To assess longer-term efficacy and safety of ofatumumab up to 6 years in people with MS early in the disease course (EDSS≤3) and without high disease activity.

Ofatumumab showed superior efficacy and comparable safety versus teriflunomide in the Phase 3 ASCLEPIOS I/II overall population and in various subgroups, including recently diagnosed treatment-naive (RDTN) participants. Data from the ALITHIOS open-label extension (OLE) demonstrated sustained efficacy for up to 6 years in the overall and RDTN groups.

These post-hoc analyses include cumulative data up to 6 years from the early MS subgroup with non-highly active disease activity (Max. 1 relapse in the last year and max. 2 relapses in the last 2 years plus treatment-naive or treated with 1 prior DMT with symptom onset ≤5 years) randomized to ofatumumab in the core (continuous group) and those originally randomized to teriflunomide and switching to ofatumumab in ALITHIOS (switch group).

The subgroup comprised 214/216 people in the continuous/switch groups (mean age at baseline: 36.4/35.2 years; 71.0/63.4% female; mean EDSS:1.82/1.83. In the continuous group, the odds of achieving no evidence of disease activity (NEDA-3) increased from 91% at year 2 to 93% at Year 6, and in the switch group from 33% to 58% at year 2-3, reaching 93% at year 6. Continuous ofatumumab treatment was associated with fewer 6mCDW events and a risk reduction of 33.2% compared to the switch group in OLE. 83.5% patients remained free from 6mCDW events in the continuous group after up to 6 years. sNfL levels were reduced with ofatumumab in the core and maintained at a low level in the continuous group in the OLE. Safety findings were consistent with those of the overall population.

Ofatumumab demonstrates sustained long-term efficacy and safety in non-highly active MS patients early in the disease course.