Safety profile of belatacept in a real-life setting: disproportionality analysis of the WHO pharmacovigilance database
This study highlights discrepancies between the belatacept SmPC and real-world pharmacovigilance data. Several labeled ADRs were not reported frequently in VigiBase<sup>®</sup>, suggesting that they may be less commonly observed in real-world settings. Others, particularly infections, warrant further scrutiny. Yet, these findings should be interpreted with caution due to the inherent limitations of pharmacovigilance data, including underreporting, reporting bias, and residual confounding. Pharmacovigilance approaches generate signals, but cannot definitively establish or exclude a causal relationship. Nonetheless, these findings suggest the need for periodic reassessment of belatacept's safety profile to ensure accurate and clinically relevant information for healthcare providers.
Authors
- Alexandre Destère (ORCID: https://orcid.org/0000-0001-6147-9201)
- A Sicard (ORCID: https://orcid.org/0000-0003-3427-3894)
- Nouha Ben Othman (ORCID: https://orcid.org/0000-0002-9346-5020)
- Milou‐Daniel Drici (ORCID: https://orcid.org/0000-0003-4121-530X)
- Alexandre Olivier Gérard (ORCID: https://orcid.org/0000-0001-6591-6966)
- Fanny Rocher (ORCID: https://orcid.org/0000-0002-5835-6224)
- Diane Merino (ORCID: https://orcid.org/0000-0001-7669-2339)
- Delphine Viard (ORCID: https://orcid.org/0000-0001-6140-4664)
- Elliot Ewig (ORCID: https://orcid.org/0009-0003-6519-7756)
Institutions
- Centre National de la Recherche Scientifique (FR)
- Université Côte d'Azur (FR)
- Centre Hospitalier Universitaire de Nice (FR)
Publication Details
- Journal
- BMC Pharmacology and Toxicology
- Published
- 2025-08-11
- DOI
- https://doi.org/10.1186/s40360-025-00972-6
- Citations
- 2
- Primary Topic
- Drug-Induced Adverse Reactions
- Type
- article
- Field-Weighted Citation Impact
- 2.79
Funders
- Agence Nationale de Sécurité du Médicament et des Produits de Santé