ArticleTherapeutic advances in neurological disorders2021
Safety and effectiveness of eculizumab in Japanese patients with generalized myasthenia gravis: interim analysis of post-marketing surveillance.
Article in Therapeutic advances in neurological disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02301624 (A Phase III, Open-label Extension Trial of ECU-MG-301 to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis), which is not on this map. Cited by 19 papers, 1 of them a synthesis 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.
A Phase III, Open-label Extension Trial of ECU-MG-301 to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.
- Clinical Efficacy and Safety of Eculizumab for Treating Myasthenia Gravis.Frontiers in immunology · 2021Pooled it
- Italian recommendations for the diagnosis and treatment of myasthenia gravis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026Article
- Real-world efficacy of eculizumab in generalized myasthenia gravis patients with poor early response to efgartigimod: a prospective cohort study.Frontiers in immunology · 2026Article
- Beyond the Surface: Investigating the Potential Mechanisms of Non-Motor Symptoms in Myasthenia Gravis.European journal of neurology · 2025Review
- C5 complement inhibition versus FcRn modulation in generalised myasthenia gravis.Journal of neurology, neurosurgery, and psychiatry · 2025Observational
- Complement inhibitor therapy in thymoma-associated myasthenia gravis: a real-world experience.Frontiers in immunology · 2025Article
- United States clinical practice experience with eculizumab in myasthenia gravis: symptoms, function, and immunosuppressant therapy use.Journal of neurology · 2024Article
- Myasthenia Gravis Disease Burden and Its Impact on Satisfaction with Life: A Qualitative Survey of Patients' Perspectives in Japan.Neurology and therapy · 2024Article
- Real-world experience with eculizumab and switching to ravulizumab for generalized myasthenia gravis.Annals of clinical and translational neurology · 2024Article
- Serious Bacterial Infections Associated with Eculizumab: A Pharmacovigilance Study.Internal medicine (Tokyo, Japan) · 2024Article
- Registered trials on novel therapies for myasthenia gravis: a cross-sectional study on ClinicalTrials.gov.Scientific reports · 2024Article
- Eculizumab in thymoma-associated myasthenia gravis: a real-world cohort study.Therapeutic advances in neurological disorders · 2024Article
- Myasthenia Gravis Treatment: From Old Drugs to Innovative Therapies with a Glimpse into the Future.CNS drugs · 2024Review
- Real-world safety profile of eculizumab in patients with paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, or generalized myasthenia gravis: an integrated analysis of post-marketing surveillance in Japan.International journal of hematology · 2023Article
- Anti-complement Agents for Autoimmune Neurological Disease.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022Review
- Practical Management for Use of Eculizumab in the Treatment of Severe, Refractory, Non-Thymomatous, AChR + Generalized Myasthenia Gravis: A Systematic Review.Therapeutics and clinical risk management · 2022Review
- The Dual Role of a Polyvalent IgM/IgA-Enriched Immunoglobulin Preparation in Activating and Inhibiting the Complement System.Biomedicines · 2021Article
- Evaluation of the Quantitative Myasthenia Gravis Score and Grip Strength in Chinese Patients With Myasthenia Gravis: An Observational Study.Frontiers in neurology · 2021Article
- Eculizumab in myasthenia gravis: A review.Saudi journal of ophthalmology : official journal of the Saudi Ophthalmological SocietyArticle
Corrections and comments
- Erratum issued
Authors and funding
6 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEculizumab, a humanized monoclonal antibody targeted to terminal complement protein C5, is approved in Japan for treatment of patients with anti-acetylcholine receptor antibody-positive (AChR+) generalized myasthenia gravis (gMG) whose symptoms are difficult to control with high-dose intravenous immunoglobulin (IVIg) therapy or plasmapheresis.
methodsThis interim analysis of mandatory post-marketing surveillance in Japan assessed the safety and effectiveness of eculizumab at 26 weeks after treatment initiation in patients with AChR+ gMG.
resultsData were available for 40 adult patients in Japan [62.5% (25/40) female; mean age at eculizumab initiation, 51.0 years]. Fifteen patients had a history of thymoma. Six patients were excluded from the effectiveness analysis set due to participation in the open-label extension part of the phase III, randomized, double-blind, placebo-controlled REGAIN study [ClinicalTrials.gov identifier: NCT02301624]. After 26 weeks' follow up, 32 patients (80%) were continuing eculizumab treatment. Adverse drug reactions were reported by seven patients [most frequently headache (
conclusionIn a real-world setting, eculizumab was effective and well tolerated for the treatment of AChR+ gMG in adult Japanese patients whose disease was refractory to IVIg or plasmapheresis. These findings are consistent with the efficacy and safety results from the global phase III REGAIN study of eculizumab.
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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.