Kesimpta Treatment for Patients with RMS Results in Reduced Relapse Rates, Suppression of MRI Lesion Activity, and an Increase in NEDA-3 Rates According to Results from ALITHIOS

Results from the ALITHIOS open-label extension study (NCT03650114) presented at the 2023 European Academy of Neurology (EAN) meeting showed suppressed relapse rates, reduced MRI lesion, and high rates of no evidence of disease activity (NEDA-3) for up to 5 years in patients with relapsing multiple sclerosis (RMS) treated with Kesimpta (ofatumumab; Novartis, Cambridge, MA).

The ALITHIOS study is an extension of the phase 3, randomized ASCLEPIOS I/II clinical trials (NCT02792218 and NCT02792231) in which participants with RMS received either Kesimpta or Aubagio (teriflunomide; Sanofi, Bridgewater, NJ). ALITHIOS study results were derived from ASCLEPIOS participants who either continued to receive Kesimpta (n=690) or switched from Aubagio to Kesimpta treatment (n=677). Participants who continued Kesimpta treatment maintained a low annual relapse rate (ARR) and suppression of MRI lesion activity (Gd+T1 and new/enlarging T2 lesions) through 5 years, and the odds of achieving NEDA-3 increased from year 2 (80%) and reached a maximum at year 5 (93.4%). In participants who switched from Aubagio to Kesimpta, a reduction in ARR was observed from year 2 to 3 (0.15-0.07) and maintained through years 3-5 (0.05), MRI lesion activity was suppressed from years 3-5, and NEDA-3 rates increased.

Commenting on the significance of these results, Novartis Pharmaceuticals Innovative Medicines US President Victor Bultó noted, “These longer-term data continue to reinforce the favorable safety profile of Kesimpta, as well as its ability to slow disease progression, supporting its earlier use in people with relapsing multiple sclerosis.” The study was supported by Novartis.