Open Clinical Trial of Methotrexate Alone and Combination of Methotrexate and Hydroxychloroquine in the Treatment of Rheumatoid Arthritis

Abstract

Objective: To assess the relative efficacy of combination therapy of methotrexate(MTX) and hydroxychloroquine(HCQ) in rheumatoid arthritis, we performed an open clinical trial for 6 months. Methods: We compared the efficacy of combination therapy of MTX(7.5-15mg/week) and HCQ(300-400mg/ day) with that of MTX(7.5-15mg/week) alone. Twenty six and thirty two patients were allocated in each treatment arm. Disease activity was assessed by visual analogue pain scale(VAPS), duration of morning stiffness(MS), modified health assessment questionnaire (MHAQ), physician´s global assessment(PGA), tender joint count(TJC), swollen joint count(SJC), ESR and CRP at 0, 3, 6 months. Adverse effects were monitored monthly. Results: At the end of trial, all parameters were significantly decreased in both group except CRP in combination therapy group. But the extent of response was not significantly different between two groups except VAPS and MHAQ. Mean values of liver enzymes were significantly increased in MTX alone group, but incidence of hepatotoxicity and extent of elevated enzyme were not significantly different between two groups. Conclusion: Both regimens were effective in the treatment of RA patients, but the efficacy of combination therapy was not superior to MTX alone.