Clinical trial · Observational
Examining the Risk of Skin Cancer in Multiple Sclerosis Patients Using Fingolimod: a Population-Based Study
Fingolimod and Risk of Skin Cancer Among Individuals with Multiple Sclerosis: a Population-based Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this retrospective observational study is to investigate the long-term safety of Fingolimod in individuals with Multiple Sclerosis (MS), specifically focusing on the risk of developing skin cancer. The main question it aims to answer is: • Does the use of Fingolimod increase the incidence of skin cancer in individuals with MS compared to those using other disease-modifying therapies? Participants who are new users of Fingolimod or other active comparators as part of their regular medical care for MS will be included in this study. Researchers will use advanced causal inference techniques to analyze healthcare data and compare the incidence of skin cancer between these groups.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Sclerosis | — | UNRESOLVED | — |
| Multiple Sclerosis (MS) - Relapsing-remitting | — | UNRESOLVED | — |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
| Skin Cancer Melanoma | — | UNRESOLVED | — |
| Skin Cancers - Basal Cell Carcinoma | — | UNRESOLVED | — |
| Skin Cancer, Squamous Cell | Malignant Skin Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab | Drug | Alemtuzumab | ALIAS |
| Dimethyl fumarate (DMF) | Drug | — | UNRESOLVED |
| Fingolimod | Drug | — | UNRESOLVED |
| Natalizumab | Drug | — | UNRESOLVED |
| Teriflunomide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adult patients with multiple sclerosis
- description
- Adult participants with Multiple Sclerosis (MS), identified through a validated case definition, were observed in this retrospective cohort study. This case definition requires an individual to have at least three health care encounters (any combination of inpatient encounters, outpatient encounter, or disease-modifying-therapy (DMT) dispensation) for MS in a 1-year window. In this study, administrative claims data of participants between 2003 to 2020 were evaluated. The lower bound of this time period was selected based on data availability for the main drugs of interest. MS patients who initiated treatment with fingolimod or the active comparator drugs were identified to compare the incidence of skin cancer.
- interventionNames
- Drug: Fingolimod
- Drug: Natalizumab
- Drug: Dimethyl fumarate (DMF)
- Drug: Alemtuzumab
- Drug: Teriflunomide
Primary outcomes (2)
- measure
- Number of participants who developed skin cancer
- timeFrame
- From Index drug dispensation to the first of the following events, whichever occurred first: development of skin cancer; lost to follow-up; death; administrative end of follow-up; initiation of a comparator drug, assessed up to 180 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Identified MS cohort with hospital/physician and prescription claims classified according to the international classification of disease codes and drug identification numbers respectively, using a validated case definition. This case definition requires an individual to have at least three health care encounters (any combination of inpatient encounter, outpatient encounter, or DMT dispensation) for MS in a 1-year window * MS patients who initiated and used fingolimod, natalizumab, alemtuzumab, dimethyl fumarate, or teriflunomide as monotherapy following MS identification. Exclusion Criteria: * Pediatric (\<18 years old) MS cases. * MS cases with less than three years of baseline data before the first drug dispensation. * MS cases with skin cancer in the three-year baseline period
References
Publications (1)
- DERIVEDJia A, Kuramoto L, Khakban A, Sio WS, Traboulsee A, De Vera MA, Oh J, Loree J, Tam R, Lynd LD, Cragg JJ. Fingolimod and risk of skin cancer among individuals with multiple sclerosis: a population-based cohort study protocol. BMJ Open. 2025 Jan 23;15(1):e088924. doi: 10.1136/bmjopen-2024-088924. PMID 39855661