Only a few weeks prior to the MSVirtual 2020, the fully human anti-CD20 monoclonal antibody ofatumumab was approved by the FDA for the treatment of relapsing forms of MS. In the open-label extension study ALITHIOS, ofatumumab’s very good safety profile was consistent with data from the core phase 3 ASCLEPIOS I/ASCLEPIOS II trials [1,2].
The indication of ofatumumab is to include clinically isolated syndrome (CIS), relapsing-remitting MS, and active secondary progressive MS in adults. In the ASCLEPIOS trials, ofatumumab demonstrated superior efficacy versus teriflunomide and a favourable safety profile in relapsing-remitting MS patients . Long-term safety data continues to be collected from the open-label phase 3b ALITHIOS extension study.
The overall safety data of all participants in ALITHIOS was reported . This data included 1,230 patients who were randomised to ofatumumab in the core phase 2 APLIOS (12 weeks) or phase 3 ASCLEPIOS I/II (up to 30 months) trials and continued in ALITHIOS, or completed/discontinued the core study and continued the safety follow-up; and 643 patients who were randomised to teriflunomide in ASCLEPIOS I/II and switched to ofatumumab in ALITHIOS.
The overall exposure was 2,118 patient-years.
The most frequently reported adverse events (AEs) were injection-related reactions and upper respiratory tract infections. Most AEs were mild to moderate in severity; the incidence of AEs, serious AEs, or grade 3/4 AEs did not increase in either group. There were no deaths. The overall safety profile was consistent with reports from the core ASCLEPIOS I/II trials. In the newly switched group, injection-related reactions were mild to moderate; none were serious or led to treatment discontinuation. Concerning AEs of special interest: there were no opportunistic infections, hepatitis B reactivation, or progressive multifocal leukoencephalopathy (PML) events. There were no new cases of malignancies in the continuous or newly switched patients either.
- Cross AH, et al. Safety experience with extended exposure to ofatumumab in patients with relapsing multiple sclerosis from Phase 2 and 3 clinical trials. MSVirtual 2020, P0234.
- Hauser SL, et al. N Engl J Med. 2020;383:546–57.
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Table of Contents: MS Virtual 2020
Letter from the Editor
MS Virtual 2020 Highlights Podcast
COVID-19 and MS
Treatment Strategies and Results
Management of progressive MS with approved DMT
Novel Treatment Directions
Neuromyelitis Optica Spectrum Disorders
No increased risk with IFN-β use during pregnancy
More evidence that some MS drugs may diminish SARS-CoV-2 vaccine response
Predicting autoimmunity in patients treated with alemtuzumab