Drug Clearance in Patients with Inflammatory Bowel Disease Treated with Biologics

Biological therapy is very effective for treating patients with moderate to severe inflammatory bowel disease (IBD). However, up to 40% can have primary non-response, and up to 50% of the patients can experience a loss of response to anti-tumor necrosis factor therapy. These undesirable outcomes can...

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Main Authors: Tina Deyhim, Adam S. Cheifetz, Konstantinos Papamichael
Format: Article
Language:English
Published: MDPI AG 2023-11-01
Series:Journal of Clinical Medicine
Subjects:
Online Access:https://www.mdpi.com/2077-0383/12/22/7132
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author Tina Deyhim
Adam S. Cheifetz
Konstantinos Papamichael
author_facet Tina Deyhim
Adam S. Cheifetz
Konstantinos Papamichael
author_sort Tina Deyhim
collection DOAJ
description Biological therapy is very effective for treating patients with moderate to severe inflammatory bowel disease (IBD). However, up to 40% can have primary non-response, and up to 50% of the patients can experience a loss of response to anti-tumor necrosis factor therapy. These undesirable outcomes can be attributed to either a mechanistic failure or pharmacokinetic (PK) issues characterized by an inadequate drug exposure and a high drug clearance. There are several factors associated with accelerated clearance of biologics including increased body weight, low serum albumin and immunogenicity. Drug clearance has gained a lot of attention recently as cumulative data suggest that there is an association between drug clearance and therapeutic outcomes in patients with IBD. Moreover, clearance is used by model informed precision dosing (MIDP) tools, or PK dashboards, to adjust the dosing for reaching a target drug concentration threshold towards a more personalized application of TDM. However, the role of drug clearance in clinical practice is yet to be determined. This comprehensive review aims to present data regarding the variables affecting the clearance of specific biologics, the association of clearance with therapeutic outcomes and the role of clearance monitoring and MIPD in patients with IBD.
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spelling doaj.art-d0ff8ab353c34d2c90375bf7d97647aa2023-11-24T14:49:35ZengMDPI AGJournal of Clinical Medicine2077-03832023-11-011222713210.3390/jcm12227132Drug Clearance in Patients with Inflammatory Bowel Disease Treated with BiologicsTina Deyhim0Adam S. Cheifetz1Konstantinos Papamichael2Center for Inflammatory Bowel Diseases, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA 02215, USACenter for Inflammatory Bowel Diseases, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA 02215, USACenter for Inflammatory Bowel Diseases, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA 02215, USABiological therapy is very effective for treating patients with moderate to severe inflammatory bowel disease (IBD). However, up to 40% can have primary non-response, and up to 50% of the patients can experience a loss of response to anti-tumor necrosis factor therapy. These undesirable outcomes can be attributed to either a mechanistic failure or pharmacokinetic (PK) issues characterized by an inadequate drug exposure and a high drug clearance. There are several factors associated with accelerated clearance of biologics including increased body weight, low serum albumin and immunogenicity. Drug clearance has gained a lot of attention recently as cumulative data suggest that there is an association between drug clearance and therapeutic outcomes in patients with IBD. Moreover, clearance is used by model informed precision dosing (MIDP) tools, or PK dashboards, to adjust the dosing for reaching a target drug concentration threshold towards a more personalized application of TDM. However, the role of drug clearance in clinical practice is yet to be determined. This comprehensive review aims to present data regarding the variables affecting the clearance of specific biologics, the association of clearance with therapeutic outcomes and the role of clearance monitoring and MIPD in patients with IBD.https://www.mdpi.com/2077-0383/12/22/7132clearanceinflammatory bowel diseasetherapeutic drug monitoringanti-TNF therapyvedolizumabustekinumab
spellingShingle Tina Deyhim
Adam S. Cheifetz
Konstantinos Papamichael
Drug Clearance in Patients with Inflammatory Bowel Disease Treated with Biologics
Journal of Clinical Medicine
clearance
inflammatory bowel disease
therapeutic drug monitoring
anti-TNF therapy
vedolizumab
ustekinumab
title Drug Clearance in Patients with Inflammatory Bowel Disease Treated with Biologics
title_full Drug Clearance in Patients with Inflammatory Bowel Disease Treated with Biologics
title_fullStr Drug Clearance in Patients with Inflammatory Bowel Disease Treated with Biologics
title_full_unstemmed Drug Clearance in Patients with Inflammatory Bowel Disease Treated with Biologics
title_short Drug Clearance in Patients with Inflammatory Bowel Disease Treated with Biologics
title_sort drug clearance in patients with inflammatory bowel disease treated with biologics
topic clearance
inflammatory bowel disease
therapeutic drug monitoring
anti-TNF therapy
vedolizumab
ustekinumab
url https://www.mdpi.com/2077-0383/12/22/7132
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