Long-Term Use of Ofatumumab May Suppress Disease Activity in Relapsing MS

Early and continuous use of ofatumumab for the treatment of relapsing multiple sclerosis (MS) was associated with a near complete and sustained suppression of disease activity, according to study results presented at the 2023 American Academy of Neurology (AAN) Annual Meeting, held from April 22 to 27, in Boston, Massachusetts.

In clinical trials, ofatumumab was associated with decreased serum neurofilament light chain (sNfL) levels and an increased likelihood of achieving 3-parameter no evidence of disease activity (NEDA-3) relative to teriflunomide among patients with relapsing MS.

The objective of this study was to evaluate the long-term sNfL and NEDA-3 outcomes of ofatumumab. To that end, data from ASCLEPIOS I (ClinicalTrials.gov Identifier: NCT02792218), ASCLEPIOS II (ClinicalTrials.gov Identifier: NCT02792231), and ALITHIOS (ClinicalTrial.gov Identifier: NCT03650114) were pooled. Overall, 946 patients received ofatumumab and 936 received teriflunomide for 96 weeks in ASCLEPIOS I/II and in ALITHIOS. A total of 690 ofatumumab recipients continued receiving ofatumumab and 677 teriflunomide recipients switched to ofatumumab during an open-label extension period.

At months 12 (8.03 vs 10.25 pg/mL; P <.001) and 24 (7.96 vs 9.97 pg/mL; P <.001) of ASCLEPIOS I/II, ofatumumab was associated with significant reductions in sNfL levels compared with teriflunomide, respectively.

The patients who continued receiving ofatumumab in ALITHIOS maintained their low sNfL levels, whereas the patients who switched to ofatumumab in ALITHIOS had significantly reduced sNfL levels (8.31 pg/mL) compared with those who maintained ofatumumab (9.07 pg/mL; P <.001) at 6 months. From month 12 of ALITHIOS, both groups had similar sNfL levels (8.23-8.50 pg/mL).

At months 12 (odds ratio [OR], 3.39; 95% CI, 2.71-4.25; P <.001) and 24 (OR, 10.09; 95% CI, 7.82-13.02; P <.001) of ASCLEPIOS I/II, ofatumumab associated with a higher likelihood of achieving NEDA-3 compared with teriflunomide.

In ALITHIOS, approximately 80% of the patients who maintained ofatumumab treatment and approximately 60% of the patients who switched to ofatumumab achieved NEDA-3 in year 1 (OR, 4.50; 95% CI, 3.40-5.94; P <.001). Similar findings were observed in year 2 (OR, 1.55; 95% CI, 1.07-2.22; P =.019).

The major limitation of this study was that no long-term safety analysis was included.

This study indicated that continuous use of ofatumumab associated with maintenance of low sNfL and high achievement of NEDA-3 among patients with relapsing MS. Researchers concluded, “A near complete and sustained suppression of disease activity was achieved with early and continuous use of OMB [ofatumumab], and a rapid reduction in disease activity followed conversion from TER [teriflunomide] to OMB.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.