Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data
| Autor: | Coles, Alasdair J., Jones, Joanne L., Vermersch, Patrick, Traboulsee, Anthony, Bass, Ann D., Boster, Aaron, Chan, Andrew, Comi, Giancarlo, Fernández, Óscar, Giovannoni, Gavin, Kubala Havrdova, Eva, LaGanke, Christopher, Montalban, Xavier, Oreja-Guevara, Celia, Piehl, Fredrik, Wiendl, Heinz, Ziemssen, Tjalf, Universitat Autònoma de Barcelona |
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| Přispěvatelé: | Institut Català de la Salut, [Coles AJ, Jones JL] Department of Clinical Neuroscience, School of Medicine, University of Cambridge, Cambridge, UK. [Vermersch P] Univ. Lille, INSERM UMR-S1172—Lille Neuroscience et Cognition, CHU Lille, FHU Precise, Lille, France. [Traboulsee A] The University of British Columbia, Vancouver, BC, Canada. [Bass AD] Neurology Center of San Antonio, San Antonio, TX, USA. [Boster A] Boster MS Center, Columbus, OH, USA. [Montalban X] Servei de Neurologia-Neuroimmunologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus, Coles, Alasdair [0000-0003-4738-0760], Jones, Joanna [0000-0003-4974-1371], Boster, Aaron [0000-0003-3056-9065], Oreja-Guevara, Celia [0000-0002-9221-5716], Ziemssen, Tjalf [0000-0003-4310-3432], Apollo - University of Cambridge Repository |
| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
Multiple Sclerosis
Immune System Phenomena::Immunity::Autoimmunity [PHENOMENA AND PROCESSES] Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] Autoimmunity 610 Medicine & health Other subheadings::Other subheadings::/drug therapy [Other subheadings] FOS: Economics and business Clinical Trials Phase II as Topic Multiple Sclerosis Relapsing-Remitting alemtuzumab Humans post-marketing Alemtuzumab Marketing fenómenos del sistema inmunitario::inmunidad::autoinmunidad [FENÓMENOS Y PROCESOS] Autoimmunitat autoimmunity risk assessment Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases CNS::Multiple Sclerosis [DISEASES] diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS DIAGNÓSTICOS Y TERAPÉUTICOS] Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT] Clinical Trials Phase III as Topic Neurology enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple [ENFERMEDADES] treatment outcome Avaluació de resultats (Assistència sanitària) Neurology (clinical) Esclerosi múltiple - Tractament product surveillance |
| Zdroj: | Coles, Alasdair J; Jones, Joanne L; Vermersch, Patrick; Traboulsee, Anthony; Bass, Ann D; Boster, Aaron; Chan, Andrew; Comi, Giancarlo; Fernández, Óscar; Giovannoni, Gavin; Kubala Havrdova, Eva; LaGanke, Christopher; Montalban, Xavier; Oreja-Guevara, Celia; Piehl, Fredrik; Wiendl, Heinz; Ziemssen, Tjalf (2022). Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data. Multiple sclerosis journal, 28(5), pp. 842-846. Sage 10.1177/13524585211061335 Scientia |
| DOI: | 10.1177/13524585211061335 |
| Popis: | Funder: Sanofi; FundRef: https://doi.org/10.13039/100004339 Funder: Bayer Healthcare Pharmaceuticals Does preexisting or treatment-emergent autoimmunity increase the risk of subsequent autoimmune disease in individuals with relapsing-remitting multiple sclerosis (MS) after alemtuzumab? In the extended phase 2/3 trials, 34/96 (35.4%) patients with and 395/1120 (35.3%) without preexisting autoimmunity developed non-MS autoimmunity. Thyroid autoimmunity after alemtuzumab courses 1 or 2 did not increase subsequent non-thyroid autoimmune adverse events. Therefore, autoimmune disease before or after alemtuzumab treatment does not predict autoimmunity after further courses, so should not preclude adequate alemtuzumab dosing to control MS. Finally, post-marketing safety data contribute toward a full record of the alemtuzumab benefit/risk profile for the MS field. |
| Databáze: | OpenAIRE |
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