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Mult Scler. 2009 Jun;15(6):767-70. doi: 10.1177/1352458509103610.

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 study.

Author information

1
Department of Neurology, Medical University of Lublin, Lublin, Poland.

Abstract

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.

PMID:
19482866
DOI:
10.1177/1352458509103610
[Indexed for MEDLINE]

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