Intestinal ResearchPub Date : 2025-07-01Epub Date: 2025-07-29DOI: 10.5217/ir.2025.00114
Hyeon Jin Cho, Eun Soo Kim
{"title":"Upadacitinib after tofacitinib in ulcerative colitis.","authors":"Hyeon Jin Cho, Eun Soo Kim","doi":"10.5217/ir.2025.00114","DOIUrl":"10.5217/ir.2025.00114","url":null,"abstract":"","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":"23 3","pages":"229-230"},"PeriodicalIF":3.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12332281/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144789087","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Tuberculosis risk in patients with Crohn's disease on biologics: a retrospective analysis of the Japanese Medical Claims Database.","authors":"Koji Fujimoto, Shuhei Hosomi, Yumie Kobayashi, Rieko Nakata, Yu Nishida, Masaki Ominami, Yuji Nadatani, Shusei Fukunaga, Koji Otani, Fumio Tanaka, Satoko Ohfuji, Yasuhiro Fujiwara","doi":"10.5217/ir.2024.00076","DOIUrl":"10.5217/ir.2024.00076","url":null,"abstract":"<p><strong>Background/aims: </strong>Treatment using tumor necrosis factor-α (TNF-α) inhibitors is one of the risk factors for active tuberculosis (TB) in patients with Crohn's disease (CD). Biologics, such as ustekinumab (UST) and vedolizumab (VDZ), are less likely to cause opportunistic infections. However, large-scale studies for active TB and biologics other than TNF-α inhibitors are limited. We aimed to investigate the association between biologics and active TB utilizing a Japanese medical claims database.</p><p><strong>Methods: </strong>We analyzed retrospectively the association of the risk of active TB development with treatment using TNF-α inhibitors and other biologics (UST and VDZ) in patients with CD using the Japanese Medical Data Vision (MDV) database between April 2008 and June 2022. The durations of each biologic and biologic-free treatment were calculated for each patient. Univariate and multivariate analyses were performed using the Cox proportional hazards model, with the utilization of biologics considered as time-dependent covariates.</p><p><strong>Results: </strong>We included 28,811 patients with CD in MDV database. Finally, 17,169 patients were analyzed. In total, 7,064 patients were categorized as biologic-naïve, while 10,105 were classified as biologic-experienced. Seventeen patients developed active TB, including 7 on infliximab, 5 on adalimumab, and 5 on no biologics. None of the patients treated with UST and VDZ developed active TB. Multivariate analysis suggested that TNF-α inhibitors were the risk factors for active TB (hazard ratio, 3.66; P= 0.020).</p><p><strong>Conclusions: </strong>TNF-α inhibitors, but not UST or VDZ, are risk factors for active TB in Japanese patients with CD.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":"309-317"},"PeriodicalIF":3.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12332282/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141999938","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Intestinal ResearchPub Date : 2025-07-01Epub Date: 2025-01-22DOI: 10.5217/ir.2024.00145
Makoto Tanaka, Momoko Takai, Sayaka Wakai, Kayoko Sakagami, Hiroaki Ito
{"title":"Understanding fatigue among Japanese patients with inflammatory bowel disease: insights from international comparisons and meta-analysis.","authors":"Makoto Tanaka, Momoko Takai, Sayaka Wakai, Kayoko Sakagami, Hiroaki Ito","doi":"10.5217/ir.2024.00145","DOIUrl":"10.5217/ir.2024.00145","url":null,"abstract":"<p><strong>Background/aims: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":"372-381"},"PeriodicalIF":3.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12332287/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005244","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Ulcerative colitis disease severity affects the speed of symptom relief under filgotinib treatment: a post hoc analysis of the phase 2b/3 SELECTION study.","authors":"Masayuki Saruta, Silvio Danese, Yoshie Takatori, Toshihiko Kaise, Christine Rudolph, Marc Ferrante, Toshifumi Hibi","doi":"10.5217/ir.2024.00169","DOIUrl":"https://doi.org/10.5217/ir.2024.00169","url":null,"abstract":"<p><strong>Background/aims: </strong>Filgotinib is an oral, once-daily, Janus kinase 1 preferential inhibitor approved for the treatment of ulcerative colitis (UC). This study aimed to assess symptomatic response with filgotinib 200 mg (FIL200) according to disease severity using baseline partial Mayo Clinic Score (pMCS).</p><p><strong>Methods: </strong>In the phase 2b/3 SELECTION study (NCT02914522), adults with moderate-to-severe UC were randomized to receive FIL200, filgotinib 100 mg, or placebo for 11 weeks in induction studies A (biologic-naive) and B (biologic-experienced). In this post hoc analysis, symptomatic remission (Mayo rectal bleeding subscore of 0 and stool frequency subscore ≤ 1) rates were assessed daily from baseline to day 15 and fortnightly from week 2 to week 10 by baseline pMCS (pMCS ≥ 7, pMCS < 7) in patients who received induction FIL200.</p><p><strong>Results: </strong>Of those who received FIL200 in induction studies A and B, 90 and 148 patients had a pMCS ≥ 7, and 155 and 114 had a pMCS < 7, respectively. Symptomatic remission rates were generally significantly higher in the pMCS < 7 than ≥ 7 group from day 2-15 (day 2: 8.4% vs. 1.1%, P= 0.009 [induction study A]; 8.8% vs. 0.7%, P= 0.004 [induction study B]). However, by week 10, there was no longer a significant difference in the rates between the pMCS ≥ 7 and < 7 groups (43.3% vs. 54.8%, P= 0.124 [induction study A]; 26.4% vs. 39.5%, P= 0.099 [induction study B]).</p><p><strong>Conclusions: </strong>Symptomatic response to FIL200 occurred more rapidly in the less severe disease groups than in the more severe disease groups; however, regardless of disease severity, both groups benefited from continued FIL200 treatment.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144527974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kwang Woo Kim, Hyoun Woo Kang, Seong-Joon Koh, Hyuk Yoon, Sihyun Kim, Yukyung Jun, Hyun Jung Lee, Jong Pil Im, Young Soo Park, Ji Won Kim, Joo Sung Kim
{"title":"A real-world comparison of subcutaneous to intravenous administration of infliximab in patients with inflammatory bowel disease.","authors":"Kwang Woo Kim, Hyoun Woo Kang, Seong-Joon Koh, Hyuk Yoon, Sihyun Kim, Yukyung Jun, Hyun Jung Lee, Jong Pil Im, Young Soo Park, Ji Won Kim, Joo Sung Kim","doi":"10.5217/ir.2025.00001","DOIUrl":"10.5217/ir.2025.00001","url":null,"abstract":"<p><strong>Background/aims: </strong>We compared intravenous and subcutaneous infliximab (IFX) as treatment for inflammatory bowel disease (IBD).</p><p><strong>Methods: </strong>This retrospective, multicenter, observational study enrolled patients treated with either intravenous or subcutaneous IFX. Sequential parameters were compared at baseline, 6 months, and 12 months following the initiation of treatment with either type of IFX. The primary outcome was the comparison of the IFX trough levels after 12 months of treatment.</p><p><strong>Results: </strong>In total, 183 participants were included in this study. After 6 months, the subcutaneous group exhibited significant differences compared to the intravenous group; in terms of clinical disease activity (0% vs. 15%, P= 0.007) and IFX trough level (21.72 ± 8.71 μg/mL vs. 7.70 ± 16.65 μg/mL, P= 0.002). After 12 months, subcutaneous, as compared to intravenous, achieved improved clinical disease activity (0% vs. 15%, P= 0.044) and IFX trough level (20.41 ± 12.91 μg/mL vs. 7.06 ± 6.81 μg/mL, P< 0.001). Analyzing the sequential changes compared with baseline data within each group, we observed significant alterations in subcutaneous; 6 months fecal calprotectin (676.3 ± 976.6 μg/g vs. 253.9 ± 483.9 μg/g, P= 0.014), 6 months IFX trough level (7.00 ± 5.67 μg/mL vs. 18.44 ± 6.34 μg/mL, P= 0.026), and 12 months IFX trough level (7.00 ± 5.67 μg/mL vs. 21.33 ± 4.50 μg/mL, P= 0.034).</p><p><strong>Conclusions: </strong>This study indicates the potential suitability of subcutaneous IFX as an alternative treatment option for IBD.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144368826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Comparative effectiveness of ustekinumab versus infliximab in the management of perianal fistulizing Crohn's disease: a retrospective study in China.","authors":"Mengqi Chen, Zihan Chen, Jianming Lin, Linxin Liu, Tong Tu, Xiaoling Li, Baili Chen, Yao He, Minhu Chen, Zhirong Zeng, Xiaojun Zhuang","doi":"10.5217/ir.2024.00168","DOIUrl":"https://doi.org/10.5217/ir.2024.00168","url":null,"abstract":"<p><strong>Background/aims: </strong>Ustekinumab (UST) and infliximab (IFX) are both effective in the treatment of perianal fistulizing Crohn's disease (CD), but limited research has focused on comparing the efficacy of UST versus IFX in this field. This study aimed to compare the effectiveness of UST or IFX in treating perianal fistula of CD patients naive to biological agents in a real-world setting.</p><p><strong>Methods: </strong>A retrospective cohort study included patients with perianal fistulizing CD treated with UST or IFX was conducted to evaluate the rates of luminal and perianal fistula response and remission at 6 months after treatment.</p><p><strong>Results: </strong>Ninety-seven patients (49 UST and 48 IFX) were enrolled. Compared to IFX, UST exhibited significantly higher rates of treatment success (89.8% vs. 50.0%, P< 0.001) and intestinal clinical response (85.7% vs. 68.8%, P= 0.048), but no significant differences in fistula remission, fistula response, fistula closure, intestinal clinical remission, endoscopic remission and endoscopic response was observed. Furthermore, multivariate analyses demonstrated complexity of fistula was conversely associated with fistula remission between the UST and IFX groups. Finally, the rates of disease relapse and operation in the IFX group were higher as compared to the UST group during follow-up.</p><p><strong>Conclusions: </strong>UST may serve as a promising alternative to IFX for the treatment of perianal fistulizing CD.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Clinical spectrum of acute severe ulcerative colitis in the biologic era: a prospective cohort study from India.","authors":"Arshdeep Singh, Mayur Luthra, Arshia Bhardwaj, Ramit Mahajan, Riya Sharma, Dharmatma Singh, Devanshi Jain, Omesh Goyal, Varun Mehta, Kirandeep Kaur, Yogesh Kumar Gupta, Vandana Midha, Ajit Sood","doi":"10.5217/ir.2024.00189","DOIUrl":"https://doi.org/10.5217/ir.2024.00189","url":null,"abstract":"<p><strong>Background/aims: </strong>Acute severe ulcerative colitis (ASUC) is a time-critical situation requiring urgent intervention. Limited data exist on the evolving clinical spectrum of ASUC in the era of advanced therapies.</p><p><strong>Methods: </strong>This prospective real-world observational cohort study included 145 adult patients hospitalized with ASUC between January 2020 and June 2024. ASUC was defined by the modified Truelove and Witts criteria. Demographics and disease characteristics, including disease severity, probable precipitating factors, and corticosteroid failure rates, were recorded.</p><p><strong>Results: </strong>The median age of patients was 36 years (interquartile range, 26-48.5 years) with 63 females (43.4%). Most patients had left-sided colitis (53.1%). The median disease duration was 1 year (IQR, 0.5-3 years), with 91 patients (62.7%) presenting with ASUC within the first year of diagnosis of ulcerative colitis. One-third of the patients had previous exposure to biologics and small molecules. The most commonly reported probable precipitants of ASUC were poor compliance with treatment (n = 43, 29.6%), antibiotic use (n = 35, 24.1%), high perceived stress (n = 32, 22.1%), and Clostridioides difficile infection (n = 19, 13.1%). Forty patients (27.5%) were non-responders to intravenous corticosteroids (IVCS). Twenty-nine patients (20%) received medical rescue therapy (infliximab, n = 14 [48.27%], cyclosporine A, n = 6 [20.68%], and tofacitinib, n = 9 [31.03%]). Seven patients (4.82%; 4 after non-response to IVCS and 3 after non-response to medical rescue therapy) underwent colectomy.</p><p><strong>Conclusions: </strong>In this cohort of ASUC patients, poor treatment compliance, antibiotic use, stress, and C. difficile infection were common precipitants of flare-ups. Nearly one-third of patients required medical rescue therapy, and a small proportion ultimately underwent colectomy.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144247860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Robert Gilmore, Amrutha Murali, Amirah Etchegaray, Ei Swe, Yoon-Kyo An, Jakob Begun
{"title":"Upadacitinib and vedolizumab combination therapy for the management of refractory ulcerative colitis and Crohn's disease.","authors":"Robert Gilmore, Amrutha Murali, Amirah Etchegaray, Ei Swe, Yoon-Kyo An, Jakob Begun","doi":"10.5217/ir.2024.00174","DOIUrl":"https://doi.org/10.5217/ir.2024.00174","url":null,"abstract":"<p><strong>Background/aims: </strong>Inflammatory bowel disease (IBD) is characterised by chronic inflammation of the gastrointestinal tract, and encompasses both ulcerative colitis (UC) and Crohn's disease (CD). Refractory disease is common, a combination of advanced drug therapies may be required to obtain maximal efficacy. We describe the use of upadacitinib therapy in combination with vedolizumab therapy for the management of refractory UC and CD.</p><p><strong>Methods: </strong>In this retrospective observational study, patients who received upadacitinib in combination with vedolizumab were identified at a tertiary IBD center between November 2022 and March 2024. Patients were followed for 6 months with clinical, biochemical, endoscopic and intestinal ultrasound outcomes.</p><p><strong>Results: </strong>Sixteen patients (7 with UC, 9 with CD) were identified. Median age was 44 years (range, 25-58 years), 11 (69%) were male, and median number of prior biologic exposures was 3 (range, 2-5). Twelve patients (75%) achieved clinical response, clinical remission, biochemical remission, corticosteroid-free clinical remission, and transmural remission by intestinal ultrasound. Eleven patients (69%) achieved endoscopic remission, with 4 (25%) achieving histological remission. Adverse events were seen in 8 patients (50%), but the majority were mild and did not require interruption of therapy.</p><p><strong>Conclusions: </strong>Upadacitinib in combination with vedolizumab may have a role in refractory UC and CD patients who have previously failed to respond to standard therapy, with a favorable safety profile. Prospective studies are required to determine the safety and efficacy of this combination in larger cohorts before routine use can be recommended.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144258110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"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.","authors":"Taku Kobayashi, Tadakazu Hisamatsu, Satoshi Motoya, Minoru Matsuura, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Ken Takeuchi, Sakiko Hiraoka, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Masaaki Shimada, Nobuaki Kuno, Mary Cavaliere, Kaori Ishiguro, Jovelle L Fernandez, Toshifumi Hibi","doi":"10.5217/ir.2024.00126","DOIUrl":"https://doi.org/10.5217/ir.2024.00126","url":null,"abstract":"<p><strong>Background/aims: </strong>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.</p><p><strong>Methods: </strong>This was a multicenter, retrospective, observational chart review of records from 16 hospitals in Japan (December 1, 2018, to February 29, 2020). Included patients who had ulcerative colitis, were aged ≥ 20 years, and received at least 1 dose of vedolizumab. Outcomes included clinical remission rates from weeks 2 to 54 according to prior biologic exposure status and factors associated with clinical remission up to week 54.</p><p><strong>Results: </strong>A total of 370 eligible patients were included. Clinical remission rates were significantly higher in biologic-naïve (n=197) than in biologic-non-naïve (n=173) patients for weeks 2 to 54 of vedolizumab treatment. Higher clinical remission rates up to week 54 were significantly associated with lower disease severity (partial Mayo score ≤ 4, P= 0.001; albumin ≥ 3.0, P= 0.019) and the duration of prior anti-tumor necrosis factor α (anti-TNFα) therapy (P= 0.026). Patients with anti-TNFα therapy durations of < 3 months, 3 to < 12 months, and ≥ 12 months had clinical remission rates of 28.1%, 32.7%, and 60.0%, respectively (P= 0.001 across groups).</p><p><strong>Conclusions: </strong>The effectiveness of vedolizumab in biologic-non-naïve patients was significantly influenced by duration of prior anti-TNFα therapy. (Japanese Registry of Clinical Trials: jRCT-1080225363).</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144215807","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}