Abstract Details

Title Real-world Tolerability, Safety, and Effectiveness of Ofatumumab in Adults With Multiple Sclerosis Over 36 Months

Topic Multiple Sclerosis

Presentation(s) P4 - Poster Session 4 (8:00 AM-9:00 AM)

Poster/Presentation
Number 20-002

Objective To evaluate ofatumumab (OMB) persistence, tolerability, safety, and effectiveness in people with MS (pwMS) over 36 months.

Background Ofatumumab (OMB) is a highly effective anti-CD20 monoclonal antibody approved for the treatment of relapsing multiple sclerosis (MS). Real-world data on OMB experience is limited.

Design/Methods Electronic medical records of pwMS treated with OMB (2020-2025) at three MS centers were reviewed. Baseline demographics, disease characteristics, and clinical and radiographic outcomes at 6-, 12-, 24-, and 36-month follow-up were analyzed using chi-square and t-tests and generalized linear and linear mixed-effects models with p<0.05 considered statistically significant.

Results A total of 329 PwMS (mean [SD] age 44.2 [10.2] years; 76% female; 78% White; mean disease duration 12.1 [9.0] years) initiated OMB; 276 (83.9%) had prior disease-modifying therapy (DMT) exposure, most commonly ocrelizumab/rituximab (32%). OMB persistence remained high (87.8%) with median [IQR] time to discontinuation 355 [93-724.5] days, mostly due to side effects/intolerability (22.5%) and disability progression (15.0%). Intolerability was primarily observed early, with 31.8% at 6 months decreasing to 11.4% by 36 months, mostly flu-like reactions. IgG levels remained stable at 36 months compared to baseline while the proportion of PwMS with low IgM increased (p=0.011). Infections occurred in 22%, 26%, 37%, and 44% at 6-, 12-, 24-, and 36-month follow-up, respectively (p<0.001), mostly due to upper respiratory and urinary tract infections. There were no unanticipated safety signals. The annualized relapse rate at 36 months was 0.02, an incident rate ratio of 0.21 compared to baseline (p<0.001). MRI activity decreased over time with new T2 lesions odds ratio (OR)=0.08 (p<0.001) and gadolinium-enhancing lesions OR=0.15 (p=0.010) at 36 months vs baseline.

Conclusions OMB was well-tolerated with robust persistence and effectiveness over 36 months. Safety was compatible with randomized clinical trial results. Infection rates rose with increasing treatment duration despite stable IgG, possibly due to IgM reduction.

Authors/Disclosures
Diana Arias, DO PRESENTER	Diana Arias, DO has nothing to disclose.
Leah Musser, MD (Cleveland Clinic Foundation)	Dr. Musser has nothing to disclose.
Kailey Carrabre	Miss Carrabre has nothing to disclose.
Mengke Du (Cleveland Clinic)	Mengke Du has nothing to disclose.
Devon Conway, MD	Dr. Conway has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Conway has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Conway has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. Dr. Conway has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen. Dr. Conway has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Conway has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. The institution of Dr. Conway has received research support from Novartis. The institution of Dr. Conway has received research support from BMS. The institution of Dr. Conway has received research support from Biogen.
Moein Amin, MD (Cleveland Clinic)	Dr. Amin has nothing to disclose.
Carrie M. Hersh, DO, MSc, FAAN (Cleveland Clinic Lou Ruvo Center for Brain Health)	Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech_GN41791. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol-Myers Squibb . Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon Therapeutics. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Genzyme. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. The institution of Dr. Hersh has received research support from Biogen. The institution of Dr. Hersh has received research support from Novartis. The institution of Dr. Hersh has received research support from Genentech_GN41791. The institution of Dr. Hersh has received research support from PCORI. The institution of Dr. Hersh has received research support from Bristol Myers Squibb.

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