Intestinal Research最新文献

Background/aims: Crohn's disease (CD) leads to bowel damage and disability if suboptimally treated. We investigated firstyear treatment decisions and real-world use of biologics in patients with CD in Japan.

Methods: In this retrospective observational study (2010-2021) from the JMDC claims database, patients with a new diagnosis of CD (no CD claims record within 12 months before index) who received ≥ 1 pre-defined treatment were grouped by use of biologics and systemic corticosteroids (SCS) within the first year of diagnosis.

Results: Of 823 patients included, 470 (57.1%) were prescribed biologics and 353 (42.9%) were not; 77.6% were male, 75.7% had adult-onset CD, and median age was 24 years. Patients prescribed biologics were younger (median: 23 years vs. 28 years) and more had perianal lesions (43.0% vs. 22.9%) than those not prescribed biologics; 64.9% (95% confidence interval, 60.4%-69.2%) received a top-down treatment approach (no SCS before biologics). Factors significantly associated with a top-down treatment approach were male sex, perianal lesions, no use of immunomodulators, and use of anti-tumor necrosis factor therapies. The proportion of patients receiving SCS before biologics (step-up approach) increased after 2018, with a shift from prednisolone to budesonide from 2016. Persistence with first biologics decreased over time, with no differences between biologic types.

Conclusions: Use of biologics for treatment of CD within the first year of diagnosis in Japan has remained stable over the past decade. However, there was a shift to a step-up treatment approach, with an increase in use of SCS before biologics over time.

Background/aims: The incidence of perianal lesions (PL) in children with Crohn's disease (CD) is higher in East Asia than in Western countries. Early intervention for PL is essential to prevent sphincter dysfunction and ostomy placement. In this study, we aimed to investigate the clinical features, treatment, and consequences of pediatric CD with PL.

Methods: We retrospectively reviewed a cohort of children diagnosed with CD from 2010 to 2020 at a Japanese children's hospital. Demographics, treatments, and outcomes were evaluated and compared among subgroups.

Results: Among 112 pediatric patients with CD, 36 (32.1%) had experienced PL during the observational period. The median ages at diagnosis and follow-up periods were 131 and 70 months, respectively. Six (85.7%) patients in the very early-onset (VEO) group (CD diagnosed before 6 years old) and 24 (82.8%) in the older age group had PL upon diagnosis of CD (P= 0.851). Biologics were given to 94.4% of patients: infliximab (67.7%), adalimumab (58.8%), ustekinumab (44.1%), risankizumab (11.8%), and vedolizumab (5.9%). Biologics were introduced within 1 year in 89.5% and 40.0% of patients diagnosed in 2016-2020 and 2010-2016, respectively (P= 0.002). Seton was frequently used in the older age group (87.5 vs. 42.9%, P= 0.190). Ostomy was frequently required in the VEO group (42.9% vs. 0.0%, P= 0.006).

Conclusions: Patients with VEO-CD and PL had a notably high risk of ostomy placement. The earlier introduction of biologics and surgical interventions reduced corticosteroids use and ostomy placement in pediatric CD patients with PL.

Background/aims: Both endoscopic resection (ER) and transanal surgery (TAS) are minimally invasive treatment options that allow organ preservation in early rectal tumors. We conducted a meta-analysis to compare treatment outcomes between the 2 treatments.

Methods: We searched all relevant studies published until January 2024 that examined the comparative outcomes between ER and TAS for rectal tumors, including adenoma, adenocarcinoma, and neuroendocrine tumor (NET). TAS included transanal excision, transanal endoscopic microsurgery, and transanal minimally invasive surgery.

Results: Seventeen studies with a total of 1,569 patients were included in this meta-analysis. For adenoma/adenocarcinoma, the R0 resection rate did not differ between ER and TAS (risk ratio [RR], 0.99; 95% confidence interval [CI], 0.94-1.03). For NET, the R0 resection rate was lower in the ER group than in the TAS group (RR, 0.76; 95% CI, 0.68-0.84) and the procedure time for ER was shorter than that for TAS. For both adenoma/adenocarcinoma and NET, ER and TAS did not differ in terms of complication rates, additional surgery, and recurrence.

Conclusions: ER and TAS showed similar treatment outcomes for adenoma/adenocarcinoma. Considering that TAS typically incurs higher costs than ER, ER may be favored in the treatment of rectal adenoma/adenocarcinoma. For rectal NET, TAS showed a superior R0 resection rate than ER. However, given that TAS requires a long procedure time, expensive equipment, and complex manipulations, TAS may be considered selectively for large NETs with suspected deep tumorous infiltration.

Background/aims: Cold snare polypectomy (CSP) is recommended for colorectal polyps <10 mm; however, the impact of snare size on clinical outcomes remains unclear. This study evaluated the efficacy and safety of 10-mm and 15-mm snares for CSP of small colorectal polyps.

Methods: In this prospective multicenter study, patients with 4-10 mm non-pedunculated polyps underwent CSP with either a 10-mm or 15-mm snare. Both snares had identical wire thickness and hexagonal loop design. The primary outcome was histological complete resection rate (CRR). Secondary outcomes included adverse events and technical parameters.

Results: In total, 182 patients were enrolled (10-mm group: n = 92; 15-mm group: n = 90). Baseline characteristics, including age, sex, polyp size, morphology, location, and pathology, were comparable between groups. Histological CRRs were 90.2% in the 10-mm group and 91.1% in the 15-mm group (P= 0.483). No significant differences were observed in the presence of submucosal tissue within specimens (P= 0.523), iatrogenic ulcer size (P= 0.532), hematoma occurrence (P= 0.391), or intraprocedural bleeding requiring hemostasis (6.5% vs. 5.6%; P= 0.974). No cases of delayed bleeding or perforation were reported. Logistic regression analysis identified iatrogenic ulcer size > 8 mm as an independent predictor of complete resection (odds ratio, 3.89; 95% confidence interval, 1.15-13.21; P= 0.029); snare size was not significantly associated with CRR (P= 0.519).

Conclusions: CSP using either a 10-mm or a 15-mm snare for 4-10 mm non-pedunculated colorectal polyps showed no significant difference in complete resection or safety outcomes within this size range. (Clinical Research Information Service [CRIS], KCT0005031).

Background/aims: Data from Asia regarding the short-term and long-term outcomes for acute severe ulcerative colitis (ASUC) are limited. We assessed the outcomes of ASUC, identified the risk factors for colectomy, and compared colectomy rates between the pre-biologics and post-biologics eras in Taiwan.

Methods: The patients with an ASUC diagnosis between January 2013 and March 2022 at 5 tertiary medical centers were retrospectively analyzed.

Results: In total, 98 patients were enrolled, with 68.4% diagnosed in the post-biologics era. In 78.6% of the ASUC patients initially received intravenous steroid therapy, for which the success rate was 74.1%. As for rescue therapy, 15 patients (93.8%) received biologics and 1 (6.3%) received cyclosporin. Biologics rescue therapy had a 93.3% success rate. One (1%) mortality due to septic shock occurred. The colectomy rate for index ASUC admission was 11.2%. Patients receiving colectomy were predominantly male (P= 0.012) and at older age (P= 0.016). Higher C-reactive protein (P= 0.035), lower albumin (P= 0.017), and hemoglobin (P= 0.023) levels were associated with colectomy risk. During a median follow-up of 24 months, 13 patients (15.1%) had recurrent ASUC and 23.1% of patients received colectomy. The accumulated colectomy rate at 3 years did not differ between the pre- and post-biologics eras (16.1% vs. 13.4%, P= 0.270).

Conclusions: This is the first Asian study on ASUC to compare colectomy rates between the prebiologics and post-biologics eras, revealing no significant difference. The recurrent ASUC had a higher colectomy rate than the index ASUC.

Background/aims: Tofacitinib and upadacitinib are small-molecule compounds that inhibit the Janus kinase pathway for the treatment of refractory ulcerative colitis. Only a few reports have compared the efficacy and safety of these 2 drugs in real-world practice. We aimed to show our real-world evidence of these drugs and compare the efficacy and safety profiles in the treatment of ulcerative colitis.

Methods: This study is a single-center retrospective analysis. Patients treated with tofacitinib or upadacitinib at our hospital between June 2018 and January 2024 who were monitored for 24 weeks were included. The primary outcome was steroid-free clinical remission at 24 weeks. Secondary outcomes were response and remission rates at each time point, time series changes in partial Mayo scores and laboratory results, treatment survival at 24 weeks, and the incidence of adverse events.

Results: A total of 68 patients treated with tofacitinib and 34 patients treated with upadacitinib were included. Steroid-free clinical remission rate at 24 weeks was significantly higher in upadacitinib-treated patients than in tofacitinibtreated patients (64.7% vs. 38.2%). The response rates in upadacitinib-treated patients exceeded 60% after 8 weeks of treatment through to 24 weeks, and the rates were higher than those in tofacitinib-treated patients. The incidences of adverse events were 79.4% in upadacitinib-treated patients and 38.2% in tofacitinib-treated patients. The most common adverse event was acne for upadacitinib.

Conclusions: Upadacitinib was more effective than tofacitinib in inducing remission in ulcerative colitis patients. The incidence of adverse events was significantly higher with upadacitinib than tofacitinib.

Background/aims: Despite the advent of advanced therapies, cases of so-called "difficult-to-treat" (D2T) ulcerative colitis (UC) persist. This study aims to clarify the epidemiological and clinical characteristics of patients with D2T UC.

Methods: We conducted a nested case-control study using the Medical Data Vision Claims Database in patients with UC who began an advanced therapy (biologics, advanced small molecules, calcineurin inhibitors) from January 2018 through April 2023. D2T UC patients were defined as having 2 or more switches of advanced therapies, or as undergoing surgery for UC, within 2 years after the first advanced therapy.

Results: Four hundred and one (16.7%) and 1,996 patients (83.3%) met the definitions of patients with D2T UC and non-D2T UC, respectively. After 1:1 matching by index year, 355 patients per group were included in the analysis. Multivariate logistic regression analyses, including sensitivity analyses based on follow-up period after the first advanced therapy, showed that a prescribed corticosteroid dose of ≥ 30 mg/day during the 6-month baseline period was associated with D2T UC. In D2T UC patients, median duration of the first advanced therapy was 99 days, and median number of advanced therapies per year was 1.7. The first advanced therapy was continued for 2 years in 78% of patients with non-D2T UC.

Conclusions: The proportion of D2T UC patients among UC patients starting advanced therapy was 16.7%. The factor most associated with D2T UC was the need for a corticosteroid dose ≥ 30 mg/day during the 6 months before initiation of advanced therapy.