Journal
JOURNAL OF NEUROLOGY
Volume 260, Issue 4, Pages 1136-1146Publisher
SPRINGER HEIDELBERG
DOI: 10.1007/s00415-012-6775-0
Keywords
Relapsing-remitting multiple sclerosis; Disease-modifying therapy; MRI outcome measures; Cladribine tablets; CLARITY study
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Funding
- Merck Serono S.A., Geneva, Switzerland
- branch of Merck Serono S.A. Coinsins, Switzerland
- Merck KGaA, Darmstadt, Germany
- Novartis
- Teva Pharmaceutical Ind. Ltd.
- Sanofi-Aventis
- Merck Serono
- Bayer Schering
- Biogen Dompe
- Serono Symposia International Foundation
- Bayer
- Biogen Idec
- Actinobac Scientific, Inc.
- Teva
- Bayer-Schering
- Genzyme
- Vertex Pharmaceuticals
- GW Pharmaceuticals
- Ironwood Pharmaceuticals
- Merz
- Teva-Aventis
- EMD Serono/Pfizer
- Acorda
- Biogen
- UCB Pharma
- MS Society of Canada
- Ilich Foundation
- Genmab
- GSK
- BioMS
- RoFAR
- Roche
- Danish Multiple Sclerosis Society
- Danish Medical Research Council
- European Union
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We herein provide a comprehensive assessment of magnetic resonance imaging (MRI) outcomes from CLARITY, a 96-week, double-blind study demonstrating significant clinical and MRI improvements in patients with relapsing-remitting multiple sclerosis (RRMS) treated with cladribine tablets. Patients with RRMS were randomized 1:1:1 to annual short-course therapy with cladribine tablets cumulative dose 3.5 or 5.25 mg/kg or placebo. MRI endpoints included mean number of T1 gadolinium-enhancing (Gd+), active T2 and combined unique (CU) lesions/patient/scan. MRI-measured disease activity was significantly reduced in both cladribine tablets groups versus placebo. The proportion of patients with no active lesions at study end was: T1 Gd+ lesions: 86.8 and 91.0 versus 48.3 % (p < 0.001); active T2 lesions: 61.7 and 62.5 versus 28.4 % (p < 0.001); CU lesions: 59.6 and 60.7 versus 26.1 % (p < 0.001). Clinically meaningful and significant reductions in active lesion counts and increases in proportions of active lesion-free patients were achieved consistently in cladribine tablet groups when data were stratified by baseline disease characteristics. For example, the percentage of patients who remained lesion-free over the study was significantly greater in cladribine tablet groups than in the placebo group for all lesion types regardless of relapse category at baseline (p < 0.001 for all analyses of patients with a parts per thousand currency sign1 or 2 relapses; p a parts per thousand currency sign 0.022 for analyses of patients with a parts per thousand yen3 relapses). MRI-measured disease activity was greatly reduced by both doses of cladribine tablets, with consistent effect across clinically relevant patient populations. These findings add to our scientific understanding of the neurological impact of this therapeutic modality in patients with RRMS.
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