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

University of British Columbia4,000 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

4,000

Conditions

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

Interventions

FingolimodDRUG

patients who received fingolimod for treating RRMS

NatalizumabDRUG

patients who received natalizumab for treating RRMS (active comparator)

Dimethyl fumarate (DMF)DRUG

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

AlemtuzumabDRUG

patients who received alemtuzumab for treating RRMS (active comparator)

TeriflunomideDRUG

patients who received teriflunomide for treating RRMS (active comparator)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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

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.