Abstract Introduction: Real-world data on long-term outcomes and predictors of vedolizumab (VDZ) persistence in ulcerative colitis (UC) and Crohn’s disease (CD) remain limited. This study aimed to evaluate long-term treatment persistence and identify predictors of VDZ persistence in patients with UC and CD. Methods: This retrospective study included 107 patients (64 UC and 43 CD) treated with VDZ. Treatment persistence was evaluated using the Kaplan–Meier method, and predictors of persistence were analyzed using Cox proportional hazards models. Results: The median observed treatment duration was 507 days in UC and 266 days in CD. The 1-year persistence rates were 69.4% in UC and 47.5% in CD, while the 2-year persistence rates were 60.2% and 32.5%, respectively. In UC, advanced age was significantly associated with lower VDZ persistence in the Cox model (hazard ratio [HR], 1.29; 95% confidence interval [CI] ,1.06–1.58; p = 0.013). Corticosteroid use at initiation, prior tacrolimus use and prior anti-TNF exposure were not identified as predictors of lower persistence. In CD, perianal disease was significantly associated with lower persistence (log-rank p < 0.01) and remained an independent predictor (HR 2.54, 95% CI 1.20–5.39; p = 0.015). Conclusions: Predictors of VDZ persistence were identified in both UC and CD. Age was associated with VDZ persistence in UC, while perianal disease was associated with VDZ persistence in CD. These findings may help guide patient selection and treatment strategies for VDZ in clinical practice.
Background and Aims: Fecal calprotectin (FCP) is a noninvasive biomarker used in treat-to-target strategies for ulcerative colitis (UC). However, treatment decisions often rely on clinical remission rather than biomarker elevation. This study evaluated the utility of elevated FCP levels for identifying patients at increased relapse risk and informing clinical decision-making among patients with UC in clinical remission receiving 5-aminosalicylic acid (5-ASA) monotherapy. Methods: We retrospectively analyzed patients with UC receiving 5-ASA monotherapy who maintained clinical remission (Lichtiger clinical activity index ≤3) with stable dosing for at least 3 months. Patients with FCP ≤142 µg/g 3 months earlier and subsequent elevation above 142 µg/g were included. Patients with proctitis-type UC were excluded. FCP was measured using a gold colloid immunoassay (Nescauto® Cp Auto, Alfresa Pharma, Japan). Patients were followed for 6 months after FCP elevation and classified into relapse and nonrelapse groups. Results: Twenty patients met the eligibility criteria and were included in the final analysis. Four patients (20%) relapsed within 6 months. Baseline characteristics and 5-ASA treatment, including dose and formulation, were similar between groups. FCP levels were significantly higher in the relapse group than in the nonrelapse group (median, 533 vs. 219 µg/g; p = 0.050). Receiver operating characteristic analysis demonstrated an area under the curve of 0.828, with an optimal cutoff value of 491 µg/g (sensitivity, 75%; specificity, 93.8%). Conclusions: Elevated FCP levels may help identify a subset of clinically asymptomatic patients with UC receiving 5-ASA monotherapy who are at increased risk of short-term relapse, suggesting a potential role for biomarker-guided monitoring even in this low-risk population.
Introduction: Budesonide Multi-Matrix System (BUD-MMX) was approved in Japan in 2023 for active ulcerative colitis (UC); however, real-world data in Asian population are limited. We evaluated the real-world effectiveness and safety of BUD-MMX in Japanese patients with UC. Methods: We retrospectively reviewed patients with UC treated with BUD-MMX between September 2023 and August 2025 at six Japanese institutions. The primary outcome was clinical remission at week 8, defined as a partial Mayo score (PMS) ≤ 1 with a rectal bleeding subscore of 0. The secondary outcomes included week 4 remission, clinical response, safety, longitudinal changes in disease activity, and baseline clinical characteristics associated with week 8 remission. Results: Of 83 patients, 53 were included in the effectiveness analysis (median age, 52 years; 60.4% male; pancolitis, 49.1%; median baseline PMS, 4.0; prior advanced therapy [AT], 24.5%). Clinical remission was achieved in 37.7% and 59.2% of patients at weeks 4 and 8, respectively, and the clinical response reached 67.3% at week 8. PMS and Patient-Reported Outcome 2 (PRO2) declined significantly by week 4. The week-8 clinical remission rate was significantly higher in AT-naïve than in AT-exposed patients and in patients with low baseline PRO2 (1–2) than in those with moderate-to-severe PRO2 (3–6). In multivariable models adjusted for age and prior AT, baseline PRO2 and PMS were independently associated with remission. Adverse events occurred in 4.8% of patients, but all were mild. Conclusion: BUD-MMX was effective and well-tolerated in Japanese patients with mild-to-moderately active UC. Lower baseline PRO2 and PMS, and the absence of prior AT, predicted week-8 remission, supporting their use for patient selection.
Background: Intestinal ultrasound (IUS) provides rapid, noninvasive assessment of transmural inflammation in inflammatory bowel disease (IBD). In clinical practice, infectious enterocolitis frequently mimics IBD activity or complicates established diseases, creating diagnostic uncertainty at presentation and increasing the risk of inappropriate treatment escalation. Summary: This case-based narrative review describes how IUS can support diagnostic assessment in patients with suspected IBD activity or infectious enterocolitis. We summarize core IUS parameters, including bowel wall thickness, mural vascularity, and bowel wall stratification, along with supportive findings, such as perienteric inflammatory fat, lymphadenopathy, and haustral changes. Validated IUS-based approaches for ulcerative colitis (UC) and Crohn’s disease (CD), including the Milan Ultrasound Criteria (MUC), International Bowel Ultrasound Segmental Activity Score (IBUS-SAS), and transperineal ultrasound (TPUS) for rectal assessment, are summarized. Using representative cases, we highlight characteristic pattern-based IUS findings across common causes of infectious enterocolitis and intestinal tuberculosis, focusing on disease distribution, symmetry, perienteric involvement, and short-interval evolution on follow-up examinations. These findings will help refine the differential diagnosis and inform subsequent testing in real-world clinical settings. Key Messages: IUS provides readily available, segment-based information that complements clinical evaluation when differentiating IBD activity from infectious enterocolitis. Pattern recognition on IUS may enhance diagnostic safety and guide subsequent investigations; however, findings should be interpreted in the context of clinical presentation and additional diagnostic modalities.
Introduction: While celiac disease (CeD) is an emerging disease worldwide, its prevalence has traditionally been very low in Japan. However, there are no regional data available regarding CeD across Japan. In this study, we screened patients with disorders of gut-brain interaction (DGBI), including irritable bowel syndrome (IBS) and functional dyspepsia (FD), who were supposedly at a high risk for CeD. Subjects were enrolled from the Hokkaido area (northern Japan) to the Kyushu area (southern Japan) to determine the biopsy-confirmed serofrequency of CeD across Japan and its regional distribution. Methods: In this study, adult patients fulfilling the criteria for IBS or FD were recruited from the outpatient departments of 23 participating centers in Japan. Anti-tissue transglutaminase IgA (TTG) titers were determined for serological screening. Further histological studies were performed in patients with TTG levels >10 u/mL. Results: In total, 583 patients were enrolled in this study. There was only one subject with TTG >10 u/mL among the subjects with diarrhea-predominant IBS, who was histologically diagnosed with CeD of Marsh 3a. Biopsy-confirmed serofrequency was estimated to be 0.17% among DGBI in Japan. The regional distribution was not evaluated because of its rarity. Conclusion: It is noteworthy that no clustering of CeD cases in Japanese patients with DGBI was observed, and the overall frequency remained extremely low across all participating centers nationwide.
