{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T18:07:40Z","timestamp":1793210860505,"version":"4.5.0"},"reference-count":39,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2023,1,1]],"date-time":"2023-01-01T00:00:00Z","timestamp":1672531200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Bayer Healthcare Pharmaceuticals"},{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Multiple Sclerosis Journal - Experimental, Translational and Clinical"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p> Alemtuzumab is an effective therapy for relapsing multiple sclerosis. Autoimmune thyroid events are a common adverse event. <\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> 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\u2019 disease, 2.5% Hashimoto's disease switching to hyperthyroidism, 15.4% Hashimoto's disease, 4.9% Graves\u2019 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> 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) <\/jats:p><\/jats:sec>","DOI":"10.1177\/20552173221142741","type":"journal-article","created":{"date-parts":[[2023,1,3]],"date-time":"2023-01-03T11:41:04Z","timestamp":1672746064000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["Endocrine and multiple sclerosis outcomes in patients with autoimmune thyroid events in the alemtuzumab CARE-MS studies"],"prefix":"10.1177","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6557-3462","authenticated-orcid":false,"given":"Colin M.","family":"Dayan","sequence":"first","affiliation":[{"name":"Cardiff University School of Medicine, Cardiff, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beatriz","family":"Lecumberri","sequence":"additional","affiliation":[{"name":"La Paz University Hospital, Universidad Aut\u00f3noma de Madrid, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2926-0722","authenticated-orcid":false,"given":"Ilaria","family":"Muller","sequence":"additional","affiliation":[{"name":"Cardiff University School of Medicine, Cardiff, UK Fondazione IRCCS Ca\u2019 Granda Ospedale Policlinico Maggiore, Milan, Italy University of Milan, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sashiananthan","family":"Ganesananthan","sequence":"additional","affiliation":[{"name":"Cardiff University School of Medicine, Cardiff, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel F.","family":"Hunter","sequence":"additional","affiliation":[{"name":"Advanced Neurosciences Institute, Franklin, TN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krzysztof W.","family":"Selmaj","sequence":"additional","affiliation":[{"name":"Department of Neurology, University of Warmia and Mazury, Olsztyn, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans-Peter","family":"Hartung","sequence":"additional","affiliation":[{"name":"Department of Neurology, Medical Faculty, Heinrich-Heine-University D\u00fcsseldorf, D\u00fcsseldorf, Germany \rBrain and Mind Centre, University of Sydney, Sydney, Australia Department of Neurology, Medical University of Vienna, Vienna, Austria Department of Neurology, Palacky University Olomouc, Olomouc, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva K.","family":"Havrdova","sequence":"additional","affiliation":[{"name":"First Medical Faculty, Department of Neurology, Charles University, Prague, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher C.","family":"LaGanke","sequence":"additional","affiliation":[{"name":"North Central Neurology Associates, Cullman, AL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8799-8202","authenticated-orcid":false,"given":"Tjalf","family":"Ziemssen","sequence":"additional","affiliation":[{"name":"Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bart","family":"Van Wijmeersch","sequence":"additional","affiliation":[{"name":"Universitair MS Centrum, Hasselt-Pelt, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sven G.","family":"Meuth","sequence":"additional","affiliation":[{"name":"Department of Neurology, Medical Faculty, Heinrich-Heine-University D\u00fcsseldorf, D\u00fcsseldorf, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David H.","family":"Margolin","sequence":"additional","affiliation":[{"name":"Sanofi, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth M.","family":"Poole","sequence":"additional","affiliation":[{"name":"Sanofi, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darren P.","family":"Baker","sequence":"additional","affiliation":[{"name":"Sanofi, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter A.","family":"Senior","sequence":"additional","affiliation":[{"name":"University of Alberta, Edmonton, Alberta, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2023,1,3]]},"reference":[{"key":"bibr1-20552173221142741","unstructured":"Genzyme Corporation LEMTRADA (alemtuzumab). https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/103948s5158lbl.pdf. 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