New efficacy and safety data on ofatumumab (Kesimpta), the first and only self-administered, targeted B-cell therapy for patients with relapsing MS (RMS), indicate potential benefits of starting high-efficacy therapy early with ofatumumab.  Ofatumumab was approved by the US Food and Drug Administration (FDA) for treatment in RMS to include clinically isolated syndrome, relapsing–remitting disease and active secondary progressive disease in adults, in August 20204:

  • New findings from the ASCLEPIOS Phase III trials demonstrate ofatumumab’s superior efficacy vs teriflunomide in newly diagnosed, treatment-naïve patients with low absolute relapse rates, very low magnetic resonance imaging (MRI) lesion activity and prolonged time to disability worsening.
  • Additional safety and efficacy data on ofatumumab show that no new safety signals were identified in patients treated with ofatumumab. In this extended analysis, ofatumumab showed a safety profile that remains consistent with data reported in the Phase II and III clinical trials.
  • Results from the ASCLEPIOS trials also demonstrated that baseline serum neurofilament light levels (sNfL) were prognostic for lesion formation and brain volume loss for at least two years. These results support that sNfL can complement clinical assessments and help identify patients at high risk for future disease activity.

For more information, visit MSVirtual 2020.