Evolving Role of Ofatumumab Since Approval

At the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress, held September 24-26, in Barcelona, Spain, new findings on ofatumumab (Kesimpta; Novartis) drew significant attention for their implications in relapsing multiple sclerosis (MS). Among them were results from the ARTIOS trial, which evaluated patients switching from fingolimod or fumarate-based therapies after breakthrough disease, showing striking reductions in both relapses and MRI activity. In addition, long-term extension data reinforced the durability of ofatumumab’s efficacy and safety profile, underscoring its role as a central B-cell–depleting therapy in the MS landscape.

In this NeurologyLive^® Special Report mini-series, Riley Bove, MD, an associate professor of neurology at the University of California, San Francisco, breaks down the latest evidence and shares key takeaways for clinical practice. Across four short episodes, Bove explores how ofatumumab differs from other therapies, interprets the new ARTIOS results, reflects on its evolving use since approval, and looks ahead to the questions still shaping MS treatment research.

Since its 2020 FDA approval, ofatumumab has become a mainstay among B-cell therapies for MS. In this third episode, Bove discusses how its subcutaneous, self-administered dosing has shaped patient care compared with infusion-based options. She also reviews real-world and emerging data, including its use as first-line therapy, during pregnancy and lactation, and in diverse clinical populations.

Transcript was edited for clarity.

Riley Bove, MD: Ofatumumab came out, as you mentioned, in 2020, at a time when we were beginning to see across multiple studies—both randomized clinical trials and real-world data—that early initiation of B-cell–depleting therapy was highly effective.

During the pandemic, there was some concern about whether patients on B-cell–depleting therapy would be able to mount effective responses to COVID-19 infection or vaccination. While there have been some signals in that area, overall, patients have thankfully done quite well.

Since its approval, ofatumumab has become one of the mainstays of B-cell–depleting therapy. One of its distinguishing features is that it’s given as a subcutaneous injection that patients can self-administer at home, in contrast to infusion-based therapies. That convenience has been important for many patients.

We now have data showing ofatumumab’s effectiveness as both a first-line therapy and as a switch therapy, as demonstrated in the ARTIOS study. We’re also seeing emerging data about its use around pregnancy and lactation. Across all these studies, ofatumumab continues to demonstrate high efficacy, and we haven’t observed new safety signals beyond those identified in the initial trials.