Combination therapy with hydroxychloroquine and methotrexate in rheumatoid arthritis.

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.