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

Eline L. Giraud, Pepijn W. A. Thomas (), Jette A. Lint, Eugene P. Puijenbroek, Tessa E. H. Römkens, Rachel L. West, Maurice G. V. M. Russel, Jeroen M. Jansen, Naomi T. Jessurun and Frank Hoentjen
Additional contact information
Eline L. Giraud: Netherlands Pharmacovigilance Centre Lareb
Pepijn W. A. Thomas: Radboud University Medical Centre
Jette A. Lint: Netherlands Pharmacovigilance Centre Lareb
Eugene P. Puijenbroek: Netherlands Pharmacovigilance Centre Lareb
Tessa E. H. Römkens: Jeroen Bosch Ziekenhuis
Rachel L. West: Franciscus Gasthuis en Vlietland
Maurice G. V. M. Russel: Medisch Spectrum Twente
Jeroen M. Jansen: Onze Lieve Vrouwe Gasthuis
Naomi T. Jessurun: Netherlands Pharmacovigilance Centre Lareb
Frank Hoentjen: Radboud University Medical Centre

Drug Safety, 2021, vol. 44, issue 5, No 7, 588 pages

Abstract: Abstract 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.

Date: 2021
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DOI: 10.1007/s40264-021-01045-3

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