ArticleBMC pharmacology & toxicology2025
Safety profile of belatacept in a real-life setting: disproportionality analysis of the WHO pharmacovigilance database.
Article in BMC pharmacology & toxicology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- A multi-centre study of belatacept and sirolimus for islet transplantation.Diabetologia · 2026Trial
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBelatacept is a co-stimulation blocker used in kidney transplant recipients to prevent allograft rejection. Unlike calcineurin inhibitors, belatacept is non-nephrotoxic and may carry a lower risk of cardiovascular and metabolic complications. However, the European Medicines Agency (EMA) Summary of Product Characteristics (SmPC) includes a broad range of adverse drug reactions (ADRs), mostly identified in small clinical trials with cyclosporine as a control, in patients exposed to other immunosuppressants. As real-world data on belatacept safety accumulate, a reassessment of its safety profile becomes essential.
methodsWe analyzed pharmacovigilance data from VigiBase
resultsWe retrieved 2795 reports involving belatacept, including 424 (15.2%) fatal cases. The disproportionality analysis highlighted 51 potential signals that were not explicitly listed in the SmPC, such as Clostridium difficile infection, hepatitis B reactivation, and hemophagocytic lymphohistiocytosis. Conversely, 47 (33.1%) of the 142 ADRs classified as "common" or "very common" in the SmPC, such as Cushing's syndrome or depression, had fewer than three reports in VigiBase
conclusionsThis study highlights discrepancies between the belatacept SmPC and real-world pharmacovigilance data. Several labeled ADRs were not reported frequently in VigiBase
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