Clinical Gastroenterology and Hepatology最新文献

{"title":"Impact of Extended Risankizumab Treatment in Patients With Ulcerative Colitis Who Did Not Respond to Induction Treatment.","authors":"Remo Panaccione, Gil Y Melmed, David Drobne, Manreet Kaur, Silvio Danese, Tadakazu Hisamatsu, Jasmina Kalabic, Su Chen, Ling Cheng, W Rachel Duan, Saajan Shah, Edouard Louis","doi":"10.1016/j.cgh.2025.09.007","DOIUrl":"10.1016/j.cgh.2025.09.007","url":null,"abstract":"<p><strong>Background & aims: </strong>The efficacy and safety of extended induction treatment with risankizumab, an interleukin-23 p19 inhibitor, in patients with moderately to severely active ulcerative colitis (UC) who, per site evaluation, did not achieve clinical response to 12 weeks of risankizumab induction was evaluated.</p><p><strong>Methods: </strong>In the phase 3 INSPIRE induction study, 209 initial nonresponders to 12 weeks of 1200 mg intravenous (IV) risankizumab induction were rerandomized to receive 12 weeks of additional 1200 mg risankizumab (weeks 12, 16, and 20) or 180 mg or 360 mg subcutaneous [SC] risankizumab (weeks 12 and 20) in a double-blind fashion. Patients from both phase 2b and 3 with week 24 clinical response to SC risankizumab (delayed responders) continued to receive blinded risankizumab at their assigned dose in the phase 3 COMMAND maintenance study. Efficacy and safety were evaluated at week 24 of induction and week 52 of maintenance.</p><p><strong>Results: </strong>Initial nonresponders (1200 mg IV [n = 68], 180 mg SC [n = 71], or 360 mg SC [n = 70]) had week 24 clinical response rates of 50%, 56.3%, and 57.1%, respectively; patients also achieved clinical remission, histologic endoscopic mucosal improvement (8.8%, 12.7%, and 15.7% for both endpoints), endoscopic improvement (17.6%, 18.3%, and 24.3%), and endoscopic remission (1.5%, 8.5%, and 5.7%). Efficacy rates were generally highest with 360 mg. In maintenance, delayed responders demonstrated sustained rates of clinical remission and increased rates of endoscopic outcomes and histologic endoscopic mucosal improvement at week 52. The safety with extended risankizumab treatment was consistent with the known risankizumab safety profile.</p><p><strong>Conclusions: </strong>Over 50% of initial nonresponders achieved clinical response with extended risankizumab treatment. Additional clinical and endoscopic outcomes were also achieved, with sustained or improved efficacy observed following maintenance. Extended treatment was well tolerated with no new safety risks identified. ClincialTrials.gov, Numbers. NCT03398148 (INSPIRE), NCT03398135 (COMMAND).</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":12.0,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145069095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Maintenance Treatment for Type 1 Autoimmune Pancreatitis: Effectiveness and Development of the PrescrAIP Relapse Prediction Model.","authors":"Marco Lanzillotta, Peter Macinga, Jakob L Poulsen, Olof Vinge-Holmquist, A Fatih Demirci, Matteo Tacelli, Johanna Backhus, Hana Algül, Clémence Descourvieres, Mariia Kiriukova, Elisabetta Goni, Marcus Hollenbach, Rainer C Miksch, Lumir Kunovsky, Miroslav Vujasinovic, Sara Nikolic, Luke Dickerson, Michael Hirth, Markus F Neurath, Malte Zumblick, Josephine Vila, Mustafa Jalal, Georg Beyer, Fabian Frost, Silvia Carrara, Zdenek Kala, Petr Jabandziev, Gurhan Sisman, Filiz Akyuz, Gabriele Capurso, Massimo Falconi, Alexander Arlt, Frank P Vleggaar, Luca Barresi, Bill Greenhalf, László Czakó, Peter Hegyi, Andrew Hopper, Manu K Nayar, Thomas M Gress, Francesco Vitali, Alexander Schneider, Chris M Halloran, Jan Trna, Alexey V Okhlobystin, Lorenzo Dagna, Djuna L Cahen, Dmitry Bordin, Vinciane Rebours, Julia Mayerle, Alisan Kahraman, Sebastian Rasch, Emma Culver, Alexander Kleger, Emma Martínez-Moneo, Tomas Hucl, Søren S Olesen, Marco J Bruno, Ulrich Beuers, Emanuel Della-Torre, J Matthias Löhr, Jonas Rosendahl, Kasper A Overbeek","doi":"10.1016/j.cgh.2025.09.005","DOIUrl":"10.1016/j.cgh.2025.09.005","url":null,"abstract":"<p><strong>Background & aims: </strong>Type 1 autoimmune pancreatitis (AIP) is a relapsing remitting disorder that often requires multiple treatment courses. Our aims were to assess the efficacy of maintenance treatment in preventing relapse and to develop the PrescrAIP risk score predicting relapse risk and the benefit of maintenance treatment.</p><p><strong>Methods: </strong>We retrospectively analyzed patients meeting international diagnostic criteria for type 1 AIP who reached partial or complete remission after initial treatment. The primary outcome was disease relapse, defined as recurrence of symptoms and/or radiologic findings. We developed a multivariable prediction model using Cox proportional hazards regression, performed internal and internal-external validation, and built a predictive nomogram.</p><p><strong>Results: </strong>We included 577 patients (68% male). During a median follow-up of 34 months (interquartile range, 13-69 months), we observed 154 relapses. The overall 3-year relapse risk was 28% (95% confidence interval [CI], 24%-32%), lower in patients receiving maintenance treatment than in those without (22% vs 35%; P < .001). The final PrescrAIP model incorporated protective factors (maintenance treatment, prior surgery, focal mass, female sex) and risk factors (biliary involvement, other organ involvement, IgG4 elevation, allergy, jaundice, acute pancreatitis). The model showed moderate discrimination (Concordance index, 0.69) and good calibration. Internal-external validation yielded Concordance index values ranging from 0.64 to 0.71. Maintenance treatment significantly reduced relapse in patients with a PrescrAIP score >155, but not in those with lower scores.</p><p><strong>Conclusion: </strong>Maintenance therapy reduced relapse only in patients at high relapse risk. Once externally validated, the PrescrAIP score may guide personalized maintenance treatment decisions.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":12.0,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145069114","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Considerations on TIPS Stent Diameter Selection in Patients With Cirrhosis at Risk of Hepatic Encephalopathy.","authors":"Xinxing Tantai, Lu Li, Shejiao Dai","doi":"10.1016/j.cgh.2025.08.039","DOIUrl":"10.1016/j.cgh.2025.08.039","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":12.0,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145069142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Novel Tools for Assessment of Neurocognitive Outcomes in Infants Born to Women With Inflammatory Bowel Disease.","authors":"Ralley Prentice, Megan Burns, Sally J Bell","doi":"10.1016/j.cgh.2025.07.047","DOIUrl":"10.1016/j.cgh.2025.07.047","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":12.0,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145069100","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reply.","authors":"Joan B Gornals, Albert Sumalla-Garcia, Carme Loras","doi":"10.1016/j.cgh.2025.08.037","DOIUrl":"10.1016/j.cgh.2025.08.037","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":12.0,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145063423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Early Ileocecal Resection or Tumor Necrosis Factor Inhibitor in Crohn's Disease: Replication in a Swedish Cohort.","authors":"Mads Damsgaard Wewer, Jonas Söderling, Jonas F Ludvigsson, Pär Myrelid, Johan Burisch, Ola Olén","doi":"10.1016/j.cgh.2025.07.046","DOIUrl":"10.1016/j.cgh.2025.07.046","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":12.0,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145058355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reply.","authors":"Robert P Hirten, Bruce E Sands, Mayte Suarez-Farinas","doi":"10.1016/j.cgh.2025.09.004","DOIUrl":"10.1016/j.cgh.2025.09.004","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":12.0,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145039131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Inverted Hyperplastic Polyp Masquerading as a Gastric Subepithelial Tumor.","authors":"Han-Hui Lee, Hsing-Yu Chen, Chung-Ying Lee","doi":"10.1016/j.cgh.2025.05.028","DOIUrl":"10.1016/j.cgh.2025.05.028","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":12.0,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145039155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Incidence of Hepatocellular Carcinoma in Metabolic Dysfunction-associated Steatotic Liver Disease: A Reconstructed Individual Patient Data Meta-analysis.","authors":"Ryan Yanzhe Lim, Faith Xin Ning Tan, Glenn Jun Kit Ho, Ethan Kai Jun Tham, Alfred Kow, Guoyue Lv, Zhong-Qi Fan, Nicholas Syn, Masahito Nakano, Wenhao Li, Karn Wijarnpreecha, Jörn M Schattenberg, Vincent Chen, Ming-Hua Zheng, Pojsakorn Danpanichkul, Hirokazu Takahashi, Cheng Han Ng, Yoshio Sumida, Atsushi Nakajima, Mazen Noureddin, Mark D Muthiah, Daniel Q Huang","doi":"10.1016/j.cgh.2025.08.036","DOIUrl":"10.1016/j.cgh.2025.08.036","url":null,"abstract":"<p><strong>Background & aims: </strong>Metabolic dysfunction-associated steatotic liver disease (MASLD) is the fastest rising etiology of hepatocellular carcinoma (HCC). The time-dependent incidence of HCC in people with MASLD has not been reported. We aimed to provide robust estimates for HCC incidence in MASLD.</p><p><strong>Methods: </strong>Medline and Embase were searched from inception to November 2024. Individual participant data were reconstructed from published Kaplan-Meier curves, and a pooled analysis of cumulative HCC incidence from time-to-event data was performed using a random-effects model.</p><p><strong>Results: </strong>We screened 4951 articles and included 26 studies (3,995,728 individuals). The 1-, 3-, 5-, and 10-year cumulative incidence of HCC in people with MASLD and known advanced fibrosis was 0.8%, 2.4%, 3.9%, and 8.8%, respectively, in administrative database studies, and 3.9%, 11.7%, 21.0% and 48.5%, respectively, in hospital/clinic-based studies. The 1-, 3-, 5-, and 10-year cumulative incidence of HCC in people with MASLD but without advanced fibrosis was 0.1%, 0.5%, 0.7%, and 1.3%, respectively, in administrative database studies, and 1.6%, 4.7%, 8.2%, and 18.3%, respectively, in hospital/clinic-based studies. Selection bias may contribute to the elevated risk in hospital/clinic-based studies. The risk of HCC in patients with advanced fibrosis was significantly higher compared with those without advanced fibrosis in both administrative database (hazard ratio [HR], 11.09; 95% confidence interval [CI], 2.68-45.89; P < .001) and hospital/clinic-based studies (HR, 10.50; 95% CI, 3.19-34.51; P < .001).</p><p><strong>Conclusion: </strong>This reconstructed individual participant data meta-analysis provides updated estimates for HCC incidence in people with MASLD. The incidence of HCC is elevated in people with MASLD and advanced fibrosis. These data may have implications for further research in HCC surveillance and future development of surveillance algorithms.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":12.0,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145039152","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Upadacitinib is Associated With Better Clinical and Biochemical Outcomes Than Tofacitinib in Refractory, Moderate-to-severe Ulcerative Colitis.","authors":"Bernadett Farkas, Tamás Resál, Peter L Lakatos, Talat Bessissow, Jimmy K Limdi, Alessandro Armuzzi, Cristina Bezzio, Edoardo V Savarino, Simone Saibeni, George Michalopoulos, Mohamed Attauabi, Jakob Benedict Seidelin, Fotios S Fousekis, Kostas Katsanos, Péter Bacsur, Anita Bálint, Emese Ivány, Zoltán Szepes, Klaudia Farkas, Tamás Molnár","doi":"10.1016/j.cgh.2025.06.049","DOIUrl":"10.1016/j.cgh.2025.06.049","url":null,"abstract":"<p><strong>Background & aims: </strong>Comparative data on the effectiveness of tofacitinib (TOFA) and upadacitinib (UPA) in ulcerative colitis (UC) remain limited. We conducted a multicenter, retrospective cohort study to evaluate and compare the short- and mid-term effectiveness of TOFA and UPA in bio-experienced, moderate-to-severe UC.</p><p><strong>Methods: </strong>Inverse probability weighting analysis was performed for demographics, baseline Mayo score, and baseline C-reactive protein [CRP] and fecal calprotectin [FCal], as well as concomitant corticosteroid use between the 2 treatment groups. The coprimary outcome was week 12 and 24 corticosteroid-free remission (CSFR) defined as clinical remission (CR) and CRP ≤5 mg/L, as well as not receiving steroids ≥30 days. We also assessed the rate of CR and biochemical remission (defined as CRP ≤5 mg/L and FCal ≤ 250 μg/g) during the first 6 months of therapy.</p><p><strong>Results: </strong>A total of 350 patients with UC (246 TOFA, 104 UPA; mean age, 38.6 ±13.8 years; median follow-up, 11 months) were enrolled in the study. The likelihood of achieving CSFR at both week 12 (adjusted odds ratio [aOR], 2.2; 95% confidence interval [CI], 1.2-4.1) and week 24 (aOR, 2.2; 95% CI,1.2-3.9) was found to be significantly higher in patients treated with UPA than in patients receiving TOFA. UPA was also associated with around 2-fold higher odds of reaching both CR (95% CI, 1.3-4.3; 95% CI, 1.0-3.4) and biochemical remission (95% CI, 1.3-4.4; 95% CI, 1.2-4.0) at the same timepoints compared with TOFA. No significant differences were seen in IBD-related hospitalization and early colectomy rates between the 2 treatment groups. No new safety signal was noted.</p><p><strong>Conclusion: </strong>UPA might be associated with better short- and mid-term clinical and biochemical outcomes compared with TOFA in refractory, moderate-to-severe UC.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":12.0,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145039247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}