ArticleMedicine2019
A pilot safety study of ublituximab, a monoclonal antibody against CD20, in acute relapses of neuromyelitis optica spectrum disorder.
Article in Medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses 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
27 citing papers in PubMed, 3 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Consensus Recommendations for the Diagnosis and Treatment of Neuromyelitis Optica Spectrum Disorders (NMOSD): The MENACTRIMS Guidelines.CNS drugs · 2026Guideline
- Systematic Review of Safety and Efficacy of Second- and Third-Generation CD20-Targeting Biologics in Treating Immune-Mediated Disorders.Frontiers in immunology · 2021Pooled it
- Effect of plasma exchange in neuromyelitis optica spectrum disorder: A systematic review and meta-analysis.Annals of clinical and translational neurology · 2020Pooled it
- A novel recombinant anti-cluster of differentiation 20 humanized monoclonal antibody (B001) for the treatment of neuromyelitis optica spectrum disorder: a phase 1, multicenter randomized, double-blind trial.Frontiers in immunology · 2026Trial
- Recognition and management of acute relapse of multiple sclerosis, neuromyelitis optica spectrum disorder and myelin oligodendrocyte glycoprotein antibody-associated disease.Cell death and differentiation · 2026Review
- Defining immune reset: achieving sustained remission in autoimmune diseases.Nature reviews. Immunology · 2025Review
- Update on the diagnosis and treatment of neuromyelitis optica spectrum disorders (NMOSD) - revised recommendations of the Neuromyelitis Optica Study Group (NEMOS). Part II: Attack therapy and long-term management.Journal of neurology · 2024Review
- Inflammatory Demyelinating Diseases of the Central Nervous System.Advances in neurobiology · 2024Review
- AQUAPORIN-4 (AQP-4) IMMUNOGLOBULIN G SEROPOSITIVE NEUROMYELITIS OPTICA: A REVIEW AND CASE REPORT.Annals of Ibadan postgraduate medicine · 2023Article
- A Clinical Approach to Existing and Emerging Therapeutics in Neuromyelitis Optica Spectrum Disorder.Current neurology and neuroscience reports · 2023Review
- B cell targeted therapies in inflammatory autoimmune disease of the central nervous system.Frontiers in immunology · 2023Review
- Aligning payer and provider strategies with the latest evidence to optimize clinical outcomes for patients with neuromyelitis optica spectrum disorder.Journal of managed care & specialty pharmacy · 2022Review
- Treatment and Relapse Prevention of Typical and Atypical Optic Neuritis.International journal of molecular sciences · 2022Review
- Next-generation antibody-based therapies in neurology.Brain : a journal of neurology · 2022Review
- Antibody-mediated cell depletion therapies in multiple sclerosis.Frontiers in immunology · 2022Review
- Neuromyelitis optica spectrum disorders: from pathophysiology to therapeutic strategies.Journal of neuroinflammation · 2021Review
- Targeting Neuromyelitis Optica Pathogenesis: Results from Randomized Controlled Trials of Biologics.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2021Review
- New progress in the treatment of neuromyelitis optica spectrum disorder with monoclonal antibodies (Review).Experimental and therapeutic medicine · 2021Review
- B Cells and Antibodies as Targets of Therapeutic Intervention in Neuromyelitis Optica Spectrum Disorders.Pharmaceuticals (Basel, Switzerland) · 2021Review
- Drug Treatment of Neuromyelitis Optica Spectrum Disorders: Out with the Old, in with the New?ImmunoTargets and therapy · 2021Review
Corrections and comments
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Authors and funding
2 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo test the safety of ublituximab, a B cell depleting agent, as add-on therapy in the acute treatment of relapses of neuromyelitis optica spectrum disorder.
methodsWe conducted an open-label phase 1b safety and proof-of-concept trial in 5 subjects with aquaporin-4 (AQP4)-immunoglobulin G (IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD) who presented with acute transverse myelitis and/or optic neuritis. In addition to treating with 1 g of daily intravenous methylprednisolone, we infused a single dose of 450 mg of ublituximab within 5 days of relapse onset. The primary outcome measure was safety, and the secondary efficacy measures included change in Expanded Disability Status Scale (EDSS), durability of remission and B cell counts.
resultsFive NMOSD subjects were enrolled, 4 of whom presented with acute transverse myelitis and 1 with acute optic neuritis. Ublituximab proved to be safe in all 5 NMOSD subjects, with no serious adverse events recorded. There were no opportunistic infections in any of the subjects; however, 1 subject experienced a transient leukopenia. EDSS scores dropped from a median of 6.5 on admission to 4.0 on 90-day follow up. Two subjects did not achieve total B cell depletion and relapsed within 3 months.
conclusionsUblituximab is a safe add-on therapy for NMOSD patients presenting with acute transverse myelitis and optic neuritis. Preliminary evidence suggests a promising benefit on durability of remission when B cell depletion is achieved. A placebo-controlled trial is necessary to confirm these findings. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for patients with NMOSD with acute transverse myelitis or optic neuritis, ublituximab is safe and may improve neurological outcome.
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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.