A randomized, double-blind, multicenter, controlled clinical trial of cyclosporine plus chloroquine vs. cyclosporine plus placebo in early-onset rheumatoid arthritis.

BACKGROUND

Our objective was to assess the efficacy and safety of cyclosporine-A (CsA) plus chloroquine (Clq) in early-onset rheumatoid arthritis (RA) compared to CsA plus placebo.

METHODS

We conducted a prospective, 12-month follow-up, multicenter, double-blind, placebo-controlled study of CsA (2.5-5 mg/kg/day[d]) plus Clq (150 mg/d) vs. CsA plus placebo in active RA of <2 years of evolution.

RESULTS

A total of 149 patients were included; 111 patients (74.4%) completed the 12-month follow-up period. Evaluation at 6 and 12 months showed improvement for all clinical disease parameters. In both groups there was a decrease in tender joint count, swollen joint count, pain, assessment of efficacy by both investigator and patient, functional assessment, and morning stiffness, all differences statistically significant. With an intention-to-treat analysis, there was 64% in the CsA plus Clq group (CsA/Clq) and 63% in the CsA plus placebo group (CsA/Plac) at 12 months in the American College of Rheumatology (ACR)-20 criteria of improvement. Response rate for ACR-50 was 48 and 47%, and for ACR-70 it was 29% in both groups; the difference was not statistically significant between study groups. Gastrointestinal complaints were common in both groups. Four patients in CsA/Clq group and five patients in CsA/placebo group increased creatinine levels; two patients in each group discontinued treatment due to this reason.

CONCLUSIONS

There was no advantage to adding chloroquine to cyclosporine in patients with RA.