Pub Date : 2023-09-21eCollection Date: 2023-10-01DOI: 10.1093/crocol/otad050
Joëlle St-Pierre, Maxime Delisle, Hengameh Kheirkhahrahimabadi, Thomas M Goodsall, Robert V Bryant, Britt Christensen, Rose Vaughan, Aysha Al-Ani, Richard J M Ingram, Joan Heatherington, Dan Carter, Cathy Lu, Christopher Ma, Kerri L Novak
Background: Patients with inflammatory bowel disease (IBD) require accessible, timely, and noninvasive strategies to monitor disease. The aim was to assess the integration of intestinal ultrasound (IUS) on decision-making and endoscopy utilization in a standardized care pathway.
Methods: This prospective, multicenter, international, observational cohort study included patients seen within a centralized model for IBD care was conducted during the COVID pandemic. Patients were evaluated with IUS alone or in combination with an in-clinic, unsedated sigmoidoscopy. Demographic, clinical, laboratory, and imaging data, clinical decisions, and need for urgent endoscopy, hospitalization, and surgeries were recorded.
Results: Of the 158 patients included, the majority had an established diagnosis of Crohn's disease (n = 123, 78%), and 47% (n = 75) of patients were on biologic therapy. IUS identified active inflammation in 65% (n = 102) of patients, and strictures in 14% (n = 22). Fecal calprotectin levels correlated with inflammation detected on IUS (median of 50 μg/g [Q1-Q3: 26-107 μg/g] without inflammation and 270 μg/g [Q1-Q3: 61-556 μg/g] with inflammation; p = 0.0271). In the majority of patients, clinical assessment with IUS led to an acute change in IBD-specific medications (57%, n = 90) and avoided or delayed the need for urgent endoscopy (85%, n = 134). Four patients were referred for urgent surgical consultation.
Conclusions: Point-of-care IUS used in a flare clinic pathway is a useful strategy to improve effective IBD care delivery and to assist in therapeutic management decisions, in many cases avoiding the acute need for endoscopy.
{"title":"Bedside Intestinal Ultrasound Performed in an Inflammatory Bowel Disease Urgent Assessment Clinic Improves Clinical Decision-Making and Resource Utilization.","authors":"Joëlle St-Pierre, Maxime Delisle, Hengameh Kheirkhahrahimabadi, Thomas M Goodsall, Robert V Bryant, Britt Christensen, Rose Vaughan, Aysha Al-Ani, Richard J M Ingram, Joan Heatherington, Dan Carter, Cathy Lu, Christopher Ma, Kerri L Novak","doi":"10.1093/crocol/otad050","DOIUrl":"10.1093/crocol/otad050","url":null,"abstract":"<p><strong>Background: </strong>Patients with inflammatory bowel disease (IBD) require accessible, timely, and noninvasive strategies to monitor disease. The aim was to assess the integration of intestinal ultrasound (IUS) on decision-making and endoscopy utilization in a standardized care pathway.</p><p><strong>Methods: </strong>This prospective, multicenter, international, observational cohort study included patients seen within a centralized model for IBD care was conducted during the COVID pandemic. Patients were evaluated with IUS alone or in combination with an in-clinic, unsedated sigmoidoscopy. Demographic, clinical, laboratory, and imaging data, clinical decisions, and need for urgent endoscopy, hospitalization, and surgeries were recorded.</p><p><strong>Results: </strong>Of the 158 patients included, the majority had an established diagnosis of Crohn's disease (<i>n</i> = 123, 78%), and 47% (<i>n</i> = 75) of patients were on biologic therapy. IUS identified active inflammation in 65% (<i>n</i> = 102) of patients, and strictures in 14% (<i>n</i> = 22). Fecal calprotectin levels correlated with inflammation detected on IUS (median of 50 μg/g [Q1-Q3: 26-107 μg/g] without inflammation and 270 μg/g [Q1-Q3: 61-556 μg/g] with inflammation; <i>p</i> = 0.0271). In the majority of patients, clinical assessment with IUS led to an acute change in IBD-specific medications (57%, <i>n</i> = 90) and avoided or delayed the need for urgent endoscopy (85%, <i>n</i> = 134). Four patients were referred for urgent surgical consultation.</p><p><strong>Conclusions: </strong>Point-of-care IUS used in a flare clinic pathway is a useful strategy to improve effective IBD care delivery and to assist in therapeutic management decisions, in many cases avoiding the acute need for endoscopy.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10558199/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41115874","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 : 2023-09-18eCollection Date: 2023-07-01DOI: 10.1093/crocol/otad049
[This corrects the article DOI: 10.1093/crocol/otad038.].
[这更正了文章DOI:10.1093/cocrocol/otad038.]。
{"title":"Correction to: Watchful Waiting After Radiological Guided Drainage of Intra-abdominal Abscess in Patients With Crohn's Disease Might Be Associated With Increased Rates of Stoma Construction.","authors":"","doi":"10.1093/crocol/otad049","DOIUrl":"https://doi.org/10.1093/crocol/otad049","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1093/crocol/otad038.].</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/66/1f/otad049.PMC10506167.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41113195","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 : 2023-09-18eCollection Date: 2023-10-01DOI: 10.1093/crocol/otad051
Tia Goss Sawhney, Angela Dobes, Sirimon O'Charoen
Background: Although it is a truism that drugs benefit patients only when taken, surprisingly little is known about real-world drug-use persistence and discontinuation, even for expensive biologic drugs.
Methods: We used longitudinal self-reported drug-use data from the inflammatory bowel disease (IBD) Partners registry of people with IBD to construct Kaplan-Meier drug-use persistency graphs for biologic drug-use spans that started between 2017 and 2022.
Results: We examined 2034 drug-use spans for 1594 survey participants. Most of the biologic drugs had a 75%+ persistency rate around the one-year mark and 60%+ persistency at the 3-year mark. The overall persistency and the differences in persistency between drugs were aligned with published literature.
Conclusions: This analysis demonstrates the feasibility of collecting IBD-specific patient-reported drug persistency data via a voluntary patient registry. Patient-reported persistency provides real-world drug persistency data and the patient's perspectives as to why they discontinued use of the drug-a combination of data and perspective that is not available from any other real-world medical record, claim, and pharmacy data source that are valuable to physician, patients, payers, healthcare policymakers, and health technology assessment organizations.
{"title":"Real-World Persistency for Inflammatory Bowel Disease Biologics Using Patient Registry Data.","authors":"Tia Goss Sawhney, Angela Dobes, Sirimon O'Charoen","doi":"10.1093/crocol/otad051","DOIUrl":"10.1093/crocol/otad051","url":null,"abstract":"<p><strong>Background: </strong>Although it is a truism that drugs benefit patients only when taken, surprisingly little is known about real-world drug-use persistence and discontinuation, even for expensive biologic drugs.</p><p><strong>Methods: </strong>We used longitudinal self-reported drug-use data from the inflammatory bowel disease (IBD) Partners registry of people with IBD to construct Kaplan-Meier drug-use persistency graphs for biologic drug-use spans that started between 2017 and 2022.</p><p><strong>Results: </strong>We examined 2034 drug-use spans for 1594 survey participants. Most of the biologic drugs had a 75%+ persistency rate around the one-year mark and 60%+ persistency at the 3-year mark. The overall persistency and the differences in persistency between drugs were aligned with published literature.</p><p><strong>Conclusions: </strong>This analysis demonstrates the feasibility of collecting IBD-specific patient-reported drug persistency data via a voluntary patient registry. Patient-reported persistency provides real-world drug persistency data and the patient's perspectives as to why they discontinued use of the drug-a combination of data and perspective that is not available from any other real-world medical record, claim, and pharmacy data source that are valuable to physician, patients, payers, healthcare policymakers, and health technology assessment organizations.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10629214/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71520772","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 : 2023-08-17eCollection Date: 2023-07-01DOI: 10.1093/crocol/otad034
William J Sandborn, Jingjing Chen, Krisztina Kisfalvi, Edward V Loftus, Geert D'Haens, Ninfa Candela, Karen Lasch, Douglas C Wolf, Sharif M Uddin, Silvio Danese
Background: Vedolizumab, an anti-α4β7 integrin approved for intravenous (IV) treatment of moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD), was evaluated as a subcutaneous (SC) formulation in maintenance therapy for UC and CD in phase 3 VISIBLE 1, 2, and open-label extension studies, and recently approved in Europe, Australia, and Canada. Our aim was to evaluate efficacy and safety of IV and SC vedolizumab in clinically relevant UC and CD scenarios.
Methods: Post hoc data analyses from VISIBLE trials examined: (1) whether baseline characteristics predict clinical response to 2 vs 3 IV vedolizumab induction doses; (2) efficacy and safety of switching during maintenance vedolizumab IV to SC in patients with UC; (3) vedolizumab SC after treatment interruption of 1-46 weeks; (4) increasing dose frequency of vedolizumab SC from every 2 weeks (Q2W) to every week (QW) after disease worsening.
Results: No baseline characteristics were identified as strong predictors of response to 2 vs 3 vedolizumab infusions. Most patients achieved clinical response after 2 or 3 doses of IV vedolizumab maintained with SC treatment. Clinical remission and response rates were maintained in patients transitioned from maintenance vedolizumab IV to SC treatment. Of patients with UC, ≥75% achieved response following resumption after dose interruption. Escalation to QW dosing resulted in ≥45% of patients regaining response after loss while receiving vedolizumab Q2W.
Conclusions: Clinical real-world scenarios with vedolizumab SC were reviewed using VISIBLE studies data. Vedolizumab SC provides an additional dosing option for patients with UC and CD.
背景:Vedolizumab是一种抗α4β7整合素,被批准用于静脉(IV)治疗中度至重度活动性溃疡性结肠炎(UC)和克罗恩病(CD),在3期VISIBLE 1、2和开放标签扩展研究中被评估为UC和CD维持治疗的皮下(SC)制剂,最近在欧洲、澳大利亚和加拿大获得批准。我们的目的是评估IV和SC vedolizumab在临床相关UC和CD情况下的疗效和安全性。方法:对VISIBLE试验的事后数据进行分析,检验:(1)基线特征是否能预测静脉注射2 vs 3维多珠单抗诱导剂量的临床反应;(2) UC患者维持性vedolizumab IV切换到SC的有效性和安全性;(3) vedolizumab SC治疗中断后1-46周;(4)病情加重后,vedolizumab SC的给药频率从每2周(Q2W)增加到每一周(QW)。结果:没有基线特征被确定为2 vs 3 vedolizumab输注反应的强预测因子。大多数患者在SC治疗维持2或3次静脉注射维多单抗后达到临床缓解。从维持性vedolizumab IV过渡到SC治疗的患者的临床缓解和缓解率保持不变。在UC患者中,≥75%的患者在中断给药后恢复治疗后获得缓解。升级至QW剂量导致≥45%的患者在接受vedolizumab Q2W治疗后恢复疗效。结论:使用VISIBLE研究数据回顾了vedolizumab SC的临床真实情况。Vedolizumab SC为UC和CD患者提供了额外的给药选择。
{"title":"Practical Primer Addressing Real-World Use Scenarios of Subcutaneous Vedolizumab in Ulcerative Colitis and Crohn's Disease: Post Hoc Analyses of VISIBLE Studies.","authors":"William J Sandborn, Jingjing Chen, Krisztina Kisfalvi, Edward V Loftus, Geert D'Haens, Ninfa Candela, Karen Lasch, Douglas C Wolf, Sharif M Uddin, Silvio Danese","doi":"10.1093/crocol/otad034","DOIUrl":"10.1093/crocol/otad034","url":null,"abstract":"<p><strong>Background: </strong>Vedolizumab, an anti-α<sub>4</sub>β<sub>7</sub> integrin approved for intravenous (IV) treatment of moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD), was evaluated as a subcutaneous (SC) formulation in maintenance therapy for UC and CD in phase 3 VISIBLE 1, 2, and open-label extension studies, and recently approved in Europe, Australia, and Canada. Our aim was to evaluate efficacy and safety of IV and SC vedolizumab in clinically relevant UC and CD scenarios.</p><p><strong>Methods: </strong>Post hoc data analyses from VISIBLE trials examined: (1) whether baseline characteristics predict clinical response to 2 vs 3 IV vedolizumab induction doses; (2) efficacy and safety of switching during maintenance vedolizumab IV to SC in patients with UC; (3) vedolizumab SC after treatment interruption of 1-46 weeks; (4) increasing dose frequency of vedolizumab SC from every 2 weeks (Q2W) to every week (QW) after disease worsening.</p><p><strong>Results: </strong>No baseline characteristics were identified as strong predictors of response to 2 vs 3 vedolizumab infusions. Most patients achieved clinical response after 2 or 3 doses of IV vedolizumab maintained with SC treatment. Clinical remission and response rates were maintained in patients transitioned from maintenance vedolizumab IV to SC treatment. Of patients with UC, ≥75% achieved response following resumption after dose interruption. Escalation to QW dosing resulted in ≥45% of patients regaining response after loss while receiving vedolizumab Q2W.</p><p><strong>Conclusions: </strong>Clinical real-world scenarios with vedolizumab SC were reviewed using VISIBLE studies data. Vedolizumab SC provides an additional dosing option for patients with UC and CD.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10449415/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10111091","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 : 2023-08-07eCollection Date: 2023-07-01DOI: 10.1093/crocol/otad043
Bincy P Abraham, Dheeraj Reddy, Adam Saleh
Intestinal ultrasound (IUS) offers a safe, noninvasive, point-of-care tool for diagnosing and monitoring disease activity in patients with inflammatory bowel disease (IBD). IUS is used widely in Europe and Canada for IBD, but it remains underutilized in the United States. Growing interest in IUS in the United States has prompted many IBD centers to train their faculty in IUS. This, however, raises questions about how to effectively use this new tool in the United States, which does not use a social medicine model like those implemented in Europe and Canada. Here, we provide a practical framework for incorporating IUS in an IBD practice in the United States, including training requirements, equipment, and protocols for implementing IUS in daily practice.
{"title":"Integrating Intestinal Ultrasound into an Inflammatory Bowel Disease Practice: How to Get Started.","authors":"Bincy P Abraham, Dheeraj Reddy, Adam Saleh","doi":"10.1093/crocol/otad043","DOIUrl":"10.1093/crocol/otad043","url":null,"abstract":"<p><p>Intestinal ultrasound (IUS) offers a safe, noninvasive, point-of-care tool for diagnosing and monitoring disease activity in patients with inflammatory bowel disease (IBD). IUS is used widely in Europe and Canada for IBD, but it remains underutilized in the United States. Growing interest in IUS in the United States has prompted many IBD centers to train their faculty in IUS. This, however, raises questions about how to effectively use this new tool in the United States, which does not use a social medicine model like those implemented in Europe and Canada. Here, we provide a practical framework for incorporating IUS in an IBD practice in the United States, including training requirements, equipment, and protocols for implementing IUS in daily practice.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4b/fd/otad043.PMC10500970.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10635107","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 : 2023-07-27eCollection Date: 2023-07-01DOI: 10.1093/crocol/otad039
Edward L Barnes, Poonam Beniwal-Patel, Parakkal Deepak, Laura Raffals, Maia Kayal, Marla Dubinsky, Shannon Chang, Peter D R Higgins, Jennifer I Barr, Chelsea Anderson, Raymond K Cross, Millie D Long, Hans H Herfarth
Background: Evidence-based recommendations regarding the influence of diet on inflammatory conditions of the pouch after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) are limited.
Methods: We analyzed dietary patterns at enrollment in a prospective registry of patients with 1 of 4 inflammatory conditions of the pouch (acute pouchitis, chronic antibiotic-dependent pouchitis, chronic antibiotic refractory pouchitis, and Crohn's disease of the pouch). We analyzed dietary intake by disease activity at enrollment and then compared dietary patterns among patients who remained in remission throughout the 12-month follow-up to those patients who experienced a disease relapse. We also compared dietary patterns among patients with inflammatory conditions of the pouch to the United States Department of Agriculture (USDA) recommended daily goals.
Results: Among 308 patients, there were no differences in dietary patterns among patients with 1 of the 4 disease states at enrollment. Additionally, among the 102 patients in remission at baseline, there were no significant differences noted among patients who went on to experience a disease flare in the 12 months after enrollment compared to those patients who remained in remission. However, patients with inflammatory conditions of the pouch demonstrated decreased intake of several food groups and macronutrients including dairy, fruits, vegetables, whole grains, and fiber when compared to USDA recommendations.
Conclusions: In a prospective cohort, we demonstrated no impact of dietary patterns on disease activity. The relative deficiencies in several food groups and macronutrients among patients after IPAA indicate the potential role of targeted nutritional counseling in this population.
{"title":"Dietary Patterns Are Not Associated With Disease Activity Among Patients With Inflammatory Conditions of the Pouch in a Prospective Cohort.","authors":"Edward L Barnes, Poonam Beniwal-Patel, Parakkal Deepak, Laura Raffals, Maia Kayal, Marla Dubinsky, Shannon Chang, Peter D R Higgins, Jennifer I Barr, Chelsea Anderson, Raymond K Cross, Millie D Long, Hans H Herfarth","doi":"10.1093/crocol/otad039","DOIUrl":"10.1093/crocol/otad039","url":null,"abstract":"<p><strong>Background: </strong>Evidence-based recommendations regarding the influence of diet on inflammatory conditions of the pouch after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) are limited.</p><p><strong>Methods: </strong>We analyzed dietary patterns at enrollment in a prospective registry of patients with 1 of 4 inflammatory conditions of the pouch (acute pouchitis, chronic antibiotic-dependent pouchitis, chronic antibiotic refractory pouchitis, and Crohn's disease of the pouch). We analyzed dietary intake by disease activity at enrollment and then compared dietary patterns among patients who remained in remission throughout the 12-month follow-up to those patients who experienced a disease relapse. We also compared dietary patterns among patients with inflammatory conditions of the pouch to the United States Department of Agriculture (USDA) recommended daily goals.</p><p><strong>Results: </strong>Among 308 patients, there were no differences in dietary patterns among patients with 1 of the 4 disease states at enrollment. Additionally, among the 102 patients in remission at baseline, there were no significant differences noted among patients who went on to experience a disease flare in the 12 months after enrollment compared to those patients who remained in remission. However, patients with inflammatory conditions of the pouch demonstrated decreased intake of several food groups and macronutrients including dairy, fruits, vegetables, whole grains, and fiber when compared to USDA recommendations.</p><p><strong>Conclusions: </strong>In a prospective cohort, we demonstrated no impact of dietary patterns on disease activity. The relative deficiencies in several food groups and macronutrients among patients after IPAA indicate the potential role of targeted nutritional counseling in this population.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c2/3f/otad039.PMC10374273.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9899696","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 : 2023-07-25eCollection Date: 2023-10-01DOI: 10.1093/crocol/otad040
Karin Cerna, Dana Duricova, Martin Lukas, Martin Kolar, Nadezda Machkova, Veronika Hruba, Katarina Mitrova, Kristyna Kubickova, Marta Kostrejova, Jakub Jirsa, Kristyna Kastylova, Stepan Peterka, Gabriela Vojtechova, Milan Lukas
Background: A subcutaneous formulation of infliximab (IFX-SC) approved to treat patients with inflammatory bowel disease may offer improved efficacy versus intravenous infliximab.
Methods: Patients with refractory Crohn's disease (CD, n = 32) previously treated unsuccessfully with at least 2 biologics were treated with IFX-SC and followed from baseline at Week 0 (W0) to Week 30 (W30). The study's primary endpoint was the treatment's persistence at W30, while secondary goals included the analysis of serum infliximab trough levels (TL IFX), dynamics of anti-IFX antibodies (ATIs), and clinical, serum and fecal markers of CD activity during IFX-SC treatment.
Results: Midterm treatment persistence with the continuation of treatment after W30 was 53%. TL IFX median values showed rapid, significant upward dynamics and exceeded 15.5 μg/mL at W30, whereas median ATI levels significantly declined. Among ATI-negative patients at W0 (n = 15), only one showed IFX immunogenicity with newly developed ATIs at W30. Among ATI-positive patients at W0, ATI seroconversion from ATI-positive to ATI-negative status was observed in 10 of 17 patients (58.8%). Patients who had continued IFX-SC treatment at W30 showed significant decreases in C-reactive protein (P = .0341), fecal calprotectin (P = .0002), and Harvey-Bradshaw index (P = .0029) since W0.
Conclusions: Patients with refractory CD previously treated with at least 2 biologics exhibited clinically relevant improvement with IFX-SC, which showed less immunogenic potential than IFX-IV and highly stable TL IFX.
{"title":"Subcutaneous Infliximab in Refractory Crohn's Disease Patients: A Possible Biobetter?","authors":"Karin Cerna, Dana Duricova, Martin Lukas, Martin Kolar, Nadezda Machkova, Veronika Hruba, Katarina Mitrova, Kristyna Kubickova, Marta Kostrejova, Jakub Jirsa, Kristyna Kastylova, Stepan Peterka, Gabriela Vojtechova, Milan Lukas","doi":"10.1093/crocol/otad040","DOIUrl":"10.1093/crocol/otad040","url":null,"abstract":"<p><strong>Background: </strong>A subcutaneous formulation of infliximab (IFX-SC) approved to treat patients with inflammatory bowel disease may offer improved efficacy versus intravenous infliximab.</p><p><strong>Methods: </strong>Patients with refractory Crohn's disease (CD, <i>n</i> = 32) previously treated unsuccessfully with at least 2 biologics were treated with IFX-SC and followed from baseline at Week 0 (W0) to Week 30 (W30). The study's primary endpoint was the treatment's persistence at W30, while secondary goals included the analysis of serum infliximab trough levels (TL IFX), dynamics of anti-IFX antibodies (ATIs), and clinical, serum and fecal markers of CD activity during IFX-SC treatment.</p><p><strong>Results: </strong>Midterm treatment persistence with the continuation of treatment after W30 was 53%. TL IFX median values showed rapid, significant upward dynamics and exceeded 15.5 μg/mL at W30, whereas median ATI levels significantly declined. Among ATI-negative patients at W0 (<i>n</i> = 15), only one showed IFX immunogenicity with newly developed ATIs at W30. Among ATI-positive patients at W0, ATI seroconversion from ATI-positive to ATI-negative status was observed in 10 of 17 patients (58.8%). Patients who had continued IFX-SC treatment at W30 showed significant decreases in C-reactive protein (<i>P</i> = .0341), fecal calprotectin (<i>P</i> = .0002), and Harvey-Bradshaw index (<i>P =</i> .0029) since W0.</p><p><strong>Conclusions: </strong>Patients with refractory CD previously treated with at least 2 biologics exhibited clinically relevant improvement with IFX-SC, which showed less immunogenic potential than IFX-IV and highly stable TL IFX.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10640858/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85085579","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 : 2023-07-19eCollection Date: 2023-07-01DOI: 10.1093/crocol/otad038
Alaa El-Hussuna, Casper Steenholdt, Mette Louise Merrild Karer, Natasja Nyggard Uldall Nielsen, Angela Mujukian, Phillip R Fleshner, Igors Iesalnieks, Nir Horesh, Uri Kopylov, Harel Jacoby, Haider Mahmoud Al-Qaisi, Francesco Colombo, Gianluca M Sampietro, Marco V Marino, Mark Ellebæk, Nina Sørensen, Valerio Celentano, Nikhil Ladwa, Janindra Warusavitarne, Gianluca Pellino, Aurang Zeb, Francesca Di Candido, Luis Hurtado-Pardo, Matteo Frasson, Lumir Kunovsky, Ali Yalcinkaya, Sandra Alonso, Miguel Pera, Cristina Antón Rodríguez, Ana-Minaya Bravo, Alvaro Garcia Granero, Ozan Can Tatar, Antonino Spinelli, Niels Qvist
Background: Management of spontaneous intra-abdominal abscess (IAA) in patients with Crohn's disease (CD) with radiologically guided percutaneous drainage (PD) was debated.
Methods: This is a secondary analysis from a multicenter, retrospective cohort study of all the patients with CD who underwent PD followed by surgery at 19 international tertiary centers.
Results: Seventeen patients (4.8%) who did not undergo surgery after PD were compared to those who had PD followed by surgical intervention 335/352 (95.2%). Patients who had PD without surgery were those with longer disease duration, more frequently had previous surgery for CD (laparotomies/laparoscopies), enteric fistula, on steroid treatment before and continue to have it after PD. Patients who had PD without subsequent surgical resection had a higher risk of stoma construction at later stages 8/17 (47.1%) versus 90/326 (27.6%) (P < .01). Patients with PD with no subsequent surgery had numerically higher rates of abscess recurrence 5/17 (29.4%) compared to those who had PD followed by surgery 45/335 (13.4%) the difference was not statistically significant (P = .07).
Conclusions: Even with the low number of patients enrolled in this study who had PD of IAA without subsequent surgery, the findings indicate a markedly worse prognosis in terms of recurrence, length of stay, readmission, and stoma construction. Watchful waiting after PD to treat patients with spontaneous IAA might be indicated in selected patients with poor health status or poor prognostic factors.
背景:在放射学指导下经皮穿刺引流(PD)治疗克罗恩病(CD)患者的自发性腹腔内脓肿(IAA)一直存在争议。方法:这是一项多中心、回顾性队列研究的二次分析,该研究对19个国际三级中心所有接受PD手术的CD患者进行了研究。结果:17例(4.8%)PD后未接受手术的患者与335/352例(95.2%)PD后接受手术干预的患者进行了比较。未经手术的PD患者病程较长,更频繁地在PD前接受过CD(剖腹/腹腔镜)手术、肠瘘和类固醇治疗,并在PD后继续接受。未经手术切除的PD患者在后期造瘘的风险较高,8/17(47.1%)高于90/326(27.6%)(P P = .07)。结论:即使在本研究中,很少有患者在没有后续手术的情况下患有IAA PD,但研究结果表明,在复发、住院时间、再次入院和造瘘方面,预后明显较差。在选定的健康状况不佳或预后因素较差的患者中,PD后等待治疗自发性IAA可能是有意义的。
{"title":"Watchful Waiting After Radiological Guided Drainage of Intra-abdominal Abscess in Patients With Crohn's Disease Might Be Associated With Increased Rates of Stoma Construction.","authors":"Alaa El-Hussuna, Casper Steenholdt, Mette Louise Merrild Karer, Natasja Nyggard Uldall Nielsen, Angela Mujukian, Phillip R Fleshner, Igors Iesalnieks, Nir Horesh, Uri Kopylov, Harel Jacoby, Haider Mahmoud Al-Qaisi, Francesco Colombo, Gianluca M Sampietro, Marco V Marino, Mark Ellebæk, Nina Sørensen, Valerio Celentano, Nikhil Ladwa, Janindra Warusavitarne, Gianluca Pellino, Aurang Zeb, Francesca Di Candido, Luis Hurtado-Pardo, Matteo Frasson, Lumir Kunovsky, Ali Yalcinkaya, Sandra Alonso, Miguel Pera, Cristina Antón Rodríguez, Ana-Minaya Bravo, Alvaro Garcia Granero, Ozan Can Tatar, Antonino Spinelli, Niels Qvist","doi":"10.1093/crocol/otad038","DOIUrl":"10.1093/crocol/otad038","url":null,"abstract":"<p><strong>Background: </strong>Management of spontaneous intra-abdominal abscess (IAA) in patients with Crohn's disease (CD) with radiologically guided percutaneous drainage (PD) was debated.</p><p><strong>Methods: </strong>This is a secondary analysis from a multicenter, retrospective cohort study of all the patients with CD who underwent PD followed by surgery at 19 international tertiary centers.</p><p><strong>Results: </strong>Seventeen patients (4.8%) who did not undergo surgery after PD were compared to those who had PD followed by surgical intervention 335/352 (95.2%). Patients who had PD without surgery were those with longer disease duration, more frequently had previous surgery for CD (laparotomies/laparoscopies), enteric fistula, on steroid treatment before and continue to have it after PD. Patients who had PD without subsequent surgical resection had a higher risk of stoma construction at later stages 8/17 (47.1%) versus 90/326 (27.6%) (<i>P</i> < .01). Patients with PD with no subsequent surgery had numerically higher rates of abscess recurrence 5/17 (29.4%) compared to those who had PD followed by surgery 45/335 (13.4%) the difference was not statistically significant (<i>P</i> = .07).</p><p><strong>Conclusions: </strong>Even with the low number of patients enrolled in this study who had PD of IAA without subsequent surgery, the findings indicate a markedly worse prognosis in terms of recurrence, length of stay, readmission, and stoma construction. Watchful waiting after PD to treat patients with spontaneous IAA might be indicated in selected patients with poor health status or poor prognostic factors.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/21/98/otad038.PMC10460196.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10111095","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 : 2023-07-14eCollection Date: 2023-07-01DOI: 10.1093/crocol/otad037
Jill K J Gaidos, Badr Al Bawardy, Francis A Farraye, Miguel Regueiro
Background: Inflammatory bowel disease (IBD) treatment targets include mucosal healing based on standardized endoscopic scoring systems. The rates and ease of use of these scoring systems in practice have not been well described. We aimed to assess the rates and factors associated with the use of IBD endoscopic scoring systems in practice from IBD LIVE attendees.
Methods: IBD Live is an international case-based conference focusing on the management of patients with IBD. We created a web-based survey consisting of 38 questions on the frequency and ease of use of various IBD endoscopic scores. This survey was emailed to the IBD Live listserv in March 2022 with a second email sent 14 days later. We included only respondents who are currently performing endoscopy. Continuous variables were analyzed using an unpaired student's t-test. Categorical variables were analyzed using Pearson's chi-square test.
Results: There were 65 responses out of 170 (38.2% response rate) regular attendees. Eleven responses were excluded (4 with no response on the use of endoscopy scores, and 7 were not performing endoscopy). Of the respondents, 72.2% are from the United States, 70.4% are adult gastroenterologists, 53.9% in academic practice, and 40.7% in practice for ≥15 years. Of the endoscopy scores used ≥50% of the time, 74.1% were using the Mayo Endoscopic Subscore (MES), 72.3% using the Rutgeerts Score, 61.2% using the Simple Endoscopic Score for Crohn's Disease, and 28.6% using the Pouchitis Disease Activity Index. Attending IBD LIVE ≥ monthly (P = .028), attending an IBD conference at least every 2 years (P = .020), and having the scoring system incorporated into the endoscopy documentation software (P = .002) were associated with more consistent use of the MES. Attending IBD Live at least monthly (P = .026), having an IBD volume of ≥50% (P = .011), and attending an IBD conference at least every 2 years (P = .004) was associated with more frequent use of the Rutgeerts score. There were no factors that increased the use of other endoscopic scores.
Conclusions: The MES and the Rutgeerts score are more commonly used with much lower rates of use of endoscopic scores for Crohn's disease and pouchitis. The use of these endoscopy scores is more common among those who regularly attend IBD conferences, have higher volume IBD practices, and have these scoring systems incorporated into endoscopy software. Further evaluation of barriers to use and ways to improve utilization of endoscopic scoring for Crohn's disease and pouchitis is needed.
{"title":"Use of Standardized Inflammatory Bowel Disease Endoscopy Scores in Clinical Practice.","authors":"Jill K J Gaidos, Badr Al Bawardy, Francis A Farraye, Miguel Regueiro","doi":"10.1093/crocol/otad037","DOIUrl":"10.1093/crocol/otad037","url":null,"abstract":"<p><strong>Background: </strong>Inflammatory bowel disease (IBD) treatment targets include mucosal healing based on standardized endoscopic scoring systems. The rates and ease of use of these scoring systems in practice have not been well described. We aimed to assess the rates and factors associated with the use of IBD endoscopic scoring systems in practice from IBD LIVE attendees.</p><p><strong>Methods: </strong>IBD Live is an international case-based conference focusing on the management of patients with IBD. We created a web-based survey consisting of 38 questions on the frequency and ease of use of various IBD endoscopic scores. This survey was emailed to the IBD Live listserv in March 2022 with a second email sent 14 days later. We included only respondents who are currently performing endoscopy. Continuous variables were analyzed using an unpaired student's <i>t</i>-test. Categorical variables were analyzed using Pearson's chi-square test.</p><p><strong>Results: </strong>There were 65 responses out of 170 (38.2% response rate) regular attendees. Eleven responses were excluded (4 with no response on the use of endoscopy scores, and 7 were not performing endoscopy). Of the respondents, 72.2% are from the United States, 70.4% are adult gastroenterologists, 53.9% in academic practice, and 40.7% in practice for ≥15 years. Of the endoscopy scores used ≥50% of the time, 74.1% were using the Mayo Endoscopic Subscore (MES), 72.3% using the Rutgeerts Score, 61.2% using the Simple Endoscopic Score for Crohn's Disease, and 28.6% using the Pouchitis Disease Activity Index. Attending IBD LIVE ≥ monthly (<i>P</i> = .028), attending an IBD conference at least every 2 years (<i>P</i> = .020), and having the scoring system incorporated into the endoscopy documentation software (<i>P</i> = .002) were associated with more consistent use of the MES. Attending IBD Live at least monthly (<i>P</i> = .026), having an IBD volume of ≥50% (<i>P</i> = .011), and attending an IBD conference at least every 2 years (<i>P</i> = .004) was associated with more frequent use of the Rutgeerts score. There were no factors that increased the use of other endoscopic scores.</p><p><strong>Conclusions: </strong>The MES and the Rutgeerts score are more commonly used with much lower rates of use of endoscopic scores for Crohn's disease and pouchitis. The use of these endoscopy scores is more common among those who regularly attend IBD conferences, have higher volume IBD practices, and have these scoring systems incorporated into endoscopy software. Further evaluation of barriers to use and ways to improve utilization of endoscopic scoring for Crohn's disease and pouchitis is needed.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/66/73/otad037.PMC10407976.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9963563","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}
Ashwin N Ananthakrishnan, Raj Desai, Wan-Ju Lee, Jenny Griffith, Naijun Chen, Edward V Loftus
Background: This retrospective study gathered medical/pharmacy claims data on patients with inflammatory bowel disease (IBD) between January 01, 2000 and March 31, 2019 from the IBM MarketScan commercial claims database to assess the real-world impact of fatigue on healthcare costs in patients newly diagnosed with IBD.
Methods: Eligible participants were ≥18 years, newly diagnosed with IBD (≥2 separate claims), and had ≥12 months of continuous database enrollment before and after fatigue diagnosis. The date of fatigue diagnosis was the index date; participants were followed for 12 months post-index. Patients with (cases) or without (controls) fatigue were matched 1:1 by propensity score matching. Patients with evidence of prior IBD diagnosis/treatment, or those with a chronic disease other than IBD wherein fatigue is the primary symptom, were excluded. Healthcare resource utilization (HCRU), including hospitalizations, inpatient and outpatient visits, and associated costs were compared between cases and controls.
Results: Matched IBD cohorts (21 321 cases/21 321 controls) were identified (42% Crohn's disease [CD] and 58% ulcerative colitis [UC]) with similar baseline characteristics (average age: 46 years; 60% female). Cases versus controls had significantly more all-cause outpatient visits (incidence rate ratio [IRR], 95% confidence intervals [95% CI]: 1.64 [1.61, 1.67], P < .001) and all-cause hospitalizations (IRR [95% CI]: 1.92 [1.81, 2.04], P < .001); as well as significantly higher all-cause total direct healthcare costs (mean: $24 620 vs. $15 324; P < .001). Similar findings were observed for IBD-related outcomes, as well as in CD- and UC-specific subgroups.
Conclusions: Presence of fatigue is associated with an increase in HCRU and total medical costs among patients newly diagnosed with IBD.
{"title":"Economic Burden of Fatigue in Inflammatory Bowel Disease.","authors":"Ashwin N Ananthakrishnan, Raj Desai, Wan-Ju Lee, Jenny Griffith, Naijun Chen, Edward V Loftus","doi":"10.1093/crocol/otad020","DOIUrl":"https://doi.org/10.1093/crocol/otad020","url":null,"abstract":"<p><strong>Background: </strong>This retrospective study gathered medical/pharmacy claims data on patients with inflammatory bowel disease (IBD) between January 01, 2000 and March 31, 2019 from the IBM MarketScan commercial claims database to assess the real-world impact of fatigue on healthcare costs in patients newly diagnosed with IBD.</p><p><strong>Methods: </strong>Eligible participants were ≥18 years, newly diagnosed with IBD (≥2 separate claims), and had ≥12 months of continuous database enrollment before and after fatigue diagnosis. The date of fatigue diagnosis was the index date; participants were followed for 12 months post-index. Patients with (cases) or without (controls) fatigue were matched 1:1 by propensity score matching. Patients with evidence of prior IBD diagnosis/treatment, or those with a chronic disease other than IBD wherein fatigue is the primary symptom, were excluded. Healthcare resource utilization (HCRU), including hospitalizations, inpatient and outpatient visits, and associated costs were compared between cases and controls.</p><p><strong>Results: </strong>Matched IBD cohorts (21 321 cases/21 321 controls) were identified (42% Crohn's disease [CD] and 58% ulcerative colitis [UC]) with similar baseline characteristics (average age: 46 years; 60% female). Cases versus controls had significantly more all-cause outpatient visits (incidence rate ratio [IRR], 95% confidence intervals [95% CI]: 1.64 [1.61, 1.67], <i>P</i> < .001) and all-cause hospitalizations (IRR [95% CI]: 1.92 [1.81, 2.04], <i>P</i> < .001); as well as significantly higher all-cause total direct healthcare costs (mean: $24 620 vs. $15 324; <i>P</i> < .001). Similar findings were observed for IBD-related outcomes, as well as in CD- and UC-specific subgroups.</p><p><strong>Conclusions: </strong>Presence of fatigue is associated with an increase in HCRU and total medical costs among patients newly diagnosed with IBD.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10470665/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10143893","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}