Observational studyPharmacological reports : PR2025
Real‑world safety and efficacy of biological agents in inflammatory bowel disease: a one-year post-marketing pharmacovigilance observational study in the Calabria region.
Observational study in Pharmacological reports : PR, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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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.
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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
2 citing papers in PubMed.
- Navigating renal safety in the biologic treatment of psoriasis: from immunologic mechanisms to clinical practice.Frontiers in immunology · 2026Review
- Adverse events associated with ustekinumab in Crohn's disease treatment: an analysis based on the FAERS database.Frontiers in medicine · 2025Article
Corrections and comments
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe use of immune-modifying biological agents has markedly changed the clinical course and the management of inflammatory bowel diseases (IBDs). Active post-marketing surveillance programs are essential for the early recognition of both expected and unexpected adverse events (AEs), providing a powerful tool for better defining the safety profiles of biologics in a real-world setting.
methodsPatients diagnosed with IBDs and treated with biologic drugs at two gastroenterology units in Calabria, Italy, were monitored during the period from 2023 to 2024. AEs and drug switches or swaps were recorded. The primary objective was to assess the safety profile of biological therapies in real-world practice, as measured by the occurrence of AEs. Secondary objectives focused on assessing treatment effectiveness by monitoring rates of therapeutic ineffectiveness and rigorously analyzing necessary modifications to therapy (swaps/switches) in response to treatment failure.
resultsA total of 214 patients were enrolled, including 85 with Crohn's disease (CD) and 120 with ulcerative colitis (UC). Among biologics, vedolizumab (VDZ) was the most prescribed drug (50.3%), followed by ustekinumab (UST, 33.6%). Among biosimilars, infliximab (IFX) was the most administered (70%), followed by adalimumab (ADA) (63.3%). 96 patients experienced AEs, though no serious adverse events (SAEs) were reported. The highest number of AEs was reported with VDZ (n = 31; 32.3%), followed by IFX (n = 22, 23.0%), ADA and UST (n = 17, 17.7%), and golimumab (GOL) (n = 7; 7.3%). The biological drugs associated with the fewest AEs were upadacitinib (UPA) and tofacitinib (TFC) (n = 1; 1.0%).
conclusionsThis study confirms the importance of pharmacovigilance in monitoring the safety of biologics in IBDs. The results offer useful insights into the actual use of monoclonals in gastroenterology and support more targeted prescribing. CLINICAL TRIAL NUMBER: Not applicable.
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