Gaidos, Jill

Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, are disorders caused by inflammation in the gastrointestinal tract leading to a wide variety of symptoms. The presence of symptoms may not always correlate with active intestinal inflammation, and the lack of symptoms does not always indicate control of inflammation. Owing to the variable correlation between clinical symptoms and active intestinal inflammation, the targets for IBD management have been updated to include objective measures of inflammation to complement clinical end points. In addition to clinical remission, these targets include improvements in biochemical markers and endoscopic measures to objectively measure and monitor disease remission. In this review, we will discuss the different strategies for assessing disease activity and the timing of evaluation for each treatment target for outpatient IBD care. We will also highlight the role of radiographic assessment with a focus on intestinal ultrasound for monitoring these treatment end points.

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 .

Importance The clinical effects of risankizumab (a monoclonal antibody that selectively targets the p19 subunit of IL-23) for the treatment of ulcerative colitis are unknown. Objective To evaluate the efficacy and safety of risankizumab when administered as an induction and a maintenance therapy for patients with ulcerative colitis. Design, Setting, and Participants Two phase 3 randomized clinical trials were conducted. The induction trial was conducted at 261 clinical centers (in 41 countries) and enrolled 977 patients from November 5, 2020, to August 4, 2022 (final follow-up on May 16, 2023). The maintenance trial was conducted at 238 clinical centers (in 37 countries) and enrolled 754 patients from August 28, 2018, to March 30, 2022 (final follow-up on April 11, 2023). Eligible patients had moderately to severely active ulcerative colitis; a history of intolerance or inadequate response to 1 or more conventional therapies, advanced therapies, or both types of therapies; and no prior exposure to risankizumab. Interventions For the induction trial, patients were randomized 2:1 to receive 1200 mg of risankizumab or placebo administered intravenously at weeks 0, 4, and 8. For the maintenance trial, patients with a clinical response (determined using the adapted Mayo score) after intravenous treatment with risankizumab were randomized 1:1:1 to receive subcutaneous treatment with 180 mg or 360 mg of risankizumab or placebo (no longer receiving risankizumab) every 8 weeks for 52 weeks. Main Outcomes and Measures The primary outcome was clinical remission (stool frequency score ≤1 and not greater than baseline, rectal bleeding score of 0, and endoscopic subscore ≤1 without friability) at week 12 for the induction trial and at week 52 for the maintenance trial. Results Among the 975 patients analyzed in the induction trial (aged 42.1 [SD, 13.8] years; 586/973 [60.1%] were male; and 677 [69.6%] were White), the clinical remission rates at week 12 were 132/650 (20.3%) for 1200 mg of risankizumab and 20/325 (6.2%) for placebo (adjusted between-group difference, 14.0% [95% CI, 10.0%-18.0%], P < .001). Among the 548 patients analyzed in the maintenance trial (aged 40.9 [SD, 14.0] years; 313 [57.1%] were male; and 407 [74.3%] were White), the clinical remission rates at week 52 were 72/179 (40.2%) for 180 mg of risankizumab, 70/186 (37.6%) for 360 mg of risankizumab, and 46/183 (25.1%) for placebo (adjusted between-group difference for 180 mg of risankizumab vs placebo, 16.3% [97.5% CI, 6.1%-26.6%], P < .001; adjusted between-group difference for 360 mg of risankizumab vs placebo, 14.2% [97.5% CI, 4.0%-24.5%], P = .002). No new safety risks were detected in the treatment groups. Conclusion and Relevance Compared with placebo, risankizumab improved clinical remission rates in an induction trial and in a maintenance trial for patients with moderately to severely active ulcerative colitis. Further study is needed to identify benefits beyond the 52-week follow-up. Trial Registration ClinicalTrials.gov Identifiers: NCT03398148 and NCT03398135

Abstract 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. Methods Cases have been recorded/archived since May 2018; we reviewed all 371 cases from May 2018–February 2023. IBD-mimics were analyzed/categorized according to their diagnostic and therapeutic workup. Results Confirmed IBD cases made up 82.5% (306/371; 193 Crohn’s disease, 107 ulcerative colitis, and 6 IBD-unclassified). Sixty-five (17.5%) cases were found to be mimics, most commonly medication-induced (n = 8) or vasculitis (n = 7). The evaluations that ultimately resulted in correct diagnosis included additional endoscopic biopsies (n = 13, 21%), surgical exploration/pathology (n = 10, 16.5%), biopsies from outside the GI tract (n = 10, 16.5%), genetic/laboratory testing (n = 8, 13%), extensive review of patient history (n = 8, 13%), imaging (n = 5, 8%), balloon enteroscopy (n = 5, 8%), and capsule endoscopy (n = 2, 3%). Twenty-five patients (25/65, 38%) were treated with biologics for presumed IBD, 5 of whom subsequently experienced adverse events requiring discontinuation of the biologic. Many patients were prescribed steroids, azathioprine, mercaptopurine, or methotrexate, and 3 were trialed on tofacitinib. Conclusions The diverse presentation of IBD and IBD-mimics necessitates periodic consideration of the differential diagnosis, and reassessment of treatment in presumed IBD patients without appropriate clinical response. The substantial differences and often conflicting treatment approaches to IBD versus IBD-mimics directly impact the quality and cost of patient care.

Abstract Background Inflammatory bowel disease (IBD) treatment targets include mucosal healing based on standardized endoscopic scoring systems. The rates and ease of use of these scoring systems in practice have not been well described. We aimed to assess the rates and factors associated with the use of IBD endoscopic scoring systems in practice from IBD LIVE attendees. Methods IBD Live is an international case-based conference focusing on the management of patients with IBD. We created a web-based survey consisting of 38 questions on the frequency and ease of use of various IBD endoscopic scores. This survey was emailed to the IBD Live listserv in March 2022 with a second email sent 14 days later. We included only respondents who are currently performing endoscopy. Continuous variables were analyzed using an unpaired student’s t-test. Categorical variables were analyzed using Pearson’s chi-square test. Results There were 65 responses out of 170 (38.2% response rate) regular attendees. Eleven responses were excluded (4 with no response on the use of endoscopy scores, and 7 were not performing endoscopy). Of the respondents, 72.2% are from the United States, 70.4% are adult gastroenterologists, 53.9% in academic practice, and 40.7% in practice for ≥15 years. Of the endoscopy scores used ≥50% of the time, 74.1% were using the Mayo Endoscopic Subscore (MES), 72.3% using the Rutgeerts Score, 61.2% using the Simple Endoscopic Score for Crohn’s Disease, and 28.6% using the Pouchitis Disease Activity Index. Attending IBD LIVE ≥ monthly (P = .028), attending an IBD conference at least every 2 years (P = .020), and having the scoring system incorporated into the endoscopy documentation software (P = .002) were associated with more consistent use of the MES. Attending IBD Live at least monthly (P = .026), having an IBD volume of ≥50% (P = .011), and attending an IBD conference at least every 2 years (P = .004) was associated with more frequent use of the Rutgeerts score. There were no factors that increased the use of other endoscopic scores. Conclusions The MES and the Rutgeerts score are more commonly used with much lower rates of use of endoscopic scores for Crohn’s disease and pouchitis. The use of these endoscopy scores is more common among those who regularly attend IBD conferences, have higher volume IBD practices, and have these scoring systems incorporated into endoscopy software. Further evaluation of barriers to use and ways to improve utilization of endoscopic scoring for Crohn’s disease and pouchitis is needed.

Background: Consequences of physician burnout include medical errors, higher rate of staff turnover, and decreased patient satisfaction. We examined the prevalence of burnout and identified the contributing factors in gastroenterologists and fellows in training. Methods: We performed 3 separate surveys through the American College of Gastroenterology. (1) A national survey of practicing gastroenterologists in the United States that measured burnout and contributing factors, (2) a survey of gastroenterology fellows in training to determine self-identified burnout, as well as mitigating and exacerbating factors, and (3) a follow-up survey of fellows during the COVID-19 pandemic. Results: One thousand and twenty-one persons responded (9.2% response rate) to the first survey, including 756 individuals who completed the Maslach Burnout Inventory survey. Overall, the prevalence of high burnout was 49.3%. Factors associated with high burnout included female sex, younger age, shorter duration in practice, considering the electronic health record non–user-friendly, 2 or more hours of patient-related work at home per day, 8 or more hours of outpatient time per day, 6 or more inpatient consults per day, taking call with procedures 10 or more times per year, and having children at home. With regard to lifestyle factors, taking 20 days or more of vacation time was associated with a lower rate of burnout. The level of burnout for fellows was observed to be high (42.7% in survey 2 and 35.3% in survey 3). Conclusions: Burnout is high in gastroenterologists and fellows in training. Specific contributing factors were both systems based and personal and provide insight into changes that can be made to address burnout.

Abstract Background and study aims Endoscopy-related injury (ERI) is widespread among practicing gastroenterologists. However, less is known about the incidence among trainees. This study assesses the rate of self-reported ERI occurrence, patterns of injury, and knowledge of preventive strategies in a nationally representative sample of gastroenterology fellows. Methods A 38-item electronic survey was sent to members of the American College of Gastroenterology. One hundred and sixty-eight gastroenterology fellows were included in analyses. Descriptive and univariate analyses evaluated the likelihood of ERI by workload parameters and gender. Results ERI was reported by 54.8 % of respondents. ERI was most common in the thumb (58.7 %), hand/finger (56.5 %), and wrist (47.8 %). There was no significant difference in the reported occurrence of ERI between male and female gastroenterology fellows. However, female fellows were significantly more likely to report a greater number of body areas affected by ERI, and male fellows were more likely to report elbow pain. Most respondents (85.1 %) reported discussion about, or training in, ergonomic strategies during gastroenterology fellowship. Conclusions ERI is reported to occur as early as gastroenterology fellowship. Results of this study support this finding and highlight the need for ongoing implementation and monitoring of a formal ergonomics training program as well as development of ergonomically appropriate instruments. Implications of these findings likely extend to trainees in other procedural related specialties like orthopedics and general surgery, though further research is required. Ergonomics training in gastroenterology fellowship and monitoring of its impact on trainees reported ERI is important due to negative effects on productivity and career longevity.

INTRODUCTION: Endoscopy-related injury (ERI) is common in gastroenterologists (GI). The study aim was to assess the prevalence of self-reported ERI, patterns of injury, and endoscopist knowledge of preventative strategies in a nationally representative sample. METHODS: A 38-item electronic survey was sent to 15,868 American College of Gastroenterology physician members. The survey was completed by 1,698 members and was included in analyses. Descriptive, univariate, and multivariate analyses were conducted to evaluate the likelihood of ERI based on workload parameters and gender. RESULTS: ERI was reported by 75% of respondents. ERI was most common in the thumb (63.3%), neck (59%), hand/finger (56.5%), lower back (52.6%), shoulder (47%), and wrist (45%). There was no significant difference in the prevalence of ERI between men and women GI. However, women GI were significantly more likely to report upper extremity ERI while men were more likely to report lower-back pain-related ERI. Significant gender differences were noted in the reported mechanisms attributed to ERI. Most respondents did not discuss ergonomic strategies in their current practice (63%). ERI was less likely to be reported in GI who took breaks during endoscopy ( P = 0.002). DISCUSSION: ERI is highly prevalent in GI physicians. Significant gender differences regarding specific sites affected by ERI and the contributing mechanisms were observed. Results strongly support institution of training in ergonomics for all GI as a strategy to prevent its impact on providers of endoscopy. JOURNAL/ajgast/04.03/00000434-202103000-00021/inline-graphic1/v/2026-07-10T100418Z/r/image-tiff