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Difficult-to-treat-pediatric Crohn’s disease: focus on adalimumab

Adalimumab is a fully humanized anti-tumor necrosis factor alpha monoclonal antibody that was recently granted regulatory approval in the USA for the treatment of moderate to severe Crohn’s disease (CD) in children. Like infliximab, the first biologic agent used to treat pediatric CD, regulatory app...

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Detalles Bibliográficos
Autores principales: Zeisler, Bella, Hyams, Jeffrey S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5683269/
https://www.ncbi.nlm.nih.gov/pubmed/29388607
http://dx.doi.org/10.2147/PHMT.S40948
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author Zeisler, Bella
Hyams, Jeffrey S
author_facet Zeisler, Bella
Hyams, Jeffrey S
author_sort Zeisler, Bella
collection PubMed
description Adalimumab is a fully humanized anti-tumor necrosis factor alpha monoclonal antibody that was recently granted regulatory approval in the USA for the treatment of moderate to severe Crohn’s disease (CD) in children. Like infliximab, the first biologic agent used to treat pediatric CD, regulatory approval was secured many years following approval for adults. The long delay between adult and pediatric approval has led to many years of off-label use of adalimumab, although it is anticipated that the use of adalimumab may further increase with official regulatory approval. To date, pediatric literature on the use of adalimumab for treatment of CD is limited, and pediatric practitioners have mostly extrapolated from research and experience provided by the adult literature. The aim of this paper is to review the literature regarding adalimumab for the treatment of pediatric CD, and includes a review of landmark adult studies as well as the pivotal pediatric study that facilitated regulatory approval. We also discuss the role of anti-tumor necrosis factor alpha agents including adalimumab in the current treatment paradigm for pediatric CD.
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spelling pubmed-56832692018-01-31 Difficult-to-treat-pediatric Crohn’s disease: focus on adalimumab Zeisler, Bella Hyams, Jeffrey S Pediatric Health Med Ther Review Adalimumab is a fully humanized anti-tumor necrosis factor alpha monoclonal antibody that was recently granted regulatory approval in the USA for the treatment of moderate to severe Crohn’s disease (CD) in children. Like infliximab, the first biologic agent used to treat pediatric CD, regulatory approval was secured many years following approval for adults. The long delay between adult and pediatric approval has led to many years of off-label use of adalimumab, although it is anticipated that the use of adalimumab may further increase with official regulatory approval. To date, pediatric literature on the use of adalimumab for treatment of CD is limited, and pediatric practitioners have mostly extrapolated from research and experience provided by the adult literature. The aim of this paper is to review the literature regarding adalimumab for the treatment of pediatric CD, and includes a review of landmark adult studies as well as the pivotal pediatric study that facilitated regulatory approval. We also discuss the role of anti-tumor necrosis factor alpha agents including adalimumab in the current treatment paradigm for pediatric CD. Dove Medical Press 2015-04-28 /pmc/articles/PMC5683269/ /pubmed/29388607 http://dx.doi.org/10.2147/PHMT.S40948 Text en © 2015 Zeisler and Hyams. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited.
spellingShingle Review
Zeisler, Bella
Hyams, Jeffrey S
Difficult-to-treat-pediatric Crohn’s disease: focus on adalimumab
title Difficult-to-treat-pediatric Crohn’s disease: focus on adalimumab
title_full Difficult-to-treat-pediatric Crohn’s disease: focus on adalimumab
title_fullStr Difficult-to-treat-pediatric Crohn’s disease: focus on adalimumab
title_full_unstemmed Difficult-to-treat-pediatric Crohn’s disease: focus on adalimumab
title_short Difficult-to-treat-pediatric Crohn’s disease: focus on adalimumab
title_sort difficult-to-treat-pediatric crohn’s disease: focus on adalimumab
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5683269/
https://www.ncbi.nlm.nih.gov/pubmed/29388607
http://dx.doi.org/10.2147/PHMT.S40948
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