Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2022
Rapid and sustained B-cell depletion with subcutaneous ofatumumab in relapsing multiple sclerosis: APLIOS, a randomized phase-2 study.
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. It is linked to trial NCT03560739 (A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients), which is not on this map. Cited by 45 papers.
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.
A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients
Who cites it
45 citing papers in PubMed, 60 citations in OpenAlex.
- Efficacy and safety of four-year ofatumumab treatment in relapsing multiple sclerosis: The ALITHIOS open-label extension.Multiple sclerosis (Houndmills, Basingstoke, England) · 2023Trial
- Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years.Multiple sclerosis (Houndmills, Basingstoke, England) · 2022Trial
- Real-World Outcomes of Ocrelizumab and Ofatumumab Treatment in Pediatric-Onset Multiple Sclerosis.Paediatric drugs · 2026Article
- CAR-T Cell Therapy and Gut Microbiota Modulation in Multiple Sclerosis: Emerging Therapeutic Strategies and Current Limitations.Current issues in molecular biology · 2026Review
- Use of blood-based neurofilament light chain as an endpoint in clinical trials of neurodegenerative conditions: a scoping review.Journal of neurology · 2026Article
- Clinical Qualification of Subcutaneous Injection Devices for Monoclonal Antibodies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Ofatumumab Treatment Used in Pediatric MOGAD: A Retrospective Case Series.Journal of central nervous system disease · 2026Article
- Case Report: Marburg variant of multiple sclerosis and review of its complicated treatment.Frontiers in immunology · 2026Review
- Pharmacodynamics and Pharmacokinetics of Ublituximab Compared with Other Anti-CD20 Monoclonal Antibodies for Multiple Sclerosis Treatment.Current neuropharmacology · 2026Review
- Early treatment with ofatumumab increases the likelihood of stabilizing disease in patients with relapsing-remitting multiple sclerosis.Archives of medical science : AMS · 2026Article
- Sequential efgartigimod and ofatumumab for stiff-person syndrome: a case report illustrating a pathophysiology-informed strategy and literature review.Frontiers in immunology · 2026Review
- 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
- Five-Year Safety and Efficacy Outcomes with Ofatumumab in Patients with Relapsing Multiple Sclerosis.Neurology and therapy · 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
- Anti-B Cell Strategy in Nephrotic Syndrome: Beyond Rituximab.Biomedicines · 2025Review
- Review
- Subcutaneous ofatumumab in recurrent focal segmental glomerulosclerosis after kidney transplantation.Clinical kidney journal · 2025Article
- Different Treatment Outcomes of Multiple Sclerosis Patients Receiving Ocrelizumab or Ofatumumab.Annals of neurology · 2025Article
- Ofatumumab in pediatric multiple sclerosis: a case series.Therapeutic advances in neurological disorders · 2025Article
- The real-world safety of Ofatumumab: a pharmacovigilance analysis based on the FDA adverse event reporting system.Frontiers in immunology · 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
33 authors at 20 institutions in 10 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOfatumumab, the first fully human anti-CD20 monoclonal antibody, is approved in several countries for relapsing multiple sclerosis (RMS).
objectiveTo demonstrate the bioequivalence of ofatumumab administered by an autoinjector versus a pre-filled syringe (PFS) and to explore the effect of ofatumumab on B-cell depletion.
methodsAPLIOS (NCT03560739) is a 12-week, open-label, parallel-group, phase-2 study in patients with RMS receiving subcutaneous ofatumumab 20 mg every 4 weeks (q4w) (from Week 4, after initial doses on Days 1, 7, and 14). Patients were randomized 10:10:1:1 to autoinjector or PFS in the abdomen, or autoinjector or PFS in the thigh, respectively. Bioequivalence was determined by area under the curve (AUC
resultsA total of 256 patients contributed to the bioequivalence analyses (autoinjector-abdomen,
conclusionOfatumumab 20 mg q4w self-administered subcutaneously via autoinjector is bioequivalent to PFS administration and provides rapid B-cell depletion.
Indexed as
Identifiers
What OpenQuestion holds
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.