دورية أكاديمية
Endocrine and multiple sclerosis outcomes in patients with autoimmune thyroid events in the alemtuzumab CARE-MS studies
| العنوان: | Endocrine and multiple sclerosis outcomes in patients with autoimmune thyroid events in the alemtuzumab CARE-MS studies |
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| المؤلفون: | 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. |
| المساهمون: | Selmaj, Krzysztof/0000-0003-1213-7218, Ziemssen, Tjalf/0000-0001-8799-8202, Senior, Peter/0000-0003-1033-8673, 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. |
| بيانات النشر: | SAGE PUBLICATIONS INC |
| سنة النشر: | 2023 |
| المجموعة: | Document Server@UHasselt (Universiteit Hasselt) |
| مصطلحات موضوعية: | Alemtuzumab, disease-modifying therapy, multiple sclerosis, thyroid, Graves' disease, Hashimoto's disease |
| الوصف: | 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) ; Editorial support for the development of this paper was provided by Elevate Scientific Solutions (Panos Xenopoulos PhD, Richard Hogan PhD, and Renee E. Granger PhD) and was funded by Sanofi. The CARE-MS I, CARE-MS II, and extension studies were funded by Sanofi and Bayer Healthcare Pharmaceuticals. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 2055-2173 |
| العلاقة: | Multiple Sclerosis Journal-Experimental Translational and Clinical, 9 (1); http://hdl.handle.net/1942/40749Test; 000998883600001 |
| DOI: | 10.1177/20552173221142741 |
| الإتاحة: | https://doi.org/10.1177/20552173221142741Test http://hdl.handle.net/1942/40749Test |
| حقوق: | 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/4.0Test/) 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-sageTest). ; info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.EC8B072C |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 20552173 |
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| DOI: | 10.1177/20552173221142741 |