ArticleFrontiers in immunology2025
The real-world safety of Ofatumumab: a pharmacovigilance analysis based on the FDA adverse event reporting system.
Article in Frontiers in immunology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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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.
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Who cites it
8 citing papers in PubMed.
- CAR-T Cell Therapy and Gut Microbiota Modulation in Multiple Sclerosis: Emerging Therapeutic Strategies and Current Limitations.Current issues in molecular biology · 2026Review
- Real-World Effectiveness and Safety of Ofatumumab in Relapsing Multiple Sclerosis: Comparison of Treatment-Naïve Patients and Switchers in a Multicenter Cohort.Drugs - real world outcomes · 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
- Safety profile of complement C5 inhibitors and FcRn inhibitors in the treatment of myasthenia gravis: analysis of the FAERS database and disease-gene interaction network.Frontiers in immunology · 2025Article
- A real-world drug safety surveillance study from the FAERS database of hepatocellular carcinoma patients receiving durvalumab in combination with tremelimumab.Frontiers in immunology · 2025Article
- Drug-induced headache reports: a comprehensive disproportionality and time-to-onset pharmacovigilance study using the FAERS database (2018-2024).Frontiers in pain research (Lausanne, Switzerland) · 2025Article
- Successful sequential treatment with ofatumumab followed by efgartigimod for refractory autoimmune encephalitis with dual anti-NMDAR and anti-GFAP antibody positivity: first case report.Frontiers in immunology · 2025Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Ofatumumab is a humanized monoclonal antibody that targets CD20-positive B cells. It was approved by the FDA in 2020 for the treatment of relapsing multiple sclerosis (RMS) in adult patients, and in 2009 for the treatment of Chronic Lymphocytic Leukemia (CLL). With the escalating clinical application of Ofatumumab, comprehending its safety profile within actual healthcare environments is of considerable importance. Methods: This study compiled a dataset derived from the FAERS database, which included real-world safety data on Ofatumumab from Q4 2009 to Q2 2024. We applied four distinct methodologies, including ROR, PRR, MGPS, and BCPNN, to perform a disproportionality analysis of adverse events (AEs) associated with Ofatumumab. Furthermore, we utilized the Weibull distribution model to estimate the temporal risk pattern of AEs. Results: The investigation incorporated a total of 24,468 case reports pertaining to AEs associated with Ofatumumab. The commonly observed AEs encompass Fatigue, Headache, Chills, Pyrexia, Pain, Nausea, Nasopharyngitis, Vomiting, Urinary tract infection, and Pneumonia. Additionally, we identified potential AEs not specified on the drug label, such as Asthenia, Hypoesthesia, Dizziness, Malaise, Injection site pain, Paresthesia, and Diarrhea. Conclusions: This investigation has identified several AEs associated with Ofatumumab and revealed previously unacknowledged potential adverse reaction signals. Healthcare providers can refer to these adverse reaction signals to more comprehensively consider the possible conditions that patients may present with during actual clinical practice.
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