Significant advantages for first line treatment with TNF-alpha inhibitors in pediatric patients with inflammatory bowel disease – Data from the multicenter CEDATA-GPGE registry study

Background and aimsIn recent years, biological agents, such as anti-TNF-α blockers, have been introduced and have shown efficacy in pediatric patients with inflammatory bowel disease (IBD). Here, the prescription mode differentiated into a first/second line application, and efficacy and side effects...

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Main Authors: Merle Claßen, Jan de Laffolie, Martin Claßen, Alexander Schnell, Keywan Sohrabi, André Hoerning
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-07-01
Series:Frontiers in Pediatrics
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fped.2022.903677/full
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author Merle Claßen
Jan de Laffolie
Martin Claßen
Alexander Schnell
Keywan Sohrabi
André Hoerning
author_facet Merle Claßen
Jan de Laffolie
Martin Claßen
Alexander Schnell
Keywan Sohrabi
André Hoerning
author_sort Merle Claßen
collection DOAJ
description Background and aimsIn recent years, biological agents, such as anti-TNF-α blockers, have been introduced and have shown efficacy in pediatric patients with inflammatory bowel disease (IBD). Here, the prescription mode differentiated into a first/second line application, and efficacy and side effects are evaluated beginning from 2004 until today.MethodsStatistical analyses of the prospective and ongoing CEDATA multicenter registry data from the Society of Pediatric Gastroenterology and Nutrition (GPGE) were performed for patients receiving a biological agent at least once during the period from June 2004 until November 2020 (n = 487). The analyzed parameters were patient demographics, disease extent and behavior, prior or concurrent therapies, duration and outcome of biological therapy, disease-associated complications, drug-related complications, laboratory parameters and treatment response as determined by the Physician’s Global Assessment.ResultsCrohn’s disease (CD) was present in 71.5% of patients, and 52% were boys. Patients showed high disease activity when receiving a first-line TNF-α blocker. After 2016, patients who failed to respond to anti-TNF-α induction therapy were treated with off-label biologics (vedolizumab 4.3% and ustekinumab 2.1%). Propensity score matching indicated that patients with CD and higher disease activity benefitted significantly more from early anti-TNF-α therapy. This assessment was based on a clinical evaluation and lab parameters related to inflammation compared to delayed second-line treatment. Additionally, first-line treatment resulted in less treatment failure and fewer extraintestinal manifestations during TNF-α blockade.ConclusionFirst-line treatment with anti-TNF-α drugs is effective and safe. An earlier start significantly reduces the risk of treatment failure and is associated with fewer extraintestinal manifestations during longitudinal follow-up.
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spelling doaj.art-4654ad414bbc44fb8eee9a4c9385bbe92022-12-22T03:55:29ZengFrontiers Media S.A.Frontiers in Pediatrics2296-23602022-07-011010.3389/fped.2022.903677903677Significant advantages for first line treatment with TNF-alpha inhibitors in pediatric patients with inflammatory bowel disease – Data from the multicenter CEDATA-GPGE registry studyMerle Claßen0Jan de Laffolie1Martin Claßen2Alexander Schnell3Keywan Sohrabi4André Hoerning5Clinic for Children and Adolescent Medicine, Friedrich Alexander University Erlangen-Nuremberg, Erlangen, GermanyAbteilung für Allgemeine Pädiatrie und Neonatologie, Justus Liebig University Gießen, Gießen, GermanyKlinik für Kinder- und Jugendmedizin, Klinikum Bremen-Mitte, Bremen, GermanyClinic for Children and Adolescent Medicine, Friedrich Alexander University Erlangen-Nuremberg, Erlangen, GermanyAbteilung für Allgemeine Pädiatrie und Neonatologie, Justus Liebig University Gießen, Gießen, GermanyClinic for Children and Adolescent Medicine, Friedrich Alexander University Erlangen-Nuremberg, Erlangen, GermanyBackground and aimsIn recent years, biological agents, such as anti-TNF-α blockers, have been introduced and have shown efficacy in pediatric patients with inflammatory bowel disease (IBD). Here, the prescription mode differentiated into a first/second line application, and efficacy and side effects are evaluated beginning from 2004 until today.MethodsStatistical analyses of the prospective and ongoing CEDATA multicenter registry data from the Society of Pediatric Gastroenterology and Nutrition (GPGE) were performed for patients receiving a biological agent at least once during the period from June 2004 until November 2020 (n = 487). The analyzed parameters were patient demographics, disease extent and behavior, prior or concurrent therapies, duration and outcome of biological therapy, disease-associated complications, drug-related complications, laboratory parameters and treatment response as determined by the Physician’s Global Assessment.ResultsCrohn’s disease (CD) was present in 71.5% of patients, and 52% were boys. Patients showed high disease activity when receiving a first-line TNF-α blocker. After 2016, patients who failed to respond to anti-TNF-α induction therapy were treated with off-label biologics (vedolizumab 4.3% and ustekinumab 2.1%). Propensity score matching indicated that patients with CD and higher disease activity benefitted significantly more from early anti-TNF-α therapy. This assessment was based on a clinical evaluation and lab parameters related to inflammation compared to delayed second-line treatment. Additionally, first-line treatment resulted in less treatment failure and fewer extraintestinal manifestations during TNF-α blockade.ConclusionFirst-line treatment with anti-TNF-α drugs is effective and safe. An earlier start significantly reduces the risk of treatment failure and is associated with fewer extraintestinal manifestations during longitudinal follow-up.https://www.frontiersin.org/articles/10.3389/fped.2022.903677/fullCrohn’s diseaseulcerative colitisanti-TNF-α inhibitor therapyfirst-line therapypediatric inflammatory bowel disease (IBD)
spellingShingle Merle Claßen
Jan de Laffolie
Martin Claßen
Alexander Schnell
Keywan Sohrabi
André Hoerning
Significant advantages for first line treatment with TNF-alpha inhibitors in pediatric patients with inflammatory bowel disease – Data from the multicenter CEDATA-GPGE registry study
Frontiers in Pediatrics
Crohn’s disease
ulcerative colitis
anti-TNF-α inhibitor therapy
first-line therapy
pediatric inflammatory bowel disease (IBD)
title Significant advantages for first line treatment with TNF-alpha inhibitors in pediatric patients with inflammatory bowel disease – Data from the multicenter CEDATA-GPGE registry study
title_full Significant advantages for first line treatment with TNF-alpha inhibitors in pediatric patients with inflammatory bowel disease – Data from the multicenter CEDATA-GPGE registry study
title_fullStr Significant advantages for first line treatment with TNF-alpha inhibitors in pediatric patients with inflammatory bowel disease – Data from the multicenter CEDATA-GPGE registry study
title_full_unstemmed Significant advantages for first line treatment with TNF-alpha inhibitors in pediatric patients with inflammatory bowel disease – Data from the multicenter CEDATA-GPGE registry study
title_short Significant advantages for first line treatment with TNF-alpha inhibitors in pediatric patients with inflammatory bowel disease – Data from the multicenter CEDATA-GPGE registry study
title_sort significant advantages for first line treatment with tnf alpha inhibitors in pediatric patients with inflammatory bowel disease data from the multicenter cedata gpge registry study
topic Crohn’s disease
ulcerative colitis
anti-TNF-α inhibitor therapy
first-line therapy
pediatric inflammatory bowel disease (IBD)
url https://www.frontiersin.org/articles/10.3389/fped.2022.903677/full
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