A RANDOMIZED, DOUBLE-BLIND, 24-WEEK CONTROLLED-STUDY OF LOW-DOSE CYCLOSPORINE VERSUS CHLOROQUINE FOR EARLY RHEUMATOID-ARTHRITIS

Objective. To investigate whether low-dose cyclosporin A (CSA) is safe and effective in comparison with chloroquine (CQ) in patients with ea rly rheumatoid arthritis (RA). Methods. We performed a randomized, dou ble-blind study comparing CSA with CQ in patients with early RA (durat ion <2 years) who had had active disease for at least 3 months. Forty- four RA patients with a mean disease duration of 6 months were randoml y allocated to receive CSA (initial dosage 2.5 mg/kg/day, maintenance dosage 3.6 mg/kg/day) or CQ (initial dosage 300 mg/day, maintenance do sage 100 mg/day) for 24 weeks. Results. Five patients (2 taking CSA an d 3 taking CQ) discontinued the study prematurely. Intention-to-treat analysis disclosed a decrease in the swollen joint count by 7 in both groups. The erythrocyte sedimentation rate and C-reactive protein leve l did not change significantly. CSA and CQ were tolerated equally well , although mild paraesthesia occurred more frequently in the CSA-treat ed group. The serum creatinine level increased by 13 mu moles/liter (9 5% confidence interval [95% CI] 4, 22) in the CSA group and by 6 mu mo les/liter (95% CI 1, 11) in the CQ group (difference not statistically significant). Conclusion. Both CSA and CQ are effective in alleviatin g the symptoms of active early RA. There is only slightly impaired ren al function after 24 weeks of drug administration of either drug in pa tients with early RA.