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Effect of parenteral cladribine on relapse rates in patients with relapsing forms of multiple sclerosis: results of a 2-year, double-blind, placebo-controlled, crossover studyDepartment of Neurology, Medical University of Lublin, Lublin, Poland
Department of Analytics, Medical University of Lublin, Lublin, Poland
Department of Neurology, Medical University of Lublin, Lublin, Poland
Department of Analytics, Medical University of Lublin, Lublin, Poland
Department of Experimental Pharmacology, Medical Research Center, Polish Academy of Sciences, Warsaw, Poland
Department of Experimental Pharmacology, Medical Research Center, Polish Academy of Sciences, Warsaw, Polandpgrieb{at}cmdik.pan.pl Objective This randomized, 2-year, double-blind, placebo-controlled, crossover study evaluated cladribine for relapsing forms of multiple sclerosis. Design Patients (n = 84) received seven 5-day courses of subcutaneous cladribine at 5 mg/day (group A) or placebo (group B) in year 1; treatment was reversed in year 2. Results Cladribine was well tolerated and associated with a favorable safety profile. Mean Expanded Disability Status Scale scores remained stable. In group A, mean relapse rates were 0.15 in year 1 (cladribine) and 0.42 in year 2. In group B, relapse rates were 0.61 in year 1 and 0.50 in year 2 (cladribine). Patients required fewer steroid courses during cladribine periods. The therapeutic efficacy of cladribine was associated with a sustained reduction in lymphocyte count.
Key Words: cladribine • disease-modifying therapies • multiple sclerosis • outcome measurement • relapsing
Multiple Sclerosis, Vol. 15, No. 6,
767-770 (2009) |
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