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

Mult Scler. 2022 Apr;28(5):842-846. doi: 10.1177/13524585211061335. Epub 2021 Dec 9.

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.

Trial registration: ClinicalTrials.gov NCT00050778 NCT00530348 NCT00548405 NCT00930553 NCT02255656.

Keywords: Multiple sclerosis; alemtuzumab; autoimmunity; post-marketing; product surveillance; risk assessment; treatment outcome.

Publication types

  • Review
  • Research Support, Non-U.S. Gov't

MeSH terms

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

Substances

  • Alemtuzumab

Associated data

  • ClinicalTrials.gov/NCT00050778
  • ClinicalTrials.gov/NCT00530348
  • ClinicalTrials.gov/NCT00548405
  • ClinicalTrials.gov/NCT00930553
  • ClinicalTrials.gov/NCT02255656