Fingolimod and risk of skin cancer among individuals with multiple sclerosis: a population-based cohort study protocol
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
Affiliations
Lisa Kuramoto
3 Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, The University of British Columbia, Vancouver, British Columbia, Canada
Larry D Lynd
Collaboration for Outcomes Research and Evaluation, Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, British Columbia, Canada
Amir Khakban
1 Respiratory Evaluation Sciences Program, Collaboration for Outcomes Research and Evaluation, The University of British Columbia Faculty of Pharmaceutical Sciences, Vancouver, British Columbia, Canada
Jacquelyn J Cragg
International Collaboration on Repair Discoveries (ICORD), The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada
Anthony Traboulsee
1 Faculty of Medicine, Division of Neurology and Djavad Mowafaghian Centre for Brain Health, University of British Columbia, Vancover, British Columbia, Canada
Jiwon Oh
5 Division of Neurology, Department of Medicine, Unity Health Toronto, Toronto, Ontario, Canada
Analisa Jia
1 Collaboration for Outcomes Research and Evaluation (CORE), Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, British Columbia, Canada
Weng Sut Sio
1 Collaboration for Outcomes Research and Evaluation (CORE), Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, British Columbia, Canada
M A De Vera
1 Collaboration for Outcomes Research and Evaluation (CORE), Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, British Columbia, Canada
Jonathan Loree
7 Division of Medical Oncology, BC Cancer Agency, Vancouver, British Columbia, Canada
Roger Tam
8 School of Biomedical Engineering, Department of Radiology, The University of British Columbia, Vancouver, British Columbia, Canada
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.
