A Randomized Controlled Safety Trial of Interferon beta–1a and Oral Cyclophosphamide in MS
We evaluated the safety of adding oral cyclophosphamide to interferon beta-1a (IFNβ-1a; Avonex®) in a placebo-controlled randomized study of 24 patients with multiple sclerosis (MS). The clinical course was monitored during nine months of treatment. Treated patients tolerated 150 to 200 mg/m2 of weekly administered cyclophosphamide and IFNβ-1a with few reported side effects. We conclude that oral cyclophosphamide can be added safely to IFNβ-1a without intolerable acute side effects. One death unrelated to treatment occurred. Cholecystitis and a benign breast mass both developed in a single cyclophosphamide-treated participant. Leukopenia and lymphopenia were observed in treated participants. Longer, larger trials testing the efficacy of cyclophosphamide may be appropriate for some individuals with breakthrough disease activity while taking IFNβ-1a. (Int J MS Care. 2002; 4: 174–175, 180–182)