A Double‐Blind, Placebo‐Controlled, Randomized Trial of Cladribine in Relpaasing‐Remitting Multiple Sclerosis

We conducted an 18‐month, placebo‐controlled, double‐blind study to evaluate cladribine in the treatment of 52 patients with relpaasing‐remitting multiple sclerosis. Patients received either placebo or cladribine 0.07 mg/kg/day by subcutaneous injection for 5 consecutive days as six monthly courses for a total cumulative dose of 2.1 mg/kg. Analysis of results revealed a statistically significant favorable effect of cladribine on the joint frequency and severity of relpaases and magnetic resonance imaging (MRI) findings. MRI‐enhancing lesions were completely suppressed in the cladribine patients by the sixth month of treatment. Mild segmental herpes zoster occurred in two cladribine‐treated patients and one patient receiving placebo. Otherwise, there were no side effects or adverse events. We conclude that cladribine shows promise as a treatment for relpaasing‐remitting multiple sclerosis.