Publications by authors named "Toshimitsu Fujii"
Letter: Efficacy Versus Effectiveness-An Important Nuance Among Real-World Studies: Authors' Reply.
Aliment Pharmacol Ther
September 2025
Introduction: It remains unclear whether Janus kinase (JAK) inhibitors differ in efficacy and safety between elderly and non-elderly patients with ulcerative colitis.
Methods: We retrospectively compared outcomes between patients who started a JAK inhibitor at ≥65 years (elderly group) and those <65 years (non-elderly group).
Results: Among 228, 215, and 159 patients treated with upadacitinib, filgotinib, and tofacitinib, we identified 14, 36, and 13 elderly patients, respectively.
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.
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).
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.
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).
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.
View Article and Find Full Text PDFBackground: Small bowel (SB) lesions in Crohn's disease (CD) are often asymptomatic despite being highly active. Fecal calprotectin (FC) is the most widely used biomarker of CD activity, but its drawbacks include a large intra-individual sample variability and the burden of collecting stool samples. Meanwhile, serum leucine-rich alpha-2 glycoprotein (LRG) has recently attracted attention as a biomarker that can address the limitations of FC.
View Article and Find Full Text PDFBackground: Despite the availability of several biologics for ulcerative colitis (UC), there remains a critical need to identify first-line treatment biologics. The superiority of infliximab (IFX) over vedolizumab (VED) and ustekinumab (UST) was evaluated as initial UC treatments in patients with biologic-naïve UC.
Methods: This multicenter, randomized control trial was conducted across 20 Japanese medical institutions.
Letter: Toward Intra-Class Switching With JAK Inhibitors? Authors' Reply.
Aliment Pharmacol Ther
March 2025
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.
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.
View Article and Find Full Text PDFBackground: Three Janus kinase (JAK) inhibitors are approved for ulcerative colitis (UC) in Japan.
Aim: To compare the real-world efficacy and safety of these three JAK inhibitors in UC.
Methods: This was a multicentre, retrospective study of patients with UC started on JAK inhibitors.
Background/aims: The efficacy and safety of tofacitinib for the treatment of refractory ulcerative colitis (UC) has been demonstrated in clinical trials. Although, a series of reports with real-world evidence of its short-term efficacy and safety profiles have already been published, reports of long-term real-world data have been limited. We aimed to show our 3-year evidence on the clinical use of tofacitinib for the treatment of UC, focusing on its efficacy and safety profiles.
View Article and Find Full Text PDFArticle Synopsis
- The study focused on the impact of twice-daily budesonide foam enema on bowel urgency in patients with mild-to-moderate ulcerative colitis (UC), highlighting its importance for quality of life.
- Over a 4-week period, 61 patients reported their symptoms, with results showing a 58.5% resolution rate of bowel urgency and a clinical remission rate of 64.4%.
- The treatment was generally safe, with only one adverse event unrelated to the medication, indicating early improvement in bowel urgency without new safety concerns.
Article Synopsis
- This study assessed the effectiveness of NUDT15 codon 139 genotyping to improve thiopurine treatment for inflammatory bowel disease (IBD) among 4628 patients in Japan.
- Retrospective analysis showed that while genotyping did not significantly change thiopurine induction rates, it led to customized dosing that reduced adverse events (AEs) and improved treatment retention.
- Findings indicated that starting doses and genotype-based adjustments can minimize risks, with specific genotypes correlating to different reactions to thiopurine treatments—providing a basis for more tailored treatment strategies.
Article Synopsis
- Filgotinib, a JAK 1 inhibitor approved for ulcerative colitis (UC), has limited real-world data on its effectiveness and safety, prompting a multicenter study of patients using it from March 2022 to September 2023.
- The study found that among 238 UC patients, clinical remission rates increased from 47% at 10 weeks to 64.6% at 58 weeks, with a median follow-up of 28 weeks showing 39.9% achieving remission.
- Adverse events were low, with only 1.3% developing herpes zoster, indicating that filgotinib has promising efficacy and safety in the real-world setting for UC treatment.*
COVID-19 severity is associated with the risk of gastrointestinal bleeding.
BMJ Open Gastroenterol
November 2023
Objective: The association between the severity of COVID-19 and gastrointestinal (GI) bleeding is unknown. This study aimed to determine whether the severity of COVID-19 is a risk factor for GI bleeding.
Design: A multicentre, retrospective cohort study was conducted on hospitalised patients with COVID-19 between January 2020 and December 2021.
[MRI for cross-sectional imaging in treat-to-target strategy and transmural healing].
Nihon Shokakibyo Gakkai Zasshi
November 2023
Background/aims: Endoscopic activity confirmed by enteroscopy is associated with poor clinical outcome in Crohn's disease (CD). We investigated which of the existing biomarkers best reflects endoscopic activity in CD patients including the small bowel, and whether their combined use can improve accuracy.
Methods: One hundred and four consecutive patients with ileal and ileocolonic type CD who underwent balloon-assisted enteroscopy (BAE) from October 2021 to August 2022 were enrolled, with clinical and laboratory data prospectively collected and analyzed.
Background And Aims: Durable clinical remission, endoscopic healing, and biomarker normalization are key treatment goals for Crohn's disease. The selective anti-interleukin-23 p19 inhibitor risankizumab has demonstrated efficacy and safety in moderately to severely active Crohn's disease. This post-hoc analysis of data from the pivotal risankizumab maintenance study assessed whether risankizumab maintenance therapy sustained the clinical and endoscopic outcomes achieved with risankizumab induction therapy.
View Article and Find Full Text PDFArticle Synopsis
- Risankizumab, an anti-interleukin-23 antibody, is being studied as a treatment for moderate-to-severe Crohn's disease, focusing specifically on Asian patients.
- The study involved two major clinical trials that tested the drug's performance against a placebo in patients who had not responded to other treatments, with follow-up maintenance therapy for those who showed improvement.
- Results indicated that risankizumab led to significant clinical remission and endoscopic response rates, with a safety profile comparable to that of non-Asian populations, reinforcing its potential effectiveness for Asian patients with Crohn's disease.