Fingolimod and risk of skin cancer among individuals with multiple sclerosis: a population-based cohort study protocol
Introduction 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 descri...
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BMJ Publishing Group
2025-01-01
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| Series: | BMJ Open |
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| author | Lisa Kuramoto Larry D Lynd Amir Khakban Jacquelyn J Cragg Anthony Traboulsee Jiwon Oh Analisa Jia Weng Sut Sio M A De Vera Jonathan Loree Roger Tam |
| author_facet | Lisa Kuramoto Larry D Lynd Amir Khakban Jacquelyn J Cragg Anthony Traboulsee Jiwon Oh Analisa Jia Weng Sut Sio M A De Vera Jonathan Loree Roger Tam |
| author_sort | Lisa Kuramoto |
| collection | DOAJ |
| description | Introduction 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.Methods and analysis We will use population-based administrative health data from two Canadian provinces (British Columbia and Alberta) to conduct an observational cohort ‘trial emulation’ study with an active comparator and new-user design. Individuals with MS aged ≥18 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.Ethics and dissemination 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.Trial registration number NCT06705608. |
| format | Article |
| id | doaj-art-d7fd1d7a52d146edb51b46563ec2d4c1 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-d7fd1d7a52d146edb51b46563ec2d4c12025-02-03T11:05:16ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-088924Fingolimod and risk of skin cancer among individuals with multiple sclerosis: a population-based cohort study protocolLisa Kuramoto0Larry D Lynd1Amir Khakban2Jacquelyn J Cragg3Anthony Traboulsee4Jiwon Oh5Analisa Jia6Weng Sut Sio7M A De Vera8Jonathan Loree9Roger Tam103 Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, The University of British Columbia, Vancouver, British Columbia, CanadaCollaboration for Outcomes Research and Evaluation, Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, British Columbia, Canada1 Respiratory Evaluation Sciences Program, Collaboration for Outcomes Research and Evaluation, The University of British Columbia Faculty of Pharmaceutical Sciences, Vancouver, British Columbia, CanadaInternational Collaboration on Repair Discoveries (ICORD), The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada1 Faculty of Medicine, Division of Neurology and Djavad Mowafaghian Centre for Brain Health, University of British Columbia, Vancover, British Columbia, Canada5 Division of Neurology, Department of Medicine, Unity Health Toronto, Toronto, Ontario, Canada1 Collaboration for Outcomes Research and Evaluation (CORE), Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, British Columbia, Canada1 Collaboration for Outcomes Research and Evaluation (CORE), Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, British Columbia, Canada1 Collaboration for Outcomes Research and Evaluation (CORE), Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, British Columbia, Canada7 Division of Medical Oncology, BC Cancer Agency, Vancouver, British Columbia, Canada8 School of Biomedical Engineering, Department of Radiology, The University of British Columbia, Vancouver, British Columbia, CanadaIntroduction 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.Methods and analysis We will use population-based administrative health data from two Canadian provinces (British Columbia and Alberta) to conduct an observational cohort ‘trial emulation’ study with an active comparator and new-user design. Individuals with MS aged ≥18 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.Ethics and dissemination 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.Trial registration number NCT06705608.https://bmjopen.bmj.com/content/15/1/e088924.full |
| spellingShingle | Lisa Kuramoto Larry D Lynd Amir Khakban Jacquelyn J Cragg Anthony Traboulsee Jiwon Oh Analisa Jia Weng Sut Sio M A De Vera Jonathan Loree Roger Tam Fingolimod and risk of skin cancer among individuals with multiple sclerosis: a population-based cohort study protocol BMJ Open |
| title | Fingolimod and risk of skin cancer among individuals with multiple sclerosis: a population-based cohort study protocol |
| title_full | Fingolimod and risk of skin cancer among individuals with multiple sclerosis: a population-based cohort study protocol |
| title_fullStr | Fingolimod and risk of skin cancer among individuals with multiple sclerosis: a population-based cohort study protocol |
| title_full_unstemmed | Fingolimod and risk of skin cancer among individuals with multiple sclerosis: a population-based cohort study protocol |
| title_short | Fingolimod and risk of skin cancer among individuals with multiple sclerosis: a population-based cohort study protocol |
| title_sort | fingolimod and risk of skin cancer among individuals with multiple sclerosis a population based cohort study protocol |
| url | https://bmjopen.bmj.com/content/15/1/e088924.full |
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