Clinical trial · Observational
Drugs for the Treatment of Multiple Sclerosis and Risk of Cancer: a Pharmacovigilance Analysis in Vigibase
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Tumor | Malignant Neoplasm | ALIAS | 0.90 |
| Multiple Sclerosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exposure to MS drugs | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- serious cancer ICSRs (cases)
- interventionNames
- Other: Exposure to MS drugs
- label
- other serious reactions ICSRs (non-cases)
- interventionNames
- Other: Exposure to MS drugs
Primary outcomes (1)
- measure
- 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
- timeFrame
- 2000 to 2019
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDolladille C, Chretien B, Peyro-Saint-Paul L, Alexandre J, Dejardin O, Fedrizzi S, Defer G. Association Between Disease-Modifying Therapies Prescribed to Persons with Multiple Sclerosis and Cancer: a WHO Pharmacovigilance Database Analysis. Neurotherapeutics. 2021 Jul;18(3):1657-1664. doi: 10.1007/s13311-021-01073-y. Epub 2021 Jul 6. PMID 34231126