Real-World Data Support Kesimpta as First-Line Therapy in Early Relapsing Multiple Sclerosis

Real-world data from a prospective, noninterventional study suggest that Kesimpta (ofatumumab; Novartis, East Hanover, NJ) is associated with higher treatment retention, lower relapse activity, and favorable safety outcomes compared with interferon ß-1 or glatiramer acetate when used as first-line therapy in people with early relapsing multiple sclerosis (RMS) without highly active disease. Interim findings were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2026.

The multicenter study—conducted by researchers affiliated with Hanover Medical School, Hanover, Germany, NeuroMed Campus, Cologne, Germany, and Novartis Pharma, Nuremburg, Germany—enrolled treatment-naive adults with RMS diagnosed within 5 years of symptom onset and a baseline Expanded Disability Status Scale (EDSS) score of 2.5 or less. A total of 514 participants were enrolled, receiving first-line Kesimpta, interferon ß-1, or glatiramer acetate in routine clinical practice. The primary end point was treatment retention at 24 months, with secondary outcomes including effectiveness, safety, and patient-reported outcomes. Interim analyses included 404 participants treated with Kesimpta and 93 treated with interferon ß-1 or glatiramer acetate.

Key findings from the interim analysis included the following:

• Treatment retention at both 12 and 24 months was 96% with Kesimpta compared with 75% at 12 months and 65% at 24 months with interferon beta or glatiramer acetate.
• Treatment discontinuation was 7 times lower in the Kesimpta group than in the comparator group.
• Kesimpta treatment was associated with a 30% reduction in annualized relapse rate compared with interferon ß-1 or glatiramer acetate, along with less severe relapses, fewer hospitalizations, and reduced corticosteroid use.
• Kesimpta treatment was associoated with less frequent serious adverse events and discontinuations due to adverse events, and immunoglobulin G levels remained stable while immunoglobulin M levels stayed above the lower limit of normal.

According to investigators, these interim real-world findings align with results from pivotal clinical trials and provide additional insight into first-line treatment outcomes in routine RMS care.

Source: Nelles G, Skripuletz T, Meyer zu Reckendorf C, Wagner C. Real-world effectiveness and safety outcomes of ofatumumab as first-line treatment in early RMS. Presented at: ACTRIMS Forum 2026; February 2026; San Diego, CA. Abstract P426.