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Background: Because biologic and small molecule therapy is expensive, payors have mandated pre-authorizations for these medications, often resulting in a lengthy approval process. The aims of this study are to assess the frequency of and risk factors for delays in starting advanced therapies assessing insurance, care team, and patient-related factors., Methods: Retrospective, multi-center study of adult inflammatory bowel disease patients with prescriptions for an advanced therapy in two geographically distinct academic gastroenterology practices; one with and the other without a dedicated pharmacist. A priori we defined a delay in starting therapy as >14 days between prescription and first dose. Logistic regression analysis was performed to assess for risk factors for delay., Results: A total of 388 patients were prescribed advanced therapies with 46.6% receiving their first dose within 14 days. Patients who were on time vs delayed were similar in baseline demographics, disease characteristics, and disease activity. After adjusting for confounders, three independent risk factors remained significant as predictors for delay; study site (OR=5.2, 95% CI 2.894, 9.333), intravenous drug delivery as opposed to subcutaneous or oral (OR=3.07, 95% CI 1.845, 5.099), and insurance denial (OR=2.72, 95% CI 1.082, 6.825)., Conclusions: In a multicenter study, we found that a delay between prescription and administration of first dose of an advanced therapy is common, with >50% of patients having the first dose delayed by >2 weeks. Delays in starting therapy were significantly more likely if denied by insurance, given via IV induction, or at a study site without a dedicated pharmacist., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.)

Objectives: Fatigue is commonly reported in patients with Crohn's disease (CD) and ulcerative colitis (UC), including patients with inactive disease. We explored the impact of fatigue on healthcare utilization (HCU) and work productivity and activity impairment (WPAI)., Methods: Data collected between 2017 and 2022 were analyzed from the CorEvitas IBD Registry. We compared HCU and WPAI among subjects with high fatigue (PROMIS ≥55) versus low fatigue at enrollment and subjects whose fatigue score worsened or persisted versus low fatigue at 6 months. HCU was defined as an inflammatory bowel disease-related hospitalization or emergency room visit. WPAI included presenteeism, absenteeism, and lost WPAI. Logistic regression analysis was performed., Results: Study patients (640 CD, 569 UC) reported high rates of fatigue, 47% in CD and 38% in UC, that persisted at least 6 months in 88%-89% of patients. Patients with UC with high fatigue had 3-fold higher rates of HCU and 2-3-fold more absenteeism and activity impairment than patients with low fatigue. Patients with CD with high fatigue had no difference in HCU but did experience 2-4-fold more absenteeism, presenteeism, work productivity loss, and activity impairment. On subgroup analysis of patients in remission, those with high fatigue did not have higher rates of HCU but continued to have higher rates of WPAI., Conclusions: Fatigue is associated with an increase in HCU only in the setting of concomitantly active disease. On the other hand, fatigue is associated with a negative impact on WPAI in the setting of both active and inactive disease., Competing Interests: LAF: Research Support-Takeda, CorEvitas LLC; PM: Employee-CorEvitas LLC; MMC: Employee-CorEvitas LLC; ME: Employee-CorEvitas LLC; CAL: Employee-CorEvitas LLC; AML: Employee-CorEvitas LLC; JKJG: Consulting- MRM Health; Speaker Bureau—AbbVie., (© The Author(s) 2024. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)

Background: Colonoscopy withdrawal time (CWT) of at least 6-9 minutes is the minimum time needed for adequate adenoma detection in the general population. The ideal CWT in patients with inflammatory bowel disease (IBD) has not been determined. We aimed to identify the optimal CWT associated with the detection of visible dysplasia in patients with IBD., Methods: This is a retrospective study from 1/1/2017 to 9/1/2022 of adult patients with IBD in endoscopic healing undergoing surveillance via high-definition white light colonoscopy. The primary outcome was the association of CWT with visible dysplasia detection., Results: A total of 259 patients (mean age 56 ± 14.8 years; 51.3% female, 68% with ulcerative colitis; 8.9% with primary sclerosing cholangitis) underwent 330 colonoscopies. Patients with visible dysplasia were more likely to be older ( P  < .001) and have a personal history of visible dysplasia ( P  < .001) and invisible dysplasia ( P  = .023). The mean CWT was significantly longer in the visible dysplasia group at 26 minutes (interquartile range [IQR] 20-38.5) vs. 21 minutes (IQR 15-28) in procedures without visible dysplasia ( P  < .001). On multivariable analysis, increased age ( P  < .001), increased CWT ( P  = .001), and personal history of visible dysplasia ( P  = .013) were independently associated with the detection of visible dysplasia. A CWT of ≥15 minutes (odds ratio [OR] 2.71; 95% confidence interval [CI], 1.11-6.6; P  = .02] and not ≥9 minutes (OR 2.57; 95% CI, 0.33-20.2; P  = .35) is significantly associated with detection of visible dysplasia., Conclusions: For patients with IBD undergoing surveillance via high-definition white light colonoscopy, the mean CWT was independently associated with the detection of visible dysplasia., Competing Interests: B.A.-B.: Holds the position of Associate Editor for Crohn’s & Colitis 360 and has been recused from reviewing or making decisions for the manuscript. Speaker fees: AbbVie, Takeda, Bristol-Myers Squibb, Janssen Pharmaceuticals. Advisory board: Bristol-Myers Squibb, Pfizer. J.K.J.G.s: Advisory Board: Bristol-Myers Squibb, Pfizer, Takeda; Consulting: MRM Health. D.D.P.: AbbVie consulting. For the remaining authors, none were declared., (© The Author(s) 2024. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)

Description: The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update (CPU) is to review the available evidence and provide expert advice regarding the management of patients with an enteral stoma., Methods: This CPU was commissioned and approved by the AGA Institute Committee and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPU Committee and external peer review through standard procedures of Clinical Gastroenterology and Hepatology. This expert commentary incorporates important as well as recently published studies in this field, and it reflects the experiences of a multidisciplinary group of authors composed of gastroenterologists, a colorectal surgeon, a wound ostomy and continence nurse, and ostomate., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

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., Competing Interests: J.K.J.G.: AbbVie Speaker Bureau; Advisory Board: Pfizer. B.A.B: Speaker honoraria: AbbVie, Takeda. Advisory board: Bristol Meyers Squibb. F.A.F: Advisory Boards: AbbVie, BMS, Braintree Labs, IBD Educational Group, Iterative Scopes, Janssen, Pfizer, Sebela. Data Safety Monitoring Boards: Adiso Therapeutics, Lilly. M.R.: Advisory Boards and Consultant (both) for Abbvie, Janssen, UCB, Takeda, Pfizer, BMS, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET Pharma Solutions, Trellis. J.K.J.G. holds the position of Associate Editor for Crohn’s & Colitis 360 and has been recused from reviewing or making decisions for the manuscript. M.R. holds the position of Editor-in-Chief for Crohn’s & Colitis 360 and has been recused from reviewing or making decisions for the manuscript., (© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)

Objectives: Guidelines recommend performing a flexible sigmoidoscopy in patients hospitalized with acute severe ulcerative colitis (ASUC). However, it is unclear if time to sigmoidoscopy affects relevant clinical outcomes. We aimed to assess the impact of early sigmoidoscopy on clinical outcomes using a well-characterized cohort of patients with ASUC., Methods: This is a single-center, retrospective study of all patients hospitalized with ASUC from January 1, 2012 to November 1, 2021. Early sigmoidoscopy was defined as occurring within 72 hours of admission while delayed sigmoidoscopy was defined as occurring >72 hours after admission. Primary outcomes were cumulative days of intravenous (IV) corticosteroid (CS) use, length of hospital stay, and colectomy rates. Secondary outcomes were time to infliximab (IFX) rescue and inpatient opioid medication use., Results: A total of 112 patients hospitalized with ASUC who underwent sigmoidoscopy were included in the analysis. Eighty-seven patients (78%) had early sigmoidoscopy and 25 (22%) had delayed sigmoidoscopy. Patients in the early sigmoidoscopy group were exposed to significantly fewer days of IV CS (4.5 vs 9.2 days; P < .001), had shorter hospital stays (6.4 vs 19.3 days; P < .001), and shorter time to IFX rescue (3.5 vs 6.4 days; P = .004). Rates of colectomy in the early and delayed sigmoidoscopy groups were 17% versus 28%, respectively ( P = .23). Longer time to sigmoidoscopy was associated with a 16% increased risk of colectomy (HR = 1.16, P = .002)., Conclusions: In this well-characterized cohort, early sigmoidoscopy in ASUC was associated with favorable clinical outcomes. These findings highlight the benefits of early sigmoidoscopy in patients with ASUC. Larger prospective studies are needed to corroborate these findings., Competing Interests: B.A.-B.: Speaker honoraria: AbbVie, Takeda. Advisory board: Bristol Meyers Squibb. J.K.J.G.: AbbVie Speaker Bureau. D.D.P.: AbbVie consulting. All other authors have no financial disclosures or conflicts of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)

Background: Combination therapy with thiopurines and anti-tumor necrosis factor (TNF) is superior to monotherapy in Crohn's disease (CD) and ulcerative colitis (UC). The optimal dose of thiopurines in combination therapy remains unclear. We investigated the impact of thiopurine dose in combination therapy on outcomes in inflammatory bowel disease (IBD)., Methods: This was a single-center, retrospective study of patients with IBD treated with thiopurine and anti-TNF combination therapy between 1/2012 and 11/2020. A therapeutic dose of thiopurines was defined as ≥1 mg/kg for 6-mercaptopurine and ≥2 mg/kg for azathioprine. The primary outcome was anti-drug antibody (ADA) formation in patients on a therapeutic thiopurine dose vs. a lower thiopurine dose group. Secondary outcomes included steroid-free clinical remission, endoscopic healing (absence of ulcers/erosions in CD and Mayo endoscopic score ≤1 for UC), and normal serum C-reactive protein (CRP) in patients who were on combination therapy., Results: A total of 108 patients were included (median age 31.5 years; 58.3% male). A therapeutic dose of thiopurine was used in 19%. In the therapeutic thiopurine dose group, 23.8% developed ADA vs. 29.9% (P=0.58) in the lower dose group. No significant differences were noted between the therapeutic and lower dose thiopurine groups in terms of steroid-free clinical remission (57.1% vs. 60.9%, P=0.75), endoscopic healing (55% vs. 60%, P=0.69), and normal CRP (52.4% vs. 52.9%, P=0.27)., Conclusion: In our cohort of patients with IBD on anti-TNF combination therapy, thiopurine dose was not associated with significant differences in anti-TNF immunogenicity and clinical outcomes., Competing Interests: Conflict of Interest: Dr. Badr Al-Bawardy: Speaker Bureau: AbbVie, Takeda. Advisory board: Bristol-Meyers Squibb, Dr. Jill K. J. Gaidos: Speaker Bureau: AbbVie, Advisory Board: Bristol-Myers Squibb All other authors have no disclosures, (Copyright: © Hellenic Society of Gastroenterology.)

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., Competing Interests: Competing interests The authors declare that they have no conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background: Vedolizumab is used in inflammatory bowel disease (IBD), administered as a non-weight-based fixed dose. A higher body mass index (BMI) is associated with lower serum vedolizumab levels, but it is unclear whether it is associated with an unfavorable response to vedolizumab. We examined the relationship between BMI and the need for dose escalation, and the overall response to vedolizumab in IBD patients., Methods: This was a single-center, retrospective study of IBD patients who received vedolizumab between 1 st July 2014 and 1 st September 2020. The primary outcome was need for vedolizumab dose escalation or discontinuation. Secondary outcomes were steroid-free clinical remission (SFCR), endoscopic remission, and normal serum C-reactive protein (CRP). Outcomes were compared between patients with BMI <30 kg/m 2 (non-obese) or ≥30 kg/m >2 (obese)., Results: 190 patients were included, with a median follow-up time of 21 months. Median age was 37 years, 50.5% were male, and median BMI was 24.8 kg/m 2 (75.3% of patients had BMI <30 kg/m 2 ). Vedolizumab was dose-escalated in 48.9% of the obese group vs. 42% of the non-obese group (P=0.4). Vedolizumab was discontinued in 31.9% of the obese group vs. 53.2% of the non-obese group (P=0.01). The rate of CRP normalization was significantly lower in the obese group (46.2% vs. 66%, P=0.03). SFCR and endoscopic remission rates were not significantly different between the groups., Conclusions: Obesity was not associated with higher rates of vedolizumab dose escalation. However, it was associated with lower rates of vedolizumab discontinuation and CRP normalization, but not SFCR or endoscopic remission., Competing Interests: Conflict of Interest: Dr. Badr Al-Bawardy: Speaker honoraria: AbbVie, Takeda; Dr. Jill K. J. Gaidos: AbbVie Speaker Bureau; All other authors have no disclosures, (Copyright: © Hellenic Society of Gastroenterology.)

Background: Aims of this study were to assess the prevalence of and risk factors for sexual dysfunction (SD) in male veterans with inflammatory bowel disease (IBD)., Methods: We collected IBD history, quality of life (QOL), and sexual function surveys., Results: One hundred seventy-one men enrolled, mean age 50 years, 85% had SD, 92% had erectile dysfunction (ED). More severe ED ( P = 0.0001), decreased sexual desire ( P = 0.004), and decreased satisfaction ( P = 0.001) were associated with poorer QOL. Biologic use was associated with increased SD; hypertension with a decrease in sexual desire., Conclusions: SD and ED are highly prevalent and associated with poorer QOL., (Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation 2020.)