TY - JOUR
T1 - Gastrointestinal adverse drug reaction profile of etanercept
T2 - Real-world data from patients and healthcare professionals
AU - van Lint, Jette A.
AU - Jessurun, Naomi T.
AU - Tas, Sander W.
AU - van den Bemt, Bart J.F.
AU - Nurmohamed, Michael T.
AU - van Doorn, Martijn B.A.
AU - Spuls, Phyllis I.
AU - van Tubergen, Astrid M.
AU - ten Klooster, Peter M.
AU - van Puijenbroek, Eugene P.
AU - Hoentjen, Frank
AU - Vonkeman, Harald E.
N1 - Funding Information:
The Dutch Biologic Monitor was supported by the Netherlands Organisation for Health Research and Development (ZonMw), grant number 848050005. No funding was received for the conduct of this specific study. 1J.A. van Lint, PharmD, N.T. Jessurun, PharmD, Netherlands Pharmacovigilance Centre Lareb, ’s-Hertogenbosch; 2S.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; 3B.J.F. van den Bemt, PharmD, Prof. Dr., Department of Pharmacy, Sint Maartenskliniek, and Department of Pharmacy, Radboud University Medical Center, Nijmegen; 4M.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; 5M.B. van Doorn, MD, PhD, Department of Dermatology, Erasmus MC, University Medical Center, Rotterdam; 6P.I. Spuls, MD, Prof. Dr., Department of Dermatology, Public Health and Epidemiology, Immunity and Infections, Amsterdam UMC, location Academic Medical Center, Amsterdam; 7A.M. van Tubergen, MD, Prof. Dr., Department of Rheumatology, Maastricht University Medical Center, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht; 8P.M. ten Klooster, PhD, Transparency in Healthcare BV, Hengelo, and Department of Psychology, Health & Technology, University of Twente, Enschede; 9E.P. van Puijenbroek, MD, Prof. Dr., Netherlands Pharmacovigilance Centre Lareb, ’s-Hertogenbosch, and Department of Pharmacotherapy, Epidemiology & Economics, University of Groningen, Groningen; 10F. Hoentjen, MD, PhD, Department of Gastroenterology, Radboud University Medical Center, Nijmegen; 11H.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. MTN reports consulting fees from AbbVie, Celgene, Celltrion, Eli Lilly, Janssen, and Sanofi; speakers fees from AbbVie, BMS, Eli Lilly, Roche, and Sanofi; and research funding from AbbVie, BMS, Celgene, Eli Lilly, Janssen, MSD, Mundipharma, Novartis, Pfizer, Roche, and Sanofi. SWT has received consulting fees or honorarium fees from Pfizer, Gebro, GSK, AbbVie, Galvani, Arthrogen, Galapagos; and research funding from Pfizer, GSK, Celgene, BMS, Sanofi and AstraZeneca, all outside the submitted work. MBvD has received consulting fees or honorarium from Novartis, AbbVie, Pfizer, Leopharma, Sanofi, Lilly, Janssen, and Celgene; has received a grant and payment for lectures including service on speakers bureaus from Novartis, outside the submitted work. PIS has consulted for Sanofi 111017 and AbbVie 041217 (unpaid); received a departmental independent research grant for TREAT NL registry from different sponsors (multisponsored); is involved in various clinical trials sponsored by pharmaceutical companies (psoriasis and atopic dermatitis); and is Chief Investigator of TREAT NL as well as one of the main investigators of the SECURE-AD registry. AvT has received unrestricted grants from Pfizer, AbbVie, UCB, Novartis, and Biogen for
Publisher Copyright:
© 2021 The Journal of Rheumatology
PY - 2021/9/1
Y1 - 2021/9/1
N2 - 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.
AB - 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.
KW - 2022 OA procedure
KW - Biological therapy
KW - Drug monitoring
KW - Drug safety
KW - Registries
KW - Adverse drug reactions
UR - https://www.scopus.com/pages/publications/85114329979
U2 - 10.3899/jrheum.201373
DO - 10.3899/jrheum.201373
M3 - Article
C2 - 33993115
AN - SCOPUS:85114329979
SN - 0315-162X
VL - 48
SP - 1388
EP - 1394
JO - Journal of rheumatology
JF - Journal of rheumatology
IS - 9
ER -