Sustained Ofatumumab Treatment in Relapsing MS Benefits Diverse Racial Groups

Among patients with relapsing multiple sclerosis (MS), earlier initiation of and sustained treatment with ofatumumab was associated with lower serum neurofilament light (sNfL) levels and earlier 3-parameter no evidence of disease activity (NEDA), according to study results presented at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, held in Nashville, Tennessee, from May 29 to June 2, 2024.

Following the conclusion of the ASCLEPIOS I and II trials (ClinicalTrials.gov Identifiers: NCT02792218 and NCT02792231, respectively), researchers conducted an open-label extension study (ALITHIOS; ClinicalTrials.gov Identifier: NCT03650114) to understand the effects of long-term ofatumumab treatment on sNfL levels and 3-paramter NEDA in patients with relapsing MS of diverse racial/ethnic backgrounds.

Of the 1882 patients enrolled in ASCLEPIOS I and II trials, 1367 (White, n=1142; Hispanic, n=105; Asian, n=46; Other, n=43; Black, n=31) enrolled in ALITHIOS and received ofatumumab for up to 5 years. Geometric means for sNfL levels and the proportion of patients achieving 3-parameter NEDA over the course of 5 years were assessed in patients randomly assigned to receive only ofatumumab and those randomly assigned to receive teriflunomide followed by ofatumumab.

Between baseline and 5 years, sNfL levels decreased from:

• 10.9 to 8.9 pg/mL among White patients,
• 11.9 to 8.1 pg/mL among Hispanic patients,
• 13.1 to 8.5 pg/mL among Asian patients,
• 10.9 to 7.2 pg/mL among Black patients, and
• 12.3 to 8.9 pg/mL among Other subgroups who received continuous ofatumumab.

Among patients who switched from teriflunomide to ofatumumab, sNfL levels between baseline and year 5 lowered from:

• 10.6 to 9.2 pg/mL among White patients,
• 9.9 to 8.5 pg/mL among Hispanic patients,
• 10.8 to 7.4 pg/mL among Asian patients,
• 11.4 to 9.5 pg/mL among Black patients, and
• 12.9 to 8.3 pg/mL among Other subgroups.

These values indicated that long-term ofatumumab therapy was associated with decreased sNfL levels across all racial and ethnic groups.

At years 1 and 5, the rates of achieving 3-parameter NEDA with continuous ofatumumab therapy were 47.9% and 93.3%, 50.0% and 98.4%, 48.3% and 91.7%, 52.2% and 85.7%, and 40.5% and 89.3% among the White, Hispanic, Asian, Black, and Other subgroups, respectively.

The rates of achieving 3-parameter NEDA at years 1 and 5 with teriflunomide followed by ofatumumab treatment were 24.7% and 90.2%, 30.0% and 97.5%, 32.4% and 96.7%, 13.8% and 78.9%, and 30.0% and 100.0% among the White, Hispanic, Asian, Black, and Other subgroups, respectively.

These trends indicated that earlier initiation of continuous ofatumumab therapy was associated with higher rates 3-parameter NEDA achievement.

This study was limited by the small subgroup sample sizes.

“The earlier and sustained benefit of OMB-OMB [long-term ofatumumab] treatment on sNfL levels and NEDA-3 vs TER-OMB [teriflunomide followed by ofatumumab] support the value of earlier initiation of high-efficacy therapy in pwRMS [people with relapsing MS] irrespective of racial/ethnic background.”

Disclosure: This research was supported by Novartis Healthcare Pvt Ltd, Novartis Pharmaceuticals Corporation, and Novartis Pharma AG. Please see the original reference for a full list of disclosures