Pharmacotherapy of Inflammatory Bowel Disease, 2nd Edition

A Special Issue of Pharmaceuticals (ISSN 1424-8247) belonging to the section "Pharmacology".

Deadline for manuscript submissions: closed (25 July 2026) | Viewed by 1935

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 (2 papers)

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16 pages, 392 KB  
Article
Towards Precision Medicine in Inflammatory Bowel Diseases: Pharmacogenetic Predictors of Ustekinumab Effectiveness and Persistence
by Ylenia Marino, Michelangelo Rottura, Claudia Ligresti, Antonio Battaglia, Clara De Francesco, Natasha Irrera, Vincenzo Arcoraci, Walter Fries, Anna Viola and Giovanni Pallio
Pharmaceuticals 2026, 19(9), 1428; https://doi.org/10.3390/ph19091428 - 10 Sep 2026
Abstract
Background/Objectives: Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), show substantial variability in response to biologic therapies. Ustekinumab, which targets the IL-12/23 pathway, is an established treatment for moderate-to-severe IBD; however, a proportion of patients fail to achieve [...] Read more.
Background/Objectives: Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), show substantial variability in response to biologic therapies. Ustekinumab, which targets the IL-12/23 pathway, is an established treatment for moderate-to-severe IBD; however, a proportion of patients fail to achieve sustained remission or discontinue treatment over time. This study aimed to evaluate the effectiveness and persistence of ustekinumab and to explore the potential role of pharmacogenetic markers in predicting treatment outcomes. Methods: In this observational cohort study, 98 IBD patients treated with ustekinumab, with or without corticosteroid bridge therapy, in routine clinical practice were enrolled. The primary endpoint was steroid-free remission (SFR) at 12 months, defined as clinical remission without concomitant corticosteroid use, whereas treatment discontinuation was evaluated during follow-up. Genomic DNA was extracted from peripheral blood samples, and four single-nucleotide polymorphisms (SNPs) in selected immune-related genes were analyzed: PTPN2 rs7234029, HLA-C rs10484554, IL23R rs11209026, and IL12B rs6887695. Results: Of the 98 patients included, 73 (74.5%) achieved SFR, whereas 25 (25.5%) did not. Carriers of IL12B rs6887695 variant genotypes showed higher odds of achieving SFR than wild-type patients after adjustment for disease type and baseline disease activity (OR = 4.77; 95% CI, 1.60–14.23; p = 0.005). During follow-up, 16 patients (16.3%) discontinued treatment. Carriers of IL12B rs6887695 variant genotypes also showed a significantly lower hazard of ustekinumab discontinuation than wild-type patients (HR = 0.29; 95% CI, 0.10–0.85; p = 0.024). Conclusions: This study provides real-world evidence supporting the effectiveness and persistence of ustekinumab in IBD patients. IL12B rs6887695 emerged as a potential pharmacogenetic marker associated with favorable ustekinumab outcomes; however, this exploratory and hypothesis-generating finding requires external validation in larger, independent cohorts before clinical application. Full article
(This article belongs to the Special Issue Pharmacotherapy of Inflammatory Bowel Disease, 2nd Edition)
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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
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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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