Research ArticleAccepted Article

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 and Harald E. Vonkeman
The Journal of Rheumatology May 2021, jrheum.201373; DOI: https://doi.org/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 TNFα-inhibitor adalimumab.

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 adalimumab in both data sources using a Fisher’s exact test.

Results Out of 416 patients using ETN for inflammatory rheumatic diseases in the Dutch Biologic Monitor, 25 patients (6%) 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 7.14 per 1000 patient years. Most GI-ADRs concerned diarrhoea, nausea and abdominal pain. GI-ADRs led to ETN discontinuation in one patient (4%) and dose adjustment in four (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 adalimumab 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 adalimumab associated GI-ADRs. Knowledge about these previously unknown ADRs can facilitate early recognition and improve patient communication.

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