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. 2025 Feb;15(1):27-36.
doi: 10.1080/17582024.2025.2452150. Epub 2025 Jan 21.

Real world effectiveness, persistence, tolerability, and safety of ofatumumab in clinical practice

Moein Amin  1 , Tucker Harvey  2 , Dan Michael Pineda  3 , Ming-Hui Tai  4 , Qiujun Shao  4 , Brandon Brown  4 , Abhijit Gadkari  4 , Brandon Moss  1 , Devon S Conway  1 , Carrie M Hersh  5
Affiliations

Real world effectiveness, persistence, tolerability, and safety of ofatumumab in clinical practice

Moein Amin et al. Neurodegener Dis Manag. 2025 Feb.

Abstract

Aims: To describe the 12-month effectiveness, persistence, tolerability, and safety of ofatumumab (OMB), a highly effective disease-modifying therapy (DMT) for relapsing multiple sclerosis (MS), in a real-world MS population.

Patients & methods: Electronic medical records of patients starting OMB from October 2020 to August 2022 at two comprehensive MS centers were reviewed. Demographics and disease characteristics and 6- and 12-month clinical, patient-reported, and radiologic outcome measures were analyzed.

Results: A total of 175 patients started OMB with mean age 44.9 (SD 10.4) and disease duration 13.6 (SD 9.6) years. The cohort was 74% female, included 81% White and 13% Black American patients, and consisted of 80% relapsing-remitting MS or clinically isolated syndrome. Most (87%) had prior DMT exposure with 38% switching from high efficacy DMT. Over 12 months, 9.7% discontinued OMB (mean 117 days, SD 99.2), with tolerability issues being the most common reason. Thirty-nine (22%) had relapses in the year before starting OMB. By 12 months, only 1 relapse had occurred after approximately 4 months post-treatment initiation.

Discussion: This real-world study demonstrated that OMB is highly effective with robust persistence and good safety and tolerability by 12-month follow-up. Further analyses are planned to examine longer-term outcomes.

Keywords: Ofatumumab; disease modifying therapy; efficacy; multiple sclerosis; real-world; tolerability.

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Conflict of interest statement

Data collection and statistical analysis were performed by the study team at the Cleveland Clinic.

Moein Amin has received Novartis fellowship award NGC44741.

Tucker Harvey and Dan Michael Pineda have no disclosures.

Brandon Moss has received research support paid to his institution from Novartis and Genentech. He has received consulting fees from Biogen. He has an ownership interest in Pfizer.

Devon Conway has received research support paid to his institution from Novartis Pharmaceuticals, EMD Serono, Biogen, and Horizon Therapeutics. He has received speaking fees from Biogen and consulting fees from Novartis.

Carrie M. Hersh has received speaking, consulting, and advisory board fees from Genentech, Genzyme, Biogen, Novartis, EMD-Serono, Bristol Myers Squibb, TG Therapeutics, Horizon Therapeutics, and Alexion. She has received research support paid to her institution by Biogen, Novartis, Bristol Myers Squibb, Patient-Centered Outcomes Research Institute (PCORI) and NIH – NINDS 1U01NS111678-01A1 sub-award.

Ming-Hui, Tai, Qiujun Shao, Brandon Brown, Abhijit Gadkari are employees of Novartis Pharmaceuticals Corporation.

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Figures

Figure 1.
Figure 1.
Study flowchart of inclusion/exclusion criteria.
Figure 2.
Figure 2.
Number of patients discontinuing disease-modifying therapy prior to ofatumumab stratified by the reason (plot scale representing absolute counts). Radiological activity was defined as interval new lesions on MRI compared to prior scan. Disability progression was defined as documentation by the treating neurologist. Wearing-off phenomenon was defined as recurrence of symptoms attributed to MS near the end of the dose interval. Side effects were based on adverse events that could be explained by drug pharmacology while intolerance was determined based on other complaints that may not have been related to drug but correlated temporally with ofatumumab use. JCV, John Cunningham Virus antibody.
Figure 3.
Figure 3.
Number of patients discontinuing ofatumumab stratified by reason during each time window (plot demonstrating overall cumulative incidence; plot scale representing absolute counts). Radiological activity was defined as interval new lesions on MRI compared to prior scan. Disability progression was defined as documentation by the treating neurologist. Side effects were based on adverse events that could be explained by drug pharmacology while intolerance was determined based on other complaints that may not have been related to drug but correlated temporally with ofatumumab use.
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