An open-label trial of combination therapy with interferon beta-1a and oral methotrexate in MS.

An open-label study was performed to evaluate the safety and efficacy of combination therapy with weekly oral methotrexate (20 mg) and interferon beta-1a (IFN beta-1a) in 15 patients with MS who had experienced exacerbations while receiving IFN beta monotherapy. Nausea was the only major side effect. A 44% reduction in the number of gadolinium-enhanced lesions seen on MRI scan was observed during combination therapy (p = 0.02). There was a trend toward fewer exacerbations. This combination therapy appears to be safe and well tolerated, and should be studied in a controlled trial.