Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis : Benefit/risk following review of trial and post-marketing data
Coles, Alasdair J. (University of Cambridge)
Jones, Joanne L. (University of Cambridge)
Vermersch, Patrick (Université de Lille)
Traboulsee, Anthony (University of British Columbia)
Bass, Ann D. (Neurology Center of San Antonio)
Boster, Aaron (Boster Center for Multiple Sclerosis)
Chan, Andrew (University of Bern)
Comi, Giancarlo (Vita-Salute San Raffaele University)
Fernández, Óscar (Hospital Regional Universitario Carlos Haya (Málaga))
Giovannoni, Gavin (Queen Mary University of London)
Kubala Havrdova, Eva (Charles University)
LaGanke, Christopher (North Central Neurology Associates)
Montalban, Xavier (Hospital Universitari Vall d'Hebron)
Oreja-Guevara, Celia (Universidad Complutense de Madrid)
Piehl, Fredrik (Karolinska Institutet (Estocolm, Suècia))
Wiendl, Heinz (University of Münster)
Ziemssen, Tjalf (Dresden University of Technology)
Universitat Autònoma de Barcelona

Date:	2022
Description:	5 pàg.
Abstract:	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.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Alemtuzumab ; Autoimmunity ; Multiple sclerosis ; Post-marketing ; Product surveillance ; Risk assessment ; Treatment outcome
Published in:	Multiple sclerosis, Vol. 28 Núm. 5 (2022) , p. 842-846, ISSN 1477-0970

DOI: 10.1177/13524585211061335
PMID: 34882037

8 p, 1.1 MB

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