Examining the Risk of Skin Cancer in Multiple Sclerosis Patients Using Fingolimod: a Population-Based Study

NCT06705608 | Completed FDA Drug

• 1 other identifier: H24-03199
• Study Type: observational
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Multiple Sclerosis; Skin Cancer; Skin Cancer Melanoma; Skin Cancers - Basal Cell Carcinoma; Skin Cancer, Squamous Cell; Multiple Sclerosis (MS) - Relapsing-remitting

Keywords

multiple sclerosis and skin cancer; fingolimod; disease modifying therapy; FTY720; fingolimod and skin cancer

Outcome Measures

Primary Outcomes (2)

• Number of participants who developed skin cancer

  In this outcome measure, participants who developed skin cancer after receiving the respective DMT treatments are reported. ICD 9/10 codes were used for the diagnosis of skin cancer (melanoma and non-melanoma skin cancers). Skin cancers were treated as a composite outcome of basal cell carcinoma, squamous cell carcinoma, and melanoma, as well as disaggregated by skin cancer subtypes.

  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.

• Time to development of skin cancer

  Time to development of skin cancer is defined as the time from the index date (drug initiation) to the development of skin cancer. ICD 9/10 codes were used for the diagnosis of skin cancer (melanoma and non-melanoma skin cancers). Skin cancers were treated as a composite outcome of basal cell carcinoma, squamous cell carcinoma, and melanoma, as well as disaggregated by skin cancer subtypes.

  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.

Study Arms (1)

Adult patients with multiple sclerosis

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.

Drug: Fingolimod; Drug: Natalizumab; Drug: Dimethyl fumarate (DMF); Drug: Alemtuzumab; Drug: Teriflunomide

Interventions

Fingolimod DRUG

patients who received fingolimod for treating RRMS

Adult patients with multiple sclerosis

Natalizumab DRUG

patients who received natalizumab for treating RRMS (active comparator)

Adult patients with multiple sclerosis

Dimethyl fumarate (DMF) DRUG

patients who received dimethyl fumarate for treating RRMS (active comparator)

Adult patients with multiple sclerosis

Alemtuzumab DRUG

patients who received alemtuzumab for treating RRMS (active comparator)

Adult patients with multiple sclerosis

Teriflunomide DRUG

patients who received teriflunomide for treating RRMS (active comparator)

Adult patients with multiple sclerosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals diagnosed with MS at age 18 or older who received fingolimod, natalizumab, alemtuzumab, DMF, or teriflunomide for the treatment of relapsing-remitting MS between 2003 and 2020.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Related Publications (1)

• Jia 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 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Skin Neoplasms; Melanoma; Carcinoma, Basal Cell; Multiple Sclerosis, Relapsing-Remitting

Interventions

Fingolimod Hydrochloride; Natalizumab; Dimethyl Fumarate; Alemtuzumab; teriflunomide

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in the Faculty of Pharmaceutical Sciences, UBC

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 26, 2024
• Study Start: January 1, 2003
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share