Impact of Concomitant Corticosteroid Use on Adverse Events in Ulcerative Colitis Clinical Trials.

Background And Aims: Adverse events (AEs) are frequently reported in clinical trials of advanced therapies for ulcerative colitis (UC). It remains uncertain whether patients receiving concomitant corticosteroids experience higher AE rates. This study aimed to determine whether corticosteroid use is associated with increased AEs in UC trials.

Ultra-Processed Grains and Risk of Inflammatory Bowel Disease: Results from the Prospective Urban Rural Epidemiology (PURE) Study.

Background: Ultra-processed grains, commonly consumed in Western diets, undergo refining processes that often remove beneficial components and include additives to enhance taste, texture, or durability, potentially influencing gastrointestinal health. This study examines the association between ultra-processed grain consumption and the risk of developing IBD using data from the Prospective Urban Rural Epidemiology (PURE) study.

Methods: This analysis included 124,590 participants from 21 countries who had dietary data available in the PURE study.

Network Meta-Analysis: Comparative Efficacy of Biologics and Small Molecules in the Induction and Maintenance of Remission in Crohn's Disease.

Background: Advances in medical management of Crohn's disease (CD) have transformed therapeutic goals. Clinical and endoscopic remission are important endpoints.

Aim: To compare the efficacy of different advanced therapies in patients with CD.

Impact of diet on inflammatory bowel disease risk: systematic review, meta-analyses and implications for prevention.

Background: Data on dietary risk factors for inflammatory bowel disease (IBD), while extensive, are inconsistent. Our aim was to systematically review and meta-analyze available data unraveling the relationship between diet and IBD subtypes, Crohn's disease (CD) and ulcerative colitis (UC).

Methods: We conducted a systematic literature review following PRISMA guidelines, from inception to May 8 2025, using OVID Medline, Embase, and Scopus databases, to identify prospective cohorts of healthy participants, on the association between diet and the risk of CD or UC.

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.

Validation of the Modified Multiplier of SES-CD (MM-SES-CD) to Predict Endoscopic Healing in Crohn's Disease: A Post Hoc Analysis of the SEAVUE Trial.

Background: The modified multiplier of the SES-CD (MM-SES-CD) has been shown to predict future endoscopic healing (EH) in patients with Crohn's disease. The purpose of this study was to validate baseline MM-SES-CD categories of severity and determine their prognostic value for predicting 1-year EH.

Methods: Participants in the SEAVUE trial (n = 386) were classified based on baseline endoscopic disease severity using MM-SES-CD cut-offs as mild (≥ 22.

Comparative Predictive Utility of MM-SES-CD and SES-CD for Week 52 Endoscopic Remission in the Ileum and Colon in Crohn's Disease.

Background: The Simple Endoscopic Score for Crohn's disease (SES-CD) and Modified Multiplier of the SES-CD (MM-SES-CD) are endoscopic scoring systems used to assess disease severity and response to therapy in CD. This study evaluates their utility at baseline in predicting endoscopic remission (ER) of the ileum and colon at week 52.

Methods: This post-hoc analysis of 4 clinical trials (CT-P13, UNITI, EXTEND, and SEAVUE) compared baseline scores and ER outcomes at week 52 using the SES-CD and MM-SES-CD.

Effectiveness and Safety of Advanced Combination Treatment in Patients With Refractory Inflammatory Bowel Disease or Concomitant Immune-Mediated Disease or Extraintestinal Manifestations: A Multicenter Canadian Study.

Introduction: Owing to the therapeutic ceiling associated with inflammatory bowel disease (IBD) therapies, some patients may require 2 advanced therapeutic agents, known as advanced combination treatment (ACT) to control disease or treat associated extraintestinal manifestations (EIMs).

Methods: We included adult patients with IBD from 9 Canadian centers treated with either 2 biological therapies, a biological plus an oral small molecule, or 2 small molecules. Indications for ACT were the following: (i) refractory IBD, (ii) uncontrolled immune mediated diseases, and (iii) uncontrolled EIMs.

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.

Treat-to-target of endoscopic remission in patients with inflammatory bowel disease in symptomatic remission on advanced therapies (QUOTIENT): rationale, design and protocol for an open-label, multicentre, pragmatic, randomised controlled trial.

Introduction: Targeted immunomodulators (eg, advanced therapies) effectively achieve symptomatic remission in patients with inflammatory bowel disease (IBD). However, ~25%-50% of patients with IBD achieving symptomatic remission with an advanced therapy may have continued endoscopically/radiologically active bowel inflammation, and it is uncertain whether changing alternative advanced therapies in asymptomatic patients with IBD will reduce bowel inflammation and achieve durable deep remission.

Methods And Analysis: The QUality Outcomes Treating IBD to Target (QUOTIENT) study is an open-label, multicentre, pragmatic, randomised, controlled trial that aims to compare the efficacy and safety of switching to an alternative advanced therapy targeting endoscopic/radiological remission (treat-to-target) versus continuing the initial, or index, advanced therapy, in asymptomatic patients with IBD with moderate-to-severe endoscopic/radiological bowel inflammation.

Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management (The TRIUMPH Study).

Background: Tofacitinib is a rapidly acting Janus kinase (JAK) inhibitor with increasing evidence of effectiveness in patients with acute severe ulcerative colitis (ASUC). However, there are scarce prospective data analyzing the efficacy and rapidity of action in hospitalized ASUC.

Methods: The TRIUMPH study is a prospective open-label interventional trial of tofacitinib in hospitalized patients with ASUC conducted in 5 hospitals across Canada (Clinicaltrials.

Novel outcomes in inflammatory bowel disease.

Inflammatory bowel diseases (IBD), Crohn's disease (CD), and ulcerative colitis (UC) are lifelong chronic, relapsing, and remitting conditions that culminate in disease progression in many patients. Effective management of CD and UC requires consideration of both short- and long-term treatment outcomes. Historically, short-term outcomes such as clinical and endoscopic remission and symptom relief have been evaluated in clinical trials.

Definitions, diagnosis, and management of postoperative recurrence in Crohn's disease patients with permanent ileostomy-a systematic review and meta-analysis.

Background And Aims: Over 10% of patients with Crohn's disease require permanent ileostomy. We aimed to summarize the existing data on diagnosis, definitions of recurrence, and management of Crohn's disease patients with permanent ileostomy.

Methods: MEDLINE, Embase, and CENTRAL databases were searched from inception to February 6, 2024.

A Review of the Modified Multiplier of Simple Endoscopic Score for Crohn's Disease and How to Use It in Clinical Trials and Practice.

Endoscopic evaluation is valuable in the diagnosis, assessment, and management of Crohn's disease (CD). The Simple Endoscopic Score for CD (SES-CD) was created using a uniform, linear scoring scale of 0-3 for each of its 4 parameters at 5 anatomic locations and was designed to accurately indicate disease severity rather than predicting disease progression. There is evidence to suggest that all disease segments and parameters of the SES-CD do not have equal prognostic value for likelihood of achieving endoscopic remission.

Improvement in serum eosinophilia is observed in clinical responders to ustekinumab but not adalimumab in inflammatory bowel disease.

Introduction: In inflammatory bowel disease (IBD), the number of eosinophils increases in the lamina propria of the intestinal tract, but their specific patho-mechanistic role remains unclear. Elevated blood eosinophil counts in active IBD suggest their potential as biomarkers for predicting response to biological therapies. This study evaluates blood eosinophil count trends and their predictive value for clinical response and endoscopic improvement in patients with IBD receiving ustekinumab or adalimumab induction therapy.

Acceptability, feasibility, and impact of the MyGut digital health platform in the monitoring and management of inflammatory bowel disease.

Background: Digital health monitoring may help facilitate self-management strategies when caring for patients with inflammatory bowel disease (IBD).

Aims: This study investigated the feasibility of implementing the MyGut health application when caring for patients with IBD and evaluated whether its use improved health outcomes.

Methods: We conducted a prospective trial in 2 Canadian hospitals from 2020 to 2023.

Effectiveness of Ustekinumab for Patients With Moderate-to-Severe Ulcerative Colitis: A Multicenter Real-World Canadian Study.

Introduction: We aimed to evaluate the real-world effectiveness and safety of ustekinumab for the treatment of both bio-naive and bio-exposed ulcerative colitis patients in a real-world setting.

Methods: Retrospective, Canadian multicenter cohort study. Primary outcomes were clinical remission and endoscopic remission.

Corrigendum to "Differential efficacy of medical therapies for ulcerative colitis according to disease extent: patient-level analysis from multiple randomized controlled trials" volume 72, 102621.

[This corrects the article DOI: 10.1016/j.eclinm.

Use of Modified Multiplier of the Simple Endoscopic Score for Crohn's Disease Endoscopic Improvement Thresholds Enhances Effect Size Differentiation Between Adalimumab Versus Placebo: A Post Hoc Analysis of the EXTEND Trial.

Introduction: The Modified Multiplier of the Simple Endoscopic Score for Crohn's Disease (MM-SES-CD) refines the assessment of endoscopic CD severity by differentially weighting parameters in the original SES-CD. A threshold of <22.5 for MM-SES-CD suggests endoscopic remission (ER) and correlates with a low risk of long-term disease progression.

Perspectives on the sustained engagement with digital health tools: protocol for a qualitative interview study among people living with Inflammatory Bowel Disease or irritable bowel syndrome.

Introduction: Digital health tools can be beneficial in the care of patients with chronic conditions and have the potential for widespread impact as readily scalable and cost-effective health interventions. However, benefits are often contingent on users sustaining their engagement with these tools over time. Sustained engagement with digital health tools can be challenging, and high rates of attrition from digital interventions are common.

Interventions for Adjunctive Care in Patients With Inflammatory Bowel Disease and Permanent Ileostomy: A Systematic Review.

Background: The evidence for the management of patients with Crohn's disease (CD) and permanent ileostomy (PI) is limited. We aimed to summarize the interventional studies related to the provision of adjunctive ostomy care in this population.

Methods: MEDLINE, Embase, and Cochrane CENTRAL were searched from inception to January 5, 2024.

Placebo Rates in Crohn's Disease Randomized Clinical Trials: An Individual Patient Data Meta-Analysis.

Background & Aims: Understanding placebo rates is critical for efficient clinical trial design. We assessed placebo rates and associated factors using individual patient data from Crohn's disease trials.

Methods: We conducted a meta-analysis of phase 2/3 placebo-controlled trials evaluating advanced therapies in moderate to severe Crohn's disease (2010-2021).