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

Dayan, Colin M. ORCID: https://orcid.org/0000-0002-6557-3462, Lecumberri, Beatriz, Muller, Ilaria ORCID: https://orcid.org/0000-0003-2926-0722, 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. and Senior, Peter A. 2023. Endocrine and multiple sclerosis outcomes in patients with autoimmune thyroid events in the alemtuzumab CARE-MS studies. Multiple Sclerosis Journal - Experimental, Translational and Clinical 9 , 1. 10.1177/20552173221142741

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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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Publisher:	SAGE Publications
ISSN:	2055-2173
Date of First Compliant Deposit:	10 February 2023
Date of Acceptance:	16 November 2022
Last Modified:	24 May 2023 23:53
URI:	https://orca.cardiff.ac.uk/id/eprint/156885

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