2023
Safety and Efficacy of Nipocalimab in Patients With Generalized Myasthenia Gravis
Antozzi C, Guptill J, Bril V, Gamez J, Meuth S, Nowak R, Quan D, Sevilla T, Jouvin M, Jin J, Karcher K, Ramchandren S, Sun H, Ling L, Zhu Y, Arroyo S, Group F. Safety and Efficacy of Nipocalimab in Patients With Generalized Myasthenia Gravis. Neurology 2023, 102: e207937. PMID: 38165333, PMCID: PMC10962909, DOI: 10.1212/wnl.0000000000207937.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsGeneralized myasthenia gravisSignificant dose responseAdverse eventsMG-ADLDay 57Myasthenia gravisDose responseMyasthenia Gravis ActivitiesPrimary safety endpointPrimary efficacy endpointSerious adverse eventsPhase 2 studyReceptor monoclonal antibodyDaily living (IADL) total scoreClinical trial registrationMG-ADL scoreDose-dependent reductionEudraCT numberQ2W groupEfficacy endpointPlacebo groupSafety endpointCare therapyReceptor autoantibodiesSubcutaneous batoclimab in generalized myasthenia gravis: Results from a Phase 2a trial with an open‐label extension
Nowak R, Breiner A, Bril V, Allen J, Khan S, Levine T, Jacobs D, Sahagian G, Siddiqi Z, Xu J, Macias W, Benatar M, Adams L, Genge A, Habib A, Hinton J, Holmlund T, Jacobs D, Lange D, Nicolle M, Phan H, Silvestri N, Small G, Yegiaian S. Subcutaneous batoclimab in generalized myasthenia gravis: Results from a Phase 2a trial with an open‐label extension. Annals Of Clinical And Translational Neurology 2023, 11: 194-206. PMID: 38062618, PMCID: PMC10791011, DOI: 10.1002/acn3.51946.Peer-Reviewed Original ResearchAnti-acetylcholine receptor antibodiesGeneralized myasthenia gravisTotal immunoglobulin GMyasthenia gravisImmunoglobulin G subclassesReceptor antibodiesOpen-label extension studyG subclassesImmunoglobulin GMyasthenia Gravis ActivitiesPatient-administered therapyPreliminary clinical benefitsQuantitative Myasthenia GravisOpen-label extensionPlacebo-controlled trialPhase 2a trialWeekly subcutaneous injectionsReceptor monoclonal antibodyMyasthenia Gravis QualityStudy support further investigationSupport further investigationMyasthenia Gravis CompositeEligible patientsPrimary endpointSecondary endpoints
2022
Serum Autoantibody Lowering by the Anti-FcRn Monoclonal Antibody, Nipocalimab, Correlates With Clinical Improvement in Generalized Myasthenia Gravis Patients
Ramchandren S, Guptill J, Antozzi C, Bril V, Gamez J, Meuth S, Nowak R, Quan D, Mantecon M, Ling L, Zhu Y, Karcher K, Sun H. Serum Autoantibody Lowering by the Anti-FcRn Monoclonal Antibody, Nipocalimab, Correlates With Clinical Improvement in Generalized Myasthenia Gravis Patients. Neurology 2022, 99: s35-s37. DOI: 10.1212/01.wnl.0000903304.73134.e3.Peer-Reviewed Original ResearchPhase 2 studyMyasthenia gravis patientsClinical improvementGravis patientsMonoclonal antibodiesAnti-AChR autoantibodiesMuSK-positive patientsMyasthenia Gravis ActivitiesDaily living scoreSerum total IgGSerum IgG levelsMG-ADL scoreNeonatal Fc receptorGMG patientsClinical responseDose armLiving scorePathogenic autoantibodiesPositive patientsIgG levelsPathogenic antibodiesIgG autoantibodiesPharmacodynamic effectsSerum IgGTotal IgG