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Title: | Endocrine and multiple sclerosis outcomes in patients with autoimmune thyroid events in the alemtuzumab CARE-MS studies | 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. |
Issue Date: | 2023 | Publisher: | SAGE PUBLICATIONS INC | Source: | Multiple Sclerosis Journal-Experimental Translational and Clinical, 9 (1) | Abstract: | BackgroundAlemtuzumab is an effective therapy for relapsing multiple sclerosis. Autoimmune thyroid events are a common adverse event. ObjectiveDescribe 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. MethodsEndocrine 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. ResultsThyroid 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. ConclusionAdjudicated 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) | Notes: | Dayan, CM (corresponding author), Cardiff Univ, Sch Med, Room 256 C2 Link,Heath Pk, Cardiff CF14 4XN, Wales. dayancm@cardiff.ac.uk |
Keywords: | Alemtuzumab;disease-modifying therapy;multiple sclerosis;thyroid;Graves' disease;Hashimoto's disease | Document URI: | http://hdl.handle.net/1942/40749 | e-ISSN: | 2055-2173 | DOI: | 10.1177/20552173221142741 | ISI #: | 000998883600001 | Rights: | The Author(s), 2023. Article reuse guidelines: sagepub.com/journalspermissions. Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage). | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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