Ki Sung Kang, Gee Hyeun Choi, Yu Jin Kim, Won Suk Lee, Do Eun Lee, Min Yeong Kim, Hyuk Yoon, Dong Ho Lee
Background/aims: Fecal microbiota transplantation (FMT) is increasingly recognized as an alternative to antibiotics for treating recurrent Clostridioides difficile infection. The success of FMT heavily depends on the appropriate selection of donors, encompassing factors such as diet patterns, lifestyle, environmental exposures, and intestinal microbiota diversity.
Methods: A potential super donor was identified from 5 healthy adults and provided stool samples periodically over 2 years (2021-2022). The samples underwent 16S rRNA sequencing via the Illumina MiSeq platform, and microbial diversity was analyzed using QIIME 2 in comparison with 152 healthy individuals.
Results: The stool microbiome composition of the potential super donor remained stable without significant changes over a 2-year period. Both alpha and beta diversity analyses revealed significant differences between the super donor and the 152 healthy individuals. The super donor exhibited significantly higher microbial diversity based on alpha diversity metrics (P< 0.0001) and distinct compositional profiles as shown by beta diversity. Linear discriminant analysis effect size (LEfSe) analysis indicated that Faecalibacterium and Prevotella strains comprised a significant proportion, with notable differences in relative abundance patterns (P< 0.05). Furthermore, 7 bacterial species were isolated from the super donor, all of which demonstrated inhibitory effects on the growth of C. difficile in vitro.
Conclusions: These findings suggest that selecting donors with specific microbiota profiles, particularly those exhibiting higher microbial diversity, may potentially contribute to the inhibition of C. difficile, and further clinical studies are warranted to validate these findings.
{"title":"Analysis of gut microbiota in super donors for fecal microbiota transplantation and isolated gut commensal bacteria of inhibition against Clostridioides difficile.","authors":"Ki Sung Kang, Gee Hyeun Choi, Yu Jin Kim, Won Suk Lee, Do Eun Lee, Min Yeong Kim, Hyuk Yoon, Dong Ho Lee","doi":"10.5217/ir.2025.00179","DOIUrl":"https://doi.org/10.5217/ir.2025.00179","url":null,"abstract":"<p><strong>Background/aims: </strong>Fecal microbiota transplantation (FMT) is increasingly recognized as an alternative to antibiotics for treating recurrent Clostridioides difficile infection. The success of FMT heavily depends on the appropriate selection of donors, encompassing factors such as diet patterns, lifestyle, environmental exposures, and intestinal microbiota diversity.</p><p><strong>Methods: </strong>A potential super donor was identified from 5 healthy adults and provided stool samples periodically over 2 years (2021-2022). The samples underwent 16S rRNA sequencing via the Illumina MiSeq platform, and microbial diversity was analyzed using QIIME 2 in comparison with 152 healthy individuals.</p><p><strong>Results: </strong>The stool microbiome composition of the potential super donor remained stable without significant changes over a 2-year period. Both alpha and beta diversity analyses revealed significant differences between the super donor and the 152 healthy individuals. The super donor exhibited significantly higher microbial diversity based on alpha diversity metrics (P< 0.0001) and distinct compositional profiles as shown by beta diversity. Linear discriminant analysis effect size (LEfSe) analysis indicated that Faecalibacterium and Prevotella strains comprised a significant proportion, with notable differences in relative abundance patterns (P< 0.05). Furthermore, 7 bacterial species were isolated from the super donor, all of which demonstrated inhibitory effects on the growth of C. difficile in vitro.</p><p><strong>Conclusions: </strong>These findings suggest that selecting donors with specific microbiota profiles, particularly those exhibiting higher microbial diversity, may potentially contribute to the inhibition of C. difficile, and further clinical studies are warranted to validate these findings.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2026-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146113183","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":"Comments on \"Week 2 remission with vedolizumab as a predictor of long-term remission in patients with ulcerative colitis: a multicenter, retrospective, observational study\".","authors":"Philippe Pinton","doi":"10.5217/ir.2025.00234","DOIUrl":"https://doi.org/10.5217/ir.2025.00234","url":null,"abstract":"","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145998261","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}
Background/aims: Diagnosis of intestinal tuberculosis (ITB) is challenging. Histopathology and microbiological examination remain the gold standard, but previous studies show varied diagnostic performance. We aimed to systematically evaluate the accuracy of tests to diagnose ITB in both conventional and novel methods.
Methods: We searched MEDLINE and EMBASE from inception to October 2023. All studies enrolling at least 10 patients with reported information regarding the diagnosis of ITB based on endoscopic biopsy specimens, stool tests, and blood tests were included. We performed a meta-analysis using a random-effects model to estimate the performance of each test.
Results: Of 3,308 abstracts reviewed, 55 studies with 6,072 participants met the inclusion criteria. Endoscopic tissue biopsy for acid-fast bacilli, the presence of caseous granuloma on histopathology, polymerase chain reaction (PCR) for tuberculosis, mycobacterial culture, and Xpert MTB/RIF showed pooled sensitivity of 12% (95% confidence interval [CI], 8%-17%), 18% (95% CI, 12%-27%), 58% (95% CI, 44%-72%), 23% (95% CI, 12%-40%) and 29% (95% CI, 17%-46%), respectively. The liquid medium culture showed higher sensitivity than conventional Lowenstein-Jensen medium (25% [95% CI, 13%-43%] and 6% [95% CI, 3%-13%]). Pooled sensitivity and specificity of stool PCR for TB were 73% (95% CI, 43%-90%) and 95% (95% CI, 79%-99%), respectively. Additionally, the pooled sensitivity and specificity of interferon-gamma release assay (IGRA) were 86% (95% CI, 79%-91%) and 86% (95% CI, 81%-89%).
Conclusions: Endoscopic tissue biopsy samples had limited sensitivity in diagnosing ITB. IGRA showed good accuracy and may be combined with other methods to improve the diagnostic yield. Stool PCR demonstrated a good performance but based on a few studies.
{"title":"Diagnosis of intestinal tuberculosis: a systematic review and meta-analysis.","authors":"Pubet Weeranawin, Tanawat Geeratragool, Wanruchada Katchamart, Julajak Limsrivilai","doi":"10.5217/ir.2025.00098","DOIUrl":"10.5217/ir.2025.00098","url":null,"abstract":"<p><strong>Background/aims: </strong>Diagnosis of intestinal tuberculosis (ITB) is challenging. Histopathology and microbiological examination remain the gold standard, but previous studies show varied diagnostic performance. We aimed to systematically evaluate the accuracy of tests to diagnose ITB in both conventional and novel methods.</p><p><strong>Methods: </strong>We searched MEDLINE and EMBASE from inception to October 2023. All studies enrolling at least 10 patients with reported information regarding the diagnosis of ITB based on endoscopic biopsy specimens, stool tests, and blood tests were included. We performed a meta-analysis using a random-effects model to estimate the performance of each test.</p><p><strong>Results: </strong>Of 3,308 abstracts reviewed, 55 studies with 6,072 participants met the inclusion criteria. Endoscopic tissue biopsy for acid-fast bacilli, the presence of caseous granuloma on histopathology, polymerase chain reaction (PCR) for tuberculosis, mycobacterial culture, and Xpert MTB/RIF showed pooled sensitivity of 12% (95% confidence interval [CI], 8%-17%), 18% (95% CI, 12%-27%), 58% (95% CI, 44%-72%), 23% (95% CI, 12%-40%) and 29% (95% CI, 17%-46%), respectively. The liquid medium culture showed higher sensitivity than conventional Lowenstein-Jensen medium (25% [95% CI, 13%-43%] and 6% [95% CI, 3%-13%]). Pooled sensitivity and specificity of stool PCR for TB were 73% (95% CI, 43%-90%) and 95% (95% CI, 79%-99%), respectively. Additionally, the pooled sensitivity and specificity of interferon-gamma release assay (IGRA) were 86% (95% CI, 79%-91%) and 86% (95% CI, 81%-89%).</p><p><strong>Conclusions: </strong>Endoscopic tissue biopsy samples had limited sensitivity in diagnosing ITB. IGRA showed good accuracy and may be combined with other methods to improve the diagnostic yield. Stool PCR demonstrated a good performance but based on a few studies.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145911485","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}
Sara Ahmadi Badi, Hamid Reza Moradi, Ahmad Berimipour, Shima Shojaie, Arian Kariman, Hananeh Tavakoli Aval, Seyed Amirhesam Seyedi, Mehdi Davari, Mohammad Hassan Sohouli, Shohreh Khatami, Seyed Davar Siadat, Pejman Rohani
Background/aims: The gut microbiota plays a crucial role in the pathogenesis and treatment of inflammatory bowel diseases (IBD). This study aimed to investigate the effects of active, heat-inactivated, and cell-free supernatant (CFS) forms of Bacteroides thetaiotaomicron, alone or in combination with infliximab, in dextran sodium sulfate (DSS)-induced colitis in mice. Colitis was induced by oral administration of DSS for seven days. B. thetaiotaomicron in its various forms was orally administered at a dose of 1 × 108 CFU prior to and during colitis induction. Infliximab was intraperitoneally injected from days 3 to 5 of DSS exposure. Colitis severity, gene expression, tumor necrosis factor alpha levels, and gut microbiota were assessed by disease activity index, reverse transcription-quantitative polymerase chain reaction (RT-qPCR), enzyme-linked immunosorbent assay (ELISA), and qPCR, respectively.
Results: Active B. thetaiotaomicron and its CFS form significantly alleviated colitis symptoms compared to the heat-inactivated form. Furthermore, co-administration of active B. thetaiotaomicron and infliximab significantly modulated the colonic mRNA expression of Ocln, Tff3, Muc2 (upregulated), and Ace2 (downregulated). This combination also exhibited synergistic improvement in colitis severity in treated mice.
Conclusions: These findings underscore the therapeutic potential of B. thetaiotaomicron in IBD, either alone or in combination with infliximab, and support further development of microbiota-based strategies for IBD prevention and treatment.
{"title":"Preventive and therapeutic effects of co-administration of Bacteroides thetaiotaomicron and infliximab on dextran sodium sulfate-induced colitis in mice.","authors":"Sara Ahmadi Badi, Hamid Reza Moradi, Ahmad Berimipour, Shima Shojaie, Arian Kariman, Hananeh Tavakoli Aval, Seyed Amirhesam Seyedi, Mehdi Davari, Mohammad Hassan Sohouli, Shohreh Khatami, Seyed Davar Siadat, Pejman Rohani","doi":"10.5217/ir.2025.00061","DOIUrl":"https://doi.org/10.5217/ir.2025.00061","url":null,"abstract":"<p><strong>Background/aims: </strong>The gut microbiota plays a crucial role in the pathogenesis and treatment of inflammatory bowel diseases (IBD). This study aimed to investigate the effects of active, heat-inactivated, and cell-free supernatant (CFS) forms of Bacteroides thetaiotaomicron, alone or in combination with infliximab, in dextran sodium sulfate (DSS)-induced colitis in mice. Colitis was induced by oral administration of DSS for seven days. B. thetaiotaomicron in its various forms was orally administered at a dose of 1 × 108 CFU prior to and during colitis induction. Infliximab was intraperitoneally injected from days 3 to 5 of DSS exposure. Colitis severity, gene expression, tumor necrosis factor alpha levels, and gut microbiota were assessed by disease activity index, reverse transcription-quantitative polymerase chain reaction (RT-qPCR), enzyme-linked immunosorbent assay (ELISA), and qPCR, respectively.</p><p><strong>Results: </strong>Active B. thetaiotaomicron and its CFS form significantly alleviated colitis symptoms compared to the heat-inactivated form. Furthermore, co-administration of active B. thetaiotaomicron and infliximab significantly modulated the colonic mRNA expression of Ocln, Tff3, Muc2 (upregulated), and Ace2 (downregulated). This combination also exhibited synergistic improvement in colitis severity in treated mice.</p><p><strong>Conclusions: </strong>These findings underscore the therapeutic potential of B. thetaiotaomicron in IBD, either alone or in combination with infliximab, and support further development of microbiota-based strategies for IBD prevention and treatment.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145742622","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}
Background/aims: Endoscopy serves as the gold standard for assessing disease activity in inflammatory bowel disease (IBD). Noninvasive biomarkers have been under exploration as potential alternatives. This study aims to examine the diagnostic effectiveness of fecal immunochemical tests, along with levels of fecal calprotectin (FC) and fecal lactoferrin (FL), in stool samples from patients with early-onset IBD.
Methods: Children with childhood-onset IBD who visited the Department of Pediatrics and Adolescent Medicine at Juntendo University Hospital between August 2019 and July 2023 were included. FC levels, FL levels, and fecal immunochemical test results were measured using a colloidal gold agglutination assay. Fecal biomarker results and endoscopic findings were reviewed retrospectively.
Results: Sixty-five patients had ulcerative colitis (UC), 20 had Crohn's disease (CD), and 3 had unclassified IBD. The participants, aged 3-27 years (median, 18.0 years), included 56 males and 32 females. Stool samples (n = 1,105) were analyzed, from 803 with UC, 251 with CD, and 51 with IBD. Endoscopic evaluations were conducted in 45 UC patients and 18 CD patients. A significant correlation was found between the FC and FL. These biomarkers were significantly correlated with the endoscopic activity index in both UC and CD patients.
Conclusions: FC is valuable for diagnosing endoscopic inflammation and predicting recurrence. A significant correlation was observed between FC and FL. In patients with UC and CD, both markers strongly correlated with endoscopic activity. Thus, FC and FL can serve as a reliable alternative to endoscopic evaluation in pediatric patients with childhood-onset IBD.
{"title":"Fecal surrogate markers strongly correlate with endoscopic findings in pediatric onset inflammatory bowel disease: a retrospective study in Japan.","authors":"Ryoko Yoshimura, Takahiro Kudo, Masanori Toda, Kosuke Kashiwagi, Masumi Nagata, Kaori Aoki, Natsuki Ito, Kazuhide Tokita, Nobuyasu Arai, Reiko Kyodo, Masamichi Sato, Eri Miyata, Keisuke Jimbo, Yoshikazu Ohtsuka, Toshiaki Shimizu, Hiromichi Shoji","doi":"10.5217/ir.2025.00103","DOIUrl":"https://doi.org/10.5217/ir.2025.00103","url":null,"abstract":"<p><strong>Background/aims: </strong>Endoscopy serves as the gold standard for assessing disease activity in inflammatory bowel disease (IBD). Noninvasive biomarkers have been under exploration as potential alternatives. This study aims to examine the diagnostic effectiveness of fecal immunochemical tests, along with levels of fecal calprotectin (FC) and fecal lactoferrin (FL), in stool samples from patients with early-onset IBD.</p><p><strong>Methods: </strong>Children with childhood-onset IBD who visited the Department of Pediatrics and Adolescent Medicine at Juntendo University Hospital between August 2019 and July 2023 were included. FC levels, FL levels, and fecal immunochemical test results were measured using a colloidal gold agglutination assay. Fecal biomarker results and endoscopic findings were reviewed retrospectively.</p><p><strong>Results: </strong>Sixty-five patients had ulcerative colitis (UC), 20 had Crohn's disease (CD), and 3 had unclassified IBD. The participants, aged 3-27 years (median, 18.0 years), included 56 males and 32 females. Stool samples (n = 1,105) were analyzed, from 803 with UC, 251 with CD, and 51 with IBD. Endoscopic evaluations were conducted in 45 UC patients and 18 CD patients. A significant correlation was found between the FC and FL. These biomarkers were significantly correlated with the endoscopic activity index in both UC and CD patients.</p><p><strong>Conclusions: </strong>FC is valuable for diagnosing endoscopic inflammation and predicting recurrence. A significant correlation was observed between FC and FL. In patients with UC and CD, both markers strongly correlated with endoscopic activity. Thus, FC and FL can serve as a reliable alternative to endoscopic evaluation in pediatric patients with childhood-onset IBD.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145742586","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}
Background/aims: Both endoscopic resection (ER) and transanal surgery (TAS) are minimally invasive treatment options that allow organ preservation in early rectal tumors. We conducted a meta-analysis to compare treatment outcomes between the 2 treatments.
Methods: We searched all relevant studies published until January 2024 that examined the comparative outcomes between ER and TAS for rectal tumors, including adenoma, adenocarcinoma, and neuroendocrine tumor (NET). TAS included transanal excision, transanal endoscopic microsurgery, and transanal minimally invasive surgery.
Results: Seventeen studies with a total of 1,569 patients were included in this meta-analysis. For adenoma/adenocarcinoma, the R0 resection rate did not differ between ER and TAS (risk ratio [RR], 0.99; 95% confidence interval [CI], 0.94-1.03). For NET, the R0 resection rate was lower in the ER group than in the TAS group (RR, 0.76; 95% CI, 0.68-0.84) and the procedure time for ER was shorter than that for TAS. For both adenoma/adenocarcinoma and NET, ER and TAS did not differ in terms of complication rates, additional surgery, and recurrence.
Conclusions: ER and TAS showed similar treatment outcomes for adenoma/adenocarcinoma. Considering that TAS typically incurs higher costs than ER, ER may be favored in the treatment of rectal adenoma/adenocarcinoma. For rectal NET, TAS showed a superior R0 resection rate than ER. However, given that TAS requires a long procedure time, expensive equipment, and complex manipulations, TAS may be considered selectively for large NETs with suspected deep tumorous infiltration.
{"title":"Comparison between endoscopic resection and transanal surgery for treatment of rectal tumors: a systematic review and meta‑analysis.","authors":"Chan Hyuk Park, Byung Wook Jung, Yoon Suk Jung","doi":"10.5217/ir.2025.00180","DOIUrl":"https://doi.org/10.5217/ir.2025.00180","url":null,"abstract":"<p><strong>Background/aims: </strong>Both endoscopic resection (ER) and transanal surgery (TAS) are minimally invasive treatment options that allow organ preservation in early rectal tumors. We conducted a meta-analysis to compare treatment outcomes between the 2 treatments.</p><p><strong>Methods: </strong>We searched all relevant studies published until January 2024 that examined the comparative outcomes between ER and TAS for rectal tumors, including adenoma, adenocarcinoma, and neuroendocrine tumor (NET). TAS included transanal excision, transanal endoscopic microsurgery, and transanal minimally invasive surgery.</p><p><strong>Results: </strong>Seventeen studies with a total of 1,569 patients were included in this meta-analysis. For adenoma/adenocarcinoma, the R0 resection rate did not differ between ER and TAS (risk ratio [RR], 0.99; 95% confidence interval [CI], 0.94-1.03). For NET, the R0 resection rate was lower in the ER group than in the TAS group (RR, 0.76; 95% CI, 0.68-0.84) and the procedure time for ER was shorter than that for TAS. For both adenoma/adenocarcinoma and NET, ER and TAS did not differ in terms of complication rates, additional surgery, and recurrence.</p><p><strong>Conclusions: </strong>ER and TAS showed similar treatment outcomes for adenoma/adenocarcinoma. Considering that TAS typically incurs higher costs than ER, ER may be favored in the treatment of rectal adenoma/adenocarcinoma. For rectal NET, TAS showed a superior R0 resection rate than ER. However, given that TAS requires a long procedure time, expensive equipment, and complex manipulations, TAS may be considered selectively for large NETs with suspected deep tumorous infiltration.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2025-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145677493","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}
Background/aims: The introduction of anti-tumor necrosis factor-α antibodies transformed the landscape of inflammatory bowel disease (IBD) treatment. Because biologics are associated with increased medical costs, the use of biosimilars (BS) is recommended. However, high-quality evidence on the efficacy of BS in Japan remains limited. Therefore, this study aimed to evaluate the efficacy and safety of BS in patients with IBD.
Methods: Patients with IBD who underwent a non-medical switch (NMS) from infliximab originator (IFX-O) to IFX-BS at Fukuoka University Chikushi Hospital were prospectively evaluated. The observation period was up to 56 weeks after the NMS, and the rate of continuation, clinical remission at 56 weeks, safety, and changes in trough concentration were analyzed. Moreover, a questionnaire survey regarding BS and NMS was conducted.
Results: A total of 167 patients were included in this study. The continuation rate for IFX-BS therapy after NMS was high (95.6%). The remission maintenance rate at 56 weeks was 85.7% for patients with Crohn's disease and 77.8% for patients with ulcerative colitis. Adverse events were observed in 22.8% of patients. However, only 2 severe adverse events were recorded. The ratios of trough concentrations at 8, 24, and 56 weeks to that at week 0 were 115.6%, 101.2%, and 123.5%, respectively, indicating statistical non-inferiority. In a questionnaire survey, only 6.2% of the patients were aware of BS, however, more than half of them agreed with the NMS recommendation.
Conclusions: The efficacy and safety of IFX-BS after NMS are high. In addition, its trough concentration is serologically non-inferior to baseline values.
{"title":"Effectiveness, safety, and pharmacokinetics of the infliximab biosimilar CT-P13 after non-medical switch from the infliximab originator in patients with inflammatory bowel disease.","authors":"Ryohei Nomaru, Teruyuki Takeda, Atsushi Takahashi, Hiroyuki Mikumo, Shigeyoshi Yasukawa, Akihiro Koga, Takao Kanemitsu, Yoichiro Ono, Noritaka Takatsu, Masaki Miyaoka, Takashi Hisabe, Hisatomi Arima, So Imakiire, Eri Yamauchi, Shinya Ashizuka, Fumihito Hirai","doi":"10.5217/ir.2025.00118","DOIUrl":"https://doi.org/10.5217/ir.2025.00118","url":null,"abstract":"<p><strong>Background/aims: </strong>The introduction of anti-tumor necrosis factor-α antibodies transformed the landscape of inflammatory bowel disease (IBD) treatment. Because biologics are associated with increased medical costs, the use of biosimilars (BS) is recommended. However, high-quality evidence on the efficacy of BS in Japan remains limited. Therefore, this study aimed to evaluate the efficacy and safety of BS in patients with IBD.</p><p><strong>Methods: </strong>Patients with IBD who underwent a non-medical switch (NMS) from infliximab originator (IFX-O) to IFX-BS at Fukuoka University Chikushi Hospital were prospectively evaluated. The observation period was up to 56 weeks after the NMS, and the rate of continuation, clinical remission at 56 weeks, safety, and changes in trough concentration were analyzed. Moreover, a questionnaire survey regarding BS and NMS was conducted.</p><p><strong>Results: </strong>A total of 167 patients were included in this study. The continuation rate for IFX-BS therapy after NMS was high (95.6%). The remission maintenance rate at 56 weeks was 85.7% for patients with Crohn's disease and 77.8% for patients with ulcerative colitis. Adverse events were observed in 22.8% of patients. However, only 2 severe adverse events were recorded. The ratios of trough concentrations at 8, 24, and 56 weeks to that at week 0 were 115.6%, 101.2%, and 123.5%, respectively, indicating statistical non-inferiority. In a questionnaire survey, only 6.2% of the patients were aware of BS, however, more than half of them agreed with the NMS recommendation.</p><p><strong>Conclusions: </strong>The efficacy and safety of IFX-BS after NMS are high. In addition, its trough concentration is serologically non-inferior to baseline values.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2025-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145668675","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}
The incidence of rectal neuroendocrine tumors has been gradually increasing, primarily due to the widespread use of screening colonoscopy and growing awareness of the disease. Most rectal neuroendocrine tumors are small ( < 10 mm), well-differentiated, and low-grade lesions at the time of diagnosis, and they are usually asymptomatic. Given these characteristics, endoscopic resection is considered a feasible treatment option for early-stage lesions. However, due to their inherent malignant potential, a comprehensive initial diagnostic evaluation is essential. Lymph node or distal metastasis can be present at diagnosis or may develop long after apparently successful primary treatment. Therefore, achieving complete resection using the most optimal resection method is crucial. Modified endoscopic mucosal resection and endoscopic submucosal dissection are recommended over conventional forceps or snare polypectomy, which are associated with high incomplete resection rates. In case of incomplete resection, additional endoscopic resection can be a feasible option in selected cases. Furthermore, regular post-resection surveillance is needed, especially in patients with high-risk of recurrence such as poor pathologic result or incomplete resection.
{"title":"Recent updates on the endoscopic treatment of rectal neuroendocrine tumor.","authors":"Sunghyeok Ryou, Kwangwoo Nam","doi":"10.5217/ir.2025.00141","DOIUrl":"https://doi.org/10.5217/ir.2025.00141","url":null,"abstract":"<p><p>The incidence of rectal neuroendocrine tumors has been gradually increasing, primarily due to the widespread use of screening colonoscopy and growing awareness of the disease. Most rectal neuroendocrine tumors are small ( < 10 mm), well-differentiated, and low-grade lesions at the time of diagnosis, and they are usually asymptomatic. Given these characteristics, endoscopic resection is considered a feasible treatment option for early-stage lesions. However, due to their inherent malignant potential, a comprehensive initial diagnostic evaluation is essential. Lymph node or distal metastasis can be present at diagnosis or may develop long after apparently successful primary treatment. Therefore, achieving complete resection using the most optimal resection method is crucial. Modified endoscopic mucosal resection and endoscopic submucosal dissection are recommended over conventional forceps or snare polypectomy, which are associated with high incomplete resection rates. In case of incomplete resection, additional endoscopic resection can be a feasible option in selected cases. Furthermore, regular post-resection surveillance is needed, especially in patients with high-risk of recurrence such as poor pathologic result or incomplete resection.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2025-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145668660","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}
Background/aims: Surgery remains a crucial treatment option for Crohn's disease (CD), even with the introduction of biological agents. This nationwide cohort study in Taiwan investigates surgery trends and the impacts of biologics in a region with a low prevalence of CD.
Methods: This retrospective population-based cohort study used Taiwan's National Health Insurance Database from 2003 to 2018. The cohort included 725 CD patients. Patient characteristics, surgery outcomes, and impact of the biologic era on surgical risk were analyzed.
Results: During the study period, 292 CD patients (40.3%) underwent surgery, with 125 in the pre-biologic era and 167 in the post-biologic era. The incidences of intestinal surgery (IS) and perianal surgery (PS) have significantly decreased. The cumulative probabilities of IS were 20%, 35%, and 44% after 1, 5, and 10 years, respectively; the PS incidences were 3%, 5%, and 7%, respectively. The cumulative incidence of IS was significantly lower in the post-biologic era compared to the pre-biologic era (P= 0.049). CD patients had high second IS incidences of 31% at 5 years after the first IS.
Conclusions: Our study demonstrates the surgical incidences have decreased in the biologic era but remained relatively high in a region with low disease prevalence. This suggests the need for further improvements in CD management.
{"title":"Evolution of surgical trends in Crohn's disease during the biologic era: population-based cohort insights from Taiwan, a low-endemicity region.","authors":"Er-Hsiang Yang, Nai-Yu Chen, Ching-Lan Cheng, Yu-Ching Chang, Po-Chuan Chen, Lu-Hsuan Wu, Jui-Wen Kang, Hsueh-Chien Chiang, Po-Jun Chen, Bo-Wen Lin, Hsin-Yu Kuo, Chiao-Hsiung Chuang","doi":"10.5217/ir.2025.00003","DOIUrl":"https://doi.org/10.5217/ir.2025.00003","url":null,"abstract":"<p><strong>Background/aims: </strong>Surgery remains a crucial treatment option for Crohn's disease (CD), even with the introduction of biological agents. This nationwide cohort study in Taiwan investigates surgery trends and the impacts of biologics in a region with a low prevalence of CD.</p><p><strong>Methods: </strong>This retrospective population-based cohort study used Taiwan's National Health Insurance Database from 2003 to 2018. The cohort included 725 CD patients. Patient characteristics, surgery outcomes, and impact of the biologic era on surgical risk were analyzed.</p><p><strong>Results: </strong>During the study period, 292 CD patients (40.3%) underwent surgery, with 125 in the pre-biologic era and 167 in the post-biologic era. The incidences of intestinal surgery (IS) and perianal surgery (PS) have significantly decreased. The cumulative probabilities of IS were 20%, 35%, and 44% after 1, 5, and 10 years, respectively; the PS incidences were 3%, 5%, and 7%, respectively. The cumulative incidence of IS was significantly lower in the post-biologic era compared to the pre-biologic era (P= 0.049). CD patients had high second IS incidences of 31% at 5 years after the first IS.</p><p><strong>Conclusions: </strong>Our study demonstrates the surgical incidences have decreased in the biologic era but remained relatively high in a region with low disease prevalence. This suggests the need for further improvements in CD management.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2025-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145596518","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}
Minoru Matsuura, Annabelle Yoon, Jun Miyoshi, Tadakazu Hisamatsu
Background/aims: A previous health insurance claims study of Japanese patients with newly diagnosed Crohn's disease (CD) reported an increase in "step-up" approach from 2010 to 2020, with biologic use in the first year remaining stable. This study examined systemic corticosteroid (SCS) use for newly diagnosed CD in Japan and compared patients who were escalated ("step-up") and were not escalated to biologics.
Methods: This retrospective longitudinal cohort study used health insurance claims data (JMDC database). Patients diagnosed with CD from 2010 to 2020 who had no CD-related claims for ≥ 1 year before index, were traceable for ≥ 1 year after index, and treated with ≥ 1 pre-defined treatment were included. Patients classified by SCS and/or biologic use within 1 year after diagnosis were compared.
Results: Of 823 patients, 379 (46.1%) received SCS in the first year; of these, 43.5% escalated to biologics (step-up group) and 56.5% did not (SCS group). The proportion of patients receiving SCS increased from 25.8% in 2010-2011 to 55.5% in 2020; proportion escalated to biologics increased from 33.8% in 2016-2017 to 51.0% in 2020. The step-up group was significantly younger, more likely to have perianal lesions, and received more intensive treatments than the SCS group. In terms of SCS use, the step-up group was more likely to have shorter time-to-SCS initiation, and a higher initial SCS dose, than the SCS group.
Conclusions: Escalation from SCS to biologics in Japanese patients with newly diagnosed CD increased between 2016 and 2020, particularly in patients with younger onset CD or perianal complications.
{"title":"Escalation to biologics after corticosteroids in patients with newly diagnosed Crohn's disease in Japan: a claims analysis from 2010 to 2021.","authors":"Minoru Matsuura, Annabelle Yoon, Jun Miyoshi, Tadakazu Hisamatsu","doi":"10.5217/ir.2025.00059","DOIUrl":"https://doi.org/10.5217/ir.2025.00059","url":null,"abstract":"<p><strong>Background/aims: </strong>A previous health insurance claims study of Japanese patients with newly diagnosed Crohn's disease (CD) reported an increase in \"step-up\" approach from 2010 to 2020, with biologic use in the first year remaining stable. This study examined systemic corticosteroid (SCS) use for newly diagnosed CD in Japan and compared patients who were escalated (\"step-up\") and were not escalated to biologics.</p><p><strong>Methods: </strong>This retrospective longitudinal cohort study used health insurance claims data (JMDC database). Patients diagnosed with CD from 2010 to 2020 who had no CD-related claims for ≥ 1 year before index, were traceable for ≥ 1 year after index, and treated with ≥ 1 pre-defined treatment were included. Patients classified by SCS and/or biologic use within 1 year after diagnosis were compared.</p><p><strong>Results: </strong>Of 823 patients, 379 (46.1%) received SCS in the first year; of these, 43.5% escalated to biologics (step-up group) and 56.5% did not (SCS group). The proportion of patients receiving SCS increased from 25.8% in 2010-2011 to 55.5% in 2020; proportion escalated to biologics increased from 33.8% in 2016-2017 to 51.0% in 2020. The step-up group was significantly younger, more likely to have perianal lesions, and received more intensive treatments than the SCS group. In terms of SCS use, the step-up group was more likely to have shorter time-to-SCS initiation, and a higher initial SCS dose, than the SCS group.</p><p><strong>Conclusions: </strong>Escalation from SCS to biologics in Japanese patients with newly diagnosed CD increased between 2016 and 2020, particularly in patients with younger onset CD or perianal complications.</p>","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2025-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145596551","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}