Examining the Risk of Skin Cancer in Multiple Sclerosis Patients Using Fingolimod: a Population-Based Study (MS; FTY720)

University of British Columbia

Status: Completed

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT06705608

H24-03199

Details and patient eligibility

About

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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4,000 participants in 1 patient group

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.

Treatment:

Drug: Fingolimod

Drug: Alemtuzumab

Drug: Teriflunomide

Drug: Dimethyl fumarate (DMF)

Drug: Natalizumab