Patients with high disease activity in relapsing-remitting multiple sclerosis demonstrated magnetic resonance imaging (MRI) and clinical responses to 3.5 mg/kg cladribine tablets that were better than, or comparable with, the favorable responses found in the overall CLARITY study population, according to a study published in the Multiple Sclerosis Journal.

The CLARITY study examined the efficacy of cladribine tablets vs placebo for men and women with relapsing-remitting multiple sclerosis who were between 18 and 65 years, had MRI-detectable neurological lesions consistent with multiple sclerosis, had experienced at least one relapse in the 12 months, but not 28 days prior to study, and had an Expanded Disability Status Scale (EDSS) score of 0 to 5.5. The post-hoc analysis of this study assessed the efficacy of cladribine tablets in subjects with high disease activity in comparison with the overall study population. Patients with high disease activity were identified through higher relapse rates and poor treatment response, as indicated by MRI lesions.

Overall, treatment with 3.5 mg/kg cladribine led to a 47% reduction in risk for a worsening EDSS score at 6 months compared with placebo. For patients with high rates of relapse and high disease activity, cladribine led to an 82% risk reduction at 6 months. The safety profile in patients with high disease activity was comparable with that in the overall population.

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Study investigators conclude “treatment with cladribine tablets 3.5 mg/kg demonstrates significant clinical effects regardless of which highly active disease population is analyzed. Treatment with cladribine tablets 3.5 mg/kg also led to consistent results for [annualized relapse rate], time to first qualifying relapse, [no evidence of disease activity], time to 3-month-confirmed disability worsening and MRI endpoints for patients with [high disease activity].”

This study was sponsored by EMD Serono, Inc, a business of Merck KGaA, Darmstadt, Germany (in the USA) and Merck Serono SA – Geneva, an affiliate of Merck KGaA Darmstadt, Germany (ROW).


Giovannoni G, Soelberg Sorensen P, Cook S, et al. Efficacy of cladribine tablets in high disease activity subgroups of patients with relapsing multiple sclerosis: a post hoc analysis of the CLARITY study [published online May 2, 2018]. Mult Scler. doi: 10.1177/1352458518771875