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

Autoren: A. Démaris, E. S. K. Widigson, J. F. K. F. Ilvemark, C. Steenholdt, J. B. Seidelin, W. Huisinga, R. Michelet, L. B. S. Aulin, C. Kloft (2022)

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 se-
vere 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 perfor-
mance make the use of published models in a clinical setting challenging. Thus, more comprehen-
sive 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.


zur Übersicht der Publikationen