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Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data.

Published version
Peer-reviewed

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Type

Article

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Authors

Coles, Alasdair J 
Jones, Joanne L 
Vermersch, Patrick 
Traboulsee, Anthony 
Bass, Ann D 

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.

Description

Funder: Sanofi; FundRef: https://doi.org/10.13039/100004339


Funder: Bayer Healthcare Pharmaceuticals

Keywords

Multiple sclerosis, alemtuzumab, autoimmunity, post-marketing, product surveillance, risk assessment, treatment outcome, Alemtuzumab, Autoimmunity, Clinical Trials, Phase II as Topic, Clinical Trials, Phase III as Topic, Humans, Marketing, Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting

Journal Title

Mult Scler

Conference Name

Journal ISSN

1352-4585
1477-0970

Volume Title

28

Publisher

SAGE Publications
Sponsorship
Wellcome Trust (105924/Z/14/Z)
Wellcome Trust (105924/Z/14/A)
Wellcome Trust (105924/Z/14/Z)
Sanofi