{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T20:24:49Z","timestamp":1788639889079,"version":"build-2803163510"},"reference-count":71,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2025,1,23]],"date-time":"2025-01-23T00:00:00Z","timestamp":1737590400000},"content-version":"unspecified","delay-in-days":22,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000024","name":"Canadian Institutes of Health Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000024","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,12,16]]},"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:sec>\n<jats:title>Introduction<\/jats:title>\n<jats:p>Long-term population-based safety studies, applying advanced causal inference techniques, including an active comparator with new-user design, are needed to investigate skin cancer outcomes among individuals with multiple sclerosis (MS) treated with fingolimod. This study aims to describe a protocol for investigating the relationship between fingolimod use and the incidence of skin cancer among individuals with MS.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Methods and analysis<\/jats:title>\n<jats:p>We will use population-based administrative health data from two Canadian provinces (British Columbia and Alberta) to conduct an observational cohort \u2018trial emulation\u2019 study with an active comparator and new-user design. Individuals with MS aged \u226518 years will be identified using a validated algorithm. Incident users of fingolimod and active comparators (natalizumab, alemtuzumab, dimethyl fumarate, teriflunomide) will then be identified. The outcome of interest will be skin cancer (melanoma and non-melanoma skin cancers). Survival analysis will be used to estimate HRs and corresponding 95% CIs, adjusted for potential confounders.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Ethics and dissemination<\/jats:title>\n<jats:p>Ethics approval for this study was obtained from the University of British Columbia Clinical Research Ethics Board (H24-03199). No personal identifying information will be made available as part of this study. Findings will be disseminated through presentations and peer-reviewed publications.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Trial registration number<\/jats:title>\n<jats:p>\n    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clinicaltrial\" xlink:href=\"NCT06705608\">NCT06705608<\/jats:ext-link>\n.\n<\/jats:p>\n<\/jats:sec>","DOI":"10.1136\/bmjopen-2024-088924","type":"journal-article","created":{"date-parts":[[2025,1,24]],"date-time":"2025-01-24T16:41:12Z","timestamp":1737736872000},"page":"e088924","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Fingolimod and risk of skin cancer among individuals with multiple sclerosis: a population-based cohort study 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