ArticleNeurology and therapy2025
Five-Year Safety and Efficacy Outcomes with Ofatumumab in Patients with Relapsing Multiple Sclerosis.
Article in Neurology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03650114 (An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis), which is not on this map. Cited by 12 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis
Who cites it
12 citing papers in PubMed.
- Efficacy and safety of ofatumumab in participants with relapsing multiple sclerosis and breakthrough disease on oral fingolimod or fumarates: results from the ARTIOS study.Journal of neurology · 2026Trial
- Five Years of Ublituximab in Multiple Sclerosis: ULTIMATE I and II Open-Label Extension Study.JAMA neurology · 2026Trial
- Late-Onset Neutropenia After Rituximab in Multiple Sclerosis: Incidence, Predictors, and Outcomes in a Retrospective Multicenter Cohort.Neurology(R) neuroimmunology & neuroinflammation · 2026Article
- Ten Years of Ocrelizumab in Relapsing Multiple Sclerosis: The OPERA I and II Randomized Clinical Trials.JAMA neurology · 2026Article
- Persistent B-cell depletion after ublituximab for multiple sclerosis.Journal of neurology · 2026Article
- Epstein-Barr Virus and Multiple Sclerosis: Mechanistic Insights into Virus-Driven Autoimmunity.Microorganisms · 2026Review
- Real World Data of Laboratory Changes and Immunophenotyping in Patients with Multiple Sclerosis Treated with Ofatumumab-Single Center Experience.Biomedicines · 2026Article
- Two-year OCT follow-up in multiple sclerosis patients on Ofatumumab shows retinal preservation over non-antiCD20 treatments.Journal of neurology · 2026Observational
- Real-world comparison of anti-CD20 therapies: efficacy, infections, and immune profiles in a German cohort.Frontiers in immunology · 2026Article
- Real-world effectiveness and safety of ofatumumab in relapsing-remitting multiple sclerosis: Insights from naïve and switch patients.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025Article
- Real-World Data of First 12-Months of Ofatumumab Treatment in Multiple Sclerosis Patients-A Multicenter Experience from Tertiary Referral Centers.Medicina (Kaunas, Lithuania) · 2025Observational
- Continuous ofatumumab treatment until the early third trimester in multiple sclerosis with preserved neonatal immunity.Multiple sclerosis journal - experimental, translational and clinicalArticle
Corrections and comments
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionOfatumumab demonstrated superior efficacy and similar safety versus teriflunomide in ASCLEPIOS I/II in people with relapsing multiple sclerosis; no new safety concerns and sustained efficacy were observed up to 4 years in the open-label extension study ALITHIOS. Here, we further characterise the safety and efficacy of ofatumumab up to 5 years by discussing infection outcomes in the COVID-19 era and providing a comprehensive overview of participant disability outcomes.
methodsSafety (N = 1969; participants who received ≥ 1 dose of ofatumumab in ASCLEPIOS I/II, APLIOS, APOLITOS, or ALITHIOS) and efficacy sets (N = 1882; participants randomised to ofatumumab [OMB-OMB] or teriflunomide [TER-OMB] in ASCLEPIOS I/II, regardless of whether they entered ALITHIOS) were analysed. Data cutoff: 25 September 2022.
resultsThe exposure-adjusted incidence rates (per 100 patient-years) of adverse events (AEs, 124.65), serious AEs (4.68), serious infections (1.63), and malignancies (0.32) remained consistent with previous findings up to 5 years of follow-up, with no new safety signals identified. With ofatumumab treatment up to 5 years, > 80% of patients remained free of 6-month confirmed disability worsening (6mCDW). Annualised relapse rates (ARR) remained low, and magnetic resonance imaging (MRI) activity was almost completely suppressed with OMB-OMB through years 1-5; after switching from teriflunomide (years 2-3), pronounced reductions in ARR/MRI activity were observed with low rates sustained through years 3-5. During year 5, 9 of 10 participants in both groups were free of disease activity (NEDA-3).
conclusionOfatumumab has a favourable benefit-risk profile that is sustained up to 5 years.
trial registrationALITHIOS (NCT03650114): https://clinicaltrials.gov/ct2/show/NCT03650114.
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