Pub Date : 2024-10-28DOI: 10.1016/j.cgh.2024.07.048
Megan M L Engels, Calise K Berger, Douglas W Mahoney, Sanne A Hoogenboom, Dhruv Sarwal, Derk C F Klatte, Jaime De La Fuente, Sonal Gandhi, William R Taylor, Patrick H Foote, Karen A Doering, Adriana M Delgado, Kelli N Burger, Barham K Abu Dayyeh, Aliana Bofill-Garcia, Bhaumik Brahmbhatt, Vinay Chandrasekhara, Ferga C Gleeson, Victoria Gomez, Vivek Kumbhari, Ryan J Law, Frank J Lukens, Massimo Raimondo, Elizabeth Rajan, Andrew C Storm, Eric J Vargas Valls, Jeanin E van Hooft, Michael B Wallace, John B Kisiel, Shounak Majumder
Background and aims: In previous studies methylated DNA markers (MDMs) have been identified in pancreatic juice (PJ) for detecting pancreatic ductal adenocarcinoma (PDAC). In this prospective multicenter study, the sensitivity and specificity characteristics of this panel of PJ-MDMs was evaluated standalone and in combination with plasma CA 19-9.
Methods: Paired PJ and plasma were assayed from 88 biopsy-proven treatment naïve PDAC cases and 134 controls (normal pancreas: 53, chronic pancreatitis (CP): 23, intraductal papillary mucinous neoplasm (IPMN): 58). Bisulfite-converted DNA from buffered PJ was analyzed using long-probe quantitative amplified signal assay targeting 14 MDMs (NDRG4, BMP3, TBX15, C13orf18, PRKCB, CLEC11A, CD1D, ELMO1, IGF2BP1, RYR2, ADCY1, FER1L4, EMX1, and LRRC4) and a reference gene (methylated B3GALT6). Logistic regression was used to fit the previously identified 3-MDM PJ panel (FER1L4, C13orf18 and BMP3). Discrimination accuracy was summarized using area under the receiver operating characteristic curve (AUROC) with corresponding 95% confidence intervals.
Results: Methylated FER1L4 had the highest individual AUROC of 0.83 (95% CI: 0.78-0.89). The AUROC for the 3-MDM PJ + Plasma CA 19-9 model (0.95 (0.92-0.98))) was higher than both the 3-MDM PJ panel (0.87 (0.82-0.92)) and plasma CA 19-9 alone ((0.91 (0.87-0.96) (p=0.0002 and 0.0135, respectively). At a specificity of 88% (95% CI: 81-93%), the sensitivity of this model was 89% (80-94%) for all PDAC stages and 83% (64-94%) for stage I/II PDAC.
Conclusion: A panel combining PJ-MDMs and plasma CA19-9 discriminates PDAC from both healthy and disease control groups with high accuracy. This provides support for combining pancreatic juice and blood-based biomarkers for enhancing diagnostic sensitivity and successful early PDAC detection.
{"title":"Multimodal pancreatic cancer detection using methylated DNA biomarkers in pancreatic juice and plasma CA 19-9: A prospective multicenter study.","authors":"Megan M L Engels, Calise K Berger, Douglas W Mahoney, Sanne A Hoogenboom, Dhruv Sarwal, Derk C F Klatte, Jaime De La Fuente, Sonal Gandhi, William R Taylor, Patrick H Foote, Karen A Doering, Adriana M Delgado, Kelli N Burger, Barham K Abu Dayyeh, Aliana Bofill-Garcia, Bhaumik Brahmbhatt, Vinay Chandrasekhara, Ferga C Gleeson, Victoria Gomez, Vivek Kumbhari, Ryan J Law, Frank J Lukens, Massimo Raimondo, Elizabeth Rajan, Andrew C Storm, Eric J Vargas Valls, Jeanin E van Hooft, Michael B Wallace, John B Kisiel, Shounak Majumder","doi":"10.1016/j.cgh.2024.07.048","DOIUrl":"https://doi.org/10.1016/j.cgh.2024.07.048","url":null,"abstract":"<p><strong>Background and aims: </strong>In previous studies methylated DNA markers (MDMs) have been identified in pancreatic juice (PJ) for detecting pancreatic ductal adenocarcinoma (PDAC). In this prospective multicenter study, the sensitivity and specificity characteristics of this panel of PJ-MDMs was evaluated standalone and in combination with plasma CA 19-9.</p><p><strong>Methods: </strong>Paired PJ and plasma were assayed from 88 biopsy-proven treatment naïve PDAC cases and 134 controls (normal pancreas: 53, chronic pancreatitis (CP): 23, intraductal papillary mucinous neoplasm (IPMN): 58). Bisulfite-converted DNA from buffered PJ was analyzed using long-probe quantitative amplified signal assay targeting 14 MDMs (NDRG4, BMP3, TBX15, C13orf18, PRKCB, CLEC11A, CD1D, ELMO1, IGF2BP1, RYR2, ADCY1, FER1L4, EMX1, and LRRC4) and a reference gene (methylated B3GALT6). Logistic regression was used to fit the previously identified 3-MDM PJ panel (FER1L4, C13orf18 and BMP3). Discrimination accuracy was summarized using area under the receiver operating characteristic curve (AUROC) with corresponding 95% confidence intervals.</p><p><strong>Results: </strong>Methylated FER1L4 had the highest individual AUROC of 0.83 (95% CI: 0.78-0.89). The AUROC for the 3-MDM PJ + Plasma CA 19-9 model (0.95 (0.92-0.98))) was higher than both the 3-MDM PJ panel (0.87 (0.82-0.92)) and plasma CA 19-9 alone ((0.91 (0.87-0.96) (p=0.0002 and 0.0135, respectively). At a specificity of 88% (95% CI: 81-93%), the sensitivity of this model was 89% (80-94%) for all PDAC stages and 83% (64-94%) for stage I/II PDAC.</p><p><strong>Conclusion: </strong>A panel combining PJ-MDMs and plasma CA19-9 discriminates PDAC from both healthy and disease control groups with high accuracy. This provides support for combining pancreatic juice and blood-based biomarkers for enhancing diagnostic sensitivity and successful early PDAC detection.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544099","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 : 2024-10-25DOI: 10.1016/j.cgh.2024.10.006
Young-Gyun Seo, Stergios A Polyzos, Kyung-Hee Park, Christos S Mantzoros
Background and aims: Since the association of hepatic fibrosis and steatosis non-invasive indices with mortality remain controversial, their association with all-cause, cardiovascular, cancer and liver-related mortality was evaluated in the Korean population.
Methods: In this registry-based, cohort study, data were retrieved from the Korea National Health and Nutrition Examination Survey and mortality data from the Korean Cause of Death data registry; 40,491 individuals followed-up for 8.6 years (median). Hepatic fibrosis was evaluated with alanine aminotransferase (AST)-to-platelet ratio index (APRI), body mass index-AST-to-alanine aminotransferase (ALT) ratio-diabetes mellitus (BARD) and metabolic dysfunction-associated fibrosis-5 (MAF-5) score, and steatosis was evaluated with liver fat score (LFS) and lipid accumulation product (LAP).
Results: Cox regression analysis showed that APRI (<1.0 vs. ≥1.0) was independently associated with all-cause (hazard ratio [HR] 3.84, 95% confidence interval [CI] 2.30-6.43, C-index 0.870), cancer (HR 4.21, 95%CI 1.88-9.45, C-index 0.866) and liver-related (HR 25.36, 95%CI 11.02-58.38, C-index 0.909) mortality. MAF-5 (<1.0 vs. ≥1.0) was independently associated with all-cause mortality (HR 1.50, 95%CI 1.10-2.03, C-index 0.868) and liver-related mortality (HR 8.35, 95%CI 3.58-19.46, C-index 0.911). LFS (<1.257 vs. ≥1.257), was independently associated with all-cause (HR 1.55, 95%CI 1.14-2.12, C-index 0.872) and liver-related (HR 7.00, 95%CI 1.63-29.96, C-index 0.887) mortality. LAP (<38.05 vs. ≥38.05) was independently associated with cardiovascular mortality (HR 2.23, 95%CI 1.40-3.58, C-index 0.898). BARD was not associated with mortality.
Conclusions: APRI, MAF-5, LFS were independently associated with all-cause mortality, LAP (cut-off 38.05) with cardiovascular mortality, APRI with cancer mortality, and APRI, MAF-5, LFS with liver-related mortality in the adult Korean population.
{"title":"Non-invasive hepatic steatosis and fibrosis indices predict differentially mortality in the adult Korean population.","authors":"Young-Gyun Seo, Stergios A Polyzos, Kyung-Hee Park, Christos S Mantzoros","doi":"10.1016/j.cgh.2024.10.006","DOIUrl":"https://doi.org/10.1016/j.cgh.2024.10.006","url":null,"abstract":"<p><strong>Background and aims: </strong>Since the association of hepatic fibrosis and steatosis non-invasive indices with mortality remain controversial, their association with all-cause, cardiovascular, cancer and liver-related mortality was evaluated in the Korean population.</p><p><strong>Methods: </strong>In this registry-based, cohort study, data were retrieved from the Korea National Health and Nutrition Examination Survey and mortality data from the Korean Cause of Death data registry; 40,491 individuals followed-up for 8.6 years (median). Hepatic fibrosis was evaluated with alanine aminotransferase (AST)-to-platelet ratio index (APRI), body mass index-AST-to-alanine aminotransferase (ALT) ratio-diabetes mellitus (BARD) and metabolic dysfunction-associated fibrosis-5 (MAF-5) score, and steatosis was evaluated with liver fat score (LFS) and lipid accumulation product (LAP).</p><p><strong>Results: </strong>Cox regression analysis showed that APRI (<1.0 vs. ≥1.0) was independently associated with all-cause (hazard ratio [HR] 3.84, 95% confidence interval [CI] 2.30-6.43, C-index 0.870), cancer (HR 4.21, 95%CI 1.88-9.45, C-index 0.866) and liver-related (HR 25.36, 95%CI 11.02-58.38, C-index 0.909) mortality. MAF-5 (<1.0 vs. ≥1.0) was independently associated with all-cause mortality (HR 1.50, 95%CI 1.10-2.03, C-index 0.868) and liver-related mortality (HR 8.35, 95%CI 3.58-19.46, C-index 0.911). LFS (<1.257 vs. ≥1.257), was independently associated with all-cause (HR 1.55, 95%CI 1.14-2.12, C-index 0.872) and liver-related (HR 7.00, 95%CI 1.63-29.96, C-index 0.887) mortality. LAP (<38.05 vs. ≥38.05) was independently associated with cardiovascular mortality (HR 2.23, 95%CI 1.40-3.58, C-index 0.898). BARD was not associated with mortality.</p><p><strong>Conclusions: </strong>APRI, MAF-5, LFS were independently associated with all-cause mortality, LAP (cut-off 38.05) with cardiovascular mortality, APRI with cancer mortality, and APRI, MAF-5, LFS with liver-related mortality in the adult Korean population.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567790","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 : 2024-10-25DOI: 10.1016/j.cgh.2024.10.005
Hannah Bloemen, Alexandra E Livanos, Adrielly Martins, Richard Dean, Ana Catarina Bravo, Arno R Bourgonje, Michael Tankelevich, Jake Herb, Judy Cho, André Anastácio Santos, Cecília M P Rodrigues, Francesca Petralia, Jean-Frederic Colombel, Christopher L Bowlus, Thomas Schiano, Joana Torres, Cynthia Levy, Saurabh Mehandru
Background and aims: Anti-integrin αvβ6 autoantibodies (anti-αvβ6) are found in more than 50% of individuals with ulcerative colitis (UC). We aimed to determine the prevalence of anti-αvβ6 in patients with primary sclerosing cholangitis (PSC) and their association with liver disease severity.
Methods: Four cohorts of pre-liver transplant PSC patients were recruited. Patients with inflammatory bowel disease (IBD) and healthy controls (HC) served as comparators. Total IgG and anti-αvβ6 levels were measured using enzyme-linked immunosorbent assay (ELISA). Olink® inflammation panel was run on a subset of samples. Multivariable linear regression analysis was performed to assess the association between anti-αvβ6 and indices of liver disease severity.
Results: A total of 137 PSC patients (including 76 with PSC-UC, 33 with PSC-Crohn's disease (CD) and 28 with PSC alone) and 160 controls (including 91 with IBD and 69 HC) were enrolled. Anti-αvβ6 levels were significantly higher in PSC-UC and PSC-CD compared to PSC alone (p<0.0001 and 0.003) and HC (p<0.0001 and p<0.0001). However, anti-αvβ6 levels in PSC alone were not increased compared to HC. In patients with PSC-IBD, anti-αvβ6 levels correlated with markers of liver disease severity including alkaline phosphatase level (r=0.32, p=0.004), the revised Mayo PSC risk score (r=0.25, p=0.02) and liver stiffness measurement (r=0.43, p=0.008) after adjusting for age, gender, race/ethnicity and IBD subtype. Additionally, anti-αvβ6 levels were associated with markers of systemic inflammation and tissue remodeling.
Conclusion: Anti-αvβ6 autoantibodies identify a subset of PSC patients with concomitant IBD.
{"title":"Anti-integrin αvβ6 autoantibodies are increased in PSC patients with concomitant IBD and correlate with liver disease severity.","authors":"Hannah Bloemen, Alexandra E Livanos, Adrielly Martins, Richard Dean, Ana Catarina Bravo, Arno R Bourgonje, Michael Tankelevich, Jake Herb, Judy Cho, André Anastácio Santos, Cecília M P Rodrigues, Francesca Petralia, Jean-Frederic Colombel, Christopher L Bowlus, Thomas Schiano, Joana Torres, Cynthia Levy, Saurabh Mehandru","doi":"10.1016/j.cgh.2024.10.005","DOIUrl":"10.1016/j.cgh.2024.10.005","url":null,"abstract":"<p><strong>Background and aims: </strong>Anti-integrin αvβ6 autoantibodies (anti-αvβ6) are found in more than 50% of individuals with ulcerative colitis (UC). We aimed to determine the prevalence of anti-αvβ6 in patients with primary sclerosing cholangitis (PSC) and their association with liver disease severity.</p><p><strong>Methods: </strong>Four cohorts of pre-liver transplant PSC patients were recruited. Patients with inflammatory bowel disease (IBD) and healthy controls (HC) served as comparators. Total IgG and anti-αvβ6 levels were measured using enzyme-linked immunosorbent assay (ELISA). Olink® inflammation panel was run on a subset of samples. Multivariable linear regression analysis was performed to assess the association between anti-αvβ6 and indices of liver disease severity.</p><p><strong>Results: </strong>A total of 137 PSC patients (including 76 with PSC-UC, 33 with PSC-Crohn's disease (CD) and 28 with PSC alone) and 160 controls (including 91 with IBD and 69 HC) were enrolled. Anti-αvβ6 levels were significantly higher in PSC-UC and PSC-CD compared to PSC alone (p<0.0001 and 0.003) and HC (p<0.0001 and p<0.0001). However, anti-αvβ6 levels in PSC alone were not increased compared to HC. In patients with PSC-IBD, anti-αvβ6 levels correlated with markers of liver disease severity including alkaline phosphatase level (r=0.32, p=0.004), the revised Mayo PSC risk score (r=0.25, p=0.02) and liver stiffness measurement (r=0.43, p=0.008) after adjusting for age, gender, race/ethnicity and IBD subtype. Additionally, anti-αvβ6 levels were associated with markers of systemic inflammation and tissue remodeling.</p><p><strong>Conclusion: </strong>Anti-αvβ6 autoantibodies identify a subset of PSC patients with concomitant IBD.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567771","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 : 2024-10-25DOI: 10.1016/j.cgh.2024.09.023
Daryl Ramai, Chun-Wei Pan, David M Troendle, Marcello Maida, Antonio Facciorusso, Jorge D Machicado
{"title":"Prevalence of Gastroparesis in Chronic Pancreatitis and Predictive Factors: A Machine Learning Prediction Model.","authors":"Daryl Ramai, Chun-Wei Pan, David M Troendle, Marcello Maida, Antonio Facciorusso, Jorge D Machicado","doi":"10.1016/j.cgh.2024.09.023","DOIUrl":"https://doi.org/10.1016/j.cgh.2024.09.023","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567798","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 : 2024-10-24DOI: 10.1016/j.cgh.2024.09.027
Adar Zinger, David Choi, Natalie Choi, Evan Fear, Zachary Fine, Russell D Cohen, David T Rubin
Background and aims: Risankizumab is a selective IL23 inhibitor approved for the treatment of Crohn's disease (CD). We report a large long-term real-world experience with risankizumab in CD.
Methods: We performed a prospective monitoring of clinical outcomes in patients in our center who started treatment with risankizumab. Patients with active luminal disease who had at least 12 weeks of follow-up were included in the effectiveness analysis. Harvey-Bradshaw Index (HBI) as well as C-reactive protein (CRP) and fecal calprotectin (FCP) were used to monitor disease activity. Primary outcomes were clinical remission and steroid-free clinical remission rates at weeks 12, 26, and 52. Univariate analysis followed by a multivariate analysis using a logistic regression model was performed to identify predictors of steroid-free clinical remission at one year. All patients who started treatment with risankizumab for any indication were included in the safety analysis.
Results: 134 patients were included in the effectiveness analysis. 70 (52%) were ustekinumab-experienced. Clinical remission rates were 69%, 64%, and 54% at weeks 12, 26, and 52, respectively. Steroid-free clinical remission rates at 12, 26, and 52 weeks were 58%, 58%, and 50% respectively. Remission rates in ustekinumab-experienced patients were not statistically lower compared to naïve patients, and in a multivariate analysis, prior ustekinumab treatment was not associated with lower odds of achieving steroid-free clinical remission at one year. Adverse effects were assessed in 243 patients and were consistent with previous literature.
Conclusions: This large real-world experience with risankizumab with long-term follow-up demonstrates effectiveness and safety in patients with CD; there was comparable effectiveness in ustekinumab-naïve and ustekinumab-experienced patients.
{"title":"Long-term Effectiveness and Safety of Risankizumab in Patients with Crohn's Disease from a Large Tertiary Center.","authors":"Adar Zinger, David Choi, Natalie Choi, Evan Fear, Zachary Fine, Russell D Cohen, David T Rubin","doi":"10.1016/j.cgh.2024.09.027","DOIUrl":"https://doi.org/10.1016/j.cgh.2024.09.027","url":null,"abstract":"<p><strong>Background and aims: </strong>Risankizumab is a selective IL23 inhibitor approved for the treatment of Crohn's disease (CD). We report a large long-term real-world experience with risankizumab in CD.</p><p><strong>Methods: </strong>We performed a prospective monitoring of clinical outcomes in patients in our center who started treatment with risankizumab. Patients with active luminal disease who had at least 12 weeks of follow-up were included in the effectiveness analysis. Harvey-Bradshaw Index (HBI) as well as C-reactive protein (CRP) and fecal calprotectin (FCP) were used to monitor disease activity. Primary outcomes were clinical remission and steroid-free clinical remission rates at weeks 12, 26, and 52. Univariate analysis followed by a multivariate analysis using a logistic regression model was performed to identify predictors of steroid-free clinical remission at one year. All patients who started treatment with risankizumab for any indication were included in the safety analysis.</p><p><strong>Results: </strong>134 patients were included in the effectiveness analysis. 70 (52%) were ustekinumab-experienced. Clinical remission rates were 69%, 64%, and 54% at weeks 12, 26, and 52, respectively. Steroid-free clinical remission rates at 12, 26, and 52 weeks were 58%, 58%, and 50% respectively. Remission rates in ustekinumab-experienced patients were not statistically lower compared to naïve patients, and in a multivariate analysis, prior ustekinumab treatment was not associated with lower odds of achieving steroid-free clinical remission at one year. Adverse effects were assessed in 243 patients and were consistent with previous literature.</p><p><strong>Conclusions: </strong>This large real-world experience with risankizumab with long-term follow-up demonstrates effectiveness and safety in patients with CD; there was comparable effectiveness in ustekinumab-naïve and ustekinumab-experienced patients.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496182","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 : 2024-10-24DOI: 10.1016/j.cgh.2024.08.047
Mohamed Attauabi, Gorm Roager Madsen, Flemming Bendtsen, Jakob Benedict Seidelin, Johan Burisch
Background and aims: Patient-reported outcomes (PROs) are pivotal in assessing treatment efficacy and estimating the burden of inflammatory bowel diseases (IBD). We investigated PROs at the time of IBD diagnosis.
Methods: The Short Inflammatory Bowel Disease Questionnaire (SIBDQ), IBD-Disability Index (IBD-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and disease activity-related PROs were assessed in the Copenhagen IBD Inception Cohort, a prospective, population-based cohort of patients newly diagnosed with IBD between May 2021 and May 2023.
Results: A total of 203 UC and 116 CD patients were recruited. At diagnosis, 160 (78.8%) and 99 (85.3%) patients with UC and CD, respectively, reported moderate-to-severe impairment in at least one PRO (p=0.18), with 89 (43.8%) and 74 (63.8%), respectively, reporting moderate-to-severe impairment in at least two PROs (p<0.01). Being female, the disease extent of UC, and extraintestinal manifestations were associated with impaired PROs. There were no differences found according to CD phenotype. FACIT-F, IBD-DI, and SIBDQ scores showed weak, but significant, correlations with the Mayo Endoscopic Score in UC, and the FACIT-F score with C-reactive protein (CRP). In CD, SIBDQ, IBD-DI, and FACIT-F correlated moderately with CRP and fecal calprotectin, but not with the endoscopic severity of CD. None of the PROs correlated with iron, ferritin, or vitamin D levels. Among the most prevalent symptoms reported were fatigue, abdominal pain, urgency, and passing of blood in both CD and UC.
Conclusion: We found a substantial patient-reported disease burden in newly diagnosed IBD, underscoring the importance of vigilant PRO monitoring in clinical practice.
Funding: This study was funded by an unrestricted grant from the Novo Nordisk Fonden.
背景和目的:患者报告结果(PROs)对于评估治疗效果和估计炎症性肠病(IBD)的负担至关重要。我们对确诊 IBD 时的患者报告结果进行了调查:方法:我们在哥本哈根 IBD 初诊队列中评估了短式炎症性肠病问卷(SIBDQ)、IBD-残疾指数(IBD-DI)、慢性疾病治疗疲劳功能评估(FACIT-F)以及疾病活动相关的 PROs:结果:共招募了 203 名 UC 和 116 名 CD 患者。在确诊时,分别有 160 名(78.8%)和 99 名(85.3%)UC 和 CD 患者报告至少一项 PRO 存在中度至重度损伤(P=0.18),分别有 89 名(43.8%)和 74 名(63.8%)患者报告至少两项 PRO 存在中度至重度损伤(P结论:我们发现,在新诊断的 IBD 患者中,患者报告的疾病负担很重,这强调了在临床实践中警惕性监测 PRO 的重要性:本研究由诺和诺德基金会(Novo Nordisk Fonden)无限制资助。
{"title":"Multi-dimensional patient-reported outcomes and quality of life at diagnosis of IBD: A population-based inception cohort study.","authors":"Mohamed Attauabi, Gorm Roager Madsen, Flemming Bendtsen, Jakob Benedict Seidelin, Johan Burisch","doi":"10.1016/j.cgh.2024.08.047","DOIUrl":"https://doi.org/10.1016/j.cgh.2024.08.047","url":null,"abstract":"<p><strong>Background and aims: </strong>Patient-reported outcomes (PROs) are pivotal in assessing treatment efficacy and estimating the burden of inflammatory bowel diseases (IBD). We investigated PROs at the time of IBD diagnosis.</p><p><strong>Methods: </strong>The Short Inflammatory Bowel Disease Questionnaire (SIBDQ), IBD-Disability Index (IBD-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and disease activity-related PROs were assessed in the Copenhagen IBD Inception Cohort, a prospective, population-based cohort of patients newly diagnosed with IBD between May 2021 and May 2023.</p><p><strong>Results: </strong>A total of 203 UC and 116 CD patients were recruited. At diagnosis, 160 (78.8%) and 99 (85.3%) patients with UC and CD, respectively, reported moderate-to-severe impairment in at least one PRO (p=0.18), with 89 (43.8%) and 74 (63.8%), respectively, reporting moderate-to-severe impairment in at least two PROs (p<0.01). Being female, the disease extent of UC, and extraintestinal manifestations were associated with impaired PROs. There were no differences found according to CD phenotype. FACIT-F, IBD-DI, and SIBDQ scores showed weak, but significant, correlations with the Mayo Endoscopic Score in UC, and the FACIT-F score with C-reactive protein (CRP). In CD, SIBDQ, IBD-DI, and FACIT-F correlated moderately with CRP and fecal calprotectin, but not with the endoscopic severity of CD. None of the PROs correlated with iron, ferritin, or vitamin D levels. Among the most prevalent symptoms reported were fatigue, abdominal pain, urgency, and passing of blood in both CD and UC.</p><p><strong>Conclusion: </strong>We found a substantial patient-reported disease burden in newly diagnosed IBD, underscoring the importance of vigilant PRO monitoring in clinical practice.</p><p><strong>Funding: </strong>This study was funded by an unrestricted grant from the Novo Nordisk Fonden.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496184","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 : 2024-10-24DOI: 10.1016/j.cgh.2024.09.026
Emily K Wright, Michael A Kamm
{"title":"Letter Response to: Hernandez-Rocha C et al, Clin Gastroenterol Hepatol 2024.","authors":"Emily K Wright, Michael A Kamm","doi":"10.1016/j.cgh.2024.09.026","DOIUrl":"10.1016/j.cgh.2024.09.026","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496181","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}