The Food and Drug Administration (FDA) has approved ofatumumab (Kesimpta; Novartis) as an subcutaneous autoinjection for treatment of relapsing forms of multiple sclerosis (RS), including clinically isolated syndrome (CIS), relapsing-remitting disease (RRMS), and active secondary progressive MS (aSPMS), in adults. Ofatumumab is a targeted precisely dosed and delivered B-cell therapy that has shown superior efficacy compared with teriflunomide (Aubagio; Sanofi, Bridgewater, NJ) with a similar safety profile. Ofatumumab is a first-choice treatment option for individuals with relapsing forms of MS. Ofatumumab is the first B-cell therapy that can be self-administered once monthly at home via the Sensoready autoinjector pen.
Results from these 2 studies were recently published in the August 6, 2020 issue of The New England Journal of Medicine.
Traditionally, B-cell treatments, which bind to and deplete B-cells associated with disease activity in MS, have predominantly been available in hospitals or infusion treatment centers, which can add costs to the healthcare system and present a lifestyle burden for some participants. Ofatumumab provides the flexibility of self-administration via once-monthly subcutaneous dosing without premedication, eliminating the need to travel to an infusion center.
The positive results from an open-label phase 2 study to determine the bioequivalence of subcutaneous delivery of ofatumumab via a prefilled syringe and a Sensoready pen in participants with RMS—and the Asclepios studies show ofatumumab to be a highly effective B-cell therapy that can be easily self-administered at home.
Jill M. Giordano Farmer, DO
F. Stephen Benesh, MD, and Shruti P. Agnihotri, MD
Jason A. Ellis, MD; Benjamin W. Y. Lo, MD; Chirag G. Bhatia, BS; Yona Feit; Steven Mandel, MD; and Dana Shani, MD