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.

New Eczematous Eruption in Patients with Inflammatory Bowel Disease Who Stop Janus Kinase Inhibitors.

Objectives: Janus kinase inhibitors (JAKi) are small-molecule therapies used in inflammatory bowel disease (IBD). We describe eight patients with IBD who developed an eczematous eruption, presumed atopic dermatitis (AD), after stopping JAKi therapy.

Methods: This case series describes eight patients with IBD who developed de novo AD after withdrawal of JAKi therapy.

Real-World Experience of Upadacitinib Reinduction and High Dose Maintenance Therapy in Inflammatory Bowel Disease.

Background: Upadacitinib (UPA) is approved for the treatment of moderately to severely active Crohn's disease (CD) or ulcerative colitis (UC). Responders to UPA 45mg daily (QD) may lose response (LOR) after transition to lower maintenance doses. We describe our real-world experience of LOR, reinduction, and subsequent maintenance with UPA 45mg QD.

Comparative effectiveness of tofacitinib versus upadacitinib for the treatment of acute severe ulcerative colitis.

Background & Aims: Tofacitinib and upadacitinib are Janus kinase (JAK) inhibitors that are increasingly used for the treatment of acute severe ulcerative colitis (ASUC). However, comparative analyses of safety and effectiveness have not been performed for their use in this setting.

Methods: This multicenter, retrospective study enrolled hospitalized adult patients treated with tofacitinib or upadacitinib for ASUC between January 2019 and June 2024.

ACG Clinical Guideline Update: Ulcerative Colitis in Adults.

Ulcerative colitis is an idiopathic inflammatory disorder of unknown etiology that seems to be rising in incidence and prevalence throughout the world. These guidelines were developed to indicate the preferred approach to the management of adult patients with ulcerative colitis as established by valid scientific research and represent the official practice recommendations of the American College of Gastroenterology under the auspices of the Practice Parameters Committee. The scientific evidence for the recommendations made in these guidelines was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation process, assessing the quality of the evidence (high, moderate, low, or very low) and assigning a strength of recommendation based on its apparent clinical benefit (strong or conditional).

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.

Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn's disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials.

Background: Despite the availability of biological therapies, suboptimal disease control remains a problem for patients with Crohn's disease. We report the results of the GALAXI-2 and GALAXI-3 studies, which aimed to assess the efficacy and safety of intravenous induction followed by subcutaneous maintenance therapy with guselkumab over 48 weeks in adults with moderately to severely active Crohn's disease.

Methods: GALAXI-2 and GALAXI-3 were identically designed, phase 3, randomised, double-blind, triple-dummy, treat-through trials with active and placebo comparators.

Broad Impact of Bowel Urgency in Ulcerative Colitis and Crohn's Disease: US, European, and Japanese Patient and Healthcare Professional Perspectives from the Communicating Needs and Features of IBD Experiences (CONFIDE) Survey.

Introduction: Bowel urgency affects the quality of life of patients with Crohn's disease (CD) and ulcerative colitis (UC). This study used data from the Communicating Needs and Features of IBD Experiences (CONFIDE) survey to explore patient and healthcare professional (HCP) perceptions on the broad impacts of bowel urgency on patients' emotions and daily lives.

Methods: Online, quantitative, cross-sectional surveys were conducted among patients with moderate-to-severe UC or CD (defined based on previous treatment, steroid use, and/or hospitalization) and HCPs specialized in gastroenterology in Europe (France, Germany, Italy, Spain, UK), United States (US), and Japan.

Impact of moderate-to-severe ulcerative colitis and Crohn's disease on sexual activity: United States and European patient perspectives from the communicating needs and features of IBD experiences (CONFIDE) survey.

Background: Ulcerative colitis (UC) and Crohn's disease (CD) negatively affect patients' quality-of-life, and their impact on patients' sexual health is rarely addressed. This study assessed the impact of moderate-to-severe UC and CD on sexual activity using United States (US) and European data from the Communicating Needs and Features of IBD Experiences (CONFIDE) survey.

Methods: Online, quantitative, cross-sectional surveys were conducted among patients with moderate-to-severe UC or CD and health care professionals (HCPs).

Comparison Between Adalimumab and Infliximab in Perianal Crohn's Disease: A Systematic Review and Meta-Analysis.

Background And Aims: Anti-tumor necrosis factor therapy has been a mainstay of medical management of perianal Crohn's disease (CD). This systematic review and meta-analysis aimed to compare the efficacy of adalimumab (ADA) and infliximab (IFX) for the treatment of perianal fistulizing CD.

Methods: We searched PubMed, Embase, and Web of Science databases for studies that compared the efficacy of ADA with IFX for treatment of patients with perianal fistulizing CD.

Appropriate Use and Complications of Corticosteroids in Inflammatory Bowel Disease: A Comprehensive Review.

Corticosteroids are one of the most frequently prescribed medications for the management of inflammatory bowel disease. Although corticosteroids have a critical role for select cases for induction of remission, there is a notable risk of overuse and misuse of corticosteroids. This narrative review updates the evolving use of corticosteroids in the management of inflammatory bowel disease.

Histopathologic Evaluation and Single-cell Spatial Transcriptomics of the Colon Reveal Cellular and Molecular Abnormalities Linked to J-Pouch Failure in Patients With Inflammatory Bowel Disease.

Background & Aims: Total abdominal colectomy (TAC) with a staged ileal pouch-anal anastomosis (IPAA) is a common surgical treatment for ulcerative colitis (UC). However, a significant percentage of patients experience pouch failure, leading to morbidity. This retrospective case-control study identified histopathologic features of the TAC specimen associated with pouch failure and investigated the molecular mechanisms of this susceptibility using single-cell spatial transcriptomics.

A Guide to the Patient-Centric Use of Vedolizumab for Crohn's Disease.

Crohn's disease (CD) is a chronic, progressive, and debilitating disease characterized by inflammation of the gastrointestinal tract. It can have a significant impact on quality of life if not adequately controlled by appropriate treatment. In recent years, disease management strategies for CD have evolved from a focus on treating symptoms toward the additional goal of early treatment to modify disease progression and prevent bowel damage.

Development and validation of a novel Endoscopic ulcer Activity Score for Evaluation of Crohn's Disease (EASE-CD) using data from two randomised controlled trials.

Background: Endoscopy is essential for measuring luminal disease activity in Crohn's disease. Existing indices for evaluating endoscopic Crohn's disease activity are only modestly correlated with clinical disease activity, contain items with ambiguous definitions and poor interobserver reliability, and do not have validated thresholds for defining clinically relevant changes. To address these issues, we conducted a multiphase study to develop and validate a novel endoscopic index for Crohn's disease.

Microbiome mismatches from microbiota transplants lead to persistent off-target metabolic and immunomodulatory effects.

Fecal microbiota transplant (FMT) is an increasingly used intervention, but its suitability to restore regional gut microbiota, particularly in the small bowel (SB), must be questioned because of its predominant anaerobic composition. In human subjects receiving FMT by upper endoscopy, duodenal engraftment of anaerobes was observed after 4 weeks. We hypothesized that peroral FMTs create host-microbe mismatches that impact SB homeostasis.

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.

Diagnosis and Management of Upper Gastrointestinal Involvement in Adult Patients With Crohn's Disease: A Systematic Review.

Background & Aims: The diagnosis and management of ileocolonic Crohn's disease are well-established. In contrast, standardized guidance pertaining to the diagnosis and management of upper gastrointestinal Crohn's disease (UGICD) is lacking, despite its potentially severe consequences. This comprehensive systematic review describes the prevalence, clinical presentation, and medical and surgical management of involvement of the upper GI tract in adult patients with Crohn's disease.

US and European Patient and Health Care Professional Perspectives on Fatigue in Ulcerative Colitis and Crohn's Disease: Results From the Communicating Needs and Features of Inflammatory Bowel Disease Experiences Survey.

Background: Fatigue is a burdensome symptom of Crohn's disease (CD) and ulcerative colitis (UC). The Communicating Needs and Features of Inflammatory Bowel Disease Experiences (CONFIDE) study investigated how patients and health care professionals (HCPs) in the United States (US) and Europe (France, Germany, Italy, Spain, and the United Kingdom) perceived the experiences and impact of CD/UC-related symptoms.

Methods: Online, quantitative, cross-sectional surveys were conducted separately among patients with moderate-to-severe CD/UC (defined based on previous treatment, steroid use, and/or hospitalization) and HCPs who treated patients with CD/UC.

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]).

Global evolution of inflammatory bowel disease across epidemiologic stages.

During the twentieth century, inflammatory bowel disease (IBD) was considered a disease of early industrialized regions in North America, Europe and Oceania. At the turn of the twenty-first century, IBD incidence increased in newly industrialized and emerging regions in Africa, Asia and Latin America, while the prevalence in early industrialized regions continued to grow steadily. Changes in the incidence and prevalence denote the evolution of IBD across four epidemiologic stages: stage 1 (emergence), characterized by low incidence and prevalence; stage 2 (acceleration in incidence), marked by rapidly rising incidence and low prevalence; and stage 3 (compounding prevalence), where the incidence decelerates, plateaus or declines while the prevalence steadily increases.

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.

Efficacy and Safety of Mirikizumab in the Treatment of Moderately to Severely Active Ulcerative Colitis Regardless of Baseline Modified Mayo Score: Results From the Phase 3 LUCENT Trials.

Background: The modified Mayo score (mMS) is a measure for ulcerative colitis (UC) disease activity. Recent US Food and Drug Administration guidance for moderately to severely active UC trials suggests that patients should have baseline mMS of 5-9 including an endoscopy score of at least 2, as opposed to the previous range of 4-9. This disclosure reports results from patients with UC with baseline mMS of 5-9 who received mirikizumab, a monoclonal antibody directed against the interleukin-23 p19 subunit, or placebo in the phase 3 LUCENT trials.

Association of bile acid diarrhea with symptoms and disease activity in Crohn's disease: post-hoc clinical trial analysis of serum 7a-hydroxy-4cholestern-3-one, C4, in patients with active Crohn's disease.

Background And Aims: In Crohn's disease (CD), symptomatic and endoscopic assessments often show poor correlation. Bile acid malabsorption is a common comorbidity in these patients and often results in bile acid diarrhea (BAD). This post-hoc clinical trial analysis evaluated BAD presence and its association with symptoms and disease activity in patients with active CD.

Prevention and interception trials in inflammatory bowel disease: an international taskforce assessment on clinical trial design.

Therapeutic progress in inflammatory bowel disease (IBD) has hitherto focused on reducing inflammation to minimise long-term complications. However, strategies aimed at preventing IBD and attenuating its disease course are particularly appealing. This concept is derived from accumulating evidence for an "at-risk" preclinical state and the associations linking genetic background and numerous environmental exposures to disease pathogenesis.