Ulcerative Colitis and Acute Severe Ulcerative Colitis Patients Are Overlooked in Infliximab Population Pharmacokinetic Models: Results from a Comprehensive Review

Ulcerative Colitis and Acute Severe Ulcerative Colitis Patients Are Overlooked in Infliximab Population Pharmacokinetic Models: Results from a Comprehensive Review

Ulcerative colitis (UC) is part of the inflammatory bowels diseases, and moderate to severe UC patients can be treated with anti-tumour necrosis α monoclonal antibodies, including infliximab (IFX). Even though treatment of UC patients by IFX has been in place for over a decade, many gaps in modellin...

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Bibliographic Details
Published in:Pharmaceutics Vol. 14; no. 10; p. 2095
Main Authors: Démaris, Alix, Widigson, Ella S. K, Ilvemark, Johan F. K. F, Steenholdt, Casper, Seidelin, Jakob B, Huisinga, Wilhelm, Michelet, Robin, Aulin, Linda B. S, Kloft, Charlotte
Format: Journal Article
Language:English
Published: Basel MDPI AG 30-09-2022
MDPI
Subjects:
acute severe ulcerative colitis
Analysis
Biological products
Composition
Disease
disease activity
Drug dosages
Drug therapy
Endoscopy
Inflammation
Inflammatory bowel disease
Infliximab
Mortality
Patient outcomes
Patients
Pharmacokinetics
Remission (Medicine)
Review
Steroids
Ulcerative colitis
Germany
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Summary:Ulcerative colitis (UC) is part of the inflammatory bowels diseases, and moderate to severe UC patients can be treated with anti-tumour necrosis α monoclonal antibodies, including infliximab (IFX). Even though treatment of UC patients by IFX has been in place for over a decade, many gaps in modelling of IFX PK in this population remain. This is even more true for acute severe UC (ASUC) patients for which early prediction of IFX pharmacokinetic (PK) could highly improve treatment outcome. Thus, this review aims to compile and analyse published population PK models of IFX in UC and ASUC patients, and to assess the current knowledge on disease activity impact on IFX PK. For this, a semi-systematic literature search was conducted, from which 26 publications including a population PK model analysis of UC patients receiving IFX therapy were selected. Amongst those, only four developed a model specifically for UC patients, and only three populations included severe UC patients. Investigations of disease activity impact on PK were reported in only 4 of the 14 models selected. In addition, the lack of reported model codes and assessment of predictive performance make the use of published models in a clinical setting challenging. Thus, more comprehensive investigation of PK in UC and ASUC is needed as well as more adequate reports on developed models and their evaluation in order to apply them in a clinical setting.
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ISSN:1999-4923
1999-4923
DOI:10.3390/pharmaceutics14102095