Pharmacotherapy of Inflammatory Bowel Disease, 2nd Edition

A special issue of Pharmaceuticals (ISSN 1424-8247). This special issue belongs to the section "Pharmacology".

Deadline for manuscript submissions: 25 July 2026 | Viewed by 1001

Special Issue Editor


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Guest Editor
Clinic for Internal Medicine and Gastroenterology, Protestant Hospital Kalk, University of Cologne, Cologne, Germany
Interests: inflammatory bowel disease; Crohn's disease (IBD); ulcerative colitis; controlled trials in IBD; observations in rare manifestations of IBD; pharmacological studies; studies on pathogenesis of IBD
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Special Issue Information

Dear Colleagues,

Successful treatment of Inflammatory Bowel Diseases (IBD) is characterised by two challenges: the wide range of miscellaneous clinical manifestations requiring individual therapeutic strategies and the permanent advent of novel therapeutic compounds. Given the ongoing scientific work on the pathogenesis of IBD, development of pharmacological immune modulation has become a predominant focus for research groups and the pharmaceutical industry. Starting with classic immunosuppressants, the development of antibodies, oligonucelotides, and, more recently, small molecules has substantially expanded the range of pharmaceuticals available for IBD. In addition, new insights into traditional drugs have reaffirmed their value as effective remedies in daily clinical practice.

Multifaceted new therapeutic options increase the opportunities available to both patients and physicians in clinical practice. However, this expansion must be accompanied by skill enhancement grounded in scientific discussions published by experts in the field.

The aim of this Special Issue is to provide our readers with concise yet comprehensive and up-to-date reviews on the conservative management of various manifestations of IBD.

Prof. Dr. Wolfgang Kruis
Guest Editor

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Keywords

  • treatment of Crohn's Disease
  • treatment of ulcerative colitis
  • mesalamine for ulcerative colitis
  • mesalamine for Crohn's Disease
  • antibody strategies in IBD
  • small molecules for IBD
  • conservative management of Crohn's fistula
  • therapy for extraintestinal manifestations
  • new endpoints for treatment

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Published Papers (1 paper)

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15 pages, 1247 KB  
Case Report
Off-Label Ustekinumab and Vedolizumab in Pediatric Anti-TNFα Refractory IBD: Therapeutic Drug Monitoring Insights from a Case Series
by Stefania Cheli, Giulia Mosini, Vera Battini, Carla Carnovale, Sonia Radice, Marta Lebiu, Alessandro Cattoni, Giovanna Zuin and Emilio Clementi
Pharmaceuticals 2026, 19(1), 154; https://doi.org/10.3390/ph19010154 - 15 Jan 2026
Viewed by 696
Abstract
Background: Vedolizumab and ustekinumab are increasingly used off-label in pediatric inflammatory bowel disease (IBD) unresponsive or refractory to anti–TNFα therapy. Despite their increasing use in clinical practice, evidence in the pediatric population remains limited, especially regarding therapeutic exposure thresholds and the clinical [...] Read more.
Background: Vedolizumab and ustekinumab are increasingly used off-label in pediatric inflammatory bowel disease (IBD) unresponsive or refractory to anti–TNFα therapy. Despite their increasing use in clinical practice, evidence in the pediatric population remains limited, especially regarding therapeutic exposure thresholds and the clinical utility of therapeutic drug monitoring (TDM). Methods: We report a series of five pediatric cases with Crohn’s disease or ulcerative colitis treated with ustekinumab or vedolizumab after anti-TNFα failure. Trough drug concentrations, anti-drug antibodies (ADAs), clinical scores (PCDAI/PUCAI), biomarkers (fecal calprotectin, C-reactive protein), and endoscopic findings were assessed longitudinally. Results: In all cases, we observed recurrent discordance between clinical indices (PCDAI/PUCAI), biochemical markers, and endoscopic activity. Clinical improvement frequently correlated with trough concentrations above commonly cited adult-derived reference ranges (>15 µg/mL for vedolizumab; >3 µg/mL for ustekinumab), although this alignment was not uniform across patients. Notably, one patient developed high-titre ADAs with undetectable ustekinumab levels, yet remained clinically stable, suggesting substantial interindividual variability in pharmacokinetics, immunogenicity, and disease control. Conclusions: Ustekinumab and vedolizumab are promising off-label options for pediatric refractory IBD. In this case series, TDM contributed to the interpretation of pharmacokinetic variability and immunogenicity, offering contextual insights that may support dose adjustments and therapeutic decision-making. Integrating TDM with clinical, biochemical, and endoscopic monitoring may improve optimize individualized treatment in this complex and vulnerable patient group. Full article
(This article belongs to the Special Issue Pharmacotherapy of Inflammatory Bowel Disease, 2nd Edition)
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