Findings from the phase 3 ASCLEPIOS I and II studies showed that treatment with ofatumumab (Novartis), a CD20-directed cytolytic monoclonal antibody, resulted in a highly significant and clinically meaningful reduction in the number of confirmed relapses, compared with teriflunomide (Aubagio; Sanofi Genzyme), a pyrimidine synthesis inhibitor, in patients with relapsing forms of multiple sclerosis (RMS).
The ASCLEPIOS I and II trials included 1882 patients with MS between the ages of 18 and 55 years with an Expanded Disability Status Scale (EDSS) score between 0 and 5.5. Patients were randomized to receive ofatumumab 20mg monthly subcutaneously or oral teriflunomide 14mg once daily. The primary end point of both studies was annualized relapse rate (ARR) in patients treated for up to 30 months.
Results showed that in both trials, ofatumumab significantly reduced the ARR over teriflunomide. In addition, treatment with ofatumumab delayed time to confirmed disability progression (secondary end points); additional data will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Data from these trials will be included in regulatory submissions that Novartis plans to submit by the end of 2019. “Ofatumumab, if approved, could be a highly attractive treatment option for a broad RMS patient population, including early MS,” said John Tsai, Head Global Drug Development and Chief Medical Officer, Novartis.
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