{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T18:30:51Z","timestamp":1785436251806,"version":"3.56.0"},"reference-count":31,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2024,7,16]],"date-time":"2024-07-16T00:00:00Z","timestamp":1721088000000},"content-version":"vor","delay-in-days":15,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background and Objectives<\/jats:title><jats:p>Teriflunomide is a disease\u2010modifying therapy (DMT) for multiple sclerosis (MS). This post authorisation safety study assessed risks of adverse events of special interest (AESI) associated with teriflunomide use.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Secondary use of individual data from the Danish MS Registry (DMSR), the French National Health Data System (SNDS), the Belgian national database of health care claims (AIM\u2010IMA) and the Belgian Treatments in MS Registry (Beltrims). We included patients treated with a DMT at the date of teriflunomide reimbursement or initiating another DMT. Adjusted hazard rates (aHR) and 95% confidence intervals were derived from Cox models with time\u2010dependent exposure comparing teriflunomide treatment with another DMT.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 81\u2009620 patients (72% women) included in the cohort, 22\u2009324 (27%) were treated with teriflunomide. After a median follow\u2010up of 4\u2009years, teriflunomide use compared to other DMT was not associated with a risk of all\u2010cause mortality, severe infection, pneumoniae, herpes zoster reactivation, pancreatitis, cardiovascular condition and cancers. For opportunistic infections, aHR for teriflunomide versus other DMT was 2.4 (1.2\u20134.8) in SNDS, which was not bound to a particular opportunistic agent. The aHR was 2.0 (1.1\u20133.7) for renal failures in the SNDS, but no association was found in other data sources. A total of 187 SNDS patients had a history of renal failure prior to cohort entry. None of these patients (0%) had a renal failure recurrence when treated with teriflunomide for 19 (13%) recurrences reported for patients on another DMT.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>We found no evidence that teriflunomide use would be associated with an increased risk of AESI.<\/jats:p><jats:p><jats:bold>Trial Registration<\/jats:bold> EUPAS register: EU PAS 19610.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5866","type":"journal-article","created":{"date-parts":[[2024,7,17]],"date-time":"2024-07-17T02:49:42Z","timestamp":1721184582000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Long\u2010Term Safety of Teriflunomide in Multiple Sclerosis Patients: Results of Prospective Comparative Studies in Three European Countries"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0972-5222","authenticated-orcid":false,"given":"Melinda","family":"Magyari","sequence":"first","affiliation":[{"name":"Danish Multiple Sclerosis Registry Copenhagen University Hospital Rigshospitalet Denmark  Glostrup Denmark"},{"name":"Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital \u2010 Rigshospitalet  Glostrup Denmark"},{"name":"Institute for Clinical Medicine, University of Copenhagen  Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alice","family":"Koechlin","sequence":"additional","affiliation":[{"name":"International Prevention Research Institute (iPRI)  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antoine","family":"Duclos","sequence":"additional","affiliation":[{"name":"Health Data Department Hospices Civils de Lyon  Lyon 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