CLARITY Extension: Annual Short-Course Therapy with Investigational Oral Agent Effective in Relapsing MS

Tuesday, September 05, 2017 | Multiple Sclerosis & Immune Disorders , Phase 3/4 Trials , Research and Publications , Merck & Co. H


New results suggest that patients with relapsing multiple sclerosis (MS) treated with two annual short courses of the investigational cladribine tablets (EMD Serono) may have similar clinical benefits to those seen with four years of treatment with cladribine tablets. Published in the Multiple Sclerosis Journal, the data from the CLARITY Extension study assessed annualized relapse rate and confirmed three-month EDSS progression among other efficacy endpoints in 806 patients with relapsing MS. The proportion of patients who remained relapse-free at the end of four years was similar to the patients who received cladribine tablets 3.5 mg/kg in CLARITY followed by placebo in CLARITY Extension (75.6%), and those who received Cladribine Tablets 3.5 mg/kg in both studies (81.2%). The proportion of patients who remained free of three-month EDSS progression was also similar between the treatment groups (72.4% vs. 77.4%). Adverse event rates were similar in patients who received cladribine tablets in CLARITY followed by placebo in CLARITY Extension, and those who received Cladribine Tablets in both studies. 

In August 2017, the European Commission (EC) granted marketing authorization for Cladribine Tablets, marketed as Mavenclad in the European Union (EU), for the treatment of relapsing forms of multiple sclerosis in the 28 countries of the EU in addition to Norway, Liechtenstein and Iceland. Merck KGaA plans additional filings for regulatory approval in other countries, including the US.

 

 

 

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