Malignant Tumor, Multiple Sclerosis
Conditions
Keywords
pharmacovigilance
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.
Interventions
OTHERExposure to MS drugs
Exposure in ICSRs to MS drugs (dichotomous, exposed/not exposed), for each individual MS drug
Sponsors
University Hospital, Caen
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactLaure Peyro-Saint-Paul, PharmD
Outcome results
None listed