Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data.
Authors
Coles, Alasdair J
Jones, Joanne L
Vermersch, Patrick
Traboulsee, Anthony
Bass, Ann D
Chan, Andrew
Comi, Giancarlo
Fernández, Óscar
Giovannoni, Gavin
Kubala Havrdova, Eva
LaGanke, Christopher
Montalban, Xavier
Piehl, Fredrik
Wiendl, Heinz
Publication Date
2022-04Journal Title
Mult Scler
ISSN
1352-4585
Publisher
SAGE Publications
Volume
28
Issue
5
Pages
842-846
Language
en
Type
Article
This Version
VoR
Metadata
Show full item recordCitation
Coles, A. J., Jones, J. L., Vermersch, P., Traboulsee, A., Bass, A. D., Boster, A., Chan, A., et al. (2022). Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data.. Mult Scler, 28 (5), 842-846. https://doi.org/10.1177/13524585211061335
Description
Funder: Sanofi; FundRef: https://doi.org/10.13039/100004339
Funder: Bayer Healthcare Pharmaceuticals
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.
Keywords
Short Report, Multiple sclerosis, alemtuzumab, autoimmunity, treatment outcome, risk assessment, product surveillance, post-marketing
Sponsorship
Sanofi
Funder references
Wellcome Trust (105924/Z/14/Z)
Wellcome Trust (105924/Z/14/A)
Wellcome Trust (105924/Z/14/Z)
Identifiers
10.1177_13524585211061335
External DOI: https://doi.org/10.1177/13524585211061335
This record's URL: https://www.repository.cam.ac.uk/handle/1810/335741
Rights
Licence:
https://creativecommons.org/licenses/by-nc/4.0/
Statistics
Total file downloads (since January 2020). For more information on metrics see the
IRUS guide.