Clinical Gastroenterology and Hepatology最新文献

Background & aims: Efficacy of upadacitinib, an oral Janus kinase inhibitor, for moderate-to-severe Crohn's disease was demonstrated in phase 3 induction (U-EXCEL, U-EXCEED) and maintenance (U-ENDURE) trials; this post hoc analysis evaluated upadacitinib outcomes in patients with fistulizing disease in these studies.

Methods: Patients were randomized (2:1) to once daily upadacitinib 45 mg or placebo for 12 weeks. Upadacitinib 45 mg clinical responders were rerandomized (1:1:1) to upadacitinib 15 mg, upadacitinib 30 mg, or placebo for 52 weeks. In patients with fistulas (any and perianal), resolution of drainage, closure of external openings, clinical remission, endoscopic response, and safety were assessed.

Results: Of 1021 patients in U-EXCEL and U-EXCEED, 143 (14.0%) had any fistulas at baseline (66 draining); of these, most (n = 128) had perianal fistulas (56 draining). Greater proportions of patients receiving upadacitinib vs placebo achieved resolution of drainage of perianal fistulas at the end of induction (placebo: 5.6%, n/n = 1/18; upadacitinib 45 mg: 44.7%, n/n = 17/38; P = .003) and maintenance (placebo: 0%, n/n = 0/11; upadacitinib 15 mg: 28.6%, n/n = 4/14; P = .105; upadacitinib 30 mg: 23.1% n/n = 3/13; P = .223) and closure of perianal fistula external openings (for induction, placebo: 4.8%, n/n = 2/42; upadacitinib 45 mg: 22.1%, n/n = 19/86; P = .013; for maintenance, placebo: 0%, n/n = 0/30; upadacitinib 15 mg: 18.8%, n/n = 6/32; P = .024; upadacitinib 30 mg: 16.0%, n/n = 4/25; P = .037).

Conclusion: Patients with fistulizing disease (primarily perianal) treated with upadacitinib achieved higher rates of resolution of drainage, closure of external openings, clinical remission, and endoscopic response vs placebo.

Clinicaltrials: gov, Numbers: NCT03345849 (U-EXCEL), NCT03345836 (U-EXCEED), NCT03345823 (U-ENDURE).

Background and aims: Patients with screen-detected colorectal cancer (CRC) have a better stage-specific overall survival than non-screen-detected CRC. Currently, it is unknown if recurrence rates differ between screen-detected and non-screen-detected CRCs, and whether this could explain the observed difference in overall survival. Therefore, we aimed to assess the disease-free survival (DFS) rates in screen-detected and non-screen-detected CRCs and if recurrence affects overall survival.

Methods: Dutch CRC (stage I-III) patients, diagnosed by screening or not in the first 6 months of 2015, were included from the Netherlands Cancer Registry. DFS and survival data were retrieved and analyzed by Kaplan-Meier method. The association between mode of detection and recurrence and overall survival was evaluated with a Cox regression model.

Results: A total of 3725 CRC patients were included, 2073 (55.7%) non-screen detected and 1652 (44.3%) screen detected. Three-year DFS was significantly higher in screen-detected CRC compared with non-screen-detected CRC (87.8% vs 77.2%; P < .001). Stage-specific DFS rates for screen-detected vs non-screen-detected CRC were 94.7% vs 92.3% for stage I (P = .45), 84.3% vs 81.4% for stage II (P = .17), and 77.9% vs 66.7% for stage III (P < .001), respectively. Detection by screening was independently associated with a lower risk of recurrence (hazard ratio, 0.67; 95% confidence interval, 0.55-0.81; P < .001) when adjusted for age, sex, tumor location, stage and treatment. Recurrence independently predicted overall survival (hazard ratio, 15.90; 95% confidence interval, 13.28-19.04; P < .001).

Conclusion: DFS was significantly better in screen-detected compared with non-screen-detected CRCs independent of age, sex, tumor location, stage and treatment, and was associated with an overall survival benefit.

Cold snaring is now the preferred resection method for the majority of colorectal polyps encountered during colonoscopy. A key advantage of cold resection over resection utilizing electrocautery is a substantially lower risk of delayed hemorrhage. Cold snare resection is preferred for all lesions ≤10 mm and for nondysplastic sessile serrated lesions of any size but should be avoided when lesions have a significant risk of submucosal invasion or fibrosis. Cold snare resection can be considered for certain lesions 11-19 mm in size and some lateral spreading lesions ≥20 mm. This review discusses tips and techniques to optimize cold snare resection.

As the prevalence of inflammatory bowel disease (IBD) increases within historically disadvantaged communities, it is imperative to better understand how intersectionality-defined as the complex, cumulative way in which the effects of multiple forms of discrimination (such as racism, sexism, and classism)-intersects and social determinants of health influence the patient's experiences within the medical system when navigating their disease. Culturally sensitive care is characterized by the ability to deliver patient-centered care that recognizes how the intersectionality of an individual's identities impacts their disease journey. An intentional consideration and sensitivity to this impact play important roles in providing an inclusive and welcoming space for historically disadvantaged individuals living with IBD and will help address health inequity in IBD. Cultural competence implies mastery of care that understands and respects values and beliefs across cultures, while cultural humility involves recognizing the complexity of cultural identity and engaging in an ongoing learning process from individual patient experiences. Heightening our patient care goals from cultural competence to cultural sensitivity allows healthcare professionals and the systems in which they practice to lead with cultural humility as they adopt a more inclusive and humble perspective when caring for patient groups with a diverse array of identities and cultures and to avoid maintaining the status quo of implicit and explicit biases that impede the delivery of quality IBD care. In this article, we review the literature on IBD care in historically disadvantaged communities, address culturally sensitive care, and propose a framework to incorporating cultural humility in IBD practices and research.

Background & aims: Heterogeneity of treatment effects in inflammatory bowel disease (IBD) means that many individuals or patient subgroups depart from the average for whom the outcomes from traditional randomized trials may not be applicable. The N-of-1 trial is a design in which a single patient is followed over time with the treatments being randomized from period to period with the intention of finding the most effective treatment for that patient. The aim was to investigate the utility of N-of-1 trials in IBD.

Methods: To identify relevant articles for this scoping review, a MEDLINE literature search was conducted through the PubMed platform for articles published in the English language using the search terms "inflammatory bowel disease," "Crohn's disease," "ulcerative colitis," "N-of-1 trials," "single case designs," and "personalized trials."

Results: N-of-1 trials have seen a resurgence across several medical disciplines, driven by a need for more personalized medicine and patient-centered health care; their use in IBD is scarce with only 3 trials identified. Studies involving multiple N-of-1 trials can generate robust evidence for each participant and average effect estimates. The N-of-1 trial may hold potential for studying patients with IBD that are excluded from or underrepresented by randomized trials, such as those with extraintestinal manifestations, pouchitis, and proctitis. Although methodologically sound and akin to the rigor of a randomized controlled trial, the crossover periods inherent to the study design can be perceived as burdensome by patients and researchers.

Conclusions: The N-of-1 trial design provides a patient-centered means of objectively determining individual response to therapy.