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

Research output: Contribution to journal › Research article › Contributed › peer-review

Contributors

  • Alasdair J Coles - , University of Cambridge (Author)
  • Joanne L Jones - , University of Cambridge (Author)
  • Patrick Vermersch - , Université de Lille (Author)
  • Anthony Traboulsee - , University of British Columbia (Author)
  • Ann D Bass - , Neurology Center of San Antonio (Author)
  • Aaron Boster - , Boster MS Center (Author)
  • Andrew Chan - , Inselspital University Hospital Bern (Author)
  • Giancarlo Comi - , Vita-Salute San Raffaele University (Author)
  • Óscar Fernández - , Hospital Regional Universitario Carlos Haya (Author)
  • Gavin Giovannoni - , Queen Mary University of London (Author)
  • Eva Kubala Havrdova - , Charles University Prague (Author)
  • Christopher LaGanke - , North Central Neurology Associates (Author)
  • Xavier Montalban - , Vall d'Hebron University Hospital (Author)
  • Celia Oreja-Guevara - , Hospital Clinico Universitario San Carlos (Author)
  • Fredrik Piehl - , Karolinska Institutet (Author)
  • Heinz Wiendl - , University of Münster (Author)
  • Tjalf Ziemssen - , Department of Neurology, Center of Clinical Neuroscience, University Hospital Carl Gustav Carus Dresden (Author)

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.

Details

Original languageEnglish
Pages (from-to)842-846
Number of pages5
JournalMultiple Sclerosis Journal
Volume28
Issue number5
Publication statusPublished - Apr 2022
Peer-reviewedYes

External IDs

PubMedCentral PMC8978465
Scopus 85121289744
ORCID /0000-0001-8799-8202/work/171553570

Keywords

Keywords

  • Alemtuzumab/adverse effects, Autoimmunity, Clinical Trials, Phase II as Topic, Clinical Trials, Phase III as Topic, Humans, Marketing, Multiple Sclerosis, Relapsing-Remitting/drug therapy, Multiple Sclerosis/chemically induced

Library keywords