SAFETY AND EFFICACY OF HYDROXYCHLOROQUINE AS MAINTENANCE THERAPY FOR RHEUMATOID-ARTHRITIS AFTER COMBINATION THERAPY WITH METHOTREXATE AND HYDROXYCHLOROQUINE

Objective. To evaluate the ability of hydroxychloroquine sulfate (HCQ) to extend the response to combination therapy with HCQ and methotrexa te (MTX) and the safety of longterm HCQ maintenance therapy in patient s with active rheumatoid arthritis (RA). Methods. Two-part study consi sting of an open label segment evaluating combination HCQ/MTX therapy followed by a double blind segment evaluating maintenance therapy for a total of 60 weeks. First, all patients were treated with HCQ 400 mg/ day and MTX 7.5 to 15 mg/week for 24 weeks. Then, responders were rand omized into 3 groups: (1) HCQ with MTX as needed for disease flare (n = 40), (2) HCQ 400 mg/day (n = 41), or (3) placebo with MTX as needed for disease flare (n = 40), each for 36 weeks. Results. Clinical disea se and laboratory variables improved significantly during initial comb ination therapy with HCQ and MTX. After MTX withdrawal, HCQ-containing maintenance regimens delayed the onset of disease flare (p = 0.023). There were no unexpected adverse events at any time or between-group d ifferences in the distribution of adverse events during the double bli nd segment. Conclusion. Combination of HCQ and MTX appeared to be effe ctive and well tolerated for 24 weeks. After withdrawal of MTX, HCQ ex tended the response seen with combination therapy and was well tolerat ed for 36 weeks. Initial therapy with HCQ and MTX, followed by mainten ance HCQ, may be a useful alternative for the treatment of RA.