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Myasthenia gravis

Última revisión: 20 Aug 2025
Última actualización: 14 Aug 2025
14 Aug 2025

Nipocalimab approved by FDA for treatment of generalized myasthenia gravis

Nipocalimab, a neonatal Fc receptor (FcRn) antagonist monoclonal antibody, has been approved by the Food and Drug Administration (FDA) for the treatment of generalized myasthenia gravis in adults and children ≥12 years who are positive for acetylcholine receptor (AChR) or muscle-specific tyrosine kinase (MuSK) antibodies. The approval follows FDA priority review designation and provides an alternative treatment option to offer sustained disease control for a broad range of patients with troublesome symptoms caused by myasthenia gravis.

The approval was based on results from Vivacity-MG3, a phase 3 trial of patients with generalized myasthenia gravis inadequately controlled with standard therapy. Nipocalimab added to standard care was associated with long-lasting reductions in total circulating IgG and AChR antibodies, and improvements in patient-reported outcomes, with a good safety profile.

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Fuente original de la actualización

Resumen

Definición

Anamnesis y examen

Principales factores de diagnóstico

  • muscle strength fatigability
  • ptosis
  • diplopia
  • dysphagia
  • dysarthria
  • facial paresis
  • proximal limb weakness
  • shortness of breath
Todos los datos

Factores de riesgo

  • family history of autoimmune disorders
  • genetic markers
  • cancer-targeted therapy
Todos los datos

Pruebas diagnósticas

Primeras pruebas diagnósticas para solicitar

  • serum acetylcholine receptor (AChR) antibody analysis
  • muscle-specific tyrosine kinase (MuSK) antibodies
  • serial pulmonary function tests
Todos los datos

Pruebas diagnósticas que deben considerarse

  • striational receptor antibody assays
  • repetitive nerve stimulation
  • single-fiber EMG
  • CT of chest
Todos los datos

Algoritmo de tratamiento

Agudo

myasthenic crisis

En curso

mild to moderate disease (class I to III)

severe (class IV or V) or refractory disease

Colaboradores

Autores

David P. Richman, MD

Distinguished Professor

Professor of Neurology

University of California - Davis

Davis

CA

Divulgaciones

DPR declares that he has no competing interests.

Agradecimientos

Dr David Richman would like to gratefully acknowledge Dr Robert Lisak, Dr Andrea Corse, and Dr Ami Mankodi, previous contributors to this topic.

Divulgaciones

AC and AM declare that they have no competing interests. RPL is a Data and Safety Monitoring Board Member for the COUR myasthenia gravis clinical trial. RPL is a site principal investigator for clinical trials and a co-author for the clinical trial reports for myasthenia gravis therapies for Alexion, Argenx, and UCB Ra. RPL's institution receives payment for the time spent on these clinical trials. RPL has received book royalties from Oxford University Press and Blackstone, and has carried out consultancy work for Avilar.

Revisores por pares

Vern C. Juel, MD

Associate Professor of Medicine (Neurology)

Duke University

Durham

NC

Divulgaciones

VCJ declares that he has no competing interests.

Peer reviewer acknowledgements

BMJ Best Practice topics are updated on a rolling basis in line with developments in evidence and guidance. The peer reviewers listed here have reviewed the content at least once during the history of the topic.

Disclosures

Peer reviewer affiliations and disclosures pertain to the time of the review.

Referencias

Nuestros equipos internos de evidencia y editoriales colaboran con colaboradores expertos internacionales y revisores pares para garantizar que brindemos acceso a la información más clínicamente relevante posible.

Artículos principales

Narayanaswami P, Sanders DB, Wolfe G, et al. International consensus guidance for management of myasthenia gravis: 2020 update. Neurology. 2021 Jan 19;96(3):114-22.Texto completo  Resumen

Skeie GO, Apostolski S, Evoli A, et al. Guidelines for treatment of autoimmune neuromuscular transmission disorders. Eur J Neurol. 2010 Jul;17(7):893-902.Texto completo  Resumen

Gronseth GS, Barohn R, Narayanaswami P. Practice advisory: thymectomy for myasthenia gravis (practice parameter update). Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2020 Apr 21;94(16):705-9.Texto completo  Resumen

Elovaara I, Apostolski S, van Doorn P, et al. EFNS guidelines for the use of intravenous immunoglobulin in treatment of neurological diseases: EFNS task force on the use of intravenous immunoglobulin in treatment of neurological diseases. Eur J Neurol. 2008 Sep;15(9):893-908.Texto completo  Resumen

Artículos de referencia

Una lista completa de las fuentes a las que se hace referencia en este tema está disponible para los usuarios con acceso a todo BMJ Best Practice.
  • Myasthenia gravis images
  • Diferenciales

    • Lambert-Eaton myasthenic syndrome (LEMS)
    • Botulism
    • Penicillamine-induced myasthenia gravis
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  • Guías de práctica clínica

    • International consensus guidance for management of myasthenia gravis: 2020 update
    • Practice advisory: thymectomy for myasthenia gravis (practice parameter update)
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  • Folletos para el paciente

    Myasthenia gravis

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