrawn from the study because of inc reased serum creatinine. Conclusion. The study shows that cyclosporine seems to have disease-modifying effects in RA.