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New Frontiers in Therapeutic Drug Monitoring of Biologics in Inflammatory Bowel Disease and Other Immune-Mediated Inflammatory Diseases: 2nd Edition

A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Gastroenterology & Hepatopancreatobiliary Medicine".

Deadline for manuscript submissions: closed (15 December 2025) | Viewed by 3523

Special Issue Editor

Dr. Konstantinos Papamichael

E-Mail Website
Guest Editor
Department of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02115, USA
Interests: therapeutic drug monitoring; anti-TNF therapy; biologics; inflammatory bowel disease; immunogenicity
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Biological therapy is the cornerstone treatment for inflammatory bowel disease (IBD) and other immune-mediated inflammatory diseases (IMID). However, some patients either do not respond at all to biologics or may lose response over time. These unfavorable outcomes can be mostly explained by inadequate drug exposure with or without the development of antidrug antibodies, which refers more to the anti-tumor necrosis factor (anti-TNF) therapy. Cumulative data suggest that proactive TDM of anti-TNFs, aiming for a predefined therapeutic drug concentration, is associated with improved clinical outcomes. Preliminary information suggests that proactive TDM may also be efficacious in other anti-TNF biologics such as vedolizumab and ustekinumab, although data are scarce. Recent advances regarding TDM include the use of point-of-care assays and model-informed precision dosing towards a personalized application of TDM. Knowledge gaps regarding the role of TDM in clinical practice include the determination of the optimal drug concentrations to target and the role of peak drug concentrations, stool or tissue drug concentrations, and total drug exposure. Future perspectives regarding the role of TDM include the use of pharmacogenetics towards individual personalized medicine. The aim of this Special Issue is to highlight recent advances and future perspectives in the use of TDM in IBD and other IMIDs.

Dr. Konstantinos Papamichael
Guest Editor

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Keywords

  • therapeutic drug monitoring
  • inflammatory bowel diseases
  • immune mediated inflammatory diseases
  • pharmacokinetics
  • anti-TNF
  • vedolizumab
  • ustekinumab
  • risankizumab
  • point-of-care assays
  • model informed precision dosing

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Related Special Issue

Published Papers (4 papers)

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Research

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13 pages, 1806 KB  
Article
Pharmacokinetics and Exposure–Response During Infliximab Induction Therapy in Pediatric IBD Using Point-of-Care Assay
by Amy Hemperly, Jincheng Yang, Anh Ta and Niels Vande Casteele
J. Clin. Med. 2025, 14(22), 7968; https://doi.org/10.3390/jcm14227968 - 10 Nov 2025
Viewed by 396
Abstract
Background: Pharmacokinetic therapeutic failure with infliximab during induction therapy can pose a significant challenge for clinicians. The objective of this study was to conduct population pharmacokinetic and exposure–response analyses in children with inflammatory bowel disease during infliximab induction therapy. Methods: A [...] Read more.
Background: Pharmacokinetic therapeutic failure with infliximab during induction therapy can pose a significant challenge for clinicians. The objective of this study was to conduct population pharmacokinetic and exposure–response analyses in children with inflammatory bowel disease during infliximab induction therapy. Methods: A prospective single-center observational study was conducted in anti-TNF naïve pediatric patients < 21 years of age with IBD starting infliximab according to their physicians’ clinical judgment between December 2018 and December 2020. Population pharmacokinetic analysis was conducted by nonlinear mixed-effects modeling using infliximab serum levels measured by RIDASCREEN® enzyme-linked immunosorbent assay. Infliximab serum levels were also measured by point-of-care (POC) assay using RIDA®QUICK IFX monitoring and the RIDA®QUICK SCAN II. An exposure–response analysis was conducted to evaluate the association between infliximab concentrations and efficacy outcomes at week 14. Results: The typical value of infliximab clearance in a pediatric patient with IBD weighing 51 kg was 0.252 L/day, and the Vc was 3.43 L and Vp was 2.11 L. Weight and albumin were identified to be significant covariates on clearance in the final model. Tertile analysis of infliximab exposure showed an exposure–response relationship in which higher infliximab ELISA concentrations during induction therapy were associated with clinical remission at week 14 and biochemical response at week 14, but the trend did not reach statistical significance due to the small sample size. The concordance correlation coefficient between the infliximab ELISA and the POC assay was 0.905 [0.867, 0.933]. Conclusions: We report parameter estimates during infliximab induction therapy in pediatric patients with inflammatory bowel disease. Weight and albumin were identified to be significant covariates on clearance. ELISA and POC infliximab assays showed comparable results, supporting the role of POC testing for real-time therapeutic drug monitoring. Full article
(This article belongs to the Special Issue New Frontiers in Therapeutic Drug Monitoring of Biologics in Inflammatory Bowel Disease and Other Immune-Mediated Inflammatory Diseases: 2nd Edition)
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Review

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18 pages, 299 KB  
Review
Efficacy of Advanced Therapies as Prophylaxis and for Active Disease in Postoperative Crohn’s Disease: A Comprehensive Review
by Atena Karimi, Alessandro David, Omar El Ouarzadi and Robert Battat
J. Clin. Med. 2025, 14(23), 8435; https://doi.org/10.3390/jcm14238435 - 27 Nov 2025
Viewed by 516
Abstract
Postoperative recurrence (POR) in Crohn’s disease (CD) is common after intestinal resection, with over 50% developing endoscopic lesions within a year if untreated. The increasing availability of biologics and small molecules has transformed postoperative management, yet optimal strategies for prevention and treatment remain [...] Read more.
Postoperative recurrence (POR) in Crohn’s disease (CD) is common after intestinal resection, with over 50% developing endoscopic lesions within a year if untreated. The increasing availability of biologics and small molecules has transformed postoperative management, yet optimal strategies for prevention and treatment remain unclear. Infliximab and vedolizumab have the strongest evidence for preventing endoscopic recurrence in postoperative Crohn’s disease. Adalimumab and ustekinumab are viable alternatives supported by observational and post hoc trial data. Selective IL-23 inhibitors and JAK inhibitors have demonstrated high efficacy in moderate to severe luminal CD but lack dedicated postoperative trials. Personalized strategies, such as therapeutic drug monitoring (TDM), model informed dosing and pharmacogenetic profiling hold promise for improving long-term control of postoperative Crohn’s disease. Important gaps remain, particularly regarding the drug concentrations to target, the optimal timing for intervention, and the identification of patients most likely to benefit. Approaches that integrate disease location, clinical risk profiles, and knowledge of underlying immunopathogenic pathways could provide more precise clinical guidance. Finding molecular predictors of recurrence, directly comparing cutting-edge treatments, and integrating precision medicine techniques into standard postoperative care should be the main priorities of future research Full article
(This article belongs to the Special Issue New Frontiers in Therapeutic Drug Monitoring of Biologics in Inflammatory Bowel Disease and Other Immune-Mediated Inflammatory Diseases: 2nd Edition)
20 pages, 963 KB  
Review
Therapeutic Drug Monitoring in Special Circumstances in Inflammatory Bowel Disease
by Sebastian Povlsen, Kamal Patel, Xavier Roblin, Konstantinos Papamichael and Sailish Honap
J. Clin. Med. 2025, 14(22), 7956; https://doi.org/10.3390/jcm14227956 - 10 Nov 2025
Viewed by 1031
Abstract
Inflammatory bowel disease, encompassing ulcerative colitis and Crohn’s disease, is characterised by chronic immune-mediated inflammation and variable treatment response. Loss of drug efficacy due to underexposure, pharmacokinetic variability, and immunogenicity remains a key challenge. Therapeutic drug monitoring, using drug levels and anti-drug antibody [...] Read more.
Inflammatory bowel disease, encompassing ulcerative colitis and Crohn’s disease, is characterised by chronic immune-mediated inflammation and variable treatment response. Loss of drug efficacy due to underexposure, pharmacokinetic variability, and immunogenicity remains a key challenge. Therapeutic drug monitoring, using drug levels and anti-drug antibody measurements, is an important strategy for optimising the treatment of inflammatory bowel disease. It helps ensure adequate dosing and can distinguish between pharmacokinetic and mechanistic drug failure. Most evidence pertains to infliximab and adalimumab. Multiple factors influence drug pharmacokinetics, affecting both target drug levels and the doses required to achieve them. These include inflammatory burden, bodyweight, age, disease phenotype, and route of administration, all of which are important considerations for individualising treatment in inflammatory bowel disease. This narrative review explores how special clinical situations—acute severe ulcerative colitis, perianal fistulising Crohn’s disease, hypoalbuminaemia, extremes of body composition, pregnancy, paediatrics, and advanced age—alter drug pharmacokinetics and influence the utility and interpretation of therapeutic drug monitoring in inflammatory bowel disease. Full article
(This article belongs to the Special Issue New Frontiers in Therapeutic Drug Monitoring of Biologics in Inflammatory Bowel Disease and Other Immune-Mediated Inflammatory Diseases: 2nd Edition)
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8 pages, 204 KB  
Review
Personalizing IL-23 Inhibitor Therapy in IBD: Current Evidence and Future Directions in Therapeutic Drug Monitoring and Dose Optimization
by Alessandro Pedicelli, Talat Bessissow and Waqqas Afif
J. Clin. Med. 2025, 14(21), 7471; https://doi.org/10.3390/jcm14217471 - 22 Oct 2025
Viewed by 1245
Abstract
Interleukin-23 (IL-23) inhibitors have rapidly become an essential component of the therapeutic armamentarium for inflammatory bowel disease (IBD). Risankizumab, mirikizumab, and guselkumab share broadly similar pharmacokinetic and pharmacodynamic properties, including linear clearance, long half-lives, and low immunogenicity. While therapeutic drug monitoring (TDM) is [...] Read more.
Interleukin-23 (IL-23) inhibitors have rapidly become an essential component of the therapeutic armamentarium for inflammatory bowel disease (IBD). Risankizumab, mirikizumab, and guselkumab share broadly similar pharmacokinetic and pharmacodynamic properties, including linear clearance, long half-lives, and low immunogenicity. While therapeutic drug monitoring (TDM) is well established in the use of anti-TNF agents, its role in IL-23 inhibitors remains undefined. Emerging evidence, mostly for risankizumab, demonstrates dose–response relationships, suggests potential maintenance thresholds, and outlines possible dose optimization strategies. However, this preliminary data is predominantly retrospective, often single-center, and involves a small number of patients. Until more robust evidence supporting the efficacy of TDM and dose optimization emerges, routine use of this clinical practice in IBD remains investigational. Full article
(This article belongs to the Special Issue New Frontiers in Therapeutic Drug Monitoring of Biologics in Inflammatory Bowel Disease and Other Immune-Mediated Inflammatory Diseases: 2nd Edition)
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