Positive Data Reported for Subcutaneous Ofatumumab in Multiple Sclerosis
Treatment reduces number of brain lesions in phase II trial (October 10)
Positive results have been reported from a phase II study of a subcutaneous formulation of ofatumumab (Genmab) in relapsing-remitting multiple sclerosis (RRMS).
A total of 232 subjects with RRMS were enrolled in the study. There was a clear separation from placebo on the cumulative number of new gadolinium-enhancing lesions (active brain lesions) over a period of 12 weeks in subjects treated with all doses of ofatumumab compared with subjects treated with placebo (P < 0.001).
The study’s primary objective was to determine whether 3 mg, 30 mg, or 60 mg of subcutaneous ofatumumab can reduce the number of new T1-weighted gadolinium-enhancing brain lesions over 12 weeks compared with placebo in subjects with RRMS. For this endpoint, an analysis of data from weeks 0 to 12 estimated a 65% reduction in the cumulative number of new T1 gadolinium-enhancing lesions for all doses (P < 0.001). From weeks 4 to 12, analyses of data estimated a reduction of 90% or more in the cumulative number of new T1 gadolinium-enhancing lesions for all cumulative doses of ofatumumab of 30 mg or more (P < 0.001).
From weeks 0 to 12, injection-related reactions were the most common adverse events (AEs) and were observed in 52% of subjects receiving ofatumumab compared with 15% of subjects receiving placebo. Five serious AEs were reported; all of these subjects received a 60-mg dose of ofatumumab, and none of the subjects withdrew from the study.
Source: Genmab; October 11, 2013.