Ofatumumab significantly reduced the annualized relapse rate by 94.5% (from 0.486 to 0.027; p<0.001) in adults with relapsing multiple sclerosis.
Cohort (n=424)
Yes
Does ofatumumab reduce annualized relapse rate and improve clinical/radiological outcomes in adults with relapsing multiple sclerosis across different prior treatment exposures?
Ofatumumab is highly effective in reducing relapses and MRI activity in relapsing multiple sclerosis, though patients switching from high-efficacy therapies have a higher risk of infections.
Effect estimate: 94.5% reduction
Absolute Event Rate: 0.027% vs 0.486%
p-value: p=<0.001
BACKGROUND: Ofatumumab (OFA) is a fully human anti-CD20 monoclonal antibody approved for the treatment of relapsing multiple sclerosis (RMS). Real-world data on its effectiveness and safety remain limited. OBJECTIVE: To assess the effectiveness and safety of OFA in a large Italian RMS cohort and to examine the impact of prior treatment exposure on clinical, radiological, and safety outcomes in routine clinical practice. METHODS: This retrospective, multicenter study included adults with RMS who initiated OFA and had at least one follow-up visit. Patients were classified as treatment-naïve, switching from moderate-efficacy therapies (MET), or switching from high-efficacy therapies (HET). Outcomes included annualized relapse rate (ARR), magnetic resonance imaging (MRI) activity, disability measures (including confirmed disability worsening and improvement), no evidence of disease activity (NEDA-3), and adverse events (AEs). RESULTS: A total of 424 patients were analyzed, with a mean follow-up of 1.32 (± 0.61) years: 101 (23.8%) treatment-naïve and 323 (76.2%) switchers, of whom 113 were previously treated with MET and 210 with HET. During treatment, ARR decreased significantly from 0.486 to 0.027 (94.5% reduction; p < 0.001), with comparable relative reduction observed across all subgroups. MRI activity was significantly diminished, and at 12 months, 79.3% of evaluable patients achieved NEDA-3, with no significant differences between naïve, MET, and HET subgroups. Overall, OFA was well tolerated, with predominantly mild injection-related reactions and low discontinuation rates, mainly related to pregnancy planning with favorable outcomes. Infections were the only safety outcome that differed significantly among groups, occurring in 0.9% of naïve patients, 1.7% of MET switchers, and 9.5% of HET switchers (p = 0.001). Prior exposure to HET was the only independent predictor of infections. CONCLUSIONS: These findings support OFA as an effective and generally safe option for RMS across various treatment sequences, while suggesting enhanced infection monitoring in patients switching from HETs.
Mangialardi et al. (Sun,) conducted a cohort in Relapsing multiple sclerosis (n=424). Ofatumumab vs. Baseline (pre-treatment) and across prior treatment subgroups (naïve, MET, HET) was evaluated on Annualized relapse rate (ARR) (94.5% reduction, p=<0.001). Ofatumumab significantly reduced the annualized relapse rate by 94.5% (from 0.486 to 0.027; p<0.001) in adults with relapsing multiple sclerosis.