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Review
. 2021 Nov 29;10(23):5642.
doi: 10.3390/jcm10235642.

Therapeutic Drug Monitoring of Biologics in IBD: Essentials for the Surgical Patient

Rodrigo Bremer Nones  1 , Phillip R Fleshner  2 , Natalia Sousa Freitas Queiroz  3 , Adam S Cheifetz  4 , Antonino Spinelli  5   6 , Silvio Danese  6   7 , Laurent Peyrin-Biroulet  8 , Konstantinos Papamichael  4 , Paulo Gustavo Kotze  1   9
Affiliations
Review

Therapeutic Drug Monitoring of Biologics in IBD: Essentials for the Surgical Patient

Rodrigo Bremer Nones et al. J Clin Med. .

Abstract

Despite significant development in the pharmacological treatment of inflammatory bowel diseases (IBD) along with the evolution of therapeutic targets and treatment strategies, a significant subset of patients still requires surgery during the course of the disease. As IBD patients are frequently exposed to biologics at the time of abdominal and perianal surgery, it is crucial to identify any potential impact of biological agents in the perioperative period. Even though detectable serum concentrations of biologics do not seem to increase postoperative complications after abdominal procedures in IBD, there is increasing evidence on the role of therapeutic drug monitoring (TDM) in the perioperative setting. This review aims to provide a comprehensive summary of published studies reporting the association of drug concentrations and postoperative outcomes, postoperative recurrence (POR) after an ileocolonic resection for Crohn's disease (CD), colectomy rates in ulcerative colitis (UC), and perianal fistulizing CD outcomes in patients treated with biologics. Current data suggest that serum concentrations of biologics are not associated with an increased risk in postoperative complications following abdominal procedures in IBD. Moreover, higher concentrations of anti-TNF agents are associated with a reduction in colectomy rates in UC. Finally, higher serum drug concentrations are associated with reduced rates of POR after ileocolonic resections and increased rates of perianal fistula healing in CD. TDM is being increasingly used to guide clinical decision making with favorable outcomes in many clinical scenarios. However, given the lack of high quality data deriving mostly from retrospective studies, the evidence supporting the systematic application of TDM in the perioperative setting is still inconclusive.

Keywords: Crohn’s disease; anti-TNF therapy; inflammatory bowel disease; surgery; therapeutic drug monitoring; ulcerative colitis; ustekinumab; vedolizumab.

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Conflict of interest statement

RBN has no conflict of interest. PRF is a consultant for Takeda NSFQ has served as a speaker and advisory board member of Janssen, Takeda, and Abbvie. ASC reports consultancy fees from Janssen, Abbvie, Artugen, Procise, Prometheus, Arena, Grifols, Bacainn, and Bristol Myers Squibb. AS is a consultant for Takeda. SD has served as a speaker, consultant, and advisory board member for Schering-Plough, AbbVie, Actelion, Alphawasserman, AstraZeneca, Cellerix, Cosmo Pharmaceuticals, Ferring, Genentech, Grunenthal, Johnson and Johnson, Millenium Takeda, MSD, Nikkiso Europe GmbH, Novo Nordisk, Nycomed, Pfizer, Pharmacosmos, UCB Pharma, and Vifor. LPB has served as a speaker, consultant, and advisory board member for Merck, Abbvie, Janssen, Genentech, Mitsubishi, Ferring, Norgine, Tillots, Vifor, Hospira/Pfizer, Celltrion, Takeda, Biogaran, Boerhinger-Ingelheim, Lilly, HAC- Pharma, Index Pharmaceuticals, Amgen, Sandoz, Forward Pharma GmbH, Celgene, Biogen, Lycera, Samsung Bioepis, and Theravance. KP reports lecture fees from Mitsubishi Tanabe Pharma and Physicians Education Resource LLC; consultancy fee from Prometheus Laboratories Inc; and scientific advisory board fees from ProciseDx Inc. and Scipher Medicine Corporation. PGK is a speaker and consultant for Abbvie, Janssen, Pfizer, and Takeda. He also does clinical research for Lilly, Takeda, and Pfizer.

Figures

Figure 1
Figure 1
Multi-utility of TDM of biologics for the surgical IBD patient. Legend: UC—ulcerative colitis, POR—post-operative recurrence, CD—Crohn’s disease.
See this image and copyright information in PMC

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