Adverse Drug Reactions from Real-World Data in Inflammatory Bowel Disease Patients in the IBDREAM Registry.

Autor: Giraud EL; Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands., Thomas PWA; Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands. pepijn.thomas@radboudumc.nl., van Lint JA; Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands., van Puijenbroek EP; Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands., Römkens TEH; Department of Gastroenterology and Hepatology, Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, The Netherlands., West RL; Department of Gastroenterology and Hepatology, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands., Russel MGVM; Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, The Netherlands., Jansen JM; Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands., Jessurun NT; Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands., Hoentjen F; Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands.
Jazyk: angličtina
Zdroj: Drug safety [Drug Saf] 2021 May; Vol. 44 (5), pp. 581-588. Date of Electronic Publication: 2021 Feb 04.
DOI: 10.1007/s40264-021-01045-3
Abstrakt: Introduction: Inflammatory bowel disease (IBD) frequently requires chronic immunosuppressive treatment and active involvement from patients during treatment decision making. Information about the risk of developing adverse drug reactions (ADRs) to IBD therapies is required in this process.
Objective: The aim of this study was to describe the ADRs reported in IBD patients from real-world data, using the Dutch nationwide IBDREAM registry, and compare the occurrence and cumulative incidences with the Summary of Product Characteristics (SmPC) of the associated drugs.
Methods: In this retrospective multicentre study, ADRs related to IBD medication were assessed. Only reports associated with the use of drugs used for the maintenance treatment of IBD were included. All ADRs were verified by healthcare professionals and coded by trained pharmacovigilance assessors.
Results: In total, 3080 ADRs were reported in 1179 patients. Twenty-three new drug-ADR associations related to the use of azathioprine, mercaptopurine, infliximab, oral mesalamine and thioguanine were reported in the IBDREAM registry that were not mentioned in the corresponding SmPCs. The most frequently reported new association was pyrexia for azathioprine (3.1%) and mercaptopurine (4.9%). In addition, there were seven ADRs with a higher cumulative incidence in IBDREAM compared with the SmPC, and included, among others, arthralgia during mercaptopurine use (2.5%), and diarrhoea (1.4%), alopecia (1.2%) and infections (1.6%) during azathioprine use.
Conclusions: Based on real-world data, ADR reporting demonstrated new ADRs and higher incidences of ADRs to IBD therapies. This information will contribute to drug safety by updating the SmPCs, allowing better risk assessment and communication towards patients.
Databáze: MEDLINE
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