Intestinal Research最新文献

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: 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: Sarcopenia is implicated in inflammatory bowel disease (IBD) complications and surgical outcomes. This study aimed to investigate the prevalence and follow-up of sarcopenia in patients with IBD.

Methods: Consecutive consenting patients with IBD aged > 18 years were included. Patients with associated sarcopenic diseases were excluded. All had measurements of anthropometry, body mass index (BMI), mid-arm muscle circumference, muscle strength, physical performance, and muscle mass (on computed tomography scan). They were followed up for up to 12 months, and incidence of flares, fractures, and surgery was noted.

Results: Of 157 patients screened, 35 refused participation; 5 with associated sarcopenic diseases were excluded. Of 117 patients (median age, 41 years; interquartile range, 18-81 years; 65 men), 73 had ulcerative colitis, 42 Crohn's disease, and 2 IBD-unclassified. Forty (34.2%) had probable sarcopenia; 47 (40.2%) had sarcopenia (29 ulcerative colitis and 18 Crohn's disease) including 10 (8.5%) with severe sarcopenia. Ten (21.3%) were in disease remission. Of factors associated with sarcopenia in univariate analysis, only BMI was significant in multivariate analysis. Ninety-nine patients followed up for a median of 7 months (interquartile range, 2-12 months). Freedom from flares was 5.3% in patients with sarcopenia and 46.1% in those without (P= 0.004). Three patients (1 with sarcopenia, 2 without) required surgery.

Conclusions: Sarcopenia was present in 40% of patients with IBD; one-fifth of these had severe sarcopenia. One-fifth were in remission. Low BMI correlated with sarcopenia. More patients with sarcopenia had disease flare. Screening for sarcopenia should be considered in patients with IBD.

Background/aims: Fatigue is a common symptom in patients with inflammatory bowel disease (IBD). The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale has demonstrated reliability and validity in assessing fatigue in patients with IBD and is used worldwide. This study aimed to examine the current state of fatigue among Japanese patients with IBD using the FACIT-F scale and to compare these findings with data from global studies through a systematic review.

Methods: Data from 488 patients with IBD treated at a specialized IBD clinic were analyzed. Patient characteristics, such as sex, age, disease duration, disease activity, FACIT-F scores, and sleep duration, were collected. A literature search identified 8 studies that met our inclusion criteria for an international comparison. A meta-analysis was performed on the Fatigue Subscale (FS) scores of FACIT-F to estimate the pooled mean.

Results: The mean FACIT-F (FS) score in this study was 39.9 ± 8.6. Four variables were significantly associated with fatigue: low Emotional Well-Being subscale scores, sleep duration < 6 hours, albumin level below the reference value, and being unmarried. The meta-analysis revealed that the pooled mean score was 40.2 (95% confidence interval, 39.5-40.9), and between-study heterogeneity was moderate (I2 = 41%).

Conclusions: The FACIT-F (FS) scores and related factors in Japanese patients with IBD demonstrated a similar trend to those in other countries. These findings can be used to identify patients in need of support and to consider interventions for modifiable factors. This study will help promote international collaborative research.

Background/aims: Radial incision and cutting (RIC) is an alternative dilation method for stenosis of the lower gastrointestinal tract. However, its safety and efficacy for the small intestine requiring balloon-assisted enteroscopy (BAE) remain limited. Therefore, this pilot study aimed to evaluate the safety and efficacy of RIC using BAE.

Methods: We included 10 patients with Crohn's disease and performed 12 sessions of RIC for 10 lesions. The rate of adverse events 1 month after RIC was the primary outcome, whereas short- and long-term prognoses and improvements in subjective symptoms that were evaluated using a visual analog scale were the secondary outcomes.

Results: The technical success rate for RIC, defined as scope passage immediately following the procedure, was 100% (12/12). The rates of delayed bleeding and perforation were 0% (0/12). One patient developed restenosis because of the worsening of Crohn's disease and underwent surgery 2 months after RIC. The cumulative restenosis-, reintervention-, and surgery-free rates at 1 year after RIC were 67.5%, 78.7%, and 90.0%, respectively. Abdominal pain, abdominal bloating, nausea, and difficulties in defecation significantly improved 4 weeks after RIC.

Conclusions: RIC for small intestine using BAE has the potential to be safe and effective for relieving symptoms (jRCT identifier jRCTs022200040).

Background/aims: The objectives of this real-world study were to determine 1-year persistence with vedolizumab in patients with ulcerative colitis and to evaluate factors contributing to loss of response.

Methods: In this multicenter, retrospective, observational chart review, patients with moderately to severely active ulcerative colitis who received ≥ 1 dose of vedolizumab in clinical practice at 16 tertiary hospitals in Japan (from December 2018 through February 2020) were enrolled.

Results: Persistence with vedolizumab was 64.5% (n = 370); the median follow-up time was 53.2 weeks. Discontinuation due to loss of response among initial clinical remitters was reported in 12.5% (35/281) of patients. Multivariate analysis showed that concomitant use of tacrolimus (odds ratio [OR], 2.76; 95% confidence interval [CI], 1.00-7.62; P= 0.050) and shorter disease duration (OR for median duration ≥ 7.8 years vs. < 7.8 years, 0.33; 95% CI, 0.13-0.82; P= 0.017) were associated with discontinuation due to loss of response. Loss of response was not associated with prior use of anti-tumor necrosis factor alpha therapy, age at the time of treatment, disease severity, or concomitant corticosteroids or immunomodulators. Of the 25 patients with disease duration < 1 year, 32.0% discontinued due to loss of response.

Conclusions: Persistence with vedolizumab was consistent with previous reports. Use of tacrolimus and shorter disease duration were the main predictors of decreased persistence.

Background/aims: Diagnosis of cytomegalovirus (CMV) ileocolitis traditionally requires colonoscopy with tissue biopsy. Due to potential complications in high-risk patients, there is growing interest in serum and stool tests for diagnosing this condition. We aimed to evaluate the diagnostic accuracy of these noninvasive tests compared to traditional gold standards.

Methods: Two independent reviewers performed a comprehensive search on MEDLINE and Embase from inception up to October 1, 2023. Prospective and retrospective studies evaluating the performance of serum CMV polymerase chain reaction (PCR), serum CMV antigen (Ag), and stool CMV PCR in diagnosing CMV ileocolitis were included. Tissue histopathology or tissue CMV PCR served as reference standards. Diagnostic performances of each serum and stool test were calculated based on a meta-analysis using random-effects model.

Results: A total of 30 studies, comprising 23 studies of serum CMV PCR, 9 of serum CMV Ag, and 7 of stool CMV PCR, were included. The pooled sensitivity, specificity, and area under summary receiver operating characteristic curves were 62% (95% confidence interval [CI], 51%-72%), 90% (95% CI, 79%-96%), and 0.81 for serum CMV PCR, 38% (95% CI, 26%-51%), 94% (95% CI, 70%-99%), and 0.56 for serum CMV Ag, and 53% (95% CI, 35%-70%), 91% (95% CI, 84%-95%), and 0.84 for stool CMV PCR.

Conclusions: Serum and stool tests cannot replace colonoscopy for diagnosing CMV ileocolitis due to their low sensitivities but may be useful when colonoscopy is not feasible. Positive results can aid diagnosis, given their high specificities. Serum and/or stool CMV PCR are preferred over CMV Ag.

Clinical guidelines typically endorse conventional therapies such as 5-aminosalicylic acid (5-ASA) as the mainstay of ulcerative colitis management. However, the degree of adoption and application of guideline recommendations by physicians within Asia remains unclear. This study aims to understand the prescribing patterns of 5-ASA and implementation of current guideline recommendations across Asian clinical practice. A physician survey was conducted among inflammatory bowel disease specialists in 8 Asian territories to understand practices and preferences in ulcerative colitis management, focusing on the use of 5-ASA and concordance with guideline recommendations. Survey findings were validated by country experts in diverse healthcare settings. Subgroup analyses stratified data by income levels and treatment reimbursement status. Ninety-eight valid responses were received from inflammatory bowel disease specialists or gastroenterologists among 8 economic entities. Significant differences were found in clinical practices and treatment preferences for ulcerative colitis management among different income-level and government-subsidy groups. Survey results are summarized in 8 findings that illustrate trends in 5-ASA use and guideline implementation across Asian territories. This study emphasizes socioeconomic factors that impact the adoption of guideline recommendations in real-world practice. Our findings indicate an eclectic approach to guideline implementation across Asia, based on resource availability and feasibility of treatment goals.

Background/aims: Despite available treatments for ulcerative colitis (UC), unmet needs persist among patients in Japan. This study explored the health-related quality of life (HRQoL), work productivity and activity impairment (WPAI), indirect cost, and unmet needs among treated UC patients in Japan.

Methods: This cross-sectional, observational study utilized data from the online 2017, 2019, and 2021 Japan National Health and Wellness Survey. Respondents were aged ≥ 18 years and had undergone or were on UC treatment (5-aminosalicylic acid, steroids, immunomodulators/immunosuppressants, biologics/Janus kinase inhibitors [JAKi]). Demographic, general health, and clinical characteristics, medication adherence, HRQoL, WPAI, and indirect cost were collected and analyzed.

Results: Among 293 treated UC patients, 83.6% were non-biologic/JAKi users, 29.0% had UC ≥ 15 years, 34.8% had moderate-to-severe disease severity, 55.3% experienced ≥ 1 persisting UC symptom, and 91.5% reported UC as bothersome to an extent. Patients reported EuroQoL visual analog scale score of 68.1 and ≥ 35% reported anxiety and depression. Mean work productivity loss was 29.3%, resulting in an annual mean indirect loss of 1.1 million JPY (45.3 thousand USD) per person. Higher WPAI (impairment) was associated with being male, moderate-to-severe disease severity, and low treatment adherence (P< 0.05). Biologics/JAKi users had higher work impairment, and IM/IS users had higher activity impairment than 5-aminosalicylic acid users (P< 0.05).

Conclusions: Despite treatment, Japanese UC patients experienced high disease burden and persistent disease-related challenges. Overall HRQoL were lower than the mean healthy population and work productivity impairment led to high indirect costs. The findings suggest the importance of new interventions for optimizing UC outcomes.

Background/aims: Upadacitinib is a novel selective Janus kinase inhibitor approved for use in ulcerative colitis. Clinical trials had rigorous criteria and excluded many patient subgroups. Given limited real-world effectiveness data, we examined outcomes of patients treated with upadacitinib for ulcerative colitis in a real-world population.

Methods: Patients that commenced upadacitinib for moderate-to-severe ulcerative colitis from September 2022 until March 2023 were identified at 13 inflammatory bowel disease centers across Australia. Clinical, biochemical, endoscopic, and intestinal ultrasound outcomes were recorded retrospectively at baseline, week 8, and week 16.

Results: One hundred and fifty-two patients (61 female [40%], median age 38 years [interquartile range, 28-50]) were included. The primary endpoint of clinical remission was met in 79% at week 8, and 84% at week 16. A total of 42 patients (28%) with prior tofacitinib exposure were included. No significant difference in clinical remission was observed by week 16 between tofacitinib experienced compared to tofacitinib naïve patients (86% vs. 84%, P= 0.67). Complete intestinal ultrasound data was available for 36 patients, showing transmural remission in 64% at week 8 and 81% at week 16, with a decrease in median bowel wall thickness of 2.3 mm and 2.4 mm, respectively.

Conclusions: Upadacitinib resulted in high rates of clinical remission at 8 and 16 weeks in this large real-world cohort of ulcerative colitis patients. Upadacitinib is effective in patients with prior tofacitinib exposure. Intestinal ultrasound shows significant rates of transmural remission at week 8, sustained through week 16.