Ofatumumab Safety Data Reinforced By Multi-Year Study in Patients With Relapsing Multiple Sclerosis

Novartis has announced data demonstrating the safety of ofatumumab over extended exposure—approximately 3.5 years—in patients with relapsing forms of multiple sclerosis (RMS) at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis. According to the investigators, these new data support ofatumumab as a first-choice treatment for adult patients with RMS, including those who are newly diagnosed.

“Antibodies, also known as immunoglobulins, function as part of the healthy immune system, and reduced serum immunoglobulin levels have been previously linked to an apparent increased risk of infection,” said Lykke Hinsch Gylvin, Neuroscience Global Medical Franchise head at Novartis Pharmaceuticals, in a press release. “We are therefore encouraged by the results demonstrating that these levels remained within the reference range for patients taking Kesimpta. Providing safe and well-tolerated treatments with superior efficacy is of the utmost importance to Novartis in our continued efforts to reimagine MS care and improve the lives of people living with MS.”

Ofatumumab is a targeted B-cell therapy, which studies have shown to have a higher efficacy and a similar safety and tolerability profile compared to teriflunomide. In the data from the ALITHIOS phase 3b open-label extension study, mean immunoglobulin G (IgG) levels in patients treated with ofatumumab remained stable, and there was no apparent association between IgG levels and serious infection risk. The data also showed that mean immunoglobulin M levels declined over time but remained within the reference range for the majority of patients, with the overall incidence of serious infections being low.

These newest data build on previous efficacy and safety findings, which include the phase 3 ASCLEPIOS I and II studies, in which ofatumumab demonstrated superiority in comparison to teriflunomide. In the study, ofatumumab was associated with significant reductions in the annualized relapse rate, the 3-month confirmed disability progression, and the number of gadolinium-enhancing T1 and new or enlarging T2 lesions.

REFERENCE

Kesimpta® (ofatumumab) data at ECTRIMS highlights preservation of IgG levels and safety experience over extended exposure (~3.5 years) in people living with relapsing multiple sclerosis [news release]. Novartis; October 14, 2021. Accessed October 19, 2021. https://www.novartis.com/news/media-releases/kesimpta-ofatumumab-data-ectrims-highlights-preservation-igg-levels-and-safety-experience-over-extended-exposure-35-years-people-living-relapsing-multiple-sclerosis