6-Year Data Reported for Kesimpta Treatment of Individuals with Early, Non-Highly Active MS

Six-year open-label extension (OLE) results from the ALITHIOS clinical trial (NCT03650114) demonstrated that treatment with Kesimpta (ofatumumab; Novartis, East Hanover, NJ) was safe and effective for individuals with early multiple sclerosis (MS) and non-highly active disease taking continuous treatment and in those who switched treatments. Results were presented at the American Academy of Neurology (AAN) 2025 Annual Meeting.

OLE analysis included data from 430 individuals with early MS (Expanded Disability Status Scale ≤3, symptom onset ≤5 years) and non-highly active disease, defined as having a maximum of 1 relapse in the previous 1 year or 2 relapses in the previous 2 years, in addition to being treatment-naive or treated with 1 prior disease-modifying therapy with symptom onset ≤5 years. Researchers analyzed data from 2 groups of participants: individuals from the core study who were continuously treated with Kesimpta (continuous group, n=214) and those who switched from Aubagio (teriflunomide; Genzyme, Cambridge, MA) to ofatumumab during the OLE (switch group, n=216).

• The odds of achieving no evidence of disease activity (NEDA-3) increased from 33% to 58% in the switch group at year 2 through 3 and reached 93% at year 6.
• The odds of achieving NEDA-3 increased from 91% to 93% in the continuous group from years 2 to 6.
• Participants from the continuous group had fewer 6-month confirmed disability worsening (6mCDW) events and a risk reduction of 33.2% compared to the switch group, and 83.5% remained free from (6mCDW) events after up to 6 years.
• The reduction of serum neurofilament light (sNfL) levels observed in participants from the core study who were treated with Kesimpta remained low in the continuous group.
• Safety results were consistent with those of the overall population.