Association Between Disease-Modifying Therapies Prescribed to Persons with Multiple Sclerosis and Cancer: a WHO Pharmacovigilance Database Analysis.
Adult
Aged
Antineoplastic Agents, Immunological
/ therapeutic use
Cohort Studies
Cross-Sectional Studies
Data Analysis
Databases, Factual
/ statistics & numerical data
Female
Humans
Immunologic Factors
/ therapeutic use
Immunosuppressive Agents
/ therapeutic use
Male
Middle Aged
Multiple Sclerosis
/ drug therapy
Neoplasms
/ drug therapy
Pharmacovigilance
Retrospective Studies
World Health Organization
Journal
Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics
ISSN: 1878-7479
Titre abrégé: Neurotherapeutics
Pays: United States
ID NLM: 101290381
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
accepted:
09
06
2021
pubmed:
8
7
2021
medline:
4
3
2022
entrez:
7
7
2021
Statut:
ppublish
Résumé
The risk of cancer associated with persons with multiple sclerosis (pwMS) prescribed with disease modifying therapies (DMTs) is not well established. This observational, cross-sectional, pharmacovigilance cohort study examined individual case safety reports from the World Health Organization database: VigiBase®. All consecutive reports of DMTs prescribed to pwMS (alemtuzumab, dimethyl fumarate, fingolimod, glatiramer acetate, interferon-β, natalizumab, ocrelizumab, and teriflunomide), and their serious adverse event cases were eligible, excluding those reporting immunosuppressant DMTs used as anticancer therapies. The primary outcome was the multivariate odds ratio of cancer reporting (r-OR) for DMTs prescribed to pwMS after imputation of missing data. There were 5966 cancer cases from 240,993 reports of DMTs prescribed to pwMS. After adjustments on age, sex, and geographical region, natalizumab (r-OR 1.74, 95% CI 1.63-1.87), interferon-β (r-OR 1.39, 95% CI 1.30-1.49), dimethyl fumarate (r-OR 1.35, 95% CI 1.25-1.46), and fingolimod (r-OR 1.15, 95% CI 1.06-1.24) were significantly associated with a greater cancer reporting, whereas alemtuzumab, glatiramer acetate, ocrelizumab, and teriflunomide were not, in the disproportionality analysis. As exploratory analyses, upper aerodigestive tract, breast, urinary including the male genitourinary tract, and nervous system cancers were associated with natalizumab, interferon-β, and dimethyl fumarate. Fingolimod was only associated with skin cancer types. Cancer cases reporting these four DMTs prescribed to pwMS were younger in age than for non-pwMS drugs in the VigiBase® (p < 0.0001). A close and regular cancer screening in pwMS treated with natalizumab, interferon-β, dimethyl fumarate, and fingolimod may be warranted, even for persons at a younger age. Trial Registration NCT04237337.
Identifiants
pubmed: 34231126
doi: 10.1007/s13311-021-01073-y
pii: 10.1007/s13311-021-01073-y
pmc: PMC8608969
doi:
Substances chimiques
Antineoplastic Agents, Immunological
0
Immunologic Factors
0
Immunosuppressive Agents
0
Banques de données
ClinicalTrials.gov
['NCT04237337']
Types de publication
Clinical Trial
Journal Article
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1657-1664Informations de copyright
© 2021. The American Society for Experimental NeuroTherapeutics, Inc.
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