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.
OBJECTIVE
This randomized, 2-year, double-blind, placebo-controlled, crossover study evaluated cladribine for relapsing forms of multiple sclerosis.


METHODS



METHODS
(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.
Stelmasiak
Z
Z
Department of Neurology, Medical University of Lublin, Lublin, Poland.
Solski
J
J
Nowicki
J
J
Jakubowska
B
B
Ryba
M
M
Grieb
P
P
D000328:Adult; D017338:Cladribine / Q000008:administration & dosage*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D007279:Injections, Subcutaneous; D018655:Lymphocyte Count; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000276:immunology; D010919:Placebos; D055502:Secondary Prevention; D016896:Treatment Outcome; D055815:Young Adult
D007166:Immunosuppressive Agents; D010919:Placebos; D017338:Cladribine