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For patients with relapsing-remitting multiple sclerosis, cladribine tablets reduced the number of severe relapses over a 2-year period, according to a study presented at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, October 10-12, 2018, in Berlin, Germany.
Researchers in this post hoc analysis evaluated data from the CLARITY study to test the efficacy of cladribine tablets (3.5 mg/kg) on frequency and severity of relapses for patients with multiple sclerosis. The study consisted of 433 patients who received the cladribine tablets and 437 patients who received a placebo. Qualifying relapses were based on the Kurtzke Functional Score status, and the relapse relative risk was calculated at 24, 48, and 96 weeks.
At all 3 time points, the qualifying relapse relative risk was lower for the cladribine tablet group (P <.0001), and at 96 weeks, the relative risk for all relapses was 0.43 (95% CI, 0.37-0.51; P =.0001). The cladribine tablet group had a risk reduction in relapses requiring hospitalization (63%) or steroids (62%) by week 96. Covariates of age at diagnosis and prior use of disease-modifying drugs had a significant impact on relapses (P =.0011 and P =.0002, respectively).
The researchers concluded that the risk for relapses in the cladribine tablet group “was consistently and significantly lower” and that treatment with cladribine tablets 3.5 mg/kg showed strong efficacy vs placebo over 2 years in patients with relapsing multiple sclerosis.
Disclosures: This study was supported by EMD Serono, the producers of cladribine tablets. Please refer to reference for a complete list of authors’ disclosures.
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Schippling S, et al. CLARITY: an analysis of severity and frequency of relapses in patients with relapsing-remitting multiple sclerosis treated with cladribine tablets or placebo. Presented at: 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis. October 10-12, 2018; Berlin, Germany. Abstract P549.