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

November 21, 2024 updated by: Jacquelyn Cragg, University of British Columbia

Fingolimod and Risk of Skin Cancer Among Individuals with Multiple Sclerosis: a Population-based Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

4000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
patients who received fingolimod for treating RRMS
Drug: Natalizumab
patients who received natalizumab for treating RRMS (active comparator)
Drug: Dimethyl fumarate (DMF)
patients who received dimethyl fumarate for treating RRMS (active comparator)
Drug: Alemtuzumab
patients who received alemtuzumab for treating RRMS (active comparator)
Drug: Teriflunomide
patients who received teriflunomide for treating RRMS (active comparator)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who developed skin cancer
Time Frame: 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.
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 Frame: 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 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2003

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Estimated)

November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H24-03199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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