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

Caen University Hospital

Status

Unknown

Conditions

Malignant Tumor

Multiple Sclerosis

Treatments

Other: Exposure to MS drugs

Study type

Observational

Funder types

Other

Identifiers

NCT04237337

2019-PVSEP

Details and patient eligibility

About

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.

Full 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.

Enrollment

200,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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