Real-world Effectiveness, Tolerability, and Safety of Ofatumumab at 12-month Follow-up
Carrie Hersh1, Moein Amin2, Tucker Harvey3, Brandon Moss2, Ming-Hui Tai4, Abhijit Gadkari4, Brandon Brown4, Devon Conway2
1Lou Ruvo Center for Brain Health, Cleveland Clinic, 2Mellen Center for MS Treatment and Research, Cleveland Clinic, 3Quantitative Health Sciences, Cleveland Clinic, 4Novartis Pharmaceuticals Corporation
Objective:
Describe the 12-month effectiveness and tolerability/safety of ofatumumab in a real-world multiple sclerosis (MS) population.
Background:
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.
Design/Methods:
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).
Results:
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.
Conclusions:
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.