Novartis has revealed new data from the ALITHIOS open-label extension study, underscoring the long-term efficacy of Kesimpta® (ofatumumab) for relapsing multiple sclerosis (RMS). The study found that treatment-naïve patients, recently diagnosed with RMS (≤3 years), who received Kesimpta as a first-line therapy for up to six years experienced less disability and disease progression compared to those who switched from teriflunomide. These findings will be presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2024 Annual Meeting.
Patients continuously treated with Kesimpta demonstrated a higher likelihood of remaining free from 6-month confirmed disability worsening (6mCDW) and progression independent of relapse activity (6mPIRA) compared to those who transitioned from teriflunomide. Specifically, 83.4% of recently diagnosed, treatment-naïve (RDTN) patients on continuous Kesimpta were free from 6mCDW, compared to 76.3% in the switch group, while 88.9% were free from 6mPIRA versus 83.3% in the switch group. These results emphasize the importance of early Kesimpta use to slow disease progression.
The OLIKOS Phase IIIb study further reinforced Kesimpta’s benefits, showing that patients who switched from intravenous anti-CD20 therapies (primarily ocrelizumab) to Kesimpta had no new gadolinium-enhancing T1 lesions after 12 months. Nearly all patients (98%) were also free from new or enlarging T2 lesions, confirming Kesimpta’s ability to maintain disease stability after switching from IV treatments.
Kesimpta’s safety profile in both studies aligned with previous findings, with no new safety concerns. Common treatment-emergent adverse events included COVID-19, headache, and fatigue. Kesimpta’s targeted B-cell depletion via subcutaneous self-administration provides a flexible, once-monthly treatment option for adults with RMS, making it a convenient choice for both first-line and switch patients.