Nationwide estimates of patient numbers and prevalence rates of ulcerative colitis and Crohn's disease in Japan in 2023.

Background: Almost a decade has passed since the previous nationwide survey on the prevalence of ulcerative colitis (UC) and Crohn's disease (CD) in Japan was conducted in 2015. We conducted a new nationwide hospital-based survey to provide updated estimates of the patient numbers and prevalence rates of UC and CD in Japan in 2023.

Methods: Stratified random sampling was used to select hospital departments (internal medicine, surgery, pediatrics, and pediatric surgery) that routinely treat UC and CD patients.

Asia Pacific association of gastroenterology consensus statements on histopathological evaluation of inflammatory bowel diseases.

Background: Mucosal histological activity is increasingly valued as a treatment endpoint in inflammatory bowel diseases (IBD). In the Asia Pacific region, the utility and acceptability of IBD histology as a treatment endpoint are uncertain due to the heterogeneity of IBD prevalence, resourcing and level of knowledge among practitioners. There is an opportunity to engage clinicians to harmonise histology reporting and collaborate with pathologists in this field.

Post Hoc Analysis of Anxiety and Behavioral Changes in Japanese Patients With Inflammatory Bowel Disease due to the COVID-19 Pandemic: Relationship Between Municipal Population at the Place of Residence and Anxiety.

Aims: The Japan COVID-19 Survey and the Questionnaire for Inflammatory Bowel Disease (J-DESIRE) identified multiple factors associated with anxiety regarding the novel coronavirus disease 2019 (COVID-19). However, no regional differences in anxiety were observed. In this post hoc analysis of J-DESIRE, we investigated the relationship between the municipal population size at the place of residence (MPSPR) and anxiety among patients with IBD in Japan during the COVID-19 pandemic.

Lifestyle restrictions are associated with impaired quality of life but not reduction in relapse in ulcerative colitis.

Background/aims: Patients with ulcerative colitis (UC) in remission commonly restrict thir lifestyle to prevent relapse; however, the effectiveness and impact on quality of life (QOL) is unclear. This study investigated whether lifestyle restrictions are associated with relapse reduction and assessed their impact on QOL.

Methods: This multicenter, prospective cohort study was conducted in Japan (2018-2021) via the YOURS registry, enrolling patients with UC in clinical remission.

Deucravacitinib in patients with inflammatory bowel disease: 12-week efficacy and safety results from 3 randomized phase 2 studies in Crohn's disease and ulcerative colitis.

Background And Aims: Tyrosine kinase 2 is a downstream intracellular mediator of interleukin-23 signaling, which has a key role in the pathogenesis of inflammatory bowel disease. Deucravacitinib is a novel, oral, selective, allosteric tyrosine kinase 2 inhibitor currently approved for the treatment of adults with moderate to severe plaque psoriasis.

Methods: Here we describe 3 randomized, double-blind, placebo-controlled phase 2 studies of deucravacitinib in patients with moderately to severely active Crohn's disease (LATTICE-CD [NCT03599622]) or ulcerative colitis (LATTICE-UC [NCT03934216] and IM011-127 [NCT04613518]).

Clinical characteristics of patients with difficult-to-treat ulcerative colitis: a nested case-control study using a Japanese claims database.

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.

Efficacy and safety of etrasimod in Japanese patients with ulcerative colitis: results from a phase 2 dose-ranging study.

Background/aims: Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). However, its efficacy, safety, and the appropriate dosage have not been extensively investigated in the Japanese population.

Methods: This phase 2, multicenter, randomized, double-blind, placebo-controlled dose-ranging, 12-week trial was carried out among Japanese patients with moderately to severely active UC.

Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a final report of safety and effectiveness data.

Background: We present the final analysis of a tofacitinib post-marketing surveillance (PMS) study in Japanese patients with ulcerative colitis (UC).

Methods: Safety/effectiveness data were evaluated (through Sept/30/2022). All patients with UC in Japan receiving tofacitinib were registered (60-week observation period).

Persistence of advanced therapies in patients with inflammatory bowel disease: retrospective cohort study using a large healthcare claims database in Japan.

Background/aims: There are few studies that comprehensively report real-world persistence for first-line advanced therapies used to treat inflammatory bowel disease. We aimed to describe persistence of first-line advanced therapies among incident biologic or Janus kinase inhibitor users with inflammatory bowel disease.

Methods: Retrospective cohort study using the Japan Medical Data Center database from January 1, 2010, until September 30, 2022.

Inadequate Efficacy of Biologics for Treating Proximal Ileal Lesions in Crohn's Disease; A Prospective Multicenter Study.

Background & Aims: Although biologic therapy has revolutionized the treatment of Crohn's disease (CD), surgery remains unavoidable in cases involving ileal complications. We aimed to evaluate the efficacy of biologics on proximal ileal lesions using balloon-assisted enteroscopy (BAE).

Methods: This open-label multicenter prospective study was conducted at tertiary referral centers in Japan.

Anti-integrin αvβ6 antibody as a biomarker for diagnosing ulcerative colitis: a nationwide multicenter validation study.

Background: A serum biomarker for diagnosing ulcerative colitis (UC) remains to be established. Although we recently reported an anti-integrin αvβ6 antibody (V6 Ab) for diagnosing UC with high sensitivity and specificity, no large-scale validation study exists. This study aimed to validate the diagnostic value of V6 Ab for UC using a nationwide multicenter cohort study.

Long-term safety and efficacy of filgotinib for the treatment of moderately to severely active ulcerative colitis: Interim analysis from up to 4 years of follow-up in the SELECTION open-label long-term extension study.

Background: Filgotinib, an oral, once-daily, Janus kinase 1 preferential inhibitor, is an approved treatment for moderately to severely active ulcerative colitis.

Aims: The aim of this study is to assess the safety and efficacy of continued filgotinib therapy over ~4 years in the long-term extension of the phase 2b/3 SELECTION trial (SELECTIONLTE; NCT02914535).

Methods: In this interim analysis of SELECTIONLTE, SELECTION completers (week 10 responders to filgotinib who completed the maintenance study) continued their assigned treatment (double-blind filgotinib 200 mg [FIL200] or filgotinib 100 mg) and SELECTION week 10 non-responders received open-label FIL200.

A Continuous Registry of Medical Record, Patient Input, and Epidemiological Data of Patients With Ulcerative Colitis: a Multicentre, Prospective, Observational Clinical Registry Study in Japan.

Background: This registry aims to allow for a prospective non-interventional observational study of ulcerative colitis. This will facilitate monitoring of the current state of ulcerative colitis in Japan and improving the long-term disease course and adverse events associated with current treatment options.

Methods: Inclusion of patients from five centres in Japan is planned.

Machine learning using clinical data at baseline predicts the medium-term efficacy of ustekinumab in patients with ulcerative colitis.

Predicting the therapeutic response to biologics before administration is a key clinical challenge in ulcerative colitis (UC). We previously reported a model for predicting the efficacy of vedolizumab (VDZ) for UC using a machine-learning approach. Ustekinumab (UST) is now available for treating UC, but no model for predicting its efficacy has been developed.

White Blood Cell Counts and Future Relapse in Ulcerative Colitis under Low-Dose Thiopurine Treatment in Real-World Practice: A 3-Year Japanese Multi-Center Retrospective Cohort Study.

Introduction: Whether white blood cell (WBC) counts are predictors for the effectiveness of thiopurine treatment in ulcerative colitis (UC) has been inconclusive in previous studies with small sample sizes. We investigated the association between WBC counts and future relapses in UC patients in a large-scale multi-center study.

Methods: This retrospective cohort study enrolled a total of 723 UC patients in remission from 33 hospitals and followed up for 3 years.