Pub Date : 2025-02-13DOI: 10.1016/j.cgh.2024.12.024
Evan S Dellon, David A Katzka, Vincent A Mukkada, Margaret H Collins, Gary W Falk, Camilla A Richmond, Brian Terreri, Manoj Thakur, Mena Boules, Bridgett Goodwin, Ikuo Hirano
Background and aims: We investigated the long-term safety and efficacy of budesonide oral suspension (BOS) in eosinophilic esophagitis (EoE).
Methods: This study (SHP621-303) was a 4-year, phase 3, open-label study in patients with EoE who completed up to 52 weeks of BOS therapy in two preceding phase 3 studies. Based on treatment assignments in previous studies, patients were assigned to BOS-BOS or placebo-BOS groups. All patients received BOS 2.0 mg twice daily; dose reductions to once daily and interruptions were permitted. The safety and tolerability of BOS was primarily investigated, with exploratory efficacy endpoints also examined.
Results: Overall, 131 patients were included. BOS was well tolerated, with no unexpected safety signals observed. Treatment-emergent adverse events (TEAEs) occurred in 76.3% of patients; most were mild/moderate in severity and unrelated to study drug. The most frequently reported BOS-related TEAEs included abnormal adrenocorticotropic hormone stimulation test results (8.4% [11/131]; number of events [m] = 12) and adrenal insufficiency (2.3% [3/131]; m = 3). Esophageal candidiasis occurred in 3.1% of patients ([4/131]). The aforementioned TEAEs resolved in most patients. At month 48 of treatment, 50.0% and 58.3% of patients achieved/maintained a histologic response (≤6 and <15 eosinophils per high-power field, respectively). The initial reduction (-3.6) in total EoE Endoscopic Reference Score from baseline to the first visit was maintained until month 48.
Conclusion: Long-term treatment with BOS was well tolerated. Despite dosing changes/interruptions, approximately half of patients achieved/maintained a histologic response; initial improvements in endoscopic outcomes were maintained over 48 months.
{"title":"Long-Term Safety and Efficacy of Budesonide Oral Suspension for Eosinophilic Esophagitis: a 4-Year, Phase 3, Open-Label Study.","authors":"Evan S Dellon, David A Katzka, Vincent A Mukkada, Margaret H Collins, Gary W Falk, Camilla A Richmond, Brian Terreri, Manoj Thakur, Mena Boules, Bridgett Goodwin, Ikuo Hirano","doi":"10.1016/j.cgh.2024.12.024","DOIUrl":"https://doi.org/10.1016/j.cgh.2024.12.024","url":null,"abstract":"<p><strong>Background and aims: </strong>We investigated the long-term safety and efficacy of budesonide oral suspension (BOS) in eosinophilic esophagitis (EoE).</p><p><strong>Methods: </strong>This study (SHP621-303) was a 4-year, phase 3, open-label study in patients with EoE who completed up to 52 weeks of BOS therapy in two preceding phase 3 studies. Based on treatment assignments in previous studies, patients were assigned to BOS-BOS or placebo-BOS groups. All patients received BOS 2.0 mg twice daily; dose reductions to once daily and interruptions were permitted. The safety and tolerability of BOS was primarily investigated, with exploratory efficacy endpoints also examined.</p><p><strong>Results: </strong>Overall, 131 patients were included. BOS was well tolerated, with no unexpected safety signals observed. Treatment-emergent adverse events (TEAEs) occurred in 76.3% of patients; most were mild/moderate in severity and unrelated to study drug. The most frequently reported BOS-related TEAEs included abnormal adrenocorticotropic hormone stimulation test results (8.4% [11/131]; number of events [m] = 12) and adrenal insufficiency (2.3% [3/131]; m = 3). Esophageal candidiasis occurred in 3.1% of patients ([4/131]). The aforementioned TEAEs resolved in most patients. At month 48 of treatment, 50.0% and 58.3% of patients achieved/maintained a histologic response (≤6 and <15 eosinophils per high-power field, respectively). The initial reduction (-3.6) in total EoE Endoscopic Reference Score from baseline to the first visit was maintained until month 48.</p><p><strong>Conclusion: </strong>Long-term treatment with BOS was well tolerated. Despite dosing changes/interruptions, approximately half of patients achieved/maintained a histologic response; initial improvements in endoscopic outcomes were maintained over 48 months.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425099","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}
Background and aims: Inappropriate treatment of infections fuels drug-resistance, organ failures, and costs in cirrhosis. We explored proteomics to improve infection diagnosis and management in acutely decompensated (AD) cirrhosis.
Methods: We enrolled 391 patients with AD(92% males, median-age: 41 years), 84 in discovery-cohort(54 infected, 30 non-infected), 147 in validation-cohort-I(106 infected, 41 non-infected), and 160 in validation-cohort-II(108 infected, 52 non-infected). High-throughput proteomics identified biomarkers in discovery cohort, validated through ELISA in subsequent cohorts. A model for infection was evaluated through discrimination, calibration, and decision curves, and was externally validated.
Results: Infected patients exhibited higher leucocyte-counts, procalcitonin, organ failures, MELD, and 30-day mortality(p<0.001 each). Proteomics identified 516 proteins, 27 upregulated and 38 downregulated in infections. LGALS3BP, PLTP, CFP, and GPX3 were independently linked to infections (adjusting for severity and SIRS), with composite-AUC of 0.854(0.787-0.922) in validation-cohort-I. A PACIFY model(LGALS3BP+procalcitonin+CLIF-COF+lactate) predicted infections with AUC of 0.965;0.933-0.997 and 0.906;0.860-0.952 in validation-cohorts-I and II, outperforming procalcitonin, SIRS, WBC, NLR, neutrophil%, and composite models(p<0.001). Model demonstrated fair calibration, with decision curves indicating net benefit of model in treating infections, and reducing unnecessary antimicrobials use. Consistent findings were observed on external validation(AUC: 0.949; 0.916-0.982) re-enforcing the accuracy and clinical utility of model. A deployable app was developed for infection risk estimation, enhancing practical applicability. Impaired phagocytosis, complement functions, hypocoagulation, hypofibrinolysis, dysregulated carbohydrate metabolism, autophagy, heightened cell death, and proteolysis were key perturbed pathways in infections.
Conclusion: The study identifies novel protein signatures and pathways linked with infections in AD. A biomarker guided treatment of infections can limit unnecessary antimicrobials use and the burden of drug-resistance in cirrhosis.
{"title":"Proteomics guided biomarker discovery, validation, and pathway perturbation in infection-related acute decompensation of cirrhosis.","authors":"Pratibha Garg, Nipun Verma, Arun Valsan, Vivek Sarohi, Trayambak Basak, Tarana Gupta, Parminder Kaur, Samonee Ralmilay, Shreya Singh, Arka De, Madhumita Premkumar, Sunil Taneja, Ajay Duseja, Virendra Singh, Jasmohan S Bajaj","doi":"10.1016/j.cgh.2025.01.005","DOIUrl":"https://doi.org/10.1016/j.cgh.2025.01.005","url":null,"abstract":"<p><strong>Background and aims: </strong>Inappropriate treatment of infections fuels drug-resistance, organ failures, and costs in cirrhosis. We explored proteomics to improve infection diagnosis and management in acutely decompensated (AD) cirrhosis.</p><p><strong>Methods: </strong>We enrolled 391 patients with AD(92% males, median-age: 41 years), 84 in discovery-cohort(54 infected, 30 non-infected), 147 in validation-cohort-I(106 infected, 41 non-infected), and 160 in validation-cohort-II(108 infected, 52 non-infected). High-throughput proteomics identified biomarkers in discovery cohort, validated through ELISA in subsequent cohorts. A model for infection was evaluated through discrimination, calibration, and decision curves, and was externally validated.</p><p><strong>Results: </strong>Infected patients exhibited higher leucocyte-counts, procalcitonin, organ failures, MELD, and 30-day mortality(p<0.001 each). Proteomics identified 516 proteins, 27 upregulated and 38 downregulated in infections. LGALS3BP, PLTP, CFP, and GPX3 were independently linked to infections (adjusting for severity and SIRS), with composite-AUC of 0.854(0.787-0.922) in validation-cohort-I. A PACIFY model(LGALS3BP+procalcitonin+CLIF-COF+lactate) predicted infections with AUC of 0.965;0.933-0.997 and 0.906;0.860-0.952 in validation-cohorts-I and II, outperforming procalcitonin, SIRS, WBC, NLR, neutrophil%, and composite models(p<0.001). Model demonstrated fair calibration, with decision curves indicating net benefit of model in treating infections, and reducing unnecessary antimicrobials use. Consistent findings were observed on external validation(AUC: 0.949; 0.916-0.982) re-enforcing the accuracy and clinical utility of model. A deployable app was developed for infection risk estimation, enhancing practical applicability. Impaired phagocytosis, complement functions, hypocoagulation, hypofibrinolysis, dysregulated carbohydrate metabolism, autophagy, heightened cell death, and proteolysis were key perturbed pathways in infections.</p><p><strong>Conclusion: </strong>The study identifies novel protein signatures and pathways linked with infections in AD. A biomarker guided treatment of infections can limit unnecessary antimicrobials use and the burden of drug-resistance in cirrhosis.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381756","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}
Pub Date : 2025-02-03DOI: 10.1016/j.cgh.2024.12.023
Remo Panaccione, Marc Ferrante, Iris Dotan, Julian Panés, Tadakazu Hisamatsu, Peter Bossuyt, Silvio Danese, Alexandra Song, Jasmina Kalabic, Namita Joshi, Javier Zambrano, Yafei Zhang, W Rachel Duan, Kristina Kligys, Marla C Dubinsky, James O Lindsay, Severine Vermeire, Britta Siegmund, Peter M Irving, Geert D'Haens
Background and aims: The efficacy and safety of extended treatment with risankizumab (RZB), an anti-interleukin-23 p19 monoclonal antibody, were evaluated in patients with moderate to severe Crohn's disease (CD) who did not achieve clinical response to 12 weeks (W) RZB induction treatment ('initial nonresponders').
Methods: Initial nonresponders to intravenous (IV) RZB induction (600mg or 1200mg at W0, W4, and W8) were rerandomized 1:1:1 to receive extended blinded RZB treatment (1200mg IV at W12, W16, and W20, or subcutaneous [SC] 180mg or 360mg at W12 and W20). Patients with clinical response to SC RZB at W24 ('delayed responders') continued their dose in FORTIFY. Clinical, endoscopic, and safety outcomes were evaluated.
Results: Most initial nonresponders achieved SF/APS clinical response by W24 (76.2% [180mg SC], 63.7% [360mg SC], 62.3% [1200mg IV]), while a subset also achieved W24 SF/APS clinical remission (43.0%, 45.1%, 22.1%), endoscopic response (32.4%, 32.5%, 40.5%), and endoscopic remission (25.1%, 18.0%, 23.5%). Most delayed responders to SC RZB continued to demonstrate clinical response at FORTIFY W52 (56.7% [180mg SC], 69.7% [360mg SC]), along with SF/APS clinical remission (43.3%, 54.5%), endoscopic response (36.7%, 45.5%), and endoscopic remission (40.0%, 42.4%). Numerically greater efficacy was generally observed with 360mg SC vs 180mg SC. The safety profile of extended treatment was consistent with previously reported trials.
Conclusion: Most initial nonresponders to IV RZB induction who received 12W of extended RZB treatment demonstrated improved clinical and endoscopic outcomes at W24. Improvements in patients who received SC RZB extended treatment were maintained during FORTIFY. Extended treatment was well tolerated with no new safety risks identified.
{"title":"Extended Risankizumab Treatment in Patients With Crohn's Disease Who Did Not Achieve Clinical Response to Induction Treatment.","authors":"Remo Panaccione, Marc Ferrante, Iris Dotan, Julian Panés, Tadakazu Hisamatsu, Peter Bossuyt, Silvio Danese, Alexandra Song, Jasmina Kalabic, Namita Joshi, Javier Zambrano, Yafei Zhang, W Rachel Duan, Kristina Kligys, Marla C Dubinsky, James O Lindsay, Severine Vermeire, Britta Siegmund, Peter M Irving, Geert D'Haens","doi":"10.1016/j.cgh.2024.12.023","DOIUrl":"https://doi.org/10.1016/j.cgh.2024.12.023","url":null,"abstract":"<p><strong>Background and aims: </strong>The efficacy and safety of extended treatment with risankizumab (RZB), an anti-interleukin-23 p19 monoclonal antibody, were evaluated in patients with moderate to severe Crohn's disease (CD) who did not achieve clinical response to 12 weeks (W) RZB induction treatment ('initial nonresponders').</p><p><strong>Methods: </strong>Initial nonresponders to intravenous (IV) RZB induction (600mg or 1200mg at W0, W4, and W8) were rerandomized 1:1:1 to receive extended blinded RZB treatment (1200mg IV at W12, W16, and W20, or subcutaneous [SC] 180mg or 360mg at W12 and W20). Patients with clinical response to SC RZB at W24 ('delayed responders') continued their dose in FORTIFY. Clinical, endoscopic, and safety outcomes were evaluated.</p><p><strong>Results: </strong>Most initial nonresponders achieved SF/APS clinical response by W24 (76.2% [180mg SC], 63.7% [360mg SC], 62.3% [1200mg IV]), while a subset also achieved W24 SF/APS clinical remission (43.0%, 45.1%, 22.1%), endoscopic response (32.4%, 32.5%, 40.5%), and endoscopic remission (25.1%, 18.0%, 23.5%). Most delayed responders to SC RZB continued to demonstrate clinical response at FORTIFY W52 (56.7% [180mg SC], 69.7% [360mg SC]), along with SF/APS clinical remission (43.3%, 54.5%), endoscopic response (36.7%, 45.5%), and endoscopic remission (40.0%, 42.4%). Numerically greater efficacy was generally observed with 360mg SC vs 180mg SC. The safety profile of extended treatment was consistent with previously reported trials.</p><p><strong>Conclusion: </strong>Most initial nonresponders to IV RZB induction who received 12W of extended RZB treatment demonstrated improved clinical and endoscopic outcomes at W24. Improvements in patients who received SC RZB extended treatment were maintained during FORTIFY. Extended treatment was well tolerated with no new safety risks identified.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254637","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}
Pub Date : 2025-02-03DOI: 10.1016/j.cgh.2025.01.003
Brian P Lee, Justene Molina, Steve Kim, Jennifer L Dodge, Norah A Terrault
Background & aims: New nomenclature allows a single cardiometabolic risk factor (CMRF) with alcohol to classify metabolic dysfunction-associated steatotic liver disease (MASLD) and with "increased alcohol intake" (MetALD), which is controversial because alcohol causes CMRFs. Studies regarding incremental CMRFs and liver-related outcomes among alcohol users would be informative.
Methods: Using NHANES (1/2001-3/2020), we included participants aged≥20 with complete alcohol and CMRF status. CMRFs were defined by the National Cholesterol Education Program's Adult Treatment Panel III. Increased alcohol use corresponded to ≥140g/week[women] / ≥210g/week[men]. The primary outcome was FIB-4 >2.67.
Results: Among 40,898 participants, 2,282 had increased vs. 38,616 without increased alcohol use. Prevalence of high FIB-4 among increased vs. without increased alcohol use was higher at each quantity of CMRFs, and with each incremental CMRF: zero (2.3%[95%CI 1.0-5.0%] vs. 0.7%[0.5-0.9%]), one (3.0%[1.6-5.6%] vs. 1.7%[1.4-2.1%]), two (3.3%[2.1-5.1%] vs. 2.1%[1.8-2.4%]), three (5.9%[3.5-9.6%] vs. 2.5%[2.1-2.9%]), and four or five (6.1%[3.3-9.7%] vs. 4.0%[3.5-4.5%]) CMRFs. Among increased alcohol users, in multivariable logistic regression, three (aOR 2.57[0.93-7.08]), four or five (aOR 2.64[1.05-6.67]) CMRFs was associated with 2-fold higher odds of high FIB-4 (vs. 0 CMRFs), but not one (aOR 1.24[0.41-3.69]) or two (aOR 1.39[0.56-3.50]) CMRFs. Among individuals with increased alcohol use, sensitivity/specificity-based Euclidean distance suggested an optimal cut-off of ≥3 CMRFs to differentiate higher probability of high FIB-4.
Conclusions: Stratifying MetALD as ≥3 CMRFs, rather than 1 CMRF may provide more optimal fibrosis stratification. Diabetes, high waist circumference, and hypertension, are associated with significant liver fibrosis among individuals with increased alcohol use, but not dyslipidemia.
{"title":"Association of Alcohol and Incremental Cardiometabolic Risk Factors with Liver Disease: A National Cross-Sectional Study.","authors":"Brian P Lee, Justene Molina, Steve Kim, Jennifer L Dodge, Norah A Terrault","doi":"10.1016/j.cgh.2025.01.003","DOIUrl":"https://doi.org/10.1016/j.cgh.2025.01.003","url":null,"abstract":"<p><strong>Background & aims: </strong>New nomenclature allows a single cardiometabolic risk factor (CMRF) with alcohol to classify metabolic dysfunction-associated steatotic liver disease (MASLD) and with \"increased alcohol intake\" (MetALD), which is controversial because alcohol causes CMRFs. Studies regarding incremental CMRFs and liver-related outcomes among alcohol users would be informative.</p><p><strong>Methods: </strong>Using NHANES (1/2001-3/2020), we included participants aged≥20 with complete alcohol and CMRF status. CMRFs were defined by the National Cholesterol Education Program's Adult Treatment Panel III. Increased alcohol use corresponded to ≥140g/week[women] / ≥210g/week[men]. The primary outcome was FIB-4 >2.67.</p><p><strong>Results: </strong>Among 40,898 participants, 2,282 had increased vs. 38,616 without increased alcohol use. Prevalence of high FIB-4 among increased vs. without increased alcohol use was higher at each quantity of CMRFs, and with each incremental CMRF: zero (2.3%[95%CI 1.0-5.0%] vs. 0.7%[0.5-0.9%]), one (3.0%[1.6-5.6%] vs. 1.7%[1.4-2.1%]), two (3.3%[2.1-5.1%] vs. 2.1%[1.8-2.4%]), three (5.9%[3.5-9.6%] vs. 2.5%[2.1-2.9%]), and four or five (6.1%[3.3-9.7%] vs. 4.0%[3.5-4.5%]) CMRFs. Among increased alcohol users, in multivariable logistic regression, three (aOR 2.57[0.93-7.08]), four or five (aOR 2.64[1.05-6.67]) CMRFs was associated with 2-fold higher odds of high FIB-4 (vs. 0 CMRFs), but not one (aOR 1.24[0.41-3.69]) or two (aOR 1.39[0.56-3.50]) CMRFs. Among individuals with increased alcohol use, sensitivity/specificity-based Euclidean distance suggested an optimal cut-off of ≥3 CMRFs to differentiate higher probability of high FIB-4.</p><p><strong>Conclusions: </strong>Stratifying MetALD as ≥3 CMRFs, rather than 1 CMRF may provide more optimal fibrosis stratification. Diabetes, high waist circumference, and hypertension, are associated with significant liver fibrosis among individuals with increased alcohol use, but not dyslipidemia.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254597","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}
Pub Date : 2025-02-01DOI: 10.1016/j.cgh.2024.01.049
Eric D. Shah , Michael A. Curley , Amit Patel , Wai-Kit Lo , Walter W. Chan
Background and Aims
Heartburn symptoms contribute to healthcare-seeking among patients with gastroesophageal reflux disease (GERD). Despite clinical guidance, management is often dictated by insurance restrictions. Several potassium-competitive acid blockers (PCABs) are under development as a new class of therapy. We performed economic analyses to align GERD drug development with the needs of gastroenterologists, insurers and patients in a value-based environment.
Methods
A decision-analytic model was constructed to compare vonoprazan 20 mg daily (an example of a PCAB), common over-the-counter or prescription proton pump inhibitor regimens, and no treatment over a 1-year time horizon. Clinical responses were evaluated based on the proportions of heartburn-free days in a recent phase 3 multicenter trial. Healthcare utilization for persistent reflux symptoms was derived from national observational studies compared with healthy control subjects. Costs and quality-adjusted life years were reported.
Results
Without insurance coverage for appropriate therapy, patients spend $4443 and insurers spend $3784 on average per year for inadequately treated GERD symptoms. Our model estimates that PCABs could save at least $3000 in annual costs to patients and insurers, could generate quality-adjusted life year gains (+0.06 per year), and could be cost-saving to insurers as a covered option at a price up to $8.57 per pill, if these drugs are able to demonstrate similar effectiveness to proton pump inhibitors in future trials evaluating heartburn relief and erosive esophagitis healing to regulators. Threshold prices reflect pricing after all pharmacy benefits manager rebates and discounts.
Discussion
We demonstrate that aiming GERD-related drug development toward heartburn relief appears critical to align cost-effective incentives for industry and insurers with those of patients and gastroenterologists.
{"title":"Heartburn Relief Is the Major Unmet Need for Drug Development in Gastroesophageal Reflux Disease: Threshold Value Analysis","authors":"Eric D. Shah , Michael A. Curley , Amit Patel , Wai-Kit Lo , Walter W. Chan","doi":"10.1016/j.cgh.2024.01.049","DOIUrl":"10.1016/j.cgh.2024.01.049","url":null,"abstract":"<div><h3>Background and Aims</h3><div><span>Heartburn<span> symptoms contribute to healthcare-seeking among patients with gastroesophageal reflux disease (GERD). Despite clinical guidance, management is often dictated by insurance restrictions. Several potassium-competitive acid blockers (PCABs) are under development as a new class of therapy. We performed economic analyses to align GERD </span></span>drug development with the needs of gastroenterologists, insurers and patients in a value-based environment.</div></div><div><h3>Methods</h3><div>A decision-analytic model was constructed to compare vonoprazan 20 mg daily (an example of a PCAB), common over-the-counter or prescription proton pump inhibitor regimens, and no treatment over a 1-year time horizon. Clinical responses were evaluated based on the proportions of heartburn-free days in a recent phase 3 multicenter trial. Healthcare utilization for persistent reflux symptoms was derived from national observational studies compared with healthy control subjects. Costs and quality-adjusted life years were reported.</div></div><div><h3>Results</h3><div>Without insurance coverage for appropriate therapy, patients spend $4443 and insurers spend $3784 on average per year for inadequately treated GERD symptoms. Our model estimates that PCABs could save at least $3000 in annual costs to patients and insurers, could generate quality-adjusted life year gains (+0.06 per year), and could be cost-saving to insurers as a covered option at a price up to $8.57 per pill, if these drugs are able to demonstrate similar effectiveness to proton pump inhibitors in future trials evaluating heartburn relief and erosive esophagitis healing to regulators. Threshold prices reflect pricing after all pharmacy benefits manager rebates and discounts.</div></div><div><h3>Discussion</h3><div>We demonstrate that aiming GERD-related drug development toward heartburn relief appears critical to align cost-effective incentives for industry and insurers with those of patients and gastroenterologists.</div></div>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":"23 2","pages":"Pages 263-271"},"PeriodicalIF":11.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139897902","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}
Pub Date : 2025-02-01DOI: 10.1016/j.cgh.2024.06.037
Vipul Jairath , Brian G. Feagan , Mark S. Silverberg , Silvio Danese , Paolo Gionchetti , Mark Löwenberg , Brian Bressler , Marc Ferrante , Ailsa Hart , Dirk Lindner , Armella Escher , Stephen Jones , Bo Shen , Simon Travis
Background & Aims
Vedolizumab is indicated for the treatment of chronic pouchitis in the European Union. We assessed whether vedolizumab induced mucosal healing (MH) and if MH was associated with clinical improvements.
Methods
EARNEST, a randomized, double-blind, placebo-controlled study, evaluated vedolizumab efficacy and safety in adults with chronic pouchitis. Centrally read endoscopic and histologic evaluation was performed at baseline, Week (W)14, and W34. Ulcer count, adapted Simple Endoscopic Score for Crohn’s Disease in the pouch, and Pouchitis Disease Activity Index histologic component were evaluated. Pouchitis Disease Activity Index and Inflammatory Bowel Disease Questionnaire remission at W14 and W34 were compared by MH status at W14.
Results
Following treatment, mean (standard deviation) number of ulcers in vedolizumab-treated patients reduced from 15.1 (16.4) to 5.0 (4.9) at W14 and 2.7 (3.2) at W34 versus placebo-treated patients with corresponding values of 11.8 (11.3), 13.4 (18.4), and 9.7 (13.8) (vedolizumab vs placebo difference [95% confidence interval]: W14: −8.4 [−14.3, −2.6]; W34: −7.0 [−12.0, −2.0]). More patients receiving vedolizumab versus placebo achieved reduction in ulcerated pouch surface area (W14: 52.4% vs 20.0%; difference, 32.4 percentage points [p.p] [9.7, 51.4]; W34: 52.1% vs 12.9%; difference, 40.2p.p [15.6, 60.3]), absence of ulceration (W14: 23.8% vs 7.5%; difference, 16.3p.p [1.1, 31.6]; W34: 34.4% vs 15.6%; difference, 18.8p.p [−2.0, 39.5]), Simple Endoscopic Score for Crohn’s Disease remission (W14: 23.8% vs 7.5%; difference, 16.3p.p [1.1, 31.6]; W34: 34.4% vs 15.6%; difference, 18.8p.p [−2.0, 39.5]), and MH (W14: 16.7% vs 2.5%; difference, 14.2p.p [1.9, 26.4]). Patients with MH at W14 had higher rates of Pouchitis Disease Activity Index and Inflammatory Bowel Disease Questionnaire remission at W14 and W34 than those without.
Conclusions
Vedolizumab induced endoscopic improvements in patients with chronic pouchitis, which was associated with improved outcomes at W34, particularly in patients achieving MH at W14. (ClinicalTrials.gov number, NCT02790138.)
背景与目的：在欧盟，维多珠单抗适用于治疗慢性胃袋炎。我们评估了维多珠单抗是否能诱导粘膜愈合（MH），以及粘膜愈合是否与临床改善相关：EARNEST是一项随机、双盲、安慰剂对照研究，评估了维多珠单抗在成人慢性胃袋炎患者中的疗效和安全性。在基线、第14周和第34周进行了中央读取的内镜和组织学评估。评估内容包括溃疡数量、肠袋内克罗恩病简易内镜评分（SES-CD）以及肠袋炎疾病活动指数（PDAI）组织学成分。根据W14和W34时的MH状况，比较了PDAI和炎症性肠病问卷（IBDQ）在W14和W34时的缓解情况：治疗后，与安慰剂治疗患者相比，维多珠单抗治疗患者的平均（标清）溃疡数在W14时从15.1（16.4）减少到5.0（4.9），在W34时减少到2.7（3.2），相应值分别为11.8（11.3）、13.4（18.4）和9.7（13.8）（维多珠单抗与安慰剂的差异[95% CI]：W14：-8.4 [95%CI]）：W14：-8.4 [-14.3,-2.6]；W34：-7.0 [-12.0,-2.0]）。与安慰剂相比，更多接受维多珠单抗治疗的患者溃疡袋表面积减少（W14：52.4% vs 20.0%；差异32.4p.p [9.7，51.4]；W34：52.1% vs 12.9%；差异40.2p.p [15.6，60.3]），无溃疡（W14：23.8% vs 7.5%；差异16.3p.p [1.1, 31.6]；W34：34.4% vs 15.6%；差异 18.8p.p [-2.0, 39.5]）、SES-CD 缓解（W14：23.8% vs 7.5%；差异 16.3p.p[1.1，31.6]；W34：34.4% vs 15.6%；差异18.8p.p[-2.0，39.5]）和MH（W14：16.7% vs 2.5%；差异14.2p.p[1.9，26.4]）。W14时患有MH的患者在W14和W34时的PDAI和IBDQ缓解率高于未患有MH的患者：结论：维多珠单抗可改善慢性胃袋炎患者的内镜症状，这与W34时的预后改善有关，尤其是在W14时达到MH的患者。
{"title":"Mucosal Healing With Vedolizumab in Patients With Chronic Pouchitis: EARNEST, a Randomized, Double-Blind, Placebo-Controlled Trial","authors":"Vipul Jairath , Brian G. Feagan , Mark S. Silverberg , Silvio Danese , Paolo Gionchetti , Mark Löwenberg , Brian Bressler , Marc Ferrante , Ailsa Hart , Dirk Lindner , Armella Escher , Stephen Jones , Bo Shen , Simon Travis","doi":"10.1016/j.cgh.2024.06.037","DOIUrl":"10.1016/j.cgh.2024.06.037","url":null,"abstract":"<div><h3>Background & Aims</h3><div>Vedolizumab is indicated for the treatment of chronic pouchitis in the European Union. We assessed whether vedolizumab induced mucosal healing (MH) and if MH was associated with clinical improvements.</div></div><div><h3>Methods</h3><div>EARNEST, a randomized, double-blind, placebo-controlled study, evaluated vedolizumab efficacy and safety in adults with chronic pouchitis. Centrally read endoscopic and histologic evaluation was performed at baseline, Week (W)14, and W34. Ulcer count, adapted Simple Endoscopic Score for Crohn’s Disease in the pouch, and Pouchitis Disease Activity Index histologic component were evaluated. Pouchitis Disease Activity Index and Inflammatory Bowel Disease Questionnaire remission at W14 and W34 were compared by MH status at W14.</div></div><div><h3>Results</h3><div>Following treatment, mean (standard deviation) number of ulcers in vedolizumab-treated patients reduced from 15.1 (16.4) to 5.0 (4.9) at W14 and 2.7 (3.2) at W34 versus placebo-treated patients with corresponding values of 11.8 (11.3), 13.4 (18.4), and 9.7 (13.8) (vedolizumab vs placebo difference [95% confidence interval]: W14: −8.4 [−14.3, −2.6]; W34: −7.0 [−12.0, −2.0]). More patients receiving vedolizumab versus placebo achieved reduction in ulcerated pouch surface area (W14: 52.4% vs 20.0%; difference, 32.4 percentage points [p.p] [9.7, 51.4]; W34: 52.1% vs 12.9%; difference, 40.2p.p [15.6, 60.3]), absence of ulceration (W14: 23.8% vs 7.5%; difference, 16.3p.p [1.1, 31.6]; W34: 34.4% vs 15.6%; difference, 18.8p.p [−2.0, 39.5]), Simple Endoscopic Score for Crohn’s Disease remission (W14: 23.8% vs 7.5%; difference, 16.3p.p [1.1, 31.6]; W34: 34.4% vs 15.6%; difference, 18.8p.p [−2.0, 39.5]), and MH (W14: 16.7% vs 2.5%; difference, 14.2p.p [1.9, 26.4]). Patients with MH at W14 had higher rates of Pouchitis Disease Activity Index and Inflammatory Bowel Disease Questionnaire remission at W14 and W34 than those without.</div></div><div><h3>Conclusions</h3><div>Vedolizumab induced endoscopic improvements in patients with chronic pouchitis, which was associated with improved outcomes at W34, particularly in patients achieving MH at W14. (<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> number, NCT02790138.)</div></div>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":"23 2","pages":"Pages 321-330.e3"},"PeriodicalIF":11.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141723225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.cgh.2024.07.013
Sung Won Chung , Hyun Jun Um , Won-Mook Choi, Jonggi Choi, Danbi Lee, Ju Hyun Shim, Kang Mo Kim, Young-Suk Lim, Han Chu Lee
Background and Aims
Whether tenofovir or entecavir has different effects on the prevention of hepatitis B virus (HBV)–related hepatocellular carcinoma (HCC) in secondary and tertiary preventive settings is still a matter of debate. This study aimed to compare the long-term prognosis of HCC between tenofovir and entecavir in patients with chronic hepatitis B.
Methods
Chronic hepatitis B patients diagnosed with HCC between November 2008 and December 2018 and treated with either entecavir or tenofovir at a tertiary center in Korea were included. The effect of tenofovir compared with entecavir on the prognosis of HBV-related HCC was assessed using multivariable-adjusted Cox and propensity score (PS)–matched analyses. Various predefined subgroup analyses were conducted.
Results
During a median follow-up period of 3.0 years, the mortality rate for entecavir-treated patients (n = 3469) was 41.2%, while tenofovir-treated patients (n = 3056) had a mortality rate of 34.6%. Overall survival (OS) was better in the tenofovir group (adjusted hazard ratio [aHR], 0.79; P < .001), which were consistently observed in the PS-matched analysis. The magnitude of the risk difference in OS was more prominent 2 years after the diagnosis of HCC (aHR, 0.50; P < .001) than 2 years before (aHR, 0.88; P = .005), and it was more pronounced in patients with earlier HCC stages. In all subgroups, except for those with shorter life expectancy, such as those with compromised liver function, tenofovir was associated with better OS compared with entecavir.
Conclusions
Among patients with HBV-related HCC, those treated with tenofovir had a better prognosis than those treated with entecavir, particularly among those with prolonged survival.
{"title":"Tenofovir Is Associated With a Better Prognosis Than Entecavir for Hepatitis B Virus–Related Hepatocellular Carcinoma","authors":"Sung Won Chung , Hyun Jun Um , Won-Mook Choi, Jonggi Choi, Danbi Lee, Ju Hyun Shim, Kang Mo Kim, Young-Suk Lim, Han Chu Lee","doi":"10.1016/j.cgh.2024.07.013","DOIUrl":"10.1016/j.cgh.2024.07.013","url":null,"abstract":"<div><h3>Background and Aims</h3><div>Whether tenofovir or entecavir has different effects on the prevention of hepatitis B virus (HBV)–related hepatocellular carcinoma (HCC) in secondary and tertiary preventive settings is still a matter of debate. This study aimed to compare the long-term prognosis of HCC between tenofovir and entecavir in patients with chronic hepatitis B.</div></div><div><h3>Methods</h3><div>Chronic hepatitis B patients diagnosed with HCC between November 2008 and December 2018 and treated with either entecavir or tenofovir at a tertiary center in Korea were included. The effect of tenofovir compared with entecavir on the prognosis of HBV-related HCC was assessed using multivariable-adjusted Cox and propensity score (PS)–matched analyses. Various predefined subgroup analyses were conducted.</div></div><div><h3>Results</h3><div>During a median follow-up period of 3.0 years, the mortality rate for entecavir-treated patients (n = 3469) was 41.2%, while tenofovir-treated patients (n = 3056) had a mortality rate of 34.6%. Overall survival (OS) was better in the tenofovir group (adjusted hazard ratio [aHR], 0.79; <em>P</em> < .001), which were consistently observed in the PS-matched analysis. The magnitude of the risk difference in OS was more prominent 2 years after the diagnosis of HCC (aHR, 0.50; <em>P</em> < .001) than 2 years before (aHR, 0.88; <em>P</em> = .005), and it was more pronounced in patients with earlier HCC stages. In all subgroups, except for those with shorter life expectancy, such as those with compromised liver function, tenofovir was associated with better OS compared with entecavir.</div></div><div><h3>Conclusions</h3><div>Among patients with HBV-related HCC, those treated with tenofovir had a better prognosis than those treated with entecavir, particularly among those with prolonged survival.</div></div>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":"23 2","pages":"Pages 300-309.e9"},"PeriodicalIF":11.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141874347","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}
Pub Date : 2025-02-01DOI: 10.1016/j.cgh.2024.07.031
Won-Mook Choi , Terry Cheuk-Fung Yip , Grace Lai-Hung Wong , W. Ray Kim , Leland J. Yee , Craig Brooks-Rooney , Tristan Curteis , Laura J. Clark , Zarena Jafry , Chien-Hung Chen , Chi-Yi Chen , Yi-Hsiang Huang , Young-Joo Jin , Dae Won Jun , Jin-Wook Kim , Neung Hwa Park , Cheng-Yuan Peng , Hyun Phil Shin , Jung Woo Shin , Yao-Hsu Yang , Young-Suk Lim
Background & Aims
Hepatocellular carcinoma (HCC) risk persists in patients with chronic hepatitis B (CHB) despite antiviral therapy. The relationship between pre-treatment baseline hepatitis B virus (HBV) viral load and HCC risk during antiviral treatment remains uncertain.
Methods
This multinational cohort study aimed to investigate the association between baseline HBV viral load and on-treatment HCC risk in 20,826 noncirrhotic, hepatitis B e antigen (HBeAg)-positive and HBeAg-negative patients with baseline HBV DNA levels ≥2000 IU/mL (3.30 log10 IU/mL) who initiated entecavir or tenofovir treatment. The primary outcome was on-treatment HCC incidence, stratified by baseline HBV viral load as a categorical variable.
Results
In total, 663 patients developed HCC over a median follow-up of 4.1 years, with an incidence rate of 0.81 per 100 person-years (95% confidence interval [CI], 0.75–0.87). Baseline HBV viral load was significantly associated with HCC risk in a non-linear parabolic pattern, independent of other factors. Patients with baseline viral load between 6.00 and 7.00 log10 IU/mL had the highest on-treatment HCC risk (adjusted hazard ratio, 4.28; 95% CI, 2.15–8.52; P < .0001) compared with those with baseline viral load ≥8.00 log10 IU/mL, who exhibited the lowest HCC risk.
Conclusion
Baseline viral load showed a significant, non-linear, parabolic association with HCC risk during antiviral treatment in noncirrhotic patients with CHB. Early initiation of antiviral treatment based on HBV viral load may help prevent irreversible HCC risk accumulation in patients with CHB.
{"title":"Baseline Viral Load and On-Treatment Hepatocellular Carcinoma Risk in Chronic Hepatitis B: A Multinational Cohort Study","authors":"Won-Mook Choi , Terry Cheuk-Fung Yip , Grace Lai-Hung Wong , W. Ray Kim , Leland J. Yee , Craig Brooks-Rooney , Tristan Curteis , Laura J. Clark , Zarena Jafry , Chien-Hung Chen , Chi-Yi Chen , Yi-Hsiang Huang , Young-Joo Jin , Dae Won Jun , Jin-Wook Kim , Neung Hwa Park , Cheng-Yuan Peng , Hyun Phil Shin , Jung Woo Shin , Yao-Hsu Yang , Young-Suk Lim","doi":"10.1016/j.cgh.2024.07.031","DOIUrl":"10.1016/j.cgh.2024.07.031","url":null,"abstract":"<div><h3>Background & Aims</h3><div>Hepatocellular carcinoma (HCC) risk persists in patients with chronic hepatitis B (CHB) despite antiviral therapy. The relationship between pre-treatment baseline hepatitis B virus (HBV) viral load and HCC risk during antiviral treatment remains uncertain.</div></div><div><h3>Methods</h3><div>This multinational cohort study aimed to investigate the association between baseline HBV viral load and on-treatment HCC risk in 20,826 noncirrhotic, hepatitis B e antigen (HBeAg)-positive and HBeAg-negative patients with baseline HBV DNA levels ≥2000 IU/mL (3.30 log<sub>10</sub> IU/mL) who initiated entecavir or tenofovir treatment. The primary outcome was on-treatment HCC incidence, stratified by baseline HBV viral load as a categorical variable.</div></div><div><h3>Results</h3><div>In total, 663 patients developed HCC over a median follow-up of 4.1 years, with an incidence rate of 0.81 per 100 person-years (95% confidence interval [CI], 0.75–0.87). Baseline HBV viral load was significantly associated with HCC risk in a non-linear parabolic pattern, independent of other factors. Patients with baseline viral load between 6.00 and 7.00 log<sub>10</sub> IU/mL had the highest on-treatment HCC risk (adjusted hazard ratio, 4.28; 95% CI, 2.15–8.52; <em>P</em> < .0001) compared with those with baseline viral load ≥8.00 log<sub>10</sub> IU/mL, who exhibited the lowest HCC risk.</div></div><div><h3>Conclusion</h3><div>Baseline viral load showed a significant, non-linear, parabolic association with HCC risk during antiviral treatment in noncirrhotic patients with CHB. Early initiation of antiviral treatment based on HBV viral load may help prevent irreversible HCC risk accumulation in patients with CHB.</div></div>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":"23 2","pages":"Pages 310-320.e7"},"PeriodicalIF":11.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142055081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.cgh.2024.10.002
Fasiha Kanwal, Gina Reitenauer, Thoba Khumalo Petrovic, Nicholas J. Tomeo, Yan Liu, Aaron P. Thrift
{"title":"Online-Only vs Conventional Publication of Original Research Articles: A Randomized Controlled Trial","authors":"Fasiha Kanwal, Gina Reitenauer, Thoba Khumalo Petrovic, Nicholas J. Tomeo, Yan Liu, Aaron P. Thrift","doi":"10.1016/j.cgh.2024.10.002","DOIUrl":"10.1016/j.cgh.2024.10.002","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":"23 2","pages":"Pages 359-361"},"PeriodicalIF":11.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459525","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}
Pub Date : 2025-02-01DOI: 10.1016/j.cgh.2024.06.050
David I. Fudman , Ryan A. McConnell , Christina Ha , Siddharth Singh
The therapeutic armamentarium for management of inflammatory bowel diseases has expanded dramatically in the last 5 years, with the introduction of several medications with different mechanisms of action. These include the oral small molecule drugs Janus kinase inhibitors (including upadacitinib, approved for Crohn’s disease and ulcerative colitis [UC], and tofacitinib, approved for UC) and sphingosphine 1-phosphate receptor modulators (ozanimod and etrasimod, both approved for UC), and biologic agents, such as selective interleukin-23 antagonists (risankizumab approved for Crohn’s disease, and mirikizumab approved for UC). The efficacy and safety of these therapies vary. In this review, we discuss practical use of these newer advanced therapies focusing on real-world effectiveness and safety data, dosing and monitoring considerations, and special situations for their use, such as pregnancy, comorbid immune-mediated disease, use in hospitalized patients with acute severe UC, and in the perioperative setting. We also propose our approach to positioning these therapies in clinical practice, relying on careful integration of the medication’s comparative effectiveness and safety in the context of an individual patient’s risk of disease- and treatment-related complications and preferences.
{"title":"Modern Advanced Therapies for Inflammatory Bowel Diseases: Practical Considerations and Positioning","authors":"David I. Fudman , Ryan A. McConnell , Christina Ha , Siddharth Singh","doi":"10.1016/j.cgh.2024.06.050","DOIUrl":"10.1016/j.cgh.2024.06.050","url":null,"abstract":"<div><div>The therapeutic armamentarium for management of inflammatory bowel diseases has expanded dramatically in the last 5 years, with the introduction of several medications with different mechanisms of action. These include the oral small molecule drugs Janus kinase inhibitors (including upadacitinib, approved for Crohn’s disease and ulcerative colitis [UC], and tofacitinib, approved for UC) and sphingosphine 1-phosphate receptor modulators (ozanimod and etrasimod, both approved for UC), and biologic agents, such as selective interleukin-23 antagonists (risankizumab approved for Crohn’s disease, and mirikizumab approved for UC). The efficacy and safety of these therapies vary. In this review, we discuss practical use of these newer advanced therapies focusing on real-world effectiveness and safety data, dosing and monitoring considerations, and special situations for their use, such as pregnancy, comorbid immune-mediated disease, use in hospitalized patients with acute severe UC, and in the perioperative setting. We also propose our approach to positioning these therapies in clinical practice, relying on careful integration of the medication’s comparative effectiveness and safety in the context of an individual patient’s risk of disease- and treatment-related complications and preferences.</div></div>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":"23 3","pages":"Pages 454-468"},"PeriodicalIF":11.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141987572","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}
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