Pub Date : 2025-01-20eCollection Date: 2025-01-01DOI: 10.1093/crocol/otaf006
Rocio Castrillon
This editorial explores the complex relationship between inflammatory bowel disease (IBD) and extra-intestinal manifestations (EIMs) and underscores the clinician's critical need for comprehensive EIM care, as well as the physical and emotional burden imposed on the patient. The editorial concludes with actionable steps for clinicians and a call to advance IBD care with a comprehensive multidisciplinary approach that acknowledges the various challenges faced by patients. Together, we can transform the IBD journey into a partnership built on understanding, support, and shared hope.
{"title":"Living Beyond IBD: A Patient's Experience With EIMs and the Case for Multidisciplinary Care.","authors":"Rocio Castrillon","doi":"10.1093/crocol/otaf006","DOIUrl":"https://doi.org/10.1093/crocol/otaf006","url":null,"abstract":"<p><p>This editorial explores the complex relationship between inflammatory bowel disease (IBD) and extra-intestinal manifestations (EIMs) and underscores the clinician's critical need for comprehensive EIM care, as well as the physical and emotional burden imposed on the patient. The editorial concludes with actionable steps for clinicians and a call to advance IBD care with a comprehensive multidisciplinary approach that acknowledges the various challenges faced by patients. Together, we can transform the IBD journey into a partnership built on understanding, support, and shared hope.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otaf006"},"PeriodicalIF":1.8,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11811765/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143398561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-16eCollection Date: 2025-01-01DOI: 10.1093/crocol/otaf004
Linda Yoo, Mara Shapiro, Ihsan Kahveci, Isabela Hernandez, Rachael Whittemore, Tanvi Kale, Samantha Winders, Kendra Kamp
Background: Patient advisory groups are key to guiding research studies through meaningful engagement with the population of interest. Although patient advisory groups are greatly valuable to research studies, they are underutilized in inflammatory bowel disease research. Thus, this study aims to describe the development and implementation of a patient advisory group and evaluate the perspectives of researchers and members.
Methods: The Comprehensive Self-Management for inflammatory bowel disease study patient advisory group was created in 2022. The patient advisory group members and researchers completed the Public and Patient Engagement Evaluation Tool via an online survey. Thematic analysis of responses was used to identify common themes, and descriptive statistics were reported.
Results: The patient advisory group comprised of patients with inflammatory bowel disease met quarterly. Eight members and three researchers evaluated the patient advisory group. The five emerging themes were (1) lived experience of patient advisory group members; (2) diversity and representation; (3) purposeful engagement; (4) positives of patient advisory group; and (5) improvements to patient advisory group. All members agreed or strongly agreed that the meetings were a good use of their time, and all researchers strongly agreed that the group added value to the research study.
Conclusion: Patient advisory groups can create unique and positive experiences for both members and researchers when feedback is meaningfully sought, intentional, and incorporated into the study. There is a need to continue creating and using patient advisory groups with the intention of identifying problems and finding solutions alongside the inflammatory bowel disease community.
{"title":"Patient Advisory Groups in Inflammatory Bowel Disease: A Collaborative Relationship Between Patients and Researchers.","authors":"Linda Yoo, Mara Shapiro, Ihsan Kahveci, Isabela Hernandez, Rachael Whittemore, Tanvi Kale, Samantha Winders, Kendra Kamp","doi":"10.1093/crocol/otaf004","DOIUrl":"10.1093/crocol/otaf004","url":null,"abstract":"<p><strong>Background: </strong>Patient advisory groups are key to guiding research studies through meaningful engagement with the population of interest. Although patient advisory groups are greatly valuable to research studies, they are underutilized in inflammatory bowel disease research. Thus, this study aims to describe the development and implementation of a patient advisory group and evaluate the perspectives of researchers and members.</p><p><strong>Methods: </strong>The Comprehensive Self-Management for inflammatory bowel disease study patient advisory group was created in 2022. The patient advisory group members and researchers completed the Public and Patient Engagement Evaluation Tool via an online survey. Thematic analysis of responses was used to identify common themes, and descriptive statistics were reported.</p><p><strong>Results: </strong>The patient advisory group comprised of patients with inflammatory bowel disease met quarterly. Eight members and three researchers evaluated the patient advisory group. The five emerging themes were (1) lived experience of patient advisory group members; (2) diversity and representation; (3) purposeful engagement; (4) positives of patient advisory group; and (5) improvements to patient advisory group. All members agreed or strongly agreed that the meetings were a good use of their time, and all researchers strongly agreed that the group added value to the research study.</p><p><strong>Conclusion: </strong>Patient advisory groups can create unique and positive experiences for both members and researchers when feedback is meaningfully sought, intentional, and incorporated into the study. There is a need to continue creating and using patient advisory groups with the intention of identifying problems and finding solutions alongside the inflammatory bowel disease community.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otaf004"},"PeriodicalIF":1.8,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11780840/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064136","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-16eCollection Date: 2025-01-01DOI: 10.1093/crocol/otaf003
Katherine Jones, Katherine Baker, Garry A Tew, Jenni Naisby
Background: Crohn's disease (CD) is a lifelong condition that poses unique challenges. This study reports findings from a person's perspective of living with CD to help enhance the understanding of an individual's specific care and support needs.
Methods: Semi-structured telephone interviews were conducted with a convenience sample of adults with Crohn's disease recruited from Newcastle Hospitals NHS Foundation Trust. Data were analyzed after data collection using thematic analysis.
Results: Forty-one (68% female) participants aged 49.1 ± 12 years with a disease duration between 1 and 55 years were interviewed. Three overarching themes emerged, along with 12 subthemes: (1) reactions to presenting symptoms, emotions, and challenges at diagnosis; (2) reality of living with the condition, seeking information, decision making, psychological challenges, experiencing symptoms/complications during remission and the impact on social life, education, employment, and relationships; (3) Resilience involving emotional adaptations, strategies on self-management, social comparisons as a means of coping and barriers to resilience.
Conclusions: The results highlight the complex health journey and challenges faced by people living with Crohn's disease and provide health care professionals with a greater insight into the psychological challenges and emotional complexities of the condition to facilitate a more holistic approach to planning care.
{"title":"Reactions, Reality, and Resilience in Adults with Crohn's Disease: A Qualitative Study.","authors":"Katherine Jones, Katherine Baker, Garry A Tew, Jenni Naisby","doi":"10.1093/crocol/otaf003","DOIUrl":"10.1093/crocol/otaf003","url":null,"abstract":"<p><strong>Background: </strong>Crohn's disease (CD) is a lifelong condition that poses unique challenges. This study reports findings from a person's perspective of living with CD to help enhance the understanding of an individual's specific care and support needs.</p><p><strong>Methods: </strong>Semi-structured telephone interviews were conducted with a convenience sample of adults with Crohn's disease recruited from Newcastle Hospitals NHS Foundation Trust. Data were analyzed after data collection using thematic analysis.</p><p><strong>Results: </strong>Forty-one (68% female) participants aged 49.1 ± 12 years with a disease duration between 1 and 55 years were interviewed. Three overarching themes emerged, along with 12 subthemes: (1) reactions to presenting symptoms, emotions, and challenges at diagnosis; (2) reality of living with the condition, seeking information, decision making, psychological challenges, experiencing symptoms/complications during remission and the impact on social life, education, employment, and relationships; (3) Resilience involving emotional adaptations, strategies on self-management, social comparisons as a means of coping and barriers to resilience.</p><p><strong>Conclusions: </strong>The results highlight the complex health journey and challenges faced by people living with Crohn's disease and provide health care professionals with a greater insight into the psychological challenges and emotional complexities of the condition to facilitate a more holistic approach to planning care.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otaf003"},"PeriodicalIF":1.8,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11799741/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143363806","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-14eCollection Date: 2025-01-01DOI: 10.1093/crocol/otae081
Viviana Parra-Izquierdo, William Otero-Regino, Fabian Juliao-Baños, Juan Sebastián Frías-Ordoñez, Edgar Ibañez-Pinilla, Fabio Leonel Gil-Parada, Hernando Marulanda-Fernández, Lina Otero-Parra, Elder Otero-Ramos, Fabian Eduardo Puentes-Manosalva, Gerardo Andrés Guzmán Rojas, Kenneth Ernest-Suárez, Keyla Villa-Ovalles, Juan Eloy Paredes-Mendez, María Luisa Jara-Alba, David Andrade-Zamora, Manuel Alonso Ardila-Báez, Cristian Flórez-Sarmiento, Guillermo Veitia, Abel Sánchez, Lazaro Antonio Arango-Molano, Fernando Fluxa, Natália Sousa Freitas Queiroz, Mariastella Serrano
Background: The prevalence of colorectal cancer (CRC) in patients with ulcerative colitis (UC) is higher than in the general population, in Latin America there is a progressive increase of UC, and information about CRC screening in inflammatory bowel disease (IBD) is scarce. The aim of this study was to analyze the findings of endoscopic surveillance of CRC in patients with IBD according to available technology.
Methods: Multicenter, cross-sectional, analytical study conducted in Latin American countries, in patients with UC, predominantly with more than 8 years of diagnosis and different degrees of disease activity. Surveillance colonoscopies were performed according to available technology. Risk factors for dysplasia detection were analyzed.
Results: One hundred and forty-four patients, 55.5% women, mean age 47.3 (range 17.1 to 90; SD 15.64) years and mean duration of disease 12.71 (range 0.64 to 57.13; SD 8.08) years. Forty-nine lesions were identified, 18 corresponded to dysplasia. The detection rate of dysplasia per lesion and per procedure was 36.7% and 12.5%, respectively. By logistic regression analysis, the duration of disease (OR 1.12;95%CI:1.047 to 1.215, P = .002) and the presence of post-inflammatory polyps (OR 3.4;95%CI:1.11 to 10.36, P = .031) were risk factors for higher detection of dysplasia. Digital chromoendoscopy was associated with greater detection of dysplasia (OR 4.99, 95%CI: 1.092 to 22.864, P = .038).
Conclusions: In our region, the duration of disease and the presence of post-inflammatory polyps were the factors with the highest association for dysplasia detection, and digital chromoendoscopy with directed biopsies was the technique of choice. The implementation of a specific surveillance program in colonoscopy in IBD is an effective strategy to achieve high detection rates.
背景:溃疡性结肠炎(UC)患者中结直肠癌(CRC)的患病率高于一般人群,在拉丁美洲,UC的发病率呈进行性增加,关于炎症性肠病(IBD)中CRC筛查的信息很少。本研究的目的是根据现有技术分析IBD患者CRC的内镜监测结果。方法:在拉丁美洲国家进行多中心、横断面、分析性研究,研究对象为UC患者,主要是诊断超过8年且不同程度的疾病活动。根据现有技术进行监测结肠镜检查。分析异常增生检测的危险因素。结果:144例患者,女性55.5%,平均年龄47.3岁(范围17.1 ~ 90岁;SD 15.64)年,平均病程12.71(范围0.64 ~ 57.13;SD 8.08)年。发现49个病变,18个对应于发育不良。每个病变和每个手术的异常增生检出率分别为36.7%和12.5%。通过logistic回归分析,病程(OR 1.12;95%CI:1.047 ~ 1.215, P = 0.002)和炎症后息肉的存在(OR 3.4;95%CI:1.11 ~ 10.36, P = 0.031)是异常增生检出率较高的危险因素。数字彩色内镜检查与更高的异常增生检出率相关(OR 4.99, 95%CI: 1.092 ~ 22.864, P = 0.038)。结论:在我们的地区,疾病的持续时间和炎症后息肉的存在是异常增生检测的最高相关性因素,数字彩色内镜与定向活检是首选技术。在IBD结肠镜检查中实施特定的监测计划是实现高检出率的有效策略。
{"title":"Dysplasia and Colorectal Cancer Surveillance in Ulcerative Colitis Patients in Latin America: Real-World Data.","authors":"Viviana Parra-Izquierdo, William Otero-Regino, Fabian Juliao-Baños, Juan Sebastián Frías-Ordoñez, Edgar Ibañez-Pinilla, Fabio Leonel Gil-Parada, Hernando Marulanda-Fernández, Lina Otero-Parra, Elder Otero-Ramos, Fabian Eduardo Puentes-Manosalva, Gerardo Andrés Guzmán Rojas, Kenneth Ernest-Suárez, Keyla Villa-Ovalles, Juan Eloy Paredes-Mendez, María Luisa Jara-Alba, David Andrade-Zamora, Manuel Alonso Ardila-Báez, Cristian Flórez-Sarmiento, Guillermo Veitia, Abel Sánchez, Lazaro Antonio Arango-Molano, Fernando Fluxa, Natália Sousa Freitas Queiroz, Mariastella Serrano","doi":"10.1093/crocol/otae081","DOIUrl":"https://doi.org/10.1093/crocol/otae081","url":null,"abstract":"<p><strong>Background: </strong>The prevalence of colorectal cancer (CRC) in patients with ulcerative colitis (UC) is higher than in the general population, in Latin America there is a progressive increase of UC, and information about CRC screening in inflammatory bowel disease (IBD) is scarce. The aim of this study was to analyze the findings of endoscopic surveillance of CRC in patients with IBD according to available technology.</p><p><strong>Methods: </strong>Multicenter, cross-sectional, analytical study conducted in Latin American countries, in patients with UC, predominantly with more than 8 years of diagnosis and different degrees of disease activity. Surveillance colonoscopies were performed according to available technology. Risk factors for dysplasia detection were analyzed.</p><p><strong>Results: </strong>One hundred and forty-four patients, 55.5% women, mean age 47.3 (range 17.1 to 90; SD 15.64) years and mean duration of disease 12.71 (range 0.64 to 57.13; SD 8.08) years. Forty-nine lesions were identified, 18 corresponded to dysplasia. The detection rate of dysplasia per lesion and per procedure was 36.7% and 12.5%, respectively. By logistic regression analysis, the duration of disease (OR 1.12;95%CI:1.047 to 1.215, <i>P</i> = .002) and the presence of post-inflammatory polyps (OR 3.4;95%CI:1.11 to 10.36, <i>P</i> = .031) were risk factors for higher detection of dysplasia. Digital chromoendoscopy was associated with greater detection of dysplasia (OR 4.99, 95%CI: 1.092 to 22.864, <i>P</i> = .038).</p><p><strong>Conclusions: </strong>In our region, the duration of disease and the presence of post-inflammatory polyps were the factors with the highest association for dysplasia detection, and digital chromoendoscopy with directed biopsies was the technique of choice. The implementation of a specific surveillance program in colonoscopy in IBD is an effective strategy to achieve high detection rates.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otae081"},"PeriodicalIF":1.8,"publicationDate":"2025-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11744193/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001636","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-09eCollection Date: 2025-01-01DOI: 10.1093/crocol/otae082
João Augusto Dos Reis Guerra, Daniela Oliveira Magro, Claudio Saddy Rodrigues Coy, Douglas A Valverde, Emilia Sousa de Oliveira, Abel Botelho Quaresma, Paulo Gustavo Kotze
Introduction: Biological therapy has transformed the natural course of inflammatory bowel disease, but there are still controversies regarding its potential to reduce surgical rates for Crohn's disease (CD). This study, conducted with the support of the Brazilian National Healthcare System, aimed to analyze temporal trends in surgery and hospitalization rates among patients with CD and to correlate these data with the dispensing of azathioprine (AZA), infliximab (IFX), and adalimumab (ADA).
Methodology: This retrospective observational study used data from the National Public Healthcare Department of Informatics through the TT Disease Explorer® platform from 2012 to 2022. Demographic data, medications used, and the prevalence of surgical procedures and hospitalizations associated with the International Classification of Diseases codes for CD were analyzed. Annual average percent changes (AAPCs) were calculated to assess temporal trends.
Results: Between 2012 and 2022, there was a significant increase of 288.07% in the diagnoses of CD, rising from 27 551 to 106 917 cases. Concurrently, there was an increase in the absolute number of patients treated with AZA, IFX, and ADA, with increasing rates of 65.79%, 251.09%, and 242.48%, respectively. However, the proportion of patients receiving AZA per CD patients decreased by 57.28%, from 44.79% to 19.13% (AAPC = -7.94%, 95% CI, -8.05 to -7.83; P < .001). The use of IFX remained relatively stable, with a slight change from 13.82% to 12.50% (AAPC = 0.01%, 95% CI, -0.20 to 0.22; P = .935), while the use of ADA decreased by 11.75%, from 11.65% to 10.28% (AAPC = -1.74%, 95% CI, -2.48 to -1.82; P < .001). The absolute number of hospitalizations related to CD increased by 57.71%. Despite the rise in the number of cases and the greater availability of biological treatments, the proportion of hospitalized patients decreased by 59.29%, from 6.19% to 2.52% (AAPC = -7.04%, 95% CI, -7.42 to -6.66; P < .001). Similarly, the proportion of surgical procedures relative to the total number of cases decreased by 55.08%, from 1.09% to 0.49% (AAPC = -5.73%, 95% CI, -6.68 to -4.77; P < .001).
Conclusions: Despite the cumulative increase in the prevalence of CD cases in the country and the absolute increase in the dispensing of biologics, the proportion of hospitalizations and surgical procedures among CD patients treated in the public health system in Brazil decreased.
{"title":"Temporal Trends in Surgery and Hospitalization Rates for Crohn's Disease in Brazil: A Population-Based Study.","authors":"João Augusto Dos Reis Guerra, Daniela Oliveira Magro, Claudio Saddy Rodrigues Coy, Douglas A Valverde, Emilia Sousa de Oliveira, Abel Botelho Quaresma, Paulo Gustavo Kotze","doi":"10.1093/crocol/otae082","DOIUrl":"https://doi.org/10.1093/crocol/otae082","url":null,"abstract":"<p><strong>Introduction: </strong>Biological therapy has transformed the natural course of inflammatory bowel disease, but there are still controversies regarding its potential to reduce surgical rates for Crohn's disease (CD). This study, conducted with the support of the Brazilian National Healthcare System, aimed to analyze temporal trends in surgery and hospitalization rates among patients with CD and to correlate these data with the dispensing of azathioprine (AZA), infliximab (IFX), and adalimumab (ADA).</p><p><strong>Methodology: </strong>This retrospective observational study used data from the National Public Healthcare Department of Informatics through the TT Disease Explorer<sup>®</sup> platform from 2012 to 2022. Demographic data, medications used, and the prevalence of surgical procedures and hospitalizations associated with the International Classification of Diseases codes for CD were analyzed. Annual average percent changes (AAPCs) were calculated to assess temporal trends.</p><p><strong>Results: </strong>Between 2012 and 2022, there was a significant increase of 288.07% in the diagnoses of CD, rising from 27 551 to 106 917 cases. Concurrently, there was an increase in the absolute number of patients treated with AZA, IFX, and ADA, with increasing rates of 65.79%, 251.09%, and 242.48%, respectively. However, the proportion of patients receiving AZA per CD patients decreased by 57.28%, from 44.79% to 19.13% (AAPC = -7.94%, 95% CI, -8.05 to -7.83; <i>P</i> < .001). The use of IFX remained relatively stable, with a slight change from 13.82% to 12.50% (AAPC = 0.01%, 95% CI, -0.20 to 0.22; <i>P</i> = .935), while the use of ADA decreased by 11.75%, from 11.65% to 10.28% (AAPC = -1.74%, 95% CI, -2.48 to -1.82; <i>P</i> < .001). The absolute number of hospitalizations related to CD increased by 57.71%. Despite the rise in the number of cases and the greater availability of biological treatments, the proportion of hospitalized patients decreased by 59.29%, from 6.19% to 2.52% (AAPC = -7.04%, 95% CI, -7.42 to -6.66; <i>P</i> < .001). Similarly, the proportion of surgical procedures relative to the total number of cases decreased by 55.08%, from 1.09% to 0.49% (AAPC = -5.73%, 95% CI, -6.68 to -4.77; <i>P</i> < .001).</p><p><strong>Conclusions: </strong>Despite the cumulative increase in the prevalence of CD cases in the country and the absolute increase in the dispensing of biologics, the proportion of hospitalizations and surgical procedures among CD patients treated in the public health system in Brazil decreased.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otae082"},"PeriodicalIF":1.8,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11979744/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143978342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-08eCollection Date: 2025-04-01DOI: 10.1093/crocol/otaf002
Bincy Abraham, Jianmin Wu, Séverine Vermeire, Gil Melmed, Ryan Ungaro, Aline Charabaty, Richard Moses, Faye Chan-Diehl, Jerome Paulissen, Baojin Zhu, Edward L Barnes, Adam C Ehrlich, David T Rubin
Background: The modified Mayo score (mMS) is a measure for ulcerative colitis (UC) disease activity. Recent US Food and Drug Administration guidance for moderately to severely active UC trials suggests that patients should have baseline mMS of 5-9 including an endoscopy score of at least 2, as opposed to the previous range of 4-9. This disclosure reports results from patients with UC with baseline mMS of 5-9 who received mirikizumab, a monoclonal antibody directed against the interleukin-23 p19 subunit, or placebo in the phase 3 LUCENT trials.
Methods: Mirikizumab was evaluated in the randomized, double-blind, placebo-controlled LUCENT-1 (NCT03518086) and LUCENT-2 (NCT03524092) trials, and the ongoing long-term LUCENT-3 (NCT03519945) trial, which use mMS 4-9. Analyses for patients with baseline mMS of 5-9 (excluding patients with mMS of 4) were conducted according to LUCENT trial statistical analysis plans. Categorical efficacy endpoints were summarized using proportions and confidence intervals. Continuous efficacy endpoints are presented as least-squares mean (standard error) changes from baseline.
Results: Mirikizumab demonstrated efficacy for the primary endpoint of clinical remission and major secondary endpoints including clinical response, endoscopic improvement, histologic-endoscopic mucosal improvement/remission, bowel urgency remission, and corticosteroid-free remission. Importantly, mirikizumab exhibited greater improvements versus placebo in the Inflammatory Bowel Disease Questionnaire, fatigue, symptomatic remission, and work productivity. Finally, mirikizumab demonstrated long-term (104-week) sustained, durable efficacy across all studied endpoints. No new safety signals were identified during the 2-year follow-up.
Conclusions: Mirikizumab delivered significant clinical benefit for patients with baseline mMS of 5-9 and demonstrated a favorable safety profile.
{"title":"Efficacy and Safety of Mirikizumab in the Treatment of Moderately to Severely Active Ulcerative Colitis Regardless of Baseline Modified Mayo Score: Results From the Phase 3 LUCENT Trials.","authors":"Bincy Abraham, Jianmin Wu, Séverine Vermeire, Gil Melmed, Ryan Ungaro, Aline Charabaty, Richard Moses, Faye Chan-Diehl, Jerome Paulissen, Baojin Zhu, Edward L Barnes, Adam C Ehrlich, David T Rubin","doi":"10.1093/crocol/otaf002","DOIUrl":"https://doi.org/10.1093/crocol/otaf002","url":null,"abstract":"<p><strong>Background: </strong>The modified Mayo score (mMS) is a measure for ulcerative colitis (UC) disease activity. Recent US Food and Drug Administration guidance for moderately to severely active UC trials suggests that patients should have baseline mMS of 5-9 including an endoscopy score of at least 2, as opposed to the previous range of 4-9. This disclosure reports results from patients with UC with baseline mMS of 5-9 who received mirikizumab, a monoclonal antibody directed against the interleukin-23 p19 subunit, or placebo in the phase 3 LUCENT trials.</p><p><strong>Methods: </strong>Mirikizumab was evaluated in the randomized, double-blind, placebo-controlled LUCENT-1 (NCT03518086) and LUCENT-2 (NCT03524092) trials, and the ongoing long-term LUCENT-3 (NCT03519945) trial, which use mMS 4-9. Analyses for patients with baseline mMS of 5-9 (excluding patients with mMS of 4) were conducted according to LUCENT trial statistical analysis plans. Categorical efficacy endpoints were summarized using proportions and confidence intervals. Continuous efficacy endpoints are presented as least-squares mean (standard error) changes from baseline.</p><p><strong>Results: </strong>Mirikizumab demonstrated efficacy for the primary endpoint of clinical remission and major secondary endpoints including clinical response, endoscopic improvement, histologic-endoscopic mucosal improvement/remission, bowel urgency remission, and corticosteroid-free remission. Importantly, mirikizumab exhibited greater improvements versus placebo in the Inflammatory Bowel Disease Questionnaire, fatigue, symptomatic remission, and work productivity. Finally, mirikizumab demonstrated long-term (104-week) sustained, durable efficacy across all studied endpoints. No new safety signals were identified during the 2-year follow-up.</p><p><strong>Conclusions: </strong>Mirikizumab delivered significant clinical benefit for patients with baseline mMS of 5-9 and demonstrated a favorable safety profile.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 2","pages":"otaf002"},"PeriodicalIF":1.8,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12010086/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143965094","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-08eCollection Date: 2025-01-01DOI: 10.1093/crocol/otae064
Mariely Garcia, Anketse Debebe, Farhan Mahmood, Sharon Nirenberg, Alexa Rendon, Eunyoung Yang, Jiani Xiang, Jean-Frédéric Colombel, Tamara Kahan, Ghoncheh Ghiasian, Adam S Faye, Irving Levine, Michael Farber, Michael Ramada, Tisor Omoakhe, Keith Sultan, David B Sachar
Background: Intravenous (IV) steroids are commonly used to treat acute flares of Crohn's disease (CD). However, it is unclear if they are beneficial in the setting of uncomplicated small bowel obstruction (SBO). We sought to examine if IV steroid administration improved short-term outcomes in patients with CD hospitalized for acute, uncomplicated SBO across three New York City hospital systems.
Methods: This retrospective study included patients ≥ 18 years old admitted between January 1, 2011, and December 31, 2019, with Crohn's disease and an admission diagnosis of uncomplicated acute SBO, defined as cases without adhesions, fistula, phlegmon, and sepsis. Primary endpoints (length of stay and frequency of surgery) were compared between patients who received IV steroids upon admission and those who did not.
Results: Our analysis included 674 unique patients. Ninety-two (14%) received IV steroids, and 582 (86%) did not. IV steroid use did not result in shorter hospital stays (median days [IQR]: 3.0 (2.0-5.5) days vs 3.0 (2.0-6.0) days in the no-steroid group, P = .65) or reduce the need for surgery (4 patients (4.4%) vs 28 patients (4.8%) in the no-steroid group, P = .85). Sex, age, disease duration, concomitant biologic therapy, and NG tube placement did not independently contribute to either outcome.
Conclusions: These findings suggest that IV steroid administration for uncomplicated SBO in CD patients does not decrease hospital length of stay or need for surgery. Further research may help identify specific obstruction patterns or other therapies associated with different outcomes.
{"title":"Intravenous Steroids Do Not Improve Short-Term Outcomes of Patients With Crohn's Disease Presenting With an Acute Small Bowel Obstruction.","authors":"Mariely Garcia, Anketse Debebe, Farhan Mahmood, Sharon Nirenberg, Alexa Rendon, Eunyoung Yang, Jiani Xiang, Jean-Frédéric Colombel, Tamara Kahan, Ghoncheh Ghiasian, Adam S Faye, Irving Levine, Michael Farber, Michael Ramada, Tisor Omoakhe, Keith Sultan, David B Sachar","doi":"10.1093/crocol/otae064","DOIUrl":"10.1093/crocol/otae064","url":null,"abstract":"<p><strong>Background: </strong>Intravenous (IV) steroids are commonly used to treat acute flares of Crohn's disease (CD). However, it is unclear if they are beneficial in the setting of uncomplicated small bowel obstruction (SBO). We sought to examine if IV steroid administration improved short-term outcomes in patients with CD hospitalized for acute, uncomplicated SBO across three New York City hospital systems.</p><p><strong>Methods: </strong>This retrospective study included patients ≥ 18 years old admitted between January 1, 2011, and December 31, 2019, with Crohn's disease and an admission diagnosis of uncomplicated acute SBO, defined as cases without adhesions, fistula, phlegmon, and sepsis. Primary endpoints (length of stay and frequency of surgery) were compared between patients who received IV steroids upon admission and those who did not.</p><p><strong>Results: </strong>Our analysis included 674 unique patients. Ninety-two (14%) received IV steroids, and 582 (86%) did not. IV steroid use did not result in shorter hospital stays (median days [IQR]: 3.0 (2.0-5.5) days vs 3.0 (2.0-6.0) days in the no-steroid group, <i>P</i> = .65) or reduce the need for surgery (4 patients (4.4%) vs 28 patients (4.8%) in the no-steroid group, <i>P</i> = .85). Sex, age, disease duration, concomitant biologic therapy, and NG tube placement did not independently contribute to either outcome.</p><p><strong>Conclusions: </strong>These findings suggest that IV steroid administration for uncomplicated SBO in CD patients does not decrease hospital length of stay or need for surgery. Further research may help identify specific obstruction patterns or other therapies associated with different outcomes.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otae064"},"PeriodicalIF":1.8,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11744190/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-04eCollection Date: 2025-01-01DOI: 10.1093/crocol/otae076
Jeanne Jiang, Bridgett Goodwin, Amod Athavale, Susan E Cazzetta, Lily Chen, Josiah Edelblut, Tao Fan, Nandini Hadker, Pradeep P Nazarey
Background: Crohn's perianal fistulas (CPF) are difficult to manage and often require multiple interventions. This study aimed to assess the preferences of patients and healthcare professionals (HCPs) for attributes of CPF-related procedures/surgeries to better inform CPF management.
Methods: This US cross-sectional, observational study was conducted via a web-enabled questionnaire (October 2021-January 2022) among patients aged 21-89 years with a self-reported physician diagnosis of CPF (with or without CPF-related surgery experience) and HCPs (gastroenterologists and colorectal surgeons who managed ≥3 patients with CPF in the past 12 months). Patient and HCP preferences for CPF-related procedure/surgery attributes were assessed using a discrete choice experiment and stated preference methodology.
Results: In total, 100 patients and 137 HCPs were recruited. Benefits of therapy (symptom control and/or fistula closure) were rated as the most important CPF treatment attribute by both patients and HCPs influencing treatment decisions (mean relative importance 23.9 and 36.3, respectively). The mean relative importance of procedure invasiveness and postoperative discomfort was higher for patients (19.3 and 20.2, respectively) than for HCPs (14.3 and 11.0, respectively), whereas the mean relative importance of fecal incontinence was greater for HCPs than patients (25.0 vs. 19.3, respectively).
Conclusions: Patients and HCPs have different perspectives on the importance of specific CPF-related procedure/surgery attributes. The attributes identified as important to patients and HCPs in this study should be considered when managing patients with CPF and making treatment decisions.
{"title":"Patient and Healthcare Professional Perspectives on Crohn's Perianal Fistula Treatment: Results From a Discrete Choice Experiment.","authors":"Jeanne Jiang, Bridgett Goodwin, Amod Athavale, Susan E Cazzetta, Lily Chen, Josiah Edelblut, Tao Fan, Nandini Hadker, Pradeep P Nazarey","doi":"10.1093/crocol/otae076","DOIUrl":"10.1093/crocol/otae076","url":null,"abstract":"<p><strong>Background: </strong>Crohn's perianal fistulas (CPF) are difficult to manage and often require multiple interventions. This study aimed to assess the preferences of patients and healthcare professionals (HCPs) for attributes of CPF-related procedures/surgeries to better inform CPF management.</p><p><strong>Methods: </strong>This US cross-sectional, observational study was conducted via a web-enabled questionnaire (October 2021-January 2022) among patients aged 21-89 years with a self-reported physician diagnosis of CPF (with or without CPF-related surgery experience) and HCPs (gastroenterologists and colorectal surgeons who managed ≥3 patients with CPF in the past 12 months). Patient and HCP preferences for CPF-related procedure/surgery attributes were assessed using a discrete choice experiment and stated preference methodology.</p><p><strong>Results: </strong>In total, 100 patients and 137 HCPs were recruited. Benefits of therapy (symptom control and/or fistula closure) were rated as the most important CPF treatment attribute by both patients and HCPs influencing treatment decisions (mean relative importance 23.9 and 36.3, respectively). The mean relative importance of procedure invasiveness and postoperative discomfort was higher for patients (19.3 and 20.2, respectively) than for HCPs (14.3 and 11.0, respectively), whereas the mean relative importance of fecal incontinence was greater for HCPs than patients (25.0 vs. 19.3, respectively).</p><p><strong>Conclusions: </strong>Patients and HCPs have different perspectives on the importance of specific CPF-related procedure/surgery attributes. The attributes identified as important to patients and HCPs in this study should be considered when managing patients with CPF and making treatment decisions.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otae076"},"PeriodicalIF":1.8,"publicationDate":"2025-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11711682/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946108","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background and aims: Vedolizumab is s gut-selective advanced therapy that is safe and efficacious for the treatment of ulcerative colitis (UC). Once patients achieve successful induction, there is a risk of loss of response leading to eventual flare. We aimed to identify these predictive factors and develop a practical scoring system to determine the ongoing efficacy of vedolizumab.
Methods: We performed logistic regression on prospectively recruited UC subjects from the Vedolizumab Immunomodulator Enforced Withdrawal Study (VIEWS). All patients were in corticosteroid-free clinical remission and endoscopic improvement at baseline and continued vedolizumab. Predictive factors of 2-year corticosteroid-free clinical remission were determined and modeled into the VIEWS score, then validated in a real-world UC cohort.
Results: Of 62 patients in the derivation cohort, 48 (77.4%) maintained clinical remission over two years. The predictive factors of remission were female (odds ratio [OR] 6.0, 95% confidence interval [CI], 1.2-29.7), antitumor necrosis factor naive (OR 3.8, 95% CI,1.0-14.0), baseline histological remission (OR 10.8, 95% CI, 2.4-48.4), thiopurine combination (OR 3.6, 95% CI, 0.7-18.0), and fecal calprotectin level ≤250 µg/g (OR 6.3, 95% CI, 0.9-42.2). These factors were incorporated into VIEWS score, yielding an area under the receiver-operating characteristic (AUROC) curve of 0.89 (95% CI, 0.81-0.98) in the prediction of 2-year clinical remission. Of 64 UC patients in the validation cohort, 40 (62.5%) remained in clinical remission at 2 years with AUROC of 0.77 (95% CI, 0.60-0.94). At the cut-off threshold of 4, the VIEWS score identified 2-year clinical remission with a sensitivity of 88.4% and specificity of 63.6%.
Conclusions: Our study determined predictive factors and proposed a scoring system of ongoing clinical remission in UC patients on maintenance vedolizumab. In patients at high risk of relapse, combination therapy with thiopurine may be beneficial.
{"title":"Development and Validation of a Scoring System to Predict 2-Year Clinical Remission in Ulcerative Colitis Patients on Vedolizumab.","authors":"Thanaboon Chaemsupaphan, Aviv Pudipeddi, Huiyu Lin, Sudarshan Paramsothy, Viraj Kariyawasam, Melissa Kermeen, Rupert W Leong","doi":"10.1093/crocol/otae068","DOIUrl":"https://doi.org/10.1093/crocol/otae068","url":null,"abstract":"<p><strong>Background and aims: </strong>Vedolizumab is s gut-selective advanced therapy that is safe and efficacious for the treatment of ulcerative colitis (UC). Once patients achieve successful induction, there is a risk of loss of response leading to eventual flare. We aimed to identify these predictive factors and develop a practical scoring system to determine the ongoing efficacy of vedolizumab.</p><p><strong>Methods: </strong>We performed logistic regression on prospectively recruited UC subjects from the Vedolizumab Immunomodulator Enforced Withdrawal Study (VIEWS). All patients were in corticosteroid-free clinical remission and endoscopic improvement at baseline and continued vedolizumab. Predictive factors of 2-year corticosteroid-free clinical remission were determined and modeled into the VIEWS score, then validated in a real-world UC cohort.</p><p><strong>Results: </strong>Of 62 patients in the derivation cohort, 48 (77.4%) maintained clinical remission over two years. The predictive factors of remission were female (odds ratio [OR] 6.0, 95% confidence interval [CI], 1.2-29.7), antitumor necrosis factor naive (OR 3.8, 95% CI,1.0-14.0), baseline histological remission (OR 10.8, 95% CI, 2.4-48.4), thiopurine combination (OR 3.6, 95% CI, 0.7-18.0), and fecal calprotectin level ≤250 µg/g (OR 6.3, 95% CI, 0.9-42.2). These factors were incorporated into VIEWS score, yielding an area under the receiver-operating characteristic (AUROC) curve of 0.89 (95% CI, 0.81-0.98) in the prediction of 2-year clinical remission. Of 64 UC patients in the validation cohort, 40 (62.5%) remained in clinical remission at 2 years with AUROC of 0.77 (95% CI, 0.60-0.94). At the cut-off threshold of 4, the VIEWS score identified 2-year clinical remission with a sensitivity of 88.4% and specificity of 63.6%.</p><p><strong>Conclusions: </strong>Our study determined predictive factors and proposed a scoring system of ongoing clinical remission in UC patients on maintenance vedolizumab. In patients at high risk of relapse, combination therapy with thiopurine may be beneficial.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otae068"},"PeriodicalIF":1.8,"publicationDate":"2024-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11700619/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-23eCollection Date: 2025-01-01DOI: 10.1093/crocol/otae069
Brittaney Bonhomme, Neilanjan Nandi, Shivali Berera, Helen Lee, Galen Leung, Chung Sang Tse, Alexandra Weiss, Lisa Nessel, Yue Ren, Hongzhe Li, Faten N Aberra, James D Lewis
Background: While patients with Crohn's disease commonly report fatigue, an association of Crohn's disease with mild neurocognitive impairment has also been suggested. This study investigated the relationship between Crohn's disease activity, fatigue, and neurocognitive functioning.
Methods: In this cross-sectional study, adults with Crohn's disease (n = 25) and healthy controls (n = 26) completed the PROMIS Fatigue 7a form and Multidimensional Fatigue Inventory and neurocognitive testing across 6 domains. Symptomatic and endoscopic remission were assessed with a short Crohn's Disease Activity Index and Simple Endoscopic Score for Crohn's Disease. Linear regression adjusting for age and sex was used to compare fatigue and neurocognition among patients with Crohn's disease versus controls and those with active Crohn's disease versus those in remission.
Results: Compared to controls, adults with Crohn's disease reported greater overall and domain-specific fatigue (general, physical, and mental) (P < .05 for all comparisons). Patients in symptomatic remission had significantly less fatigue (P < .05). No differences were found in neurocognitive accuracy or speed between Crohn's disease and controls. Disease activity was not associated with accuracy on neurocognitive testing; however, patients with symptomatic Crohn's disease had longer correct response times for social cognition and episodic memory compared to asymptomatic patients (P < .05). Endoscopic disease activity was associated with longer correct response times for tasks linked to social cognition, episodic memory, and complex cognition (P < .05). These differences persisted after adjusting for fatigue.
Conclusions: Patients with symptomatic Crohn's disease experience greater fatigue and have slower response times on neurocognitive testing. However, fatigue does not appear to mediate the slower response times.
背景:虽然克罗恩病患者通常报告疲劳,但克罗恩病与轻度神经认知障碍也有关联。本研究调查了克罗恩病活动性、疲劳和神经认知功能之间的关系。方法:在这项横断面研究中,克罗恩病成人(n = 25)和健康对照(n = 26)完成了PROMIS疲劳7a表格、多维疲劳量表和6个领域的神经认知测试。用短克罗恩病活动指数和简单克罗恩病内窥镜评分评估症状缓解和内窥镜缓解。采用调整年龄和性别的线性回归来比较克罗恩病患者与对照组、活动期克罗恩病患者与缓解期克罗恩病患者的疲劳和神经认知。结果:与对照组相比,患有克罗恩病的成人报告了更大的整体和特定领域的疲劳(一般,身体和精神)(P P P P P)结论:有症状的克罗恩病患者经历更大的疲劳,在神经认知测试中反应时间更慢。然而,疲劳似乎并不能调节较慢的反应时间。
{"title":"Greater Fatigue and Reduced Neurocognitive Speed With Symptomatic Crohn's Disease.","authors":"Brittaney Bonhomme, Neilanjan Nandi, Shivali Berera, Helen Lee, Galen Leung, Chung Sang Tse, Alexandra Weiss, Lisa Nessel, Yue Ren, Hongzhe Li, Faten N Aberra, James D Lewis","doi":"10.1093/crocol/otae069","DOIUrl":"10.1093/crocol/otae069","url":null,"abstract":"<p><strong>Background: </strong>While patients with Crohn's disease commonly report fatigue, an association of Crohn's disease with mild neurocognitive impairment has also been suggested. This study investigated the relationship between Crohn's disease activity, fatigue, and neurocognitive functioning.</p><p><strong>Methods: </strong>In this cross-sectional study, adults with Crohn's disease (<i>n</i> = 25) and healthy controls (<i>n</i> = 26) completed the PROMIS Fatigue 7a form and Multidimensional Fatigue Inventory and neurocognitive testing across 6 domains. Symptomatic and endoscopic remission were assessed with a short Crohn's Disease Activity Index and Simple Endoscopic Score for Crohn's Disease. Linear regression adjusting for age and sex was used to compare fatigue and neurocognition among patients with Crohn's disease versus controls and those with active Crohn's disease versus those in remission.</p><p><strong>Results: </strong>Compared to controls, adults with Crohn's disease reported greater overall and domain-specific fatigue (general, physical, and mental) (<i>P</i> < .05 for all comparisons). Patients in symptomatic remission had significantly less fatigue (<i>P</i> < .05). No differences were found in neurocognitive accuracy or speed between Crohn's disease and controls. Disease activity was not associated with accuracy on neurocognitive testing; however, patients with symptomatic Crohn's disease had longer correct response times for social cognition and episodic memory compared to asymptomatic patients (<i>P</i> < .05). Endoscopic disease activity was associated with longer correct response times for tasks linked to social cognition, episodic memory, and complex cognition (<i>P</i> < .05). These differences persisted after adjusting for fatigue.</p><p><strong>Conclusions: </strong>Patients with symptomatic Crohn's disease experience greater fatigue and have slower response times on neurocognitive testing. However, fatigue does not appear to mediate the slower response times.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otae069"},"PeriodicalIF":1.8,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11684080/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142913860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}