Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data.
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Authors
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
2021-12-09Journal Title
Mult Scler
ISSN
1352-4585
Publisher
SAGE Publications
Type
Article
This Version
AM
Metadata
Show full item recordCitation
Coles, A., Jones, J., Vermersch, P., Traboulsee, A., Bass, A. D., Boster, A., Chan, A., et al. (2021). Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data.. Mult Scler https://doi.org/10.1177/13524585211061335
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.
Sponsorship
Sanofi
Funder references
Wellcome Trust (105924/Z/14/Z)
Wellcome Trust (105924/Z/14/A)
Wellcome Trust (105924/Z/14/Z)
Identifiers
External DOI: https://doi.org/10.1177/13524585211061335
This record's URL: https://www.repository.cam.ac.uk/handle/1810/330953
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