AI Article Synopsis
- The study aimed to investigate gastrointestinal adverse drug reactions (GI-ADRs) related to etanercept (ETN) in patients with rheumatic diseases, comparing findings with adalimumab (ADA).
- Data was collected from Dutch Biologic Monitor and DREAM registries, where 6% of ETN patients reported GI-ADRs, with symptoms mainly including diarrhea, nausea, and abdominal pain.
- The frequency of GI-ADRs for ETN was found to be similar to that of ADA, indicating that awareness of these ADRs can enhance patient communication and care management.
Article 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%, = 0.07; DREAM: ETN 2.8% vs ADA 4.7%, = 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.
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| http://dx.doi.org/10.3899/jrheum.201373 | DOI Listing |
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