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Abstract Details

Real-world Effectiveness, Tolerability, and Safety of Ofatumumab at 12-month Follow-up
Multiple Sclerosis
P9 - Poster Session 9 (8:00 AM-9:00 AM)
6-014
Ofatumumab is a highly effective disease-modifying therapy (DMT) approved for relapsing MS. Real-world data are needed to evaluate ofatumumab’s effectiveness and safety in a broader population.
Describe the 12-month effectiveness and tolerability/safety of ofatumumab in a real-world multiple sclerosis (MS) population.

Electronic medical records of patients starting ofatumumab (October 2020 to August 2022) at two comprehensive MS centers were reviewed. Baseline demographics, disease characteristics, and clinical and radiographic outcomes at 6- and 12-month follow-up were reviewed. Wilcoxon signed-rank tests, paired t-tests, and negative binomial mixed-effects models were used to calculate overall differences between baseline and post-baseline timepoints (p<0.05 considered statistically significant).

175 patients initiated ofatumumab (mean [SD] age 44.9 [10.4] years; mean [SD] disease duration 13.6 [9.6] years; 74% female, 81% White, 13% Black American). Of these, 87% had prior DMT exposure; 38% switched from high efficacy DMT, including ocrelizumab (36%). Injection-related reactions (IRRs) occurred primarily with initial injections, in 25%, 15%, and 11% of the first 3 injections, respectively; 8 patients (5%) reported IRR between months 6-12. Over 12 months, 90% of patients remained on ofatumumab (mean [SD], 101 [78.9] days). Sixty-two patients (35%) experienced infections (upper respiratory, 24%; urinary tract, 8%; other, 3.4%). Total IgG levels remained stable; proportion of patients with IgG <lower limit of normal did not differ between time intervals (p=0.892). Thirty-nine (22%) patients had relapses the year before starting ofatumumab. By 6 months, 1 relapse (p<0.001) occurred; none between months 6-12. 52(33%)/27(17%) patients had new T2/GdE lesions at baseline (n=159) and 13(15%)/2(2%) and 9(13%)/0(0%) had new T2/GdE lesions at 6 (n=87) and 12 (n=67) months, respectively (p=0.001). No significant differences were observed in Patient Determined Disease Steps at months 6-12 vs baseline.
Results demonstrated that ofatumumab is highly effective with robust persistence and good safety/tolerability through 12-month follow-up. Analyses examining longer-term outcomes are ongoing.
Authors/Disclosures
Carrie M. Hersh, DO, MSc, FAAN (Cleveland Clinic Lou Ruvo Center for Brain Health)
PRESENTER
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 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 Novartis. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Genzyme. 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.
Moein Amin, MD (Cleveland Clinic) Dr. Amin has nothing to disclose.
No disclosure on file
Brandon P. Moss, MD (Cleveland Clinic Mellen Center) An immediate family member of Dr. Moss has stock in Pfizer. The institution of Dr. Moss has received research support from Novartis. The institution of Dr. Moss has received research support from Genentech.
No disclosure on file
No disclosure on file
No disclosure on file
Devon Conway, MD Dr. Conway has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis Pharmaceuticals. Dr. Conway has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Banner Life Sciences. Dr. Conway has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen.