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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Bibliographic Details
Published in:Journal of clinical medicine 2023-11, Vol.12 (22), p.7132
Main Authors: Deyhim, Tina, Cheifetz, Adam S, Papamichael, Konstantinos
Format: Article
Language:English
Subjects:
Albumin
Antibodies
Biological products
Body weight
Care and treatment
Chemical properties
Clinical medicine
Clinical trials
Crohn's disease
Drug dosages
Drug metabolism
Drug therapy
Feces
Gastrointestinal diseases
Health aspects
Immunotherapy
Inflammatory bowel disease
Inflammatory bowel diseases
Monoclonal antibodies
Patient outcomes
Pediatrics
Pharmacology, Experimental
Physiological aspects
Remission (Medicine)
Tumor necrosis factor
Tumor necrosis factor-TNF
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Summary: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.
ISSN:2077-0383
2077-0383
DOI:10.3390/jcm12227132