Sistema de Salut de Catalunya
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
2022-06-09T07:23:29Z
2022-06-09T07:23:29Z
2022-04-01
Alemtuzumab; Product surveillance; Risk assessment
Alemtuzumab; Vigilancia de productos; Evaluación de riesgos
Alemtuzumab; Vigilància de productes; Avaluació de riscos
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.
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The CAMMS223 and CARE-MS studies, and their extensions, were supported by Sanofi and Bayer Healthcare Pharmaceuticals. Editorial and writing assistance was supported by Sanofi.
Article
Published version
English
Esclerosi múltiple - Tractament; Avaluació de resultats (Assistència sanitària); Autoimmunitat; DISEASES::Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis; Other subheadings::Other subheadings::Other subheadings::/drug therapy; PHENOMENA AND PROCESSES::Immune System Phenomena::Immunity::Autoimmunity; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome; ENFERMEDADES::enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple; Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia; FENÓMENOS Y PROCESOS::fenómenos del sistema inmunitario::inmunidad::autoinmunidad; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento
SAGE Publications
Multiple Sclerosis Journal;28(5)
https://doi.org/10.1177/13524585211061335
Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
Articles científics - CEMCAT [136]
Articles científics - HVH [3396]
