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

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. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-021-01045-3.

Signals from the Dutch national spontaneous reporting system: Characteristics and regulatory actions

“…Signals from the Dutch SRS are less often on drugs in the class Antineoplastic and immunomodulating agents, which often contains biologicals, then those evaluated by the PRAC 4 . However, the focus of the Dutch pharmacovigilance centre has recently shifted more towards gaining knowledge on these products through the use of registries and an intensive monitoring study on drugs used in immune‐mediated inflammatory disease 22‐24 …”

“…4 However, the focus of the Dutch pharmacovigilance centre has recently shifted more towards gaining knowledge on these products through the use of registries and an intensive monitoring study on drugs used in immune-mediated inflammatory disease. [22][23][24] Signals found through the Dutch SRS can lead to multiple regulatory actions. The Dutch NCA MEB plays a pivotal role in this process, as they decide which action is suitable for the different signals.…”

Pharmacotherapy of inflammatory bowel diseases: efficacy performance and safety management

“…По данным регистра IBDREAM (Нидерланды, 2021), доля пациентов с НР при применении азатиоприна составляет 43,9%, 6-МП -39,3% (табл. 1) [5].…”

“…В 2021 г. опубликован отчет по итогам многоцентрового регистра пациентов с ВЗК, проходящих лечение в Нидерландах (IBDREAM) [5]. У 1179 пациентов, включенных в регистр, отмечено 3080 нежелательных реакций (НР) на проводимую терапию, при этом НР несколько чаще отмечались у женщин (60,4%).…”

“…Наиболее частой новой ассоциацией была гипертермия для азатиоприна (3,1%) и меркаптопурина (4,9%). Кроме того, в IBDREAM отмечены побочные эффекты, которые встречались более часто по сравнению с фармакологическими инструкциями, включившие артралгию во время использования меркаптопурина (2,5%), диарею (1,4%), алопецию (1,2%) и инфекции (1,6%) при применении азатиоприна [5].…”