Crohn's & Colitis 360最新文献

Background: Crohn's disease (CD) treatment is associated with increased risks of infection and malignancies. Although the safety of certolizumab pegol (CZP) is well established, long-term data from community-based observational studies are lacking.

Aim: This study aimed to evaluate long-term safety outcomes of patients from the SECURE registry receiving CZP relative to other CD treatments, including corticosteroids, immunosuppressants, and biologics. The primary outcome of this observational study was the evaluation of malignancies.

Methods: Adult patients with CD were prospectively monitored for up to 8 years. Pre-specified data were collected for all enrolled patients. Adverse events of interest (AEoIs) were reported per 100 patient-years (PY) of exposure. Incidence rate ratios (IRRs) were calculated for AEoIs using multivariate regression analysis accounting for exposure to multiple treatments. Malignancies reported after any exposure to CZP were attributed to CZP. Post-hoc analyses were conducted to evaluate non-melanoma skin cancer (NMSC), lymphoma, and pregnancy outcomes.

Results: A total of 3072 patients were enrolled in the study. The risk of AEoIs was similar between patients with only CZP exposure versus comparator exposure. Among patients with any CZP exposure, there was a higher frequency of serious infections (IRR: 2.56 [95% confidence interval (CI): 2.00, 3.29]) and hypersensitivity or anaphylactic reactions (IRR: 4.11 [95% CI: 1.80, 9.38]) versus patients with comparator exposure. Malignancy rates were similar across groups; however, concomitant use of thiopurines was associated with higher odds of NMSC (odds ratio: 2.30 [95% CI: 1.09, 4.89]). Most cases of lymphoma (5/7) occurred in patients with exposure to thiopurines. Pregnancy outcomes were similar across groups.

Conclusions: No new safety signals were identified for CZP; the use of thiopurines was identified as a risk factor for NMSC.

Trial registration: NCT00844285.

Background: Common variable immunodeficiency (CVID) predisposes patients to inflammatory bowel disease (IBD). There are limited studies characterizing adults with concomitant CVID and IBD (CVID-IBD).

Methods: Demographics, clinical courses, endoscopic findings, and disease-specific therapies were obtained in adults ≥18 years with CVID-IBD over a 5-year period.

Results: We identified 11 patients with CVID-IBD, 6 with Crohn's disease (CD), and 5 with ulcerative colitis (UC). The presenting symptoms in 10 (91%) were abdominal pain and diarrhea. A majority of patients were diagnosed with IBD before CVID. Patients with CVID-IBD were diagnosed with CVID at an older age compared to patients with CVID only. The most prevalent endoscopic finding in CD was either erythema or erosions in the ileum, whereas in UC, it was pancolitis. One patient with CD and 1 with UC required treatment with immunomodulators to achieve remission. Three patients with CD and 2 with UC required treatment with biologics to achieve remission. Eight received intravenous immunoglobulin (IVIG) for CVID. Four patients with CD and 1 with UC were diagnosed with either leukemia or lymphoma, and the most common malignancy was chronic lymphocytic leukemia (n = 3).

Conclusions: This is one of few studies evaluating demographic, clinical, endoscopic, histologic features, and therapeutic management in patients with CVID-IBD. Further studies are required to elucidate long-term differences in the clinical course and treatment of patients with CVID-IBD.

Background: Many patients with medically refractory ulcerative colitis undergo ileal pouch-anal anastomosis, which typically includes the creation of a temporary loop ileostomy. The impact of the interval between ileal pouch-anal anastomosis and loop ileostomy closure regarding endoscopic pouch inflammation has not been well defined. The aim for this project was to assess if delayed loop ileostomy closure increases patients' risk of endoscopic pouch inflammation.

Methods: This is a cohort study of patients with ulcerative colitis who underwent ileal pouch-anal anastomosis between 01/2010 and 12/2020. Patients were divided into groups-early (12-116 days) or late closure (>180 days)-based on interval between ileal pouch-anal anastomosis and loop ileostomy closure. The late closure group was further sub-divided by indication for delay which included post-operative complications and non-medical reasons. The primary outcome was development of endoscopic inflammatory pouch disease, which was a composite of pouch disease activity index score of ≥ 4, mucosal breaks beyond anastomotic lines, and diffuse pouch inflammation.

Results: Two-hundred ninety patients were included which comprised early and late cohorts of 217 and 73 patients, respectively. Compared to early closure, late closures for non-medical and pouch-related surgical complications were both not found to be associated with development of our composite outcome (P = .43 and P = .80, respectively).

Conclusions: Delaying ileostomy closure due to patient preference or logistical limitations did not result in an increased risk of endoscopic pouch inflammation, but there appears to be an association of extraintestinal manifestations with endoscopic inflammatory pouch disease, suggesting the need for a vigilant surveillance in these patients.

This editorial explores the complex relationship between inflammatory bowel disease (IBD) and extra-intestinal manifestations (EIMs) and underscores the clinician's critical need for comprehensive EIM care, as well as the physical and emotional burden imposed on the patient. The editorial concludes with actionable steps for clinicians and a call to advance IBD care with a comprehensive multidisciplinary approach that acknowledges the various challenges faced by patients. Together, we can transform the IBD journey into a partnership built on understanding, support, and shared hope.

Background: Patient advisory groups are key to guiding research studies through meaningful engagement with the population of interest. Although patient advisory groups are greatly valuable to research studies, they are underutilized in inflammatory bowel disease research. Thus, this study aims to describe the development and implementation of a patient advisory group and evaluate the perspectives of researchers and members.

Methods: The Comprehensive Self-Management for inflammatory bowel disease study patient advisory group was created in 2022. The patient advisory group members and researchers completed the Public and Patient Engagement Evaluation Tool via an online survey. Thematic analysis of responses was used to identify common themes, and descriptive statistics were reported.

Results: The patient advisory group comprised of patients with inflammatory bowel disease met quarterly. Eight members and three researchers evaluated the patient advisory group. The five emerging themes were (1) lived experience of patient advisory group members; (2) diversity and representation; (3) purposeful engagement; (4) positives of patient advisory group; and (5) improvements to patient advisory group. All members agreed or strongly agreed that the meetings were a good use of their time, and all researchers strongly agreed that the group added value to the research study.

Conclusion: Patient advisory groups can create unique and positive experiences for both members and researchers when feedback is meaningfully sought, intentional, and incorporated into the study. There is a need to continue creating and using patient advisory groups with the intention of identifying problems and finding solutions alongside the inflammatory bowel disease community.

Background: Crohn's disease (CD) is a lifelong condition that poses unique challenges. This study reports findings from a person's perspective of living with CD to help enhance the understanding of an individual's specific care and support needs.

Methods: Semi-structured telephone interviews were conducted with a convenience sample of adults with Crohn's disease recruited from Newcastle Hospitals NHS Foundation Trust. Data were analyzed after data collection using thematic analysis.

Results: Forty-one (68% female) participants aged 49.1 ± 12 years with a disease duration between 1 and 55 years were interviewed. Three overarching themes emerged, along with 12 subthemes: (1) reactions to presenting symptoms, emotions, and challenges at diagnosis; (2) reality of living with the condition, seeking information, decision making, psychological challenges, experiencing symptoms/complications during remission and the impact on social life, education, employment, and relationships; (3) Resilience involving emotional adaptations, strategies on self-management, social comparisons as a means of coping and barriers to resilience.

Conclusions: The results highlight the complex health journey and challenges faced by people living with Crohn's disease and provide health care professionals with a greater insight into the psychological challenges and emotional complexities of the condition to facilitate a more holistic approach to planning care.

Background: The prevalence of colorectal cancer (CRC) in patients with ulcerative colitis (UC) is higher than in the general population, in Latin America there is a progressive increase of UC, and information about CRC screening in inflammatory bowel disease (IBD) is scarce. The aim of this study was to analyze the findings of endoscopic surveillance of CRC in patients with IBD according to available technology.

Methods: Multicenter, cross-sectional, analytical study conducted in Latin American countries, in patients with UC, predominantly with more than 8 years of diagnosis and different degrees of disease activity. Surveillance colonoscopies were performed according to available technology. Risk factors for dysplasia detection were analyzed.

Results: One hundred and forty-four patients, 55.5% women, mean age 47.3 (range 17.1 to 90; SD 15.64) years and mean duration of disease 12.71 (range 0.64 to 57.13; SD 8.08) years. Forty-nine lesions were identified, 18 corresponded to dysplasia. The detection rate of dysplasia per lesion and per procedure was 36.7% and 12.5%, respectively. By logistic regression analysis, the duration of disease (OR 1.12;95%CI:1.047 to 1.215, P = .002) and the presence of post-inflammatory polyps (OR 3.4;95%CI:1.11 to 10.36, P = .031) were risk factors for higher detection of dysplasia. Digital chromoendoscopy was associated with greater detection of dysplasia (OR 4.99, 95%CI: 1.092 to 22.864, P = .038).

Conclusions: In our region, the duration of disease and the presence of post-inflammatory polyps were the factors with the highest association for dysplasia detection, and digital chromoendoscopy with directed biopsies was the technique of choice. The implementation of a specific surveillance program in colonoscopy in IBD is an effective strategy to achieve high detection rates.

Introduction: Biological therapy has transformed the natural course of inflammatory bowel disease, but there are still controversies regarding its potential to reduce surgical rates for Crohn's disease (CD). This study, conducted with the support of the Brazilian National Healthcare System, aimed to analyze temporal trends in surgery and hospitalization rates among patients with CD and to correlate these data with the dispensing of azathioprine (AZA), infliximab (IFX), and adalimumab (ADA).

Methodology: This retrospective observational study used data from the National Public Healthcare Department of Informatics through the TT Disease Explorer^® platform from 2012 to 2022. Demographic data, medications used, and the prevalence of surgical procedures and hospitalizations associated with the International Classification of Diseases codes for CD were analyzed. Annual average percent changes (AAPCs) were calculated to assess temporal trends.

Results: Between 2012 and 2022, there was a significant increase of 288.07% in the diagnoses of CD, rising from 27 551 to 106 917 cases. Concurrently, there was an increase in the absolute number of patients treated with AZA, IFX, and ADA, with increasing rates of 65.79%, 251.09%, and 242.48%, respectively. However, the proportion of patients receiving AZA per CD patients decreased by 57.28%, from 44.79% to 19.13% (AAPC = -7.94%, 95% CI, -8.05 to -7.83; P < .001). The use of IFX remained relatively stable, with a slight change from 13.82% to 12.50% (AAPC = 0.01%, 95% CI, -0.20 to 0.22; P = .935), while the use of ADA decreased by 11.75%, from 11.65% to 10.28% (AAPC = -1.74%, 95% CI, -2.48 to -1.82; P < .001). The absolute number of hospitalizations related to CD increased by 57.71%. Despite the rise in the number of cases and the greater availability of biological treatments, the proportion of hospitalized patients decreased by 59.29%, from 6.19% to 2.52% (AAPC = -7.04%, 95% CI, -7.42 to -6.66; P < .001). Similarly, the proportion of surgical procedures relative to the total number of cases decreased by 55.08%, from 1.09% to 0.49% (AAPC = -5.73%, 95% CI, -6.68 to -4.77; P < .001).

Conclusions: Despite the cumulative increase in the prevalence of CD cases in the country and the absolute increase in the dispensing of biologics, the proportion of hospitalizations and surgical procedures among CD patients treated in the public health system in Brazil decreased.

Background: The modified Mayo score (mMS) is a measure for ulcerative colitis (UC) disease activity. Recent US Food and Drug Administration guidance for moderately to severely active UC trials suggests that patients should have baseline mMS of 5-9 including an endoscopy score of at least 2, as opposed to the previous range of 4-9. This disclosure reports results from patients with UC with baseline mMS of 5-9 who received mirikizumab, a monoclonal antibody directed against the interleukin-23 p19 subunit, or placebo in the phase 3 LUCENT trials.

Methods: Mirikizumab was evaluated in the randomized, double-blind, placebo-controlled LUCENT-1 (NCT03518086) and LUCENT-2 (NCT03524092) trials, and the ongoing long-term LUCENT-3 (NCT03519945) trial, which use mMS 4-9. Analyses for patients with baseline mMS of 5-9 (excluding patients with mMS of 4) were conducted according to LUCENT trial statistical analysis plans. Categorical efficacy endpoints were summarized using proportions and confidence intervals. Continuous efficacy endpoints are presented as least-squares mean (standard error) changes from baseline.

Results: Mirikizumab demonstrated efficacy for the primary endpoint of clinical remission and major secondary endpoints including clinical response, endoscopic improvement, histologic-endoscopic mucosal improvement/remission, bowel urgency remission, and corticosteroid-free remission. Importantly, mirikizumab exhibited greater improvements versus placebo in the Inflammatory Bowel Disease Questionnaire, fatigue, symptomatic remission, and work productivity. Finally, mirikizumab demonstrated long-term (104-week) sustained, durable efficacy across all studied endpoints. No new safety signals were identified during the 2-year follow-up.

Conclusions: Mirikizumab delivered significant clinical benefit for patients with baseline mMS of 5-9 and demonstrated a favorable safety profile.

Background: Intravenous (IV) steroids are commonly used to treat acute flares of Crohn's disease (CD). However, it is unclear if they are beneficial in the setting of uncomplicated small bowel obstruction (SBO). We sought to examine if IV steroid administration improved short-term outcomes in patients with CD hospitalized for acute, uncomplicated SBO across three New York City hospital systems.

Methods: This retrospective study included patients ≥ 18 years old admitted between January 1, 2011, and December 31, 2019, with Crohn's disease and an admission diagnosis of uncomplicated acute SBO, defined as cases without adhesions, fistula, phlegmon, and sepsis. Primary endpoints (length of stay and frequency of surgery) were compared between patients who received IV steroids upon admission and those who did not.

Results: Our analysis included 674 unique patients. Ninety-two (14%) received IV steroids, and 582 (86%) did not. IV steroid use did not result in shorter hospital stays (median days [IQR]: 3.0 (2.0-5.5) days vs 3.0 (2.0-6.0) days in the no-steroid group, P = .65) or reduce the need for surgery (4 patients (4.4%) vs 28 patients (4.8%) in the no-steroid group, P = .85). Sex, age, disease duration, concomitant biologic therapy, and NG tube placement did not independently contribute to either outcome.

Conclusions: These findings suggest that IV steroid administration for uncomplicated SBO in CD patients does not decrease hospital length of stay or need for surgery. Further research may help identify specific obstruction patterns or other therapies associated with different outcomes.