Systematic Review on definitions of Intestinal Ultrasound Treatment Response and Remission in Inflammatory Bowel Disease.

Background: Intestinal ultrasound (IUS) is emerging as a valuable tool to assess treatment response in inflammatory bowel disease (IBD) clinical trials. This study details how IUS defines response and remission to evaluate treatment efficacy in IBD patients.

Methods: We conducted a comprehensive search of studies from 1984 to 31 March 2024, focusing on IUS use in assessing treatment efficacy in IBD.

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.

Tamuzimod in patients with moderately-to-severely active ulcerative colitis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 induction trial.

Background: Tamuzimod (VTX002) is a selective sphingosine 1-phosphate receptor 1 modulator in development for ulcerative colitis. We aimed to assess the safety and efficacy of tamuzimod in patients with moderately-to-severely active ulcerative colitis.

Methods: This double-blind, randomised, placebo-controlled, phase 2 induction trial was conducted at 122 centres across 15 countries in Asia, Europe, and North America.

Differential Efficacy of Advanced Therapies in Inducing Remission in Ulcerative Colitis Based on Prior Exposure to TNF Antagonists.

Background And Aims: We sought to ascertain how prior exposure to tumor necrosis factor (TNF) antagonists impacts treatment response with various classes of advanced therapies in patients with ulcerative colitis (UC), through a systematic review and meta-analysis.

Methods: Through a systematic review of multiple databases through June 30, 2024, we identified 17 randomized controlled trials in 8871 adults with moderate-severe UC who were treated with different advanced therapies vs placebo, and reported efficacy in induction of clinical remission, stratified by prior exposure to TNF antagonists. We calculated the ratio of odds ratio of achieving remission with active drug vs placebo, in TNF antagonist-naïve vs TNF antagonist-exposed patients.

Hypercoagulation after Hospital Discharge in Acute Severe Ulcerative Colitis: A Prospective Study.

Background & Aims: Venous thromboembolism is a serious complication during and following hospitalization with acute severe ulcerative colitis (ASUC). We evaluated serial thrombotic profiles of patients with ASUC from the point of hospitalization up to 12 weeks postdischarge and compared these with control patients with quiescent ulcerative colitis.

Methods: Twenty-seven patients with ASUC and 25 control patients with quiescent ulcerative colitis were recruited.

Discordance between MR enterography and endoscopic detection of Crohn's disease ileal strictures: evidence to inform recommendations.

Purpose: To evaluate correlation between terminal ileal (TI) stricture diagnosis at MR enterography (MRE) and ileocolonoscopy (IC) in patients with Crohn's disease (CD).

Methods: One hundred and four patients with CD (51% females; 41 ± 15 years) underwent IC and MRE within 3 months in this retrospective case-control study. Positive cases had TI strictures diagnosed by endoscopy (n = 35); or MRE (threshold small bowel dilation ≥ 3cm; n = 34).

Acute Severe Ulcerative Colitis: An International Delphi Consensus on Clinical Trial Design and Endpoints.

Background & Aims: Interventional clinical trials in acute severe ulcerative colitis (ASUC) are characterized by substantial heterogeneity due to a lack of consensus in several key areas of trial design-this impedes clinical research efforts to identify novel therapies. The objective of this initiative was to achieve the first consensus and provide clear position statements on ASUC trial design.

Methods: A modified Delphi consensus approach was employed with a panel of 20 clinicians with international representation and expertise in ASUC trial design and delivery.

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.

A randomized controlled trial of a through-the-scope stiffening wire to increase the depth of insertion during double-balloon enteroscopy.

Background And Aims: We investigated whether use of a stiffening wire increased insertion depth during double-balloon enteroscopy (DBE).

Methods: A total of 54 patients were randomized to the stiffening wire or the control group after reaching the maximum insertion depth using a conventional technique. Further advancement was then attempted.

Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study.

Background: Mirikizumab, a humanised monoclonal antibody that inhibits IL-23p19, is effective in moderate-to-severe ulcerative colitis. We aimed to evaluate the efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease.

Methods: VIVID-1 was a global phase 3, randomised, double-blind, double-dummy, placebo-controlled and active-controlled, treat-through study.

Meta-Analysis: Evaluating Placebo Rates Across Outcomes in Eosinophilic Oesophagitis Randomised Controlled Trials.

Background: High placebo responses have limited drug development in eosinophilic oesophagitis. The optimal configuration of trial outcomes is uncertain.

Aims: To inform more efficient future trial designs, to characterise clinical, endoscopic and histologic placebo responses in eosinophilic oesophagitis randomised controlled trials (RCTs).

Heterogeneity of definition of upper gastrointestinal tract in different guidelines of Crohn's disease: A scoping review.

Crohn's Disease (CD) can affect any part of the gastrointestinal (GI) tract, including the upper GI tract (UGIT). However, the definitions and classifications of upper GI CD (UGICD) vary. We conducted a scoping review to explore how UGIT and UGICD are defined and to assess the heterogeneity of these definitions in published CD guidelines, aiming to inform future initiatives for harmonizing definitions.

Psychometric evaluation of the Functional Assessment of chronic illness therapy-fatigue (FACIT-Fatigue) in adults with moderately to severely active Crohn's disease.

Purpose: To provide further evidence on the psychometric properties of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in moderately to severely active Crohn's disease (CD), and to determine thresholds for meaningful improvement in fatigue.

Methods: The FACIT-Fatigue is a 13-item patient-reported outcome measure (range, 0-52) assessing fatigue over the previous week. Using pooled data from the Phase 3 VIVID-1 study of moderately to severely active CD, psychometric properties of FACIT-Fatigue were evaluated up to Week 52.

Use of MM-SES-CD Endoscopic Improvement Thresholds Enhances Effect Size Differentiation between Adalimumab vs. Placebo: A Post-hoc Analysis of the EXTEND Trial.

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

Efficacy and safety of Advanced Combination Treatment in immune-mediated inflammatory disease: A systematic review and meta-analysis of randomized controlled trials.

Objectives: Advanced combination treatment (ACT), defined as a combination of at least 2 biologic agents, a biologic agent and an oral small molecule, 2 oral small molecules drug with different mechanisms of action is a proposed strategy to improve outcomes in patients with immune-mediated inflammatory disease (IMID). We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing ACT with monotherapy in patients with select IMIDs.

Methods: Through a systematic literature search, we identified 10 RCTs (n = 1154) comparing ACT with single agent therapy (monotherapy).

Risankizumab Is Associated With Normalization of Biomarkers in Patients With Crohn's Disease: Results From the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies.

Background And Aims: Normalization of high-sensitivity C-reactive protein [hs-CRP] and fecal calprotectin [FCP] are suggested Crohn's disease [CD] intermediate treatment targets. This analysis evaluates achievement of biomarker normalization and the relationship between improvements in biomarker concentrations and clinical and endoscopic outcomes among patients treated with risankizumab.

Methods: This post hoc analysis included patients with moderately to severely active CD and elevated baseline hs-CRP [> 5 mg/L] or FCP [> 250 µg/g] concentrations from the 12-week ADVANCE and MOTIVATE induction studies, and the 52-week FORTIFY maintenance study.

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.

IL-23 inhibition for chronic inflammatory disease.

Biological monoclonal antibody drugs inhibit overactive cytokine signalling that drives chronic inflammatory disease in different organ systems. In the last 10 years, interleukin (IL)-23 inhibitors have attained an important position in the treatment of psoriatic skin and joint disease as well as inflammatory bowel diseases. Addressing an upstream pathological mechanism shared between these disorders, this drug class has high efficacy rates and a durable response that extends dosing intervals up to 3 months.

International expert guidance for defining and monitoring small bowel strictures in Crohn's disease on intestinal ultrasound: a consensus statement.

Background: Diagnostic imaging using CT enterography, magnetic resonance enterography, and intestinal ultrasound are important tools in evaluating stricturing Crohn's disease. Definitions of strictures have been developed for CT enterography and magnetic resonance enterography. However, expert recommendations for definitions and treatment response of strictures on intestinal ultrasound are not available.

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).