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

Publikation: Beitrag in FachzeitschriftForschungsartikelBeigetragenBegutachtung

Beitragende

  • Alasdair J Coles - , University of Cambridge (Autor:in)
  • Joanne L Jones - , University of Cambridge (Autor:in)
  • Patrick Vermersch - , Université de Lille (Autor:in)
  • Anthony Traboulsee - , University of British Columbia (Autor:in)
  • Ann D Bass - , Neurology Center of San Antonio (Autor:in)
  • Aaron Boster - , Boster MS Center (Autor:in)
  • Andrew Chan - , Inselspital - Universitätsspital Bern (Autor:in)
  • Giancarlo Comi - , Vita-Salute San Raffaele University (Autor:in)
  • Óscar Fernández - , Hospital Regional Universitario Carlos Haya (Autor:in)
  • Gavin Giovannoni - , Queen Mary University of London (Autor:in)
  • Eva Kubala Havrdova - , Karlsuniversität Prag (Autor:in)
  • Christopher LaGanke - , North Central Neurology Associates (Autor:in)
  • Xavier Montalban - , Hospital Universitari Vall d'Hebron (Autor:in)
  • Celia Oreja-Guevara - , Hospital Clinico Universitario San Carlos (Autor:in)
  • Fredrik Piehl - , Karolinska Institutet (Autor:in)
  • Heinz Wiendl - , Westfälische Wilhelms-Universität Münster (Autor:in)
  • Tjalf Ziemssen - , Klinik und Poliklinik für Neurologie, Zentrum für klinische Neurowissenschaften, Universitätsklinikum Carl Gustav Carus Dresden (Autor:in)

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

OriginalspracheEnglisch
Seiten (von - bis)842-846
Seitenumfang5
FachzeitschriftMultiple Sclerosis Journal
Jahrgang28
Ausgabenummer5
PublikationsstatusVeröffentlicht - Apr. 2022
Peer-Review-StatusJa

Externe IDs

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

Schlagworte

Schlagwörter

  • 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

Bibliotheksschlagworte