ArticleCNS drugs2022
Population Pharmacokinetic-B Cell Modeling for Ofatumumab in Patients with Relapsing Multiple Sclerosis.
Article in CNS drugs, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
31 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.
- 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
- Pharmacokinetic-Pharmacodynamic Modelling of Repeated Ocrelizumab Dosing in Relapsing-Remitting Multiple Sclerosis.Clinical pharmacokinetics · 2026Observational
- Translating B-Cell and Plasma-Cell Targeting from Oncology to Autoimmunity: Modalities, Quantitative Bridging, and a Development Roadmap.Clinical pharmacology and therapeutics · 2026Review
- Subcutaneous ofatumumab for remission maintenance in pediatric idiopathic nephrotic syndrome: a case series.Clinical kidney journal · 2026Article
- Ofatumumab in Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease: A Comparison With Rituximab.Annals of clinical and translational neurology · 2026Article
- [Ofatumumab in the treatment of multiple sclerosis - A summary of preclinical and clinical data].Fortschritte der Neurologie-Psychiatrie · 2026Review
- Relative increase of memory B-cell subsets under s.c. B-cell-depleting therapies in multiple sclerosis.Frontiers in immunology · 2026Article
- Case Report: Ofatumumab for the treatment of refractory anti-NMDAR-positive autoimmune encephalitis.Frontiers in immunology · 2026Article
- Pharmacodynamics and Pharmacokinetics of Ublituximab Compared with Other Anti-CD20 Monoclonal Antibodies for Multiple Sclerosis Treatment.Current neuropharmacology · 2026Review
- Article
- Model-Informed Drug Development for Ligelizumab in Patients With Chronic Spontaneous Urticaria.CPT: pharmacometrics & systems pharmacology · 2025Article
- Predicting the Pharmacokinetics of T-Cell Engagers as a Function of Target-Mediated Drug Disposition.Clinical and translational science · 2025Article
- 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
- Association of body mass index and clinical response in patients receiving ofatumumab for treatment of multiple sclerosis.Journal of neurology, neurosurgery, and psychiatry · 2025Article
- Review
- Different Treatment Outcomes of Multiple Sclerosis Patients Receiving Ocrelizumab or Ofatumumab.Annals of neurology · 2025Article
- Impact of Continuous Ofatumumab Exposure During Pregnancy in Multiple Sclerosis.Neurology. Clinical practice · 2025Article
- The effectiveness and safety of ofatumumab for the treatment of pemphigus vulgaris: a cohort study based on a registry database.Frontiers in immunology · 2025Article
- Sequelae of B-Cell Depleting Therapy: An Immunologist's Perspective.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 4 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOfatumumab, a fully human anti-CD20 monoclonal antibody indicated for the treatment of relapsing forms of multiple sclerosis (RMS), binds to a unique conformational epitope, thereby depleting B cells very efficiently and allowing subcutaneous administration at lower doses.
objectivesThe aims were to characterize the relationship between ofatumumab concentration and B cell levels, including the effect of covariates such as body weight, age, or baseline B cell count, and use simulations to confirm the chosen therapeutic dose.
methodsGraphical and regression analyses previously performed based on data from a dose-range finding study provided the B cell depletion target used in the present work. All available adult phase 2/3 data for ofatumumab in RMS patients were pooled to develop a population pharmacokinetics (PK)-B cell count model, using nonlinear mixed-effects modeling. The population PK-B cell model was used to simulate B cell depletion and repletion times and the effect of covariates on PK and B cell metrics, as well as the dose response across a range of subcutaneous ofatumumab monthly doses.
resultsThe final PK-B cell model was developed using data from 1486 patients. The predetermined B cell target was best achieved and sustained with the 20-mg dose regimen, with median B cell count reaching 8 cells/µL in 11 days and negligible repletion between doses. Only weight had a significant effect on PK, which did not translate into any clinically relevant effect on B cell levels.
conclusionThe PK-B cell modeling confirms the dose chosen for the licensed ofatumumab regimen and demonstrates no requirement for dose adjustment based on adult patient characteristics.
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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.