Endocrine and multiple sclerosis outcomes in patients with autoimmune thyroid events in the alemtuzumab CARE-MS studies. Issue 1 (January 2023)

• Record Type: Journal Article
• Authors: Dayan, Colin M.; Lecumberri, Beatriz; Muller, Ilaria; Ganesananthan, Sashiananthan; Hunter, Samuel F.; Selmaj, Krzysztof W.; Hartung, Hans-Peter; Havrdova, Eva K.; LaGanke, Christopher C.; Ziemssen, Tjalf; Van Wijmeersch, Bart; Meuth, Sven G.; Margolin, David H.; Poole, Elizabeth M.; Baker, Darren P.; Senior, Peter A.
• Is Part Of: Multiple sclerosis journal, experimental, translational and clinical. Volume 9:Issue 1(2023)
• Publication Date: 2023-01
• Subjects: Alemtuzumab -- disease-modifying therapy -- multiple sclerosis -- thyroid -- Graves' disease -- Hashimoto's disease; Multiple sclerosis -- Periodicals; 616.834
• DOI: 10.1177/20552173221142741
• Languages: English
• ISSNs: 2055-2173

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 Registration Numbers: CARE-MS I (NCT00530348); CARE-MS II (NCT00548405); CARE-MS Extension (NCT00930553)