The Bidirectional Relationship Between Sleep and Pain in Crohn's Disease: A Daily Diary Study.

Background: Pain is common in Crohn's disease (CD) even after endoscopic healing is achieved. Depression, sleep disturbances, fatigue, and worry about pain impact the pain experience. There is a bidirectional relationship between sleep and pain, though it has received minimal attention in CD.

Three-Year Efficacy and Safety of Mirikizumab Following 152 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study.

Background: Mirikizumab, a p19-directed interleukin-23 monoclonal antibody, has demonstrated induction of clinical remission at week 12 with maintenance through week 104 in patients with moderately-to-severely active ulcerative colitis (UC). Results are presented from the LUCENT-3 open-label extension study through week 152.

Methods: Of 868 LUCENT clinical trial program mirikizumab-treated induction patients, 544 were responders of whom 365 were rerandomized to mirikizumab maintenance.

A Hybrid Markov-SPC Approach to Assess Cost Differences in Urgent Care Utilization Using Patient-Reported Data in Inflammatory Bowel Disease.

Background: Cost is a key outcome in quality and value, but it is often difficult to estimate reliably and efficiently for use in real-time improvement efforts. We describe a method using patient-reported outcomes (PROs), Markov modeling, and statistical process control (SPC) analytics in a real-time cost-estimation prototype designed to assess cost differences between usual care and improvement conditions in a national multicenter improvement collaborative-the IBD Qorus Learning Health System (LHS).

Methods: The IBD Qorus Learning Health System (LHS) collects PRO data, including emergency department utilization and hospitalizations from patients prior to their clinical visits.

Treatment Pathways in Patients With Crohn's Disease and Ulcerative Colitis: Understanding the Road to Advanced Therapy.

Background: Patients with Crohn's disease (CD) or ulcerative colitis (UC) often cycle through conventional therapies (CT) with different mechanisms of action (MOA) before initiating advanced therapy (AT). We describe treatment patterns among patients with CD/UC.

Methods: Using Merative MarketScan Research databases, adult patients with CD/UC were identified from medical/pharmacy claims (2017-2021).

Benefit-Risk Trade-offs and Patient Preferences for Therapy Selection in Ulcerative Colitis: a Multicountry Preference Study.

Background: To help navigate the complex treatment landscape of ulcerative colitis (UC), we quantified the benefit-risk trade-offs that patients were willing to make when choosing treatment.

Methods: Patients completed an online discrete choice experiment. Eligible patients had a UC diagnosis for ≥6 months, were aged ≥18 years, and resided in France, Germany, Italy, Spain, or the UK.

When Perfect Is the Enemy of Good: Results of a RAND Appropriateness Panel on Treat to Target in Asymptomatic Inflammatory Bowel Disease.

Background: A treat-to-target strategy for inflammatory bowel disease (IBD) recommends iterative treatment adjustments to achieve clinical and endoscopic remission. In asymptomatic patients with ongoing endoscopic activity, the risk/benefit balance of this approach is unclear, particularly with prior exposure to advanced therapies.

Methods: Using the RAND/University of California Los Angeles Appropriateness Method, 9 IBD specialists rated appropriateness of changing therapy in 126 scenarios of asymptomatic patients with ulcerative colitis and Crohn's disease and active endoscopic disease.

Development and investigation of a non-invasive disease severity index for inflammatory bowel disease.

Introduction: The disease severity index (DSI) encapsulates the inflammatory bowel disease (IBD) burden but requires endoscopic investigations. This study developed a non-invasive DSI using faecal calprotectin (DSI-fCal) and faecal myeloperoxidase (DSI-fMPO) instead of colonoscopy.

Methods: Adults with IBD were recruited prospectively.

Clinical Decision Making in Inflammatory Bowel Disease Mimics: Practice Management from Inflammatory Bowel Disease LIVE.

Background: Since 2009, inflammatory bowel disease (IBD) specialists have utilized "IBD LIVE," a weekly live video conference with a global audience, to discuss the multidisciplinary management of their most challenging cases. While most cases presented were confirmed IBD, a substantial number were diseases that mimic IBD. We have categorized all IBD LIVE cases and identified "IBD-mimics" with consequent clinical management implications.

Hyperbaric Oxygen Enabled a Transition to Oral Steroids in an Acute Severe Ulcerative Colitis Flare.

Background: Ulcerative colitis (UC) is characterized in part by a dysregulated response to tissue hypoxia. While intravenous (IV) steroids are the mainstay of treatment for acute severe UC (ASUC), up to one-third of patients are refractory to steroids alone and require rescue therapy.

Case Description: A 71-year-old female with extensive UC on infliximab presented with abdominal pain and more than 10 bloody bowel movements per day.

People with IBD evidence more microarousals during sleep architecture assessments.

Objective: Poor sleep is common in inflammatory bowel disease (IBD) and may be associated with overall worse disease outcomes. While the sleep/IBD literature is growing, the data are often self-reported. Further, much of the research using objective measures of sleep architecture, or the overall pattern of sleep depth, rely on single-night assessments, which can be of questionable validity.

The Disease Severity Index for Inflammatory Bowel Disease Is a Valid Instrument that Predicts Complicated Disease.

Background: The disease severity index (DSI) for inflammatory bowel disease (IBD) combines measures of disease phenotype, inflammatory activity, and patient-reported outcomes. We aimed to validate the DSI and assess its utility in predicting a complicated IBD course.

Methods: A multicenter cohort of adults with IBD was recruited.

Outcomes and Endpoints of Postoperative Recurrence in Crohn's Disease: Systematic Review and Consensus Conference.

Background: Outcomes after ileocolonic resection in Crohn's disease [CD] are heterogeneous, and a clear definition of postoperative recurrence remains to be determined. Our Endpoints Working Group of the International Organization for the study of Inflammatory Bowel Disease [IOIBD] aimed to standardise postoperative outcomes, to discuss which endpoints should be used for postoperative clinical trials, and to define those which could be used in trials or registries.

Methods: Based on a systematic review of the literature, recommendations and statements were drafted and sent to all IOIBD members for a first round of voting.

Analysis of Clinical Trial Screen Failures in Inflammatory Bowel Diseases [IBD]: Real World Results from the International Organization for the study of IBD.

Background: Recruitment for randomized controlled trials [RCTs] in inflammatory bowel diseases [IBD] has substantially dropped over time. This study aimed to assess reasons why IBD patients are not included in sponsored multicentre phase IIb-III RCTs.

Methods: All IOIBD members [n = 58] were invited to participate.

Leveraging Virtual Technology to Conduct Clinical Trials in Inflammatory Bowel Disease.

Clinical trials have led to major advances in inflammatory bowel disease (IBD) care over the last few decades, yet in that time most clinical trial protocols in IBD have remained markedly the same. Many IBD protocols often still require face-to-face visits and monitoring, hospital-based medication administration, paper-based forms and questionnaires, and short follow-up periods resulting in limited long-term data. These factors have recently been recognized as likely contributors to the low recruitment and lack of diversity of participants across clinical trials in IBD.