Novartis announced new data from two Kesimpta®? (ofatumumab) studies in relapsing multiple sclerosis (RMS) that will be presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 Annual Meeting in Barcelona, Spain, on September 24-26. Data from the ARTIOS Phase IIIb, open-label, single-arm, prospective study showed that patients who switched to Kesimpta after breakthrough disease on fingolimod or fumarate-based therapies had a substantial reduction in disease activity, as shown by a low annualized relapse rate (ARR, 0.06 over 96 weeks).
The data also showed an almost complete suppression of MRI activity and over 9 out of 10 participants achieving no evidence of disease activity (NEDA-3). No new safety concerns were observed following the switch to Kesimpta, irrespective of the last prior disease modifying treatment (DMT). The separate ALITHIOS open-label extension study includes recently diagnosed (3 years) treatment-naive (RDTN) people with RMS receiving first-line continuous Kesimpta.
Initial doses of Kesimpta are at weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare professional. The selective mechanism of action and subcutaneous administration of Kesimpta allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and preclinical studies have shown that it may preserve the B-cells in the spleen. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline.
Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 2015. Kesimpta has been approved for the treatment of relapsing forms of multiple sclerosis in over 92 countries worldwide with more than 150,000 patients treated as of August 20257,8,13.
