Frank Hoentjen

Background: Corticosteroids induce remission in ulcerative colitis (UC) but are associated with adverse effects, including prednisone ⩾20 mg/day associated with serious COVID-19 outcomes. Objectives: To evaluate the risk of rescue prednisone use following budesonide multimatrix system (MMX) initiation in newly diagnosed individuals with UC before and during the COVID-19 pandemic. Design: Population-based cohort study. Methods: We conducted a population-based study in Alberta, Canada, identifying adults with incident UC (2018–2022). Courses of budesonide MMX were examined for treatment failure, defined as prednisone rescue or inflammatory bowel disease-specific hospitalization within 90 days. Outcomes were compared between prepandemic (before April 2020) and pandemic periods using Cox proportional hazards models. Results: Among 269 dispensings of budesonide MMX (38 with multiple courses), 30.5% required rescue prednisone and 6.7% resulted in hospitalization. Budesonide MMX dispensing declined during the pandemic wherein, the hazard of prednisone rescue increased (HR 1.64; 95% CI: 1.01–2.67). Conclusion: Budesonide MMX was prescribed less frequently during the COVID-19 pandemic, with increased treatment failure, underscoring pandemic-related disruptions in UC management.

Background: Ulcerative colitis (UC) is a chronic, relapsing inflammatory bowel disease that requires regular monitoring. The University of Alberta IBD Unit piloted a proactive outreach protocol for biologic-naïve UC patients, including clinical and biochemical variables, and assessed its impact on UC care. Methods: Biologic-naïve UC patients without follow-up for ≥6 months were recruited by phone and completed Partial Mayo, modified Sutherland Index, and MARS-5 questionnaires, as well as blood work and fecal calprotectin (FCP). Results were sent to each patient’s gastroenterologist, who then completed a survey about intended UC management changes. Results: 81 patients completed the protocol. UC management was changed in 45 (55.6%) cases, with 82.2% of changes being expedited follow-up or management escalation. Six patients had active flares, and 17 with asymptomatic inflammation were identified. 23 patients underwent endoscopy, with 10 (43.4%) showing active disease. Six patients started biologic therapies based on protocol and endoscopic findings. UC management escalations were significantly predicted by FCP and Sutherland Index scores on logistic regression analysis. 86.4% of gastroenterologists rated the protocol helpful. Conclusions: Patient care can be improved by a one-time, proactive outreach program for biologic-naïve UC. Outreach and monitoring in biologic-naïve UC should include assessment of both FCP and clinical markers to improve UC management.

Background: There are limited data on colorectal cancer (CRC) risk after high‐grade dysplasia in inflammatory bowel disease. Aims: To determine the long‐term CRC and neoplasia risk after a first diagnosis of high‐grade dysplasia in inflammatory bowel disease, and to assess utilisation of high‐grade dysplasia treatment strategies over the past three decades. Methods: In this nationwide retrospective cohort study, patients with colonic inflammatory bowel disease and high‐grade dysplasia diagnosis between 1991 and 2021 were extracted from the Dutch nationwide pathology databank (PALGA). The primary outcome was the cumulative incidence of metachronous CRC. Kaplan–Meier curves were used to show proctocolectomy‐free survival per decade. Results: CRC was diagnosed in 348 of 1220 patients (28.5%). Of these, 204 (16.7%) were diagnosed with CRC within 6 months after the first high‐grade dysplasia diagnosis and were considered synchronous patients. Metachronous CRC was diagnosed in 144 of 1016 patients (14.2%) after a median of 3.6 years. The 1‐, 5‐ and 10‐year cumulative incidences of metachronous CRC after high‐grade dysplasia were 2.9%, 9.9% and 15.5%, respectively. The 1‐, 5‐ and 10‐year cumulative incidences of metachronous neoplasia were 18.3%, 51.2% and 68.0%, respectively. Proctocolectomy‐free survival after high‐grade dysplasia decreased over time. Conclusions: The risk of synchronous and metachronous CRC after a diagnosis of high‐grade dysplasia underlines the high‐risk profile of this subgroup of patients with inflammatory bowel disease. The possible advantages of colon‐sparing treatment should be balanced with the higher risk of metachronous CRC and the subsequent need for stringent endoscopic surveillance.

Background: Individuals with inflammatory bowel disease (IBD) require comprehensive care to address the physical and psychosocial burden of their disease. The demand for IBD care often exceeds availability, resulting in delayed access and suboptimal management. As a result, patients with IBD are required to self-manage significant aspects of their disease between appointments with their medical team. Digital self-management tools may help address this gap by empowering patients to be more engaged in managing their disease, potentially improving outcomes and reducing the strain on the health care system. Objective: This study aimed to design, implement, and evaluate a bundled digital health tool, MyIBDToolkit, with the overarching goal of improving the quality of care and self-management for patients with IBD in Alberta, Canada. Methods: A bundled digital health tool, MyIBDToolkit, will be integrated into our provincial electronic health record system to ensure broad accessibility and continuity of care. We will use a type 2 hybrid effectiveness-implementation design to evaluate both the clinical impact and real-world integration of the toolkit. We will assess effectiveness through changes in key outcomes such as health care utilization (eg, emergency visits, hospitalizations), disease burden on patients (eg, quality of life, symptom control), and burden on the health care system. These outcomes will be measured using comprehensive health care administrative data. A dual-comparison approach will be used: a within-subject comparison of health care utilization and disease burden before and after implementation of the MyIBDToolkit, and a between-group comparison of outcomes among toolkit users versus nonusers. To evaluate implementation success, we will examine reach (ie, number of patients and providers using the tool), fidelity to the planned timeline, sustained use over time, and factors influencing adoption and maintenance. Our goal is to reach 10,000 patients across Alberta, Canada, within three years. Results: We received funding for this project in January 2023. In preparation for the pilot launch, we have identified key stakeholders, including patients, health care providers and, administrators, and developed strategies to assess their readiness for MyIBDToolkit. We are also collecting mixed-methods data from patients to explore potential barriers and facilitators to using MyIBDToolkit. The first phase of MyIBDToolkit was launched in October 2024. Conclusions: MyIBDToolkit represents a scalable and patient-centered approach to the self-management of IBD care. By empowering patients to self-manage their disease between health care visits, we aim to reduce the burden of IBD on patients, providers, and the health care system. By evaluating the effectiveness and the implementation of the MyIBDToolkit, we aim to generate actionable and sustainable improvements to IBD care in Alberta.

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. Primary outcomes were cumulative rates of clinical and endoscopic response and remission at 6 and 12 months. Secondary outcomes included serious adverse events and infections. Cox-proportional hazard analyses identified independent predictors of treatment effectiveness. RESULTS: We included 105 IBD patients (76 Crohn's disease, 29 ulcerative colitis) with median age 35 years (Interquartile Range 35.4–40.8). At baseline, 39% had perianal involvement, 58% had failed at least 3 advanced therapies, and 40% had previous surgery. The primary reason for ACT was refractory IBD (63.8%), with the add-on approach used in 97.1% cases. The most frequent combination was antitumor necrosis factor + anti-integrin. At 12 months, cumulative rates of clinical and endoscopic response were 60.0% and 32.4%, respectively, and remission rates were 29.5% and 28.6%. Perianal disease was associated with reduced clinical remission (hazard ratio [HR] = 0.33, 95% confidence interval [CI]: 0.17–0.65, P = 0.001) and endoscopic response (HR = 0.42, 95% CI: 0.12–0.50, P = 0.001). Longer disease duration (HR = 0.96, 95% CI: 0.92–0.99, P = 0.035) and baseline steroid use (HR = 0.39, P = 0.006) was associated with reduced clinical remission. Serious adverse events and infections occurred in 12.4% and 7.6% of patients, respectively. DISCUSSION: ACT was effective in achieving clinical and endoscopic outcomes in patients with refractory IBD or concomitant immune-mediated diseases/EIMs, with favorable safety profile.

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. Enrolment is planned for ~250 participants in Canada/USA, randomised 1:1 to switching to alternative advanced therapy or continuing index advanced therapy, and then followed 104 weeks within routine clinical practice. Patient-reported outcomes measure efficacy and quality of life/treatment burden/safety. Primary endpoint is the time from randomisation to treatment failure. Ethics and dissemination The study is conducted in compliance with the protocol, ICH Good Clinical Practice, applicable regulatory requirements and appropriate review boards/independent ethics committees (approval numbers: Pro00077486; Pro00061437; STUDY00002062; 22-004171; i22-01269; IRB22-0890; IRB_00154397; 2000032384; SHIRB#2022.095-2; STUDY00007146; MMC#2024-18; REB#125290; 17784; Pro00142214; 20240660-01H), with documented written informed consent. Findings will be disseminated through peer-reviewed journals, scientific presentations, and publicly available Patient-Centered Outcomes Research Institute (PCORI) websites, including lay summaries. The Crohn’s & Colitis Foundation Education, Support, and Advocacy Department, and our patient advocacy stakeholder, will develop educational and marketing resources to communicate findings to a broad audience (>250 000 patients/caregivers/healthcare professionals). Trial registration number NCT05230173.