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.

Comparative study of gastric microbiota between patients with autoimmune gastritis and those with atrophic gastritis.

Fundamental treatments for autoimmune gastritis (AIG) have not yet been established; thus, analyzing AIG pathogenesis in detail to obtain useful information for prognosis prediction and treatment is crucial. This study explored bacteria involved in AIG pathogenesis by focusing on the gastric microbiota composition. Gastric biopsy tissues were collected endoscopically from the gastric corpus and antrum of patients with AIG and chronic gastritis.

Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn's disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials.

Background: Despite the availability of biological therapies, suboptimal disease control remains a problem for patients with Crohn's disease. We report the results of the GALAXI-2 and GALAXI-3 studies, which aimed to assess the efficacy and safety of intravenous induction followed by subcutaneous maintenance therapy with guselkumab over 48 weeks in adults with moderately to severely active Crohn's disease.

Methods: GALAXI-2 and GALAXI-3 were identically designed, phase 3, randomised, double-blind, triple-dummy, treat-through trials with active and placebo comparators.

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.

Week 2 remission with vedolizumab as a predictor of long-term remission in patients with ulcerative colitis: a multicenter, retrospective, observational study.

Background/aims: Vedolizumab (VDZ), a gut-selective monoclonal antibody for ulcerative colitis (UC) treatment, has no established biomarkers or clinical features that predict long-term remission. Week 2 remission, a potential predictor of long-term remission, could inform maintenance treatment strategy.

Methods: This retrospective, observational chart review included patients with UC in Japan who initiated VDZ between December 2018 and February 2020.

Expert consensus on diagnostic guidelines for pediatric inflammatory bowel disease in Japan.

Background: Inflammatory bowel disease (IBD) can occur at any age. In pediatric patients, the disease may present with a broader range of symptoms and more severe course than in adults, due to ongoing growth and development. Therefore, pediatric IBD often exhibits an atypical clinical course and laboratory findings.

Capsule Endoscopy in Inflammatory Bowel Disease: Current Status and Issues in Clinical Practice.

Inflammatory bowel diseases include Crohn's disease (CD) and ulcerative colitis (UC), both of which require endoscopic evaluation of mucosal surfaces. Capsule endoscopy has been used in clinical practice since 2000 as a minimally invasive means of mucosal evaluation. In Japan, there is an innovative algorithm that incorporates capsule endoscopy into the diagnostic algorithm for CD.

Guselkumab in East Asians With Moderate-to-Severe Ulcerative Colitis: Subgroup Analysis of the QUASAR Induction and Maintenance Studies.

Background And Aim: The global QUASAR (NCT04033445) clinical program demonstrated the efficacy and safety of guselkumab, a dual-acting interleukin-23 p19 subunit inhibitor, as induction and maintenance therapy in participants with moderate to severely active ulcerative colitis (UC). We report a subgroup analysis in East Asian participants.

Methods: The QUASAR program included two randomized, placebo-controlled, 12-week induction studies of guselkumab 200 mg (and 400 mg, Phase 2b) IV every 4 weeks (q4w) in adults with baseline modified Mayo scores of 5-9 and inadequate response/intolerance to conventional and/or advanced UC therapy.

Impact of mirikizumab treatment on fatigue in patients with moderately to severely active Crohn's disease: results from the phase 3 VIVID-1 study.

Background: Fatigue is a debilitating multifactorial symptom experienced by patients with Crohn's disease (CD). Mirikizumab, an anti-interleukin-23p19 antibody, demonstrated significant efficacy and safety in the patients with moderately to severely active CD. This analysis investigated the impact of mirikizumab on fatigue and the association between changes in clinical, endoscopic, and patient-reported outcomes with improvement in fatigue from baseline in the Phase 3 VIVID-1 study.

Machine Learning of Serum Cytokine and Chemokine Profiles Can Classify Inflammatory Bowel Disease Beyond Clinical Diagnosis.

Background And Aims: The pathophysiology of inflammatory bowel disease (IBD) including ulcerative colitis (UC) and Crohn's disease (CD) remains unclear. While IBD is heterogeneous, most molecular-targeted drugs (MTDs) are effective for both UC and CD. The immunological pathoetiology can be considered to overlap regardless of clinical manifestations.

The duration of prior anti-tumor necrosis factor agents is associated with the effectiveness of vedolizumab in patients with ulcerative colitis: a real-world multicenter retrospective study.

Background/aims: Previous literature suggests that the response of patients with ulcerative colitis to vedolizumab may be affected by previous biologic therapy exposure. This real-world study evaluated vedolizumab treatment effectiveness in biologicnon- naïve patients.

Methods: This was a multicenter, retrospective, observational chart review of records from 16 hospitals in Japan (December 1, 2018, to February 29, 2020).

Characteristic gene expression profile of intestinal mucosa early in life promotes bacterial colonization leading to healthy development of the intestinal environment.

The gut microbiome early in life plays a crucial role in development of the host and affects health throughout life. The definition of a healthy microbiome early in life has not been established, and the underlying mechanism of how a young host selects appropriate microbes for colonization remains unclear. Understanding the mechanism may provide insights into novel preventive and therapeutic strategies by correcting dysbiosis early in life.

Obefazimod in patients with moderate-to-severely active ulcerative colitis: efficacy and safety analysis from the 96-week open-label maintenance phase 2b study.

Background And Aims: Obefazimod is an oral small molecule that selectively enhances the expression of a single micro-RNA (miRNA), miR-124. Obefazimod has demonstrated safety and efficacy in patients with moderate-to-severely active ulcerative colitis (UC) in a phase 2b induction trial. This analysis presents the 2-year outcome data of the open-label maintenance (OLM) study.

Factors associated with response to filgotinib and the prognostic power of faecal calprotectin for ulcerative colitis in the phase 2b/3 SELECTION trial.

Background: Patients with moderately to severely active ulcerative colitis have distinct filgotinib response trajectories.

Aims: Evaluate factors associated with response to filgotinib over time.

Methods: Patients from SELECTION (NCT02914522) receiving filgotinib 200 mg (FIL200) or 100 mg (FIL100), or placebo were included.

Real-World Effectiveness and Safety of Vedolizumab in Patients ≥ 70 Versus < 70 Years With Ulcerative Colitis: Multicenter Retrospective Study.

Background And Aim: Vedolizumab (VDZ) is often used in older patients with ulcerative colitis (UC) in clinical practice; however, real-world evidence is still limited, including in those with late-onset UC.

Methods: This post hoc analysis of a multicenter, retrospective, observational chart review, enrolling 370 patients with UC receiving VDZ between December 2018 and February 2020, compared effectiveness and safety of VDZ among patients ≥ 70 (n = 40) versus < 70 years (n = 330), and among patients ≥ 70 years with and without late-onset UC (age at disease onset: ≥ 70 [n = 13] versus < 70 years [n = 26]).

Results: There were no differences between patients ≥ 70 and < 70 years in clinical remission rates (week 6: 57.

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.

A case of ulcerative colitis in a patient undergoing surgery due to exacerbation resulting in toxic megacolon after SARS-CoV-2 vaccination.

We herein report a case involving a patient with quiescent ulcerative colitis (UC) in long-term clinical remission whose condition rapidly worsened after receiving a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination, leading to colectomy due to toxic megacolon. The patient received the fifth dose of the Spikevax (mRNA-1273) vaccine and experienced a severe flare-up of UC 6 days later. Pathologic findings of the surgical specimens were consistent with severe active UC concomitant with cytomegalovirus infection.

Inflammation-Associated Carcinogenesis in Inflammatory Bowel Disease: Clinical Features and Molecular Mechanisms.

Inflammatory bowel disease (IBD), comprising ulcerative colitis (UC) and Crohn's disease (CD), is a chronic condition marked by persistent intestinal inflammation of unknown etiology. Disease onset involves genetic predisposition and environmental factors that disrupt the intestinal immune homeostasis. The intestinal microbiome and immune response play pivotal roles in disease progression.

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).

Recent Advances in Molecular Targeted Therapy for Inflammatory Bowel Disease.

Progress in the development of molecular targeted therapies in the field of inflammatory bowel disease has been remarkable. With the advent of molecular-targeted agents, treatment strategies have changed, and higher-level treatment goals have been set. In terms of the long-term prognosis of inflammatory bowel disease, there has been a clear decline in the rate of surgery since 2000 when anti-tumor necrosis factor antibody preparations were introduced.

Efficacy and Safety of Guselkumab Subcutaneous Induction and Maintenance in Participants With Moderately to Severely Active Crohn's Disease: Results From the Phase 3 GRAVITI Study.

Background & Aims: Subcutaneous (SC) induction and maintenance with guselkumab was evaluated in adult participants with moderately to severely active Crohn's disease.

Methods: The Phase 3 double-blind, placebo-controlled, treat-through GRAVITI study randomized 347 participants 1:1:1 to guselkumab 400 mg SC every 4 weeks→100 mg SC every 8 weeks (n = 115), guselkumab 400 mg SC every 4 weeks→200 mg SC every 4 weeks (n = 115), or placebo (n = 117). Placebo participants meeting rescue criteria received guselkumab from week 16 onward.

Development of a capsule endoscopy scoring system for the early diagnosis of small bowel Crohn's disease.

Background: Small bowel capsule endoscopy (SBCE) is a reliable method of evaluating small bowel mucosal lesions, and its use in Crohn's disease (CD) is increasing. We previously reported useful SBCE findings for early diagnosis of CD. In the present study, we developed a scoring model for early diagnosis of CD using SBCE findings.