Drugs for the Treatment of Multiple Sclerosis and Risk of Cancer: a Pharmacovigilance Analysis in Vigibase

• Conditions: Multiple Sclerosis; Malignant Tumor
• Interventions: Other: Exposure to MS drugs

• Registration Number: NCT04237337
• Lead Sponsor: University Hospital, Caen

Brief Summary

Even though the therapeutic panel for multiple sclerosis (MS) treatment has improved in the last 20 years, safety data especially for the second-line and innovative treatments are lacking. The association between MS and cancer has long been investigated but has led to conflicting results. No studies have reported an increased risk of cancer after long-term exposure to immuno-modulators. The present study will assess whether drugs for the treatment of MS are associated with an increased risk of cancer by analyzing the disproportionality of reports in the World Health Organization (WHO) pharmacovigilance database.

Detailed Description

A case non-case study using Vigibase®, the World Health Organization Global Individual Case Safety Reports (ICSRs) database which includesreports forwarded to the WHO Uppsala Monitoring Center by national pharmacovigilance systems from over 130 countries around the world since 1967. Information on the adverse effects reported include patient demographics and medical relevant history, drugs recorded according to the WHO Drug dictionary and adverse drug reactions coded with Medical Dictionary for Regulatory Activities (MedDRA) terms will be perform.

Study Timeline

• Status Verified: 2019-12
• Study Start: 2020-01
• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-20
• Last Update Submitted: 2020-01-20
• Study First Posted: 2020-01-23
• Last Update Posted: 2020-01-23
• Primary Completion: 2020-02
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200000

Inclusion Criteria

• Serious cases reported in the World Health Organization (WHO) database of individual safety case report from 2000 to September 2019
• Cancer overall reported by a term included in the Standardized MedDRA query (SMQ) "Malignant tumours"

Exclusion Criteria

• Non serious cases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
other serious reactions ICSRs (non-cases)	Exposure to MS drugs	-
serious cancer ICSRs (cases)	Exposure to MS drugs	-

Primary Outcome Measures

Name	Time	Method
Risk of reporting cancer overall specific cancers [ Time Frame: Reported in the World Health Organization (WHO) database of individual safety case reports from 2000 to 12/31/2019 ] performing a disproportionality analysis	2000 to 2019	o Risk of reporting cancer overall and for specific cancer types (including breast, lung, lymphoma, cervical, melanoma and NMSC) with a specific drug of MS (β-interferon, glatiramer acetate, fumaric acid, teriflunomide, fingolimod, natalizumab, ocrelizumab or alemtuzumab) compared with the others drugs of MS

Secondary Outcome Measures

Name	Time	Method
Risk of reporting cancer specific cancers [ Time Frame: Reported in the World Health Organization (WHO) database of individual safety case reports from 2000 to 12/31/2019 ] performing a disproportionality analysis	2000 to 2019	o Risk of reporting cancer specific cancer types with a specific drug of MS compared with all other non-MS drugs performing a disproportionality analysis