Gastrointestinal Adverse Drug Reaction Profile of Etanercept: Real-world Data From Patients and Healthcare Professionals

Jette A van Lint; Naomi T Jessurun; Sander W Tas; Bart J F van den Bemt; Michael T Nurmohamed; Martijn B A van Doorn; Phyllis I Spuls; Astrid M van Tubergen; Peter M Ten Klooster; Eugene P van Puijenbroek; Frank Hoentjen; Harald E Vonkeman

doi:10.3899/jrheum.201373

Gastrointestinal Adverse Drug Reaction Profile of Etanercept: Real-world Data From Patients and Healthcare Professionals

J Rheumatol. 2021 Sep;48(9):1388-1394. doi: 10.3899/jrheum.201373. Epub 2021 May 15.

Affiliations

¹ J.A. van Lint, PharmD, N.T. Jessurun, PharmD, Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch; j.vanlint@lareb.nl.
² J.A. van Lint, PharmD, N.T. Jessurun, PharmD, Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch.
³ S.W. Tas, MD, PhD, Department of Rheumatology & Clinical Immunology, Amsterdam UMC, location Academic Medical Center, University of Amsterdam, Amsterdam Infection & Immunity Institute and Amsterdam Rheumatology & immunology Center (ARC), Amsterdam.
⁴ B.J.F. van den Bemt, PharmD, Prof. Dr., Department of Pharmacy, Sint Maartenskliniek, and Department of Pharmacy, Radboud University Medical Center, Nijmegen.
⁵ M.T. Nurmohamed, MD, Prof. Dr., Amsterdam Rheumatology & immunology Center (ARC), Reade, and Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam.
⁶ M.B. van Doorn, MD, PhD, Department of Dermatology, Erasmus MC, University Medical Center, Rotterdam.
⁷ P.I. Spuls, MD, Prof. Dr., Department of Dermatology, Public Health and Epidemiology, Immunity and Infections, Amsterdam UMC, location Academic Medical Center, Amsterdam.
⁸ A.M. van Tubergen, MD, Prof. Dr., Department of Rheumatology, Maastricht University Medical Center, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht.
⁹ P.M. ten Klooster, PhD, Transparency in Healthcare BV, Hengelo, and Department of Psychology, Health & Technology, University of Twente, Enschede.
¹⁰ E.P. van Puijenbroek, MD, Prof. Dr., Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, and Department of Pharmacotherapy, Epidemiology & Economics, University of Groningen, Groningen.
¹¹ F. Hoentjen, MD, PhD, Department of Gastroenterology, Radboud University Medical Center, Nijmegen.
¹² H.E. Vonkeman, MD, PhD, Department of Psychology, Health & Technology, University of Twente, and Department of Rheumatology and Clinical Immunology, Medisch Spectrum Twente, Enschede, the Netherlands.

PMID: 33993115
DOI: 10.3899/jrheum.201373

Abstract

Objective: We aimed to describe the nature and frequency of gastrointestinal adverse drug reactions (GI-ADRs) of etanercept (ETN) using patient-reported and healthcare professional (HCP)-registered data and compared this frequency with the GI-ADR frequency of the widely used tumor necrosis factor-α inhibitor adalimumab (ADA).

Methods: Reported GI-ADRs of ETN for rheumatic diseases were collected from the Dutch Biologic Monitor and DREAM registries. We described the clinical course of GI-ADRs and compared the frequency with ADA in both data sources using Fisher exact test.

Results: Out of 416 patients using ETN for inflammatory rheumatic diseases in the Dutch Biologic Monitor, 25 (6%) patients reported 36 GI-ADRs. In the DREAM registries 11 GI-ADRs were registered for 9 patients (2.3%), out of 399 patients using ETN, with an incidence of 7.1 per 1000 patient-years. Most GI-ADRs consisted of diarrhea, nausea, and abdominal pain. GI-ADRs led to ETN discontinuation in 1 patient (4%) and dose adjustment in 4 (16%) in the Dutch Biologic Monitor. Eight GI-ADRs (73%) led to ETN discontinuation in the DREAM registries. The frequency of GI-ADRs of ETN did not significantly differ from GI-ADRs of ADA in both data sources (Dutch Biologic Monitor: ETN 8.7% vs ADA 5.3%, P = 0.07; DREAM: ETN 2.8% vs ADA 4.7%, P = 0.16).

Conclusion: Most GI-ADRs associated with ETN concerned gastrointestinal symptoms. These ADRs may lead to dose adjustment or ETN discontinuation. The frequency of ETN-associated GI-ADRs was comparable to the frequency of ADA-associated GI-ADRs. Knowledge about these previously unknown ADRs can facilitate early recognition and improve patient communication.

Keywords: adverse drug reactions; biological therapy; drug monitoring; drug safety; registries.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adalimumab
Antirheumatic Agents* / adverse effects
Delivery of Health Care
Drug-Related Side Effects and Adverse Reactions*
Etanercept / adverse effects
Humans

Substances

Antirheumatic Agents
Adalimumab
Etanercept