Management of Exacerbations and Rescue Therapy in the Phase 3 Myasthenia Gravis Inebilizumab Trial
Rattachement africain : us, jp, gb, dk. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
Importance: Uncontrolled generalized myasthenia gravis (gMG) can lead to exacerbations that often warrant rescue therapy (RT) use, especially in moderate to severe cases. Inebilizumab, a monoclonal antibody that depletes cluster of differentiation 19+ B cells, demonstrated efficacy and safety in patients with gMG enrolled in the Myasthenia Gravis Inebilizumab Trial (MINT); the present analysis evaluated its effect on exacerbations and RT use. Objective: To examine the effect of inebilizumab on exacerbations, including RT use, in participants enrolled in MINT. Design, Setting, and Participants: MINT was a phase 3, international, randomized, placebo-controlled trial that enrolled participants between August 2020 and November 2023. The randomized controlled period was 52 weeks for the anti-acetylcholine receptor antibody positive (AChR+) subpopulation and 26 weeks for the anti-muscle-specific kinase antibody positive (MuSK+) subpopulation with an optional 3-year open-label extension. Participants were enrolled at 81 academic and nonacademic sites in 18 countries. MINT screened 485 patients with gMG (AChR+ or MuSK+) and enrolled adult participants with Myasthenia Gravis Activities of Daily Life (MG-ADL) scores of 6-10. This prespecified analysis was conducted between September 2024 and March 2025. Interventions: Participants were randomized 1:1 to either inebilizumab or placebo and underwent a protocol-specified corticosteroid taper to 5 mg per day or less. Main Outcomes and Measures: The frequency of exacerbations, defined as myasthenic crisis, worsening of individual MG-ADL scores, or RT use (intravenous immunoglobulin or plasma exchange). Results: MINT enrolled 238 participants. The mean (SD) age at baseline was 47.5 (15.3) years, 144 (61%) were female, and the mean (SD) MG-ADL score was 9.1 (2.8). Inebilizumab reduced the risk of exacerbations compared with placebo in the combined population by week 26 (hazard ratio [HR], 0.41; 95% CI, 0.24-0.70), in the AChR+ subpopulation by week 52 (HR, 0.39; 95% CI, 0.23-0.68), and in the MuSK+ subpopulation by week 26 (HR, 0.21; 95% CI, 0.06-0.79). Conclusions and Relevance: In this prespecified analysis of a randomized clinical trial, inebilizumab treatment reduced exacerbation rate, including RT use, in participants with gMG who underwent a protocol-specified corticosteroid taper during MINT. These findings further support the clinical benefits of inebilizumab in AChR+ and MuSK+ gMG. Trial Registration: ClinicalTrials.gov Identifier: NCT04524273.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Management of Exacerbations and Rescue Therapy in the Phase 3 Myasthenia Gravis Inebilizumab Trial
- Date Crossref
- 10/08/2026
- Éditeur
- American Medical Association (AMA)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Yale University pays non établi dans la noticeUniversité ou école supérieure
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National Hospital Organization Hanamaki Hospital pays non établi dans la noticeÉtablissement de santé
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University of Miami Department of Neurology pays non établi dans la noticeUniversité ou école supérieure
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University of Rochester Department of Neurology pays non établi dans la noticeUniversité ou école supérieure
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University of Oxford Nuffield Department of Clinical Neurosciences pays non établi dans la noticeUniversité ou école supérieure
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University of Copenhagen Department of Neurology pays non établi dans la noticeUniversité ou école supérieure
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Copenhagen University Hospital pays non établi dans la noticeÉtablissement de santé
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Rigshospitalet pays non établi dans la noticeÉtablissement de santé
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Amgen (United States) pays non établi dans la noticeEntreprise
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University of North Carolina at Chapel Hill Department of Neurology pays non établi dans la noticeUniversité ou école supérieure
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Yale School of Medicine Program for Clinical and Translational Neuromuscular Research pays non établi dans la noticeUniversité ou école supérieure
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for the MINT investigators pays non établi dans la noticeInstitution
Yale University, National Hospital Organization Hanamaki Hospital et Department of Neurology — University of Miami, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.