International Magnetic Resonance Imaging Consensus for use in Luminal Crohn's Disease Trials and Clinical Practice.

Background And Aims: Cross sectional imaging is an integral part of evaluating disease activity and complications in Crohn's disease. There remains a need to develop guidance that may be for both clinical trials and clinical practice. This initiative aimed to develop consensus statements for definitions of response and remission, transmural healing, optimal timing for assessing, and evaluation of treatment efficacy in patients with Crohn's disease using magnetic resonance enterography (MRE) in clinical trials and clinical practice.

Is Transmural Healing an Achievable Goal in Inflammatory Bowel Disease?

: In the era of treat-to-target strategies in inflammatory bowel disease (IBD), transmural healing (TH) is gaining recognition as a promising therapeutic goal. TH has been associated with significantly better long-term outcomes, including reduced rates of hospitalization, surgery, and the need for therapy escalation. Cross-sectional imaging techniques, such as intestinal ultrasound (IUS), magnetic resonance imaging (MRI), and computed tomography enterography (CTE), offer a comprehensive, non-invasive means to assess this deeper level of healing.

Sub-cutaneous infliximab for perianal Crohn's disease: the BioLap-Rem multicentre study from the GETAID.

Background And Aims: Intravenous infliximab (IFX) is the cornerstone for treating patients with perianal Crohn's disease (pCD). Data on the recently launched subcutaneous (SC) IFX for pCD are limited. The aim of our study was to evaluate the effectiveness and safety of SC IFX in pCD.

Comparing standard versus intensified pneumococcal vaccination regimens in patients with inflammatory bowel disease on biologics: a prospective, multicenter, randomized, open-label study.

Background And Aims: Pneumococcal vaccination is essential for patients with inflammatory bowel diseases (IBD), but its efficacy is reduced in those on antitumor necrosis factor (TNF) or immunosuppressive therapy. This study compared immune responses to standard versus intensified pneumococcal vaccination strategies in IBD patients receiving anti-TNF (±immunosuppressors) or vedolizumab.

Methods: In a prospective, multicenter, randomized open-label study across 7 French university hospitals, IBD patients in clinical remission on biologic therapy (anti-TNF ± immunosuppressors, or vedolizumab) were randomized 1:1 to an intensified (PCV13/PCV13/PPSV23) or standard (PCV13/PPSV23) regimen.

Treatment sequencing in inflammatory bowel disease: Towards clinical precision medicine.

Inflammatory bowel diseases, including Crohn's disease and ulcerative colitis, raise ongoing challenges in clinical management due to their variable courses and impact on patient quality of life. The emergence of advanced therapies, from biologics to small molecules, has prompted the need for effective sequencing strategies to optimize patient outcomes. To this date, there is no algorithm for treatment sequencing and physicians must select the safest and most effective treatment according to each individual patient.

Biobetters and biosimilars in inflammatory bowel disease.

Biological therapies have revolutionized the management of inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC). Among these, biosimilars and biobetters represent a growing area of therapeutic development. Biosimilars are nearly identical copies of original biologic drugs (reference products) with comparable safety, efficacy, and quality, but they offer the advantage of reduced costs and broader access.

Treatment targets in IBD: is it time for new strategies?

Inflammatory bowel diseases' traditional management focused primarily on symptom control, often failing to prevent long-term complications such as disease progression, disabilities, hospitalizations and surgeries. The introduction of biologics and small molecules has revolutionized IBD management, enhancing inflammation control. A pivotal advance in this field is represented by the Treat-to-Target approach, which prioritizes the achievement of specific goals like endoscopic remission and biomarker normalization, thus moving beyond symptomatic relief.

Comparison of the FDA and EMA guidance on drug development in ulcerative colitis: an expert panel review.

Background And Aims: The Food and Drug Administration (FDA) and European Medicines Agency (EMA) ensure the safety, efficacy, and security of treatments, including therapies for immune-mediated disorders such as inflammatory bowel disease (IBD). Their clinical trial guidelines aid sponsors in designing robust studies. While the EMA updated its guidelines for ulcerative colitis (UC) in 2018, the FDA issued new recommendations in April 2022.

Bowel Urgency in Crohn's Disease: Effects of Mirikizumab in a Randomized Controlled Phase 3 Study.

Background And Aims: Bowel urgency (BU) is an underrecognized and debilitating symptom of Crohn's disease. Mirikizumab, an interleukin-23p19 inhibitor, is efficacious for BU resolution in ulcerative colitis. We evaluated the efficacy of mirikizumab in achieving early BU response and remission among participants with Crohn's disease enrolled in the phase 3 VIVID-1 study.

The Role of Vitamin D in Inflammatory Bowel Diseases: From Deficiency to Targeted Therapeutics and Precise Nutrition Strategies.

Background: Vitamin D plays a crucial role in immune modulation, gut barrier integrity, and inflammation regulation, making it highly relevant in inflammatory bowel disease (IBD). IBD patients often exhibit vitamin D deficiency, which has been linked to increased disease activity, impaired mucosal healing, and a higher risk of complications, including infections and osteoporosis.

Methods: This review examines the biological functions of vitamin D in maintaining intestinal homeostasis, particularly in the context of IBD.

The preclinical discovery and development of upadacitinib for the treatment of Crohn's disease.

Introduction: The JAK-STAT pathway plays a pivotal role in immune regulation and is implicated in the pathogenesis of Crohn's disease (CD). Upadacitinib is a JAK inhibitor with greater selectivity for JAK1 over JAK2 and JAK3, and is emerging as a promising alternative to biologic therapies in CD.

Areas Covered: A literature search of MEDLINE and EMBASE up to February 2025 was conducted using defined keywords to identify preclinical, clinical, and real-world studies on upadacitinib in CD.

JAK Inhibitors and Risk of Cancer in IBD Patients.

Janus kinase inhibitors, including tofacitinib, filgotinib, and upadacitinib, have emerged as effective therapeutic options for the management of inflammatory bowel diseases (IBDs). By targeting the JAK-STAT signaling pathway, these agents modulate immune responses and reduce inflammation. However, concerns regarding the potential risk of malignancy associated with their use have gained significant attention.

Positioning Guselkumab in The Treatment Algorithm of Patients with Crohn's Disease.

Guselkumab, a selective interleukin-23 (IL-23) inhibitor, has emerged as a promising biologic therapy for the management of patients with moderate-to-severe Crohn's disease (CD) and has been recently approved for its treatment. Unlike conventional therapies, guselkumab offers a different mechanism of action by selectively inhibiting IL-23, a key cytokine implicated in the pathogenesis of CD. IL-23 drives intestinal inflammation through activation of the Th17 cell pathway and other immune processes, positioning IL-23 inhibition as a critical therapeutic approach.

An International Consensus on Appropriate Management of Corticosteroids in Clinical Trials in Inflammatory Bowel Disease.

Background & Aims: Approval of new therapies for inflammatory bowel disease (IBD) requires rigorously designed and well-executed randomized controlled trials (RCTs). Corticosteroids remain a cornerstone of IBD induction therapy, and many patients in trials are enrolled while taking corticosteroids. Despite this, approaches to corticosteroid management in RCTs have been highly heterogeneous, often differing from clinical practice.

Advanced Therapies for Inflammatory Bowel Disease and Risk of Skin Cancer: What's New?

The introduction of biologic therapies and small molecule drugs has revolutionized the management of inflammatory bowel disease (IBD), providing targeted control of inflammation. However, concerns remain regarding their long-term safety profiles, particularly in relation to cancer risk. Chronic inflammation and immunosuppressive therapies contribute to malignancy risk, including skin cancers, such as melanoma and non-melanoma skin cancer (NMSC).

Obefazimod in patients with moderate-to-severely active ulcerative colitis: efficacy and safety analysis from the 96-week open-label maintenance phase 2b study.

Background And Aims: Obefazimod is an oral small molecule that selectively enhances the expression of a single micro-RNA (miRNA), miR-124. Obefazimod has demonstrated safety and efficacy in patients with moderate-to-severely active ulcerative colitis (UC) in a phase 2b induction trial. This analysis presents the 2-year outcome data of the open-label maintenance (OLM) study.

PErsistence and Safety of Subcutaneous Infliximab 1 Year After Switch From Intravenous Route in IBD Patients in REMission.

Background And Aims: Real-life data regarding inflammatory bowel disease (IBD) evolution after switch from intravenous infliximab (IV-IFX) to subcutaneous infliximab (SC-IFX) is necessary. The aim of this prospective multicenter cohort study was to describe the persistence, effectiveness and tolerance of SC-IFX after switch from IV-IFX.

Methods: IBD patients in steroid-free clinical remission for at least 6 months on IV-IFX were enrolled in a prospective national French cohort when they switched to SC-IFX.

Factors associated with response to filgotinib and the prognostic power of faecal calprotectin for ulcerative colitis in the phase 2b/3 SELECTION trial.

Background: Patients with moderately to severely active ulcerative colitis have distinct filgotinib response trajectories.

Aims: Evaluate factors associated with response to filgotinib over time.

Methods: Patients from SELECTION (NCT02914522) receiving filgotinib 200 mg (FIL200) or 100 mg (FIL100), or placebo were included.

Developing IBD Outcome Effect Size Thresholds to Inform Research, Guidelines, and Clinical Decisions.

Background: When designing clinical trials, interpreting trial outcomes for guideline development or sharing decisions with patients in clinical practice, the clinical outcomes used and the implicit choices on what constitutes a clinically significant finding can vary greatly. This can lead to diversity or even inequity in care offered to patients with inflammatory bowel disease (IBD). The GRADE approach to guideline development has proposed a process to address this prospectively to solve these issues, but this has never been used in IBD.

Deucravacitinib in patients with inflammatory bowel disease: 12-week efficacy and safety results from 3 randomized phase 2 studies in Crohn's disease and ulcerative colitis.

Background And Aims: Tyrosine kinase 2 is a downstream intracellular mediator of interleukin-23 signaling, which has a key role in the pathogenesis of inflammatory bowel disease. Deucravacitinib is a novel, oral, selective, allosteric tyrosine kinase 2 inhibitor currently approved for the treatment of adults with moderate to severe plaque psoriasis.

Methods: Here we describe 3 randomized, double-blind, placebo-controlled phase 2 studies of deucravacitinib in patients with moderately to severely active Crohn's disease (LATTICE-CD [NCT03599622]) or ulcerative colitis (LATTICE-UC [NCT03934216] and IM011-127 [NCT04613518]).

Medical Therapy for Acute Severe Ulcerative Colitis: A Systematic Review With Meta-analysis.

Background & Aims: Acute severe ulcerative colitis (ASUC) is a medical emergency associated with high morbidity and mortality. We aimed to assess the efficacy and safety of medical treatments for ASUC.

Methods: MEDLINE, EMBASE, and CENTRAL were searched to November 14, 2024 for randomized controlled trials (placebo or active comparator), and comparative cohort studies that evaluated medical therapies for hospitalized adults with ASUC.

Distribution of epithelial endoplasmic reticulum stress-related proteins in adult and pediatric Crohn's disease: Association with inflammation and fibrosis.

Background/aims: Intestinal strictures in Crohn's disease (CD), driven by fibrosis remain challenging to treat. Current treatments focus on inflammation, but are less effective against fibrosis. Endoplasmic Reticulum Stress-Related Proteins, including Protein disulfide isomerases (PDIs), may contribute to fibrosis; their roles in CD remain unclear.

Shaping the future of inflammatory bowel disease: a global research agenda for better management and public health response.

Inflammatory bowel disease (IBD) is a growing global health challenge affecting more than 7 million people worldwide. With increasing prevalence across all age groups, including children and adolescents, IBD places substantial strain on health-care systems and society, resulting in high direct medical costs, lost productivity and reduced quality of life. Despite therapeutic advances, suboptimal disease control and delays in timely diagnosis and adequate treatment persist.