Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2022
Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years.
Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
44 citing papers in PubMed, 2 syntheses or guidelines pooled it, 74 citations in OpenAlex.
- Hypogammaglobulinemia and infections in patients with multiple sclerosis treated with anti-CD20 treatments: a systematic review and meta-analysis of 19,139 multiple sclerosis patients.Frontiers in neurology · 2024Pooled it
- Systematic literature review of immunoglobulin trends for anti-CD20 monoclonal antibodies in multiple sclerosis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2023Pooled it
- Efficacy and safety of four-year ofatumumab treatment in relapsing multiple sclerosis: The ALITHIOS open-label extension.Multiple sclerosis (Houndmills, Basingstoke, England) · 2023Trial
- 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
- B Cells and B Cell Depletion in Autoimmunity and Atherosclerosis.Life (Basel, Switzerland) · 2026Review
- Article
- Real World Data of Laboratory Changes and Immunophenotyping in Patients with Multiple Sclerosis Treated with Ofatumumab-Single Center Experience.Biomedicines · 2026Article
- [Ofatumumab in the treatment of multiple sclerosis - A summary of preclinical and clinical data].Fortschritte der Neurologie-Psychiatrie · 2026Review
- Real-world comparison of anti-CD20 therapies: efficacy, infections, and immune profiles in a German cohort.Frontiers in immunology · 2026Article
- Case Report: Ofatumumab for the treatment of refractory anti-NMDAR-positive autoimmune encephalitis.Frontiers in immunology · 2026Article
- Effectiveness of Anti-CD20 B cells depleting therapy versus conventional treatment in severe Anti-N-methyl-d-aspartate receptor encephalitis: A real-world multi-center prospective cohort study.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025Article
- Five-Year Safety and Efficacy Outcomes with Ofatumumab in Patients with Relapsing Multiple Sclerosis.Neurology and therapy · 2025Article
- Secondary hypogammaglobulinemia and lymphocytopenia in patients with inflammatory neurological diseases on anti-CD20 therapy: risk of infection and infection-related mortality.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025Article
- Disease outcomes following lateral switch among different CD20-antibodies in active multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2025Article
- Neutropenia Associated With B Cell-Depleting Therapies in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder.Neurology(R) neuroimmunology & neuroinflammation · 2025Article
- Advancing Treatment in Pediatric Multiple Sclerosis: The Promise of B-Cell-Targeting Therapies.International journal of molecular sciences · 2025Review
- Selective IgM Hypogammaglobulinemia and Multiple Sclerosis Treated with Natalizumab and Ofatumumab: A Case Report.Journal of personalized medicine · 2025Article
- Review
- Real world effectiveness, persistence, tolerability, and safety of ofatumumab in clinical practice.Neurodegenerative disease management · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 13 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOfatumumab is approved for the treatment of relapsing multiple sclerosis (RMS). Ongoing safety reporting is crucial to understand its long-term benefit-risk profile.
objectiveReport the safety and tolerability of ofatumumab in RMS after extended treatment up to 3.5 years.
methodsPatients completing ASCLEPIOS I/II (phase 3), APLIOS, or APOLITOS (phase 2) trials could enter ALITHIOS, a phase 3b, open-label, long-term safety study. We analyzed cumulative data of continuous ofatumumab treatment and of patients newly switched from teriflunomide.
resultsThe safety population had 1969 patients: 1292 continuously treated with ofatumumab (median time-at-risk 35.5 months, 3253 patient-years) and 677 newly switched (median time-at-risk 18.3 months, 986 patient-years). A total of 1650 patients (83.8%) had ⩾1 adverse events and 191 (9.7%) had ⩾1 serious adverse events. No opportunistic infections or progressive multifocal leukoencephalopathy events were identified; the risk of malignancies was low. Mean serum immunoglobulin (Ig) G levels remained stable. Mean IgM levels decreased but remained above the lower limit of normal in most. Serious infection incidence was low; decreased Ig levels were not associated with serious infections.
conclusionIn patients with up to 3.5 years' exposure, ofatumumab was well tolerated, with no new safety risks identified. These findings, with its established effectiveness, support a favorable benefit-risk profile of ofatumumab in RMS.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.