Endocrine and multiple sclerosis outcomes in patients with autoimmune thyroid events in the alemtuzumab CARE-MS studies

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Colin M. Dayan - (Author)
  • Beatriz Lecumberri - (Author)
  • Ilaria Muller - (Author)
  • Sashiananthan Ganesananthan - (Author)
  • Samuel F. Hunter - (Author)
  • Krzysztof W. Selmaj - (Author)
  • Hans-Peter Hartung - (Author)
  • Eva K. Havrdova - (Author)
  • Christopher C. LaGanke - (Author)
  • Tjalf Ziemssen - , Department of Neurology (Author)
  • Bart Van Wijmeersch - (Author)
  • Sven G. Meuth - (Author)
  • David H. Margolin - (Author)
  • Elizabeth M. Poole - (Author)
  • Darren P. Baker - (Author)
  • Peter A. Senior - (Author)

Abstract

Background: Alemtuzumab is an effective therapy for relapsing multiple sclerosis. Autoimmune thyroid events are a common adverse event. Objective: Describe endocrine and multiple sclerosis outcomes over 6 years for alemtuzumab-treated relapsing multiple sclerosis patients in the phase 3 CARE-MS I, II, and extension studies who experienced adverse thyroid events. Methods: Endocrine and multiple sclerosis outcomes were evaluated over 6 years. Thyroid event cases, excluding those pre-existing or occurring after Year 6, were adjudicated retrospectively by expert endocrinologists independently of the sponsor and investigators. Results: Thyroid events were reported for 378/811 (46.6%) alemtuzumab-treated patients. Following adjudication, endocrinologists reached consensus on 286 cases (75.7%). Of these, 39.5% were adjudicated to Graves’ disease, 2.5% Hashimoto's disease switching to hyperthyroidism, 15.4% Hashimoto's disease, 4.9% Graves’ disease switching to hypothyroidism, 10.1% transient thyroiditis, and 27.6% with uncertain diagnosis; inclusion of anti-thyroid antibody status reduced the number of uncertain diagnoses. Multiple sclerosis outcomes of those with and without thyroid events were similar. Conclusion: Adjudicated thyroid events occurring over 6 years for alemtuzumab-treated relapsing multiple sclerosis patients were primarily autoimmune. Thyroid events were considered manageable and did not affect disease course. Thyroid autoimmunity is a common but manageable adverse event in alemtuzumab-treated relapsing multiple sclerosis patients. ClinicalTrials.gov

Details

Original languageEnglish
JournalMultiple sclerosis journal - experimental, translational and clinical
Volume9
Issue number1
Publication statusPublished - Jan 2023
Peer-reviewedYes

External IDs

Scopus 85146003693