Combination therapy with hydroxychloroquine and methotrexate in rheumatoid arthritis.

Abstract

The aim of the study was to compare the efficacy of hydroxychloroquine (HCQ) alone and in combination with methotrexate (MTX) in a randomized placebo-controlled study lasting 6 months. Forty patients with rheumatoid arthritis participated in the study and were randomly assigned to two groups--20 patients were treated with HCQ (200 mg daily) and placebo, 20 patients with HCQ and MTX (7.5 mg) once a week. Patients were assessed at regular intervals of 1 month up to 6 months using six clinical and five laboratory tests and one radiological measure. All six clinical variables and two laboratory variables were favorably influenced by combination therapy during the 6-month period. HCQ alone significantly influenced only three clinical variables and none of the laboratory parameters. There was a greater number of patients without radiological progression in the combination group. There was one drop-out in combination group due to general allergic reaction; otherwise the treatment was well tolerated. The results suggest that a combination of HCQ and MTX is more potent than HCQ alone.