Pub Date : 2024-01-24DOI: 10.1093/ecco-jcc/jjad212.0018
Z Serclova, D Garcia-Olmo, S T Chen, S Wexner, J Panés, C Wu, P Fleshner, B Zhang, J F Colombel, M Song, C McKay, P Nazarey, E Wright, L Raffals
Background Complex perianal fistulas are a serious complication in patients with Crohn’s disease (CD). Darvadstrocel (DVS), a suspension of expanded adult allogeneic adipose-derived mesenchymal stem cells, is approved in Europe and Japan for treatment of complex Crohn’s perianal fistulas (CPF). The global ADMIRE-CD II phase 3 randomized double-blind placebo-controlled study evaluated the efficacy and safety of DVS for treatment of complex CPF. Methods Patients aged 18–75 years with clinically controlled, inactive or mildly active CD and complex CPF (≤2 internal openings [IO] and ≤3 external openings [EOs]) who had an inadequate, or a loss of response to immunosuppressive agents or biologics were included. Patients were randomized 1:1 to receive a local injection of DVS as a single dose (120 x 106 cells/24 mL) or placebo. In all patients, fistula preconditioning included vigorous curettage and seton placement 2–3 weeks before treatment, and seton removal, a further curettage and closure of IOs immediately before treatment. The primary endpoint was combined remission (closure of all treated EOs that were draining at baseline, despite gentle finger compression, and absence of collections >2 cm confirmed by MRI) at 24 weeks. Secondary endpoints included combined remission at 52 weeks, clinical remission (closure of all treated EOs without MRI confirmation) at 24 and 52 weeks, and time to clinical remission at 24 weeks. Safety was monitored up to 52 weeks. Results From 19 Oct 2017 to 26 Jul 2023, 568 patients received DVS (n = 283) or placebo (n = 285) with fistula preconditioning; 56.3% of patients enrolled in Europe and Israel, and 43.7% in North America. Mean (SD) age, sex and race were similar in the DVS and placebo arms (38.4 [11.9] vs 37.7 [10.8] years; 42.8% vs 45.6% female; 85.9% vs 89.1% White). Combined remission rates at 24 weeks did not statistically differ between treatments (48.8% DVS vs 46.3% placebo) and there were no differences in secondary endpoints (Table 1; Figure 1). Based on health authority guidelines, post hoc analyses of patients randomized before COVID-19 (11 March 2020; n = 141 DVS, n = 143 placebo) were performed: combined remission rates at 24 weeks were 46.8% (DVS) and 38.5% (placebo). The safety profile for DVS was consistent with prior studies with no new safety signals (Table 1). Conclusion The efficacy outcomes assessed did not statistically differ between DVS and placebo, and the placebo response rate (with fistula preconditioning) was higher than expected. Post hoc analyses revealed lower placebo response rates in patients randomized before COVID-19 (similar to the pivotal ADMIRE CD I study) than the overall placebo arm. DVS was well tolerated.
背景复杂性肛周瘘是克罗恩病（CD）患者的一种严重并发症。Darvadstrocel（DVS）是一种扩增的成人异体脂肪间充质干细胞悬浮液，已在欧洲和日本获准用于治疗复杂性克罗恩病肛周瘘。全球 ADMIRE-CD II 3 期随机双盲安慰剂对照研究评估了 DVS 治疗复杂性 CPF 的疗效和安全性。方法 纳入年龄为 18-75 岁、临床控制的非活动性或轻度活动性 CD 和复杂 CPF（≤2 个内开口 [IO] 和≤3 个外开口 [EO]）患者，这些患者对免疫抑制剂或生物制剂反应不足或失去反应。患者按 1:1 随机分配接受单剂量局部注射 DVS（120 x 106 cells/24 mL）或安慰剂。在所有患者中，瘘管预处理包括在治疗前2-3周进行剧烈刮宫和放置套管，以及在治疗前立即移除套管、进一步刮宫和关闭IO。主要终点是24周时的综合缓解（所有治疗后的瘘管在基线时均有引流，尽管手指轻轻按压，瘘管仍然闭合，并且经核磁共振成像确认没有>2厘米的积液）。次要终点包括：52周时的综合缓解、24周和52周时的临床缓解（所有治疗过的EO在未经核磁共振成像确认的情况下均已闭合）以及24周时的临床缓解时间。安全性监测持续到 52 周。结果 从2017年10月19日至2023年7月26日，568名患者接受了瘘管预处理的DVS（n = 283）或安慰剂（n = 285）治疗；56.3%的患者在欧洲和以色列入组，43.7%的患者在北美入组。DVS治疗组和安慰剂治疗组的平均（标清）年龄、性别和种族相似（38.4 [11.9] 岁 vs 37.7 [10.8]岁；42.8% vs 45.6%为女性；85.9% vs 89.1%为白人）。24周的综合缓解率在统计学上没有差异（DVS为48.8%，安慰剂为46.3%），次要终点也没有差异（表1；图1）。根据卫生部门的指导方针，对在COVID-19（2020年3月11日；n = 141 DVS，n = 143安慰剂）之前随机接受治疗的患者进行了事后分析：24周时的综合缓解率分别为46.8%（DVS）和38.5%（安慰剂）。DVS的安全性与之前的研究一致，没有出现新的安全信号（表1）。结论 DVS 和安慰剂的疗效评估结果没有统计学差异，安慰剂应答率（瘘管预处理）高于预期。事后分析显示，COVID-19（类似于关键的 ADMIRE CD I 研究）之前随机分组的患者的安慰剂应答率低于整个安慰剂组。DVS 的耐受性良好。
{"title":"OP18 Efficacy and safety of darvadstrocel treatment in patients with complex perianal fistulas and Crohn’s Disease: results from the global ADMIRE-CD II phase 3 study","authors":"Z Serclova, D Garcia-Olmo, S T Chen, S Wexner, J Panés, C Wu, P Fleshner, B Zhang, J F Colombel, M Song, C McKay, P Nazarey, E Wright, L Raffals","doi":"10.1093/ecco-jcc/jjad212.0018","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0018","url":null,"abstract":"Background Complex perianal fistulas are a serious complication in patients with Crohn’s disease (CD). Darvadstrocel (DVS), a suspension of expanded adult allogeneic adipose-derived mesenchymal stem cells, is approved in Europe and Japan for treatment of complex Crohn’s perianal fistulas (CPF). The global ADMIRE-CD II phase 3 randomized double-blind placebo-controlled study evaluated the efficacy and safety of DVS for treatment of complex CPF. Methods Patients aged 18–75 years with clinically controlled, inactive or mildly active CD and complex CPF (≤2 internal openings [IO] and ≤3 external openings [EOs]) who had an inadequate, or a loss of response to immunosuppressive agents or biologics were included. Patients were randomized 1:1 to receive a local injection of DVS as a single dose (120 x 106 cells/24 mL) or placebo. In all patients, fistula preconditioning included vigorous curettage and seton placement 2–3 weeks before treatment, and seton removal, a further curettage and closure of IOs immediately before treatment. The primary endpoint was combined remission (closure of all treated EOs that were draining at baseline, despite gentle finger compression, and absence of collections >2 cm confirmed by MRI) at 24 weeks. Secondary endpoints included combined remission at 52 weeks, clinical remission (closure of all treated EOs without MRI confirmation) at 24 and 52 weeks, and time to clinical remission at 24 weeks. Safety was monitored up to 52 weeks. Results From 19 Oct 2017 to 26 Jul 2023, 568 patients received DVS (n = 283) or placebo (n = 285) with fistula preconditioning; 56.3% of patients enrolled in Europe and Israel, and 43.7% in North America. Mean (SD) age, sex and race were similar in the DVS and placebo arms (38.4 [11.9] vs 37.7 [10.8] years; 42.8% vs 45.6% female; 85.9% vs 89.1% White). Combined remission rates at 24 weeks did not statistically differ between treatments (48.8% DVS vs 46.3% placebo) and there were no differences in secondary endpoints (Table 1; Figure 1). Based on health authority guidelines, post hoc analyses of patients randomized before COVID-19 (11 March 2020; n = 141 DVS, n = 143 placebo) were performed: combined remission rates at 24 weeks were 46.8% (DVS) and 38.5% (placebo). The safety profile for DVS was consistent with prior studies with no new safety signals (Table 1). Conclusion The efficacy outcomes assessed did not statistically differ between DVS and placebo, and the placebo response rate (with fistula preconditioning) was higher than expected. Post hoc analyses revealed lower placebo response rates in patients randomized before COVID-19 (similar to the pivotal ADMIRE CD I study) than the overall placebo arm. DVS was well tolerated.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559380","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-24DOI: 10.1093/ecco-jcc/jjad212.0719
C Harris, T Gee, A Barcan, Y Yanagisawa, M Brown, J N Gordon
Background Upadacitinib is a selective Janus kinase inhibitor that has recently been approved in England for the treatment of ulcerative colitis (UC) and Crohn’s disease (CD) though real-world data is lacking. Furthermore, there is very limited information available on patient reported experiences of treatment with a small molecule compared with biological therapies. The object of this study was to provide real-world data on the efficacy of upadacitinib in the treatment of IBD in conjugation with collecting specific patient-reported feedback on acceptability and experience of treatment with upadacitinib. Methods We prospectively collected data on all IBD patients treated with upadacitinib between November 2022 and November 2023 in a large NHS Trust serving approximately 1% of the population of England. The primary objective was to assess patient response to induction at 8 weeks (UC) and 12 weeks (CD). Demographic details, biochemical markers (faecal calprotectin and CRP) and disease activity scores were recorded. We also undertook a bespoke anonymised electronic survey to assess the patient experience and views on treatment with upadacitinib in comparison to previous treatments. Results Forty-two patients were included in the study (34 UC/8 CD). The average age was 41 (range 18-76) and 27 (64%) were male. 11/34 UC patients were biologic naïve. All CD patients were biologic experienced with the majority exposed to an anti-TNF, vedolizumab and ustekinumab. Overall, 34/40 (85%) patients responded to induction treatment based on disease activity scores (27 UC, 7CD), with 68% (22 UC, 5 CD) in remission. Data was missing for two patients. Response rates were similar between biologic naïve and biologic exposed patients (82% and 86% respectively). In the UC cohort, mean calprotectin at baseline improved from 1718ug/g (range 8-6000ug/g) to 311ug/g (4-3014ug/g). In the CD cohort, mean calprotectin improved from 1719ug/g (115-5874ug/g) to 314ug/g (4-917ug/g). 3/42 (7%) of patients discontinued upadacitinib due to disease progression with the remaining 93% continuing treatment. Our patient survey results revealed very high satisfaction with treatment (85%), with the vast majority preferring treatment with upadacitinib to their previous biological therapy. Conclusion In this real-world study, induction therapy with upadacitinib was well tolerated and demonstrated good efficacy with excellent response and remission rates in a mixed patient cohort that included many with highly refractory disease. No unexpected safety signals were seen. The patient experience was overwhelmingly positive. If this data is replicated in larger studies there is an increasingly strong rationale for introducing upadacitinib earlier in the sequencing of advanced therapies.
{"title":"P589 Real-world data on upadacitinib in the treatment of inflammatory bowel disease: safe and highly effective with extremely positive patient feedback","authors":"C Harris, T Gee, A Barcan, Y Yanagisawa, M Brown, J N Gordon","doi":"10.1093/ecco-jcc/jjad212.0719","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0719","url":null,"abstract":"Background Upadacitinib is a selective Janus kinase inhibitor that has recently been approved in England for the treatment of ulcerative colitis (UC) and Crohn’s disease (CD) though real-world data is lacking. Furthermore, there is very limited information available on patient reported experiences of treatment with a small molecule compared with biological therapies. The object of this study was to provide real-world data on the efficacy of upadacitinib in the treatment of IBD in conjugation with collecting specific patient-reported feedback on acceptability and experience of treatment with upadacitinib. Methods We prospectively collected data on all IBD patients treated with upadacitinib between November 2022 and November 2023 in a large NHS Trust serving approximately 1% of the population of England. The primary objective was to assess patient response to induction at 8 weeks (UC) and 12 weeks (CD). Demographic details, biochemical markers (faecal calprotectin and CRP) and disease activity scores were recorded. We also undertook a bespoke anonymised electronic survey to assess the patient experience and views on treatment with upadacitinib in comparison to previous treatments. Results Forty-two patients were included in the study (34 UC/8 CD). The average age was 41 (range 18-76) and 27 (64%) were male. 11/34 UC patients were biologic naïve. All CD patients were biologic experienced with the majority exposed to an anti-TNF, vedolizumab and ustekinumab. Overall, 34/40 (85%) patients responded to induction treatment based on disease activity scores (27 UC, 7CD), with 68% (22 UC, 5 CD) in remission. Data was missing for two patients. Response rates were similar between biologic naïve and biologic exposed patients (82% and 86% respectively). In the UC cohort, mean calprotectin at baseline improved from 1718ug/g (range 8-6000ug/g) to 311ug/g (4-3014ug/g). In the CD cohort, mean calprotectin improved from 1719ug/g (115-5874ug/g) to 314ug/g (4-917ug/g). 3/42 (7%) of patients discontinued upadacitinib due to disease progression with the remaining 93% continuing treatment. Our patient survey results revealed very high satisfaction with treatment (85%), with the vast majority preferring treatment with upadacitinib to their previous biological therapy. Conclusion In this real-world study, induction therapy with upadacitinib was well tolerated and demonstrated good efficacy with excellent response and remission rates in a mixed patient cohort that included many with highly refractory disease. No unexpected safety signals were seen. The patient experience was overwhelmingly positive. If this data is replicated in larger studies there is an increasingly strong rationale for introducing upadacitinib earlier in the sequencing of advanced therapies.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-24DOI: 10.1093/ecco-jcc/jjad212.0352
C Soares, J Fiuza, C Rodrigues, J Gil, N Craveiro, P Ministro
Background Morphological and functional cardiac involvement is rarely seen in inflammatory bowel disease (IBD) patients but there is evidence that IBD patients have an increased risk of cardiovascular events despite the lower prevalence of traditional cardiovascular (CV) risk factors when compared to the general population. Our systematic review and meta-analysis examined the relationship between IBD and cardiac function, namely incidence of heart failure (HF) and clinical and subclinical echocardiographic changes. Methods Two medical databases, PubMed and Scopus, were systematically searched up to September 2022 to identify all studies reporting heart failure and/or echocardiographic changes in IBD patients. Results We identified 1287 original papers and included 18 in our qualitative analysis. Through analysis of echocardiographic data, we found subtle systolic and diastolic changes in IBD patients. We also found higher vascular dysfunction with increased aortic stiffness, coronary microvascular dysfunction resulting in worse cardiovascular outcomes. This group had an increased risk for HF hospitalizations compared with general population. We have also performed a meta-analysis with 9 studies which included echocardiographic data. In the IBD population we found reduced E/A ratio (Std. MD -0.51, 95% CI: -1.00 to -0.02, p = 0.04, I2 = 87%, p<0.0001), higher values of E/E’ ratio (Std. MD 1.46, 95% CI: 0.86 to 2.07, p<0.00001, I2 = 80%, p=0.02). We evaluated left ventricular function using longitudinal global strain which was decreased in IBD patients (Std. MD 0.66, 95% CI: 0.48 to 0.84, p<0.00001, I2 = 0%, p= 0.55). Overall IBD patients had increased LA diameter (Std. MD 0.06, 95% CI: 0.12 to 0.24, p = 0.50, I2 = 20%), and an increased LA area (Std. MD 0.03, 95% CI: 0.24 to 0.29, p = 0.85, I2 = 0%), but no statistical significance was not reached. A significant increase in inter-atrial and right intra-atrial conduction delay was observed in IBD patients (Std. MD 0.88, 95% CI: 0.45 to 1.31, p<0.0001, I2 = 42%; Std. MD 0.9, 95% CI: 0.57 to 1.22, p < 0.00001, I2 = 0%, respectively). We found no significant bias in our analysis using CASP checklist. Conclusion There is significant evidence to conclude that the IBD population has increased risk for LV and atrial dysfunction, vascular changes, arrhythmias, and heart failure hospitalization. Screening with sensitive imaging like speckle tracking echocardiography could identify early subclinical changes. IBD is in fact a cardiovascular risk factor and tight inflammation control may reduce the risk.
{"title":"P222 Inflammatory Bowel Disease and cardiac function: a systematic review of literature with meta-analysis","authors":"C Soares, J Fiuza, C Rodrigues, J Gil, N Craveiro, P Ministro","doi":"10.1093/ecco-jcc/jjad212.0352","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0352","url":null,"abstract":"Background Morphological and functional cardiac involvement is rarely seen in inflammatory bowel disease (IBD) patients but there is evidence that IBD patients have an increased risk of cardiovascular events despite the lower prevalence of traditional cardiovascular (CV) risk factors when compared to the general population. Our systematic review and meta-analysis examined the relationship between IBD and cardiac function, namely incidence of heart failure (HF) and clinical and subclinical echocardiographic changes. Methods Two medical databases, PubMed and Scopus, were systematically searched up to September 2022 to identify all studies reporting heart failure and/or echocardiographic changes in IBD patients. Results We identified 1287 original papers and included 18 in our qualitative analysis. Through analysis of echocardiographic data, we found subtle systolic and diastolic changes in IBD patients. We also found higher vascular dysfunction with increased aortic stiffness, coronary microvascular dysfunction resulting in worse cardiovascular outcomes. This group had an increased risk for HF hospitalizations compared with general population. We have also performed a meta-analysis with 9 studies which included echocardiographic data. In the IBD population we found reduced E/A ratio (Std. MD -0.51, 95% CI: -1.00 to -0.02, p = 0.04, I2 = 87%, p&lt;0.0001), higher values of E/E’ ratio (Std. MD 1.46, 95% CI: 0.86 to 2.07, p&lt;0.00001, I2 = 80%, p=0.02). We evaluated left ventricular function using longitudinal global strain which was decreased in IBD patients (Std. MD 0.66, 95% CI: 0.48 to 0.84, p&lt;0.00001, I2 = 0%, p= 0.55). Overall IBD patients had increased LA diameter (Std. MD 0.06, 95% CI: 0.12 to 0.24, p = 0.50, I2 = 20%), and an increased LA area (Std. MD 0.03, 95% CI: 0.24 to 0.29, p = 0.85, I2 = 0%), but no statistical significance was not reached. A significant increase in inter-atrial and right intra-atrial conduction delay was observed in IBD patients (Std. MD 0.88, 95% CI: 0.45 to 1.31, p&lt;0.0001, I2 = 42%; Std. MD 0.9, 95% CI: 0.57 to 1.22, p &lt; 0.00001, I2 = 0%, respectively). We found no significant bias in our analysis using CASP checklist. Conclusion There is significant evidence to conclude that the IBD population has increased risk for LV and atrial dysfunction, vascular changes, arrhythmias, and heart failure hospitalization. Screening with sensitive imaging like speckle tracking echocardiography could identify early subclinical changes. IBD is in fact a cardiovascular risk factor and tight inflammation control may reduce the risk.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-24DOI: 10.1093/ecco-jcc/jjad212.1117
A Giordano, I Pérez Martínez, J P Gisbert, E Ricart, M A M Dolores, F Mesonero, D C P M Luisa, M Rivero, E Iglesias Flores, S Fernández-Prada, M Calafat, M Arroyo Villarino, M Á de Jorge Turrión, E Rodríguez-González, P Corsino Roche, D Carpio, E Brunet, F Rodriguez Moranta, L Arias García, I Pascual, F Bermejo, L Madero, M Esteve, C González Muñoza, P Martínez-Montiel, J M Huguet, J L Pérez Calle, I Rodríguez-Lago, M Sierra Ausín, R H Lorente Poyatos, O García-Bosch, G Surís Marín, C Taxonera, Á Ponferrada-Díaz, M Barreiro-de Acosta, L Bujanda, R Blat Serra, L Ramos, E Domènech, E Garcia Planella
Background Crohn's disease (CD) presents differences in genetics, inflammatory components, and microbiota depending on its location. Therapy efficacy may be linked to disease location, but existing research has yielded conflicting results. This study aims to investigate the impact of CD location on first-line biologic therapy requirement and persistence and the risk of intestinal resections. Methods CD patients included in the prospectively maintained ENEIDA registry between January 2005 and May 2023 were considered for the study. Demographics, disease phenotype and location, complications, the utilization of biologic therapies, and intestinal surgeries were analyzed. Cox proportional hazards and Kaplan-Meier methods were used for the analysis of biologic requirement and persistence and risk of surgery. Results A cohort of 17,508 patients was included, with a median follow-up period of 6 years (IQR 2-10 years). The most common disease locations were ileal (43.3%) and ileocolonic (39%), with lower frequency for colonic (16.4%) and upper-gastrointestinal disease (1.2%). A first biologic was used in 54.5% of patients (n=9,543), with a higher 5-year requirement in ileocolonic disease compared to ileal and colonic disease (60.1% vs 53% vs 49.9%, p<0.001). Ileal disease presented the lowest 5-year persistence rate compared to ileocolonic and colonic location (39% vs 41.6% vs 45.1%, p=0.004). Ileal location (aHR 1.084, 95%CI 1.006-1.167), female sex (adjusted Hazard Ratio [aHR] 1.173, 95%CI 1.096-1.254), extraintestinal manifestations (aHR 1.163, 95%CI 1.080-1.251), a history of abdominal surgery (aHR 1.539, 95%CI 1.426-1.661) were independent predictors of drug discontinuation. The cumulative need for intestinal resections was 25.8% (n=4,512), with ileal disease showing the highest hazard for 5-year surgery compared to ileo-colonic and colonic location (19.5% vs 17.8 vs 8.3%, p<0.001). Ileal disease (aHR 1.194, 95%CI 1.101-1.295), stricturing (aHR 2.575, 95%CI 2.378-2.787) and penetrating phenotypes (aHR 2.485, 95%CI 2.261-2.734), a history of biologic therapy (aHR 1.386, 95%CI 1.262-1.522) and smoking (aHR 1.089, 95%CI 1.004-1.180) were independent predictors of intestinal resections. Survival analysis for biologic requirement, persistence, and the risk of intestinal resections is illustrated in Figure 1. Conclusion Ileal disease is associated with a higher requirement for biologic therapy, showing the poorest persistence. It also demonstrates the highest probability of intestinal resections among CD locations. These findings provide valuable insights into tailoring treatment strategies based on CD location.
背景克罗恩病（CD）因发病部位不同而在遗传学、炎症成分和微生物群方面存在差异。治疗效果可能与患病部位有关，但现有研究得出的结果并不一致。本研究旨在探讨 CD 所在位置对一线生物治疗需求和持续性以及肠切除风险的影响。方法 本研究考虑了 2005 年 1 月至 2023 年 5 月期间纳入前瞻性 ENEIDA 登记的 CD 患者。研究分析了人口统计学、疾病表型和部位、并发症、生物疗法的使用以及肠道手术。采用 Cox 比例危险度法和 Kaplan-Meier 法分析生物制剂需求和持续性以及手术风险。结果 共纳入 17,508 名患者，中位随访时间为 6 年（IQR 2-10 年）。最常见的疾病部位是回肠（43.3%）和回结肠（39%），结肠（16.4%）和上消化道疾病（1.2%）的发病率较低。54.5%的患者（n=9,543）首次使用生物制剂，与回肠和结肠疾病相比，回结肠疾病的5年需求量更高（60.1% vs 53% vs 49.9%，p<0.001）。与回结肠和结肠疾病相比，回肠疾病的 5 年持续率最低（39% vs 41.6% vs 45.1%，p=0.004）。回肠部位（aHR 1.084，95%CI 1.006-1.167）、女性性别（调整后危险比 [aHR] 1.173，95%CI 1.096-1.254）、肠道外表现（aHR 1.163，95%CI 1.080-1.251）、腹部手术史（aHR 1.539，95%CI 1.426-1.661）是停药的独立预测因素。肠切除术的累计需求为 25.8%（n=4,512），与回肠结肠和结肠位置相比，回肠疾病显示出最高的 5 年手术风险（19.5% vs 17.8 vs 8.3%，p<0.001）。回肠疾病（aHR 1.194，95%CI 1.101-1.295）、狭窄（aHR 2.575，95%CI 2.378-2.787）和穿透表型（aHR 2.485，95%CI 2.261-2.734）、生物治疗史（aHR 1.386，95%CI 1.262-1.522）和吸烟（aHR 1.089，95%CI 1.004-1.180）是肠切除的独立预测因素。图 1 显示了生物需求、持续性和肠切除风险的生存分析。结论 回肠疾病对生物制剂治疗的需求较高，显示出最差的持续性。同时，在 CD 病变部位中，回肠切除的概率也最高。这些发现为根据 CD 病变部位制定治疗策略提供了宝贵的见解。
{"title":"P987 Impact of Crohn’s Disease Location on Biologic Therapy Persistence and the Risk of Intestinal Surgery: Insights from the ENEIDA Registry (the DISCOLOC Study)","authors":"A Giordano, I Pérez Martínez, J P Gisbert, E Ricart, M A M Dolores, F Mesonero, D C P M Luisa, M Rivero, E Iglesias Flores, S Fernández-Prada, M Calafat, M Arroyo Villarino, M Á de Jorge Turrión, E Rodríguez-González, P Corsino Roche, D Carpio, E Brunet, F Rodriguez Moranta, L Arias García, I Pascual, F Bermejo, L Madero, M Esteve, C González Muñoza, P Martínez-Montiel, J M Huguet, J L Pérez Calle, I Rodríguez-Lago, M Sierra Ausín, R H Lorente Poyatos, O García-Bosch, G Surís Marín, C Taxonera, Á Ponferrada-Díaz, M Barreiro-de Acosta, L Bujanda, R Blat Serra, L Ramos, E Domènech, E Garcia Planella","doi":"10.1093/ecco-jcc/jjad212.1117","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.1117","url":null,"abstract":"Background Crohn's disease (CD) presents differences in genetics, inflammatory components, and microbiota depending on its location. Therapy efficacy may be linked to disease location, but existing research has yielded conflicting results. This study aims to investigate the impact of CD location on first-line biologic therapy requirement and persistence and the risk of intestinal resections. Methods CD patients included in the prospectively maintained ENEIDA registry between January 2005 and May 2023 were considered for the study. Demographics, disease phenotype and location, complications, the utilization of biologic therapies, and intestinal surgeries were analyzed. Cox proportional hazards and Kaplan-Meier methods were used for the analysis of biologic requirement and persistence and risk of surgery. Results A cohort of 17,508 patients was included, with a median follow-up period of 6 years (IQR 2-10 years). The most common disease locations were ileal (43.3%) and ileocolonic (39%), with lower frequency for colonic (16.4%) and upper-gastrointestinal disease (1.2%). A first biologic was used in 54.5% of patients (n=9,543), with a higher 5-year requirement in ileocolonic disease compared to ileal and colonic disease (60.1% vs 53% vs 49.9%, p&lt;0.001). Ileal disease presented the lowest 5-year persistence rate compared to ileocolonic and colonic location (39% vs 41.6% vs 45.1%, p=0.004). Ileal location (aHR 1.084, 95%CI 1.006-1.167), female sex (adjusted Hazard Ratio [aHR] 1.173, 95%CI 1.096-1.254), extraintestinal manifestations (aHR 1.163, 95%CI 1.080-1.251), a history of abdominal surgery (aHR 1.539, 95%CI 1.426-1.661) were independent predictors of drug discontinuation. The cumulative need for intestinal resections was 25.8% (n=4,512), with ileal disease showing the highest hazard for 5-year surgery compared to ileo-colonic and colonic location (19.5% vs 17.8 vs 8.3%, p&lt;0.001). Ileal disease (aHR 1.194, 95%CI 1.101-1.295), stricturing (aHR 2.575, 95%CI 2.378-2.787) and penetrating phenotypes (aHR 2.485, 95%CI 2.261-2.734), a history of biologic therapy (aHR 1.386, 95%CI 1.262-1.522) and smoking (aHR 1.089, 95%CI 1.004-1.180) were independent predictors of intestinal resections. Survival analysis for biologic requirement, persistence, and the risk of intestinal resections is illustrated in Figure 1. Conclusion Ileal disease is associated with a higher requirement for biologic therapy, showing the poorest persistence. It also demonstrates the highest probability of intestinal resections among CD locations. These findings provide valuable insights into tailoring treatment strategies based on CD location.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559394","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-24DOI: 10.1093/ecco-jcc/jjad212.1079
E Fuentes-Valenzuela, I Bastón-Rey, F J García-Alonso, E Leo Carnerero, I Garcia de la Filia, A Pedraza Pérez, R M Sáiz Chumillas, A Pascual Oliver, C Muñoz Villafranca, V Moreno, C Suárez Ferrer, G Molina Arriero, R Ferreiro-Iglesias, P Vega Villaamil, D Gardeazábal Mateos, J X Segarra-Ortega, A Garrido Marín, A I Doallo, A Elosua, H Alonso-Galán, E Brunet- Mas, N Jimenez García, F López Romero-Salazar, B Velayos, L Carballo-Folgoso, C Pérez Santamaría, L Mata Román, A Núñez Ortiz, J Barrio, M Barreiro-de Acosta, A Gutiérrez-Casbas
Background Few small studies have assessed the efficacy of topical therapy with tacrolimus in patients with ulcerative colitis (UC). The aim of our study was to evaluate its effectiveness and safety in a real-world setting. Methods A multicenter observational retrospective study at 25 Spanish GETECCU hospitals was performed. Adult patients with UC who received topical tacrolimus from January 2009 to January 2023 were eligible. Inclusion criteria were proctitis, left-sided, or extensive colitis with persistent distal colonic activity confirmed endoscopically during the previous 3 months. Clinical and biochemical data were collected at baseline, week 4, 8 and 54. Tacrolimus trough levels were evaluated in week 4 and 8. Primary outcome was clinical response at week 8, defined as a ≥3 points or ≥30% decrease of partial Mayo score with ≥1point reduction in the bleeding score. Mean partial mayo scores were compared using the t-test. A p<0.05 was considered statistically significant. Results 106 patients, 59 (55.6%) males, median age 48.7 years (IQR:39.9-59.7), received rectal tacrolimus during a median of 9.7 weeks (IQR:5-18.7). Sixty-four patients (60.4%) received suppositories, 41 (38.7%) enemas and 1 patient an ointment (0.9%). Thirty (28.3%) were patients with proctitis, 45 (42.4%) with left colitis and 31 (29.2%) with extensive colitis. At baseline, 54 patients (50.9%) received concomitant biological/small molecules therapy, while 14 patients received immunomodulators. Most common dose was 2 mg (84%) Q24H (71.7%). A significant decrease in mean partial mayo score was observed at week 4 and 8 (figure 1). Clinical response at week 8 was achieved in 63 patients (66.3%) and clinical remission in 42 (44.2%). 32 patients (33.7%) were non-responder at week 8. Clinical response and remission at week 4 were achieved in 56 (57.7%) and 33 (34.4%), respectively. Clinical response at week 8 was similar between the group with concomitant biological therapy and without (64.6.9% vs 68.1%, p=0.8). Clinical response at week 8 was similar among different extensions (proctitis: 55.6%; left colitis: 80%; extensive colitis 57.1%; p=0.052). Clinical outcomes are detailed in table 1. Median tacrolimus trough levels at week 4 was 3.4 ng/ml (IQR 1.5-6.7) and 2.9 ng/ml (IQR 1.5-6) at week 8. Adverse events were detected in 21 patients (19.8%), Thirteen were graded as mild and 8 moderate. Treatment was ceased due to adverse events in 11 (10.4%) patients. Conclusion Topical tacrolimus is effective in UC achieving clinical response in more than sixty percent at week 8 with even lower doses than reported in clinical trials. Adverse events reported in nearly 20% of patients were mostly mild.
{"title":"P949 Effectiveness and safety of rectal tacrolimus in patients with ulcerative colitis. TACRO-TOPIC study. A multicenter study from the young group of GETECCU","authors":"E Fuentes-Valenzuela, I Bastón-Rey, F J García-Alonso, E Leo Carnerero, I Garcia de la Filia, A Pedraza Pérez, R M Sáiz Chumillas, A Pascual Oliver, C Muñoz Villafranca, V Moreno, C Suárez Ferrer, G Molina Arriero, R Ferreiro-Iglesias, P Vega Villaamil, D Gardeazábal Mateos, J X Segarra-Ortega, A Garrido Marín, A I Doallo, A Elosua, H Alonso-Galán, E Brunet- Mas, N Jimenez García, F López Romero-Salazar, B Velayos, L Carballo-Folgoso, C Pérez Santamaría, L Mata Román, A Núñez Ortiz, J Barrio, M Barreiro-de Acosta, A Gutiérrez-Casbas","doi":"10.1093/ecco-jcc/jjad212.1079","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.1079","url":null,"abstract":"Background Few small studies have assessed the efficacy of topical therapy with tacrolimus in patients with ulcerative colitis (UC). The aim of our study was to evaluate its effectiveness and safety in a real-world setting. Methods A multicenter observational retrospective study at 25 Spanish GETECCU hospitals was performed. Adult patients with UC who received topical tacrolimus from January 2009 to January 2023 were eligible. Inclusion criteria were proctitis, left-sided, or extensive colitis with persistent distal colonic activity confirmed endoscopically during the previous 3 months. Clinical and biochemical data were collected at baseline, week 4, 8 and 54. Tacrolimus trough levels were evaluated in week 4 and 8. Primary outcome was clinical response at week 8, defined as a ≥3 points or ≥30% decrease of partial Mayo score with ≥1point reduction in the bleeding score. Mean partial mayo scores were compared using the t-test. A p&lt;0.05 was considered statistically significant. Results 106 patients, 59 (55.6%) males, median age 48.7 years (IQR:39.9-59.7), received rectal tacrolimus during a median of 9.7 weeks (IQR:5-18.7). Sixty-four patients (60.4%) received suppositories, 41 (38.7%) enemas and 1 patient an ointment (0.9%). Thirty (28.3%) were patients with proctitis, 45 (42.4%) with left colitis and 31 (29.2%) with extensive colitis. At baseline, 54 patients (50.9%) received concomitant biological/small molecules therapy, while 14 patients received immunomodulators. Most common dose was 2 mg (84%) Q24H (71.7%). A significant decrease in mean partial mayo score was observed at week 4 and 8 (figure 1). Clinical response at week 8 was achieved in 63 patients (66.3%) and clinical remission in 42 (44.2%). 32 patients (33.7%) were non-responder at week 8. Clinical response and remission at week 4 were achieved in 56 (57.7%) and 33 (34.4%), respectively. Clinical response at week 8 was similar between the group with concomitant biological therapy and without (64.6.9% vs 68.1%, p=0.8). Clinical response at week 8 was similar among different extensions (proctitis: 55.6%; left colitis: 80%; extensive colitis 57.1%; p=0.052). Clinical outcomes are detailed in table 1. Median tacrolimus trough levels at week 4 was 3.4 ng/ml (IQR 1.5-6.7) and 2.9 ng/ml (IQR 1.5-6) at week 8. Adverse events were detected in 21 patients (19.8%), Thirteen were graded as mild and 8 moderate. Treatment was ceased due to adverse events in 11 (10.4%) patients. Conclusion Topical tacrolimus is effective in UC achieving clinical response in more than sixty percent at week 8 with even lower doses than reported in clinical trials. Adverse events reported in nearly 20% of patients were mostly mild.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-24DOI: 10.1093/ecco-jcc/jjad212.0648
A Jatkowska, B White, I Campbell, E Brownson, B Short, J Clowe, J P Seenan, D R Gaya, S Din, G T Ho, E Robertson, C Mowat, S Milling, J MacDonald, K Gerasimidis
Background Biologics, such as anti-TNFα agents, are commonly used in the management of Crohn’s disease (CD). A significant proportion of patients do not respond to treatment, necessitating the exploration of pre-treatment predictors of treatment response. Methods Anti-TNFα-naïve adults with active CD (Crohn’s Disease Activity Index; CDAI≥150) participating in an RCT (NCT04859088) were randomised to receive adalimumab monotherapy or adalimumab combination therapy with 50% partial enteral nutrition (PEN). Treatment response (CDAI<150) was assessed after 6 weeks, baseline diet was assessed with EPIC-Norfolk FFQ, alternative Mediterranean diet scores (aMED), and principal component analysis (PCA) with orthogonal (varimax) rotation was used to identify data-derived dietary patterns. Baseline predictors evaluated included PEN use, steroid use, immunomodulator use, age, disease duration, CDAI, C-Reactive protein (CRP), albumin, haemoglobin, Scottish Index of Multiple Deprivation (SIMD) score, adherence to dietary patterns identified, aMED score, smoking status, alcohol consumption, physical activity level, body mass index (BMI), fat mass (kg/m2), fat-free mass (kg/m2), and handgrip strength. Differential analysis between responders and non-responders was carried out with general linear model or chi-square test when appropriate. Random forest model with recursive feature elimination (RF-RFE) was used to identify the most predictive factors of treatment response. Results Of 42 participants recruited to the study, 62% (26) responded to treatment. PCA revealed four dietary patterns (Figure 1A). Responders to adalimumab were younger (mean (SD): 36.0 (17.1) vs 50.8 (10.0), P=0.004), had lower baseline CDAI (mean (SD): 228 (62) vs 286 (78), P=0.018), higher CRP (14.5 (19.2) vs 4.6 (5.8) mg/L, P=0.036), were less likely to smoke (31% (5 of 16) vs 8% (2 of 26), and less likely to adhere to a dietary pattern characterised by high consumption of animal products (PC2) (P=0.030). Adherence to PC2 also correlated positively with age (r=0.327, P=0.035). The RF-RFE algorithm highlighted young age, low baseline CDAI and low PC2 adherence as key factors (Sensitivity: 77%, Specificity: 63%, PPV: 77%, NPV: 63%, OOB: 29%, P=0.012) (Figure 1B). Interestingly, exclusion of dietary factors improved diagnostic performance of the model (Sensitivity: 77%, Specificity: 75%, PPV: 83%, NPV: 67%, OOB: 24%, P=0.003) (Figure 1C), indicating potential interactions by other factors like age. Conclusion Young age, non-smoking, low baseline CDAI and elevated CRP predict adalimumab response in anti-TNFα-naïve adults. While dietary factors may also play a role, their impact seems confounded by other non-dietary factors. Further research is warranted in this area.
{"title":"P518 Dietary and non-dietary predictors of treatment response to adalimumab in anti-TNFα-naïve adults with Crohn’s disease","authors":"A Jatkowska, B White, I Campbell, E Brownson, B Short, J Clowe, J P Seenan, D R Gaya, S Din, G T Ho, E Robertson, C Mowat, S Milling, J MacDonald, K Gerasimidis","doi":"10.1093/ecco-jcc/jjad212.0648","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0648","url":null,"abstract":"Background Biologics, such as anti-TNFα agents, are commonly used in the management of Crohn’s disease (CD). A significant proportion of patients do not respond to treatment, necessitating the exploration of pre-treatment predictors of treatment response. Methods Anti-TNFα-naïve adults with active CD (Crohn’s Disease Activity Index; CDAI≥150) participating in an RCT (NCT04859088) were randomised to receive adalimumab monotherapy or adalimumab combination therapy with 50% partial enteral nutrition (PEN). Treatment response (CDAI&lt;150) was assessed after 6 weeks, baseline diet was assessed with EPIC-Norfolk FFQ, alternative Mediterranean diet scores (aMED), and principal component analysis (PCA) with orthogonal (varimax) rotation was used to identify data-derived dietary patterns. Baseline predictors evaluated included PEN use, steroid use, immunomodulator use, age, disease duration, CDAI, C-Reactive protein (CRP), albumin, haemoglobin, Scottish Index of Multiple Deprivation (SIMD) score, adherence to dietary patterns identified, aMED score, smoking status, alcohol consumption, physical activity level, body mass index (BMI), fat mass (kg/m2), fat-free mass (kg/m2), and handgrip strength. Differential analysis between responders and non-responders was carried out with general linear model or chi-square test when appropriate. Random forest model with recursive feature elimination (RF-RFE) was used to identify the most predictive factors of treatment response. Results Of 42 participants recruited to the study, 62% (26) responded to treatment. PCA revealed four dietary patterns (Figure 1A). Responders to adalimumab were younger (mean (SD): 36.0 (17.1) vs 50.8 (10.0), P=0.004), had lower baseline CDAI (mean (SD): 228 (62) vs 286 (78), P=0.018), higher CRP (14.5 (19.2) vs 4.6 (5.8) mg/L, P=0.036), were less likely to smoke (31% (5 of 16) vs 8% (2 of 26), and less likely to adhere to a dietary pattern characterised by high consumption of animal products (PC2) (P=0.030). Adherence to PC2 also correlated positively with age (r=0.327, P=0.035). The RF-RFE algorithm highlighted young age, low baseline CDAI and low PC2 adherence as key factors (Sensitivity: 77%, Specificity: 63%, PPV: 77%, NPV: 63%, OOB: 29%, P=0.012) (Figure 1B). Interestingly, exclusion of dietary factors improved diagnostic performance of the model (Sensitivity: 77%, Specificity: 75%, PPV: 83%, NPV: 67%, OOB: 24%, P=0.003) (Figure 1C), indicating potential interactions by other factors like age. Conclusion Young age, non-smoking, low baseline CDAI and elevated CRP predict adalimumab response in anti-TNFα-naïve adults. While dietary factors may also play a role, their impact seems confounded by other non-dietary factors. Further research is warranted in this area.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-24DOI: 10.1093/ecco-jcc/jjad212.0654
A Afzali, M Regueiro, A J Yarur, Y Zabana, S C Ng, S S Menon, A McDonnell, K Lazin, M Keating, A Bhattacharjee, D Branquinho, E Bananis, L Peyrin-Biroulet
Background Etrasimod is an oral, once-daily (QD), selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). Unlike the other S1P receptor modulator approved for UC, etrasimod and its metabolites do not have a molecular structure to inhibit monoamine oxidase (MAO).1 Coadministration of drugs that inhibit MAO with opioids and antidepressants may increase the risk of adverse events (AEs), including hypertension.2 This post hoc analysis evaluated the incidence of AEs potentially related to serotonin syndrome in patients taking etrasimod and concomitant opioids or antidepressants in the phase 3 ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369) trials. Methods Safety data pooled from both trials were analysed in patients receiving etrasimod 2 mg QD (up to 52 weeks of exposure) with/without concomitant opioids or antidepressants. We report the proportions of patients who had ≥1 concurrent AE potentially related to serotonin syndrome, consisting of one standardised MedDRA Query, one query based on the Hunter Criteria and supplemental preferred terms (pyrexia, tachycardia and hypertension-related AEs).3 Results Among 527 patients receiving etrasimod, 77 (14.6%) and 35 (6.6%) patients were taking concomitant opioids or antidepressants, respectively. Most patients on concomitant opioids or antidepressants were White (80.0–88.3%); male (50.6–51.4%); their median age was 35.0 (18.0–70.0) and 41.0 (19.0–74.0) years, respectively. More patients with vs without concomitant opioids or antidepressants, respectively, consumed alcohol (40.3% vs 24.7% and 48.6% vs 25.4%) and used tobacco (40.3% vs 20.9% and 34.3% vs 23.0%). The incidence of other AEs potentially related to serotonin syndrome was low and generally comparable in all subgroups; reported rates of pyrexia and tachycardia were similar in patients with/without concomitant opioids or antidepressants (Table). Hypertension-related AEs were infrequent and generally balanced. No AEs per the Hunter Criteria were reported in patients on concomitant opioids or antidepressants (Table). No reported AEs were serious or led to treatment discontinuation among patients taking these concomitant medications. Conclusion The incidence of AEs was low and comparable in patients receiving etrasimod with or without concomitant opioids or antidepressants. This analysis supports the low likelihood of clinically relevant drug–drug interactions between etrasimod and medications commonly prescribed to patients with UC, such as opioids or antidepressants. References 1. Lee CA et al. Clin Pharmacol Drug Dev 2023; 12: 553–571. 2. Sands BE et al. J Crohns Colitis 2023; online ahead of print. 3. Dunkley EJC et al. QJM 2003; 96: 635–642.
背景 Etrasimod 是一种口服、每日一次（QD）的选择性 1-磷酸鞘磷脂（S1P）1,4,5 受体调节剂，用于治疗中度至重度活动性溃疡性结肠炎（UC）。与其他获批用于治疗 UC 的 S1P 受体调节剂不同，依曲莫德及其代谢物不具有抑制单胺氧化酶（MAO）的分子结构1 。这项事后分析评估了ELEVATE UC 52（NCT03945188）和ELEVATE UC 12（NCT03996369）三期试验中服用依曲莫德和同时服用阿片类药物或抗抑郁药的患者中可能与血清素综合征有关的AEs的发生率。方法 我们分析了这两项试验中汇集的安全性数据，对象是接受依曲西莫德 2 毫克 QD（最多暴露 52 周）治疗，同时服用/不同时服用阿片类药物或抗抑郁药的患者。我们报告了并发≥1种可能与血清素综合征有关的AE的患者比例，包括1种标准化MedDRA查询、1种基于亨特标准的查询和补充首选术语（发热、心动过速和高血压相关AE）3 结果 在接受依曲莫德治疗的527例患者中，分别有77例（14.6%）和35例（6.6%）患者同时服用阿片类药物或抗抑郁药物。大多数同时服用阿片类药物或抗抑郁药物的患者为白人（80.0-88.3%）；男性（50.6-51.4%）；年龄中位数分别为 35.0（18.0-70.0）岁和 41.0（19.0-74.0）岁。同时服用阿片类药物或抗抑郁药物与未同时服用阿片类药物或抗抑郁药物的患者中，饮酒（40.3% 对 24.7%，48.6% 对 25.4%）和吸烟（40.3% 对 20.9%，34.3% 对 23.0%）的人数分别较多。可能与血清素综合征有关的其他 AEs 发生率较低，在所有亚组中大致相当；报告的热病和心动过速发生率在同时服用/未同时服用阿片类药物或抗抑郁药的患者中相似（表）。与高血压相关的 AEs 并不常见，总体上比较均衡。在同时服用阿片类药物或抗抑郁药物的患者中，未出现符合亨特标准的 AEs（见表）。在同时服用这些药物的患者中，没有报告严重的不良反应或导致治疗中断的不良反应。结论 在接受依曲西莫德治疗的患者中，无论是否同时服用阿片类药物或抗抑郁药物，AEs 的发生率都很低，且具有可比性。该分析表明，依曲莫德与 UC 患者常用药物（如阿片类药物或抗抑郁药）之间发生临床相关药物相互作用的可能性较低。参考文献 1.Lee CA et al. Clin Pharmacol Drug Dev 2023; 12: 553-571.2.Sands BE et al. J Crohns Colitis 2023; online ahead of print.3.Dunkley EJC et al.QJM 2003; 96: 635-642.
{"title":"P524 Etrasimod shows low risk of adverse events following concomitant use with opioids or antidepressants in patients with ulcerative colitis","authors":"A Afzali, M Regueiro, A J Yarur, Y Zabana, S C Ng, S S Menon, A McDonnell, K Lazin, M Keating, A Bhattacharjee, D Branquinho, E Bananis, L Peyrin-Biroulet","doi":"10.1093/ecco-jcc/jjad212.0654","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0654","url":null,"abstract":"Background Etrasimod is an oral, once-daily (QD), selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). Unlike the other S1P receptor modulator approved for UC, etrasimod and its metabolites do not have a molecular structure to inhibit monoamine oxidase (MAO).1 Coadministration of drugs that inhibit MAO with opioids and antidepressants may increase the risk of adverse events (AEs), including hypertension.2 This post hoc analysis evaluated the incidence of AEs potentially related to serotonin syndrome in patients taking etrasimod and concomitant opioids or antidepressants in the phase 3 ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369) trials. Methods Safety data pooled from both trials were analysed in patients receiving etrasimod 2 mg QD (up to 52 weeks of exposure) with/without concomitant opioids or antidepressants. We report the proportions of patients who had ≥1 concurrent AE potentially related to serotonin syndrome, consisting of one standardised MedDRA Query, one query based on the Hunter Criteria and supplemental preferred terms (pyrexia, tachycardia and hypertension-related AEs).3 Results Among 527 patients receiving etrasimod, 77 (14.6%) and 35 (6.6%) patients were taking concomitant opioids or antidepressants, respectively. Most patients on concomitant opioids or antidepressants were White (80.0–88.3%); male (50.6–51.4%); their median age was 35.0 (18.0–70.0) and 41.0 (19.0–74.0) years, respectively. More patients with vs without concomitant opioids or antidepressants, respectively, consumed alcohol (40.3% vs 24.7% and 48.6% vs 25.4%) and used tobacco (40.3% vs 20.9% and 34.3% vs 23.0%). The incidence of other AEs potentially related to serotonin syndrome was low and generally comparable in all subgroups; reported rates of pyrexia and tachycardia were similar in patients with/without concomitant opioids or antidepressants (Table). Hypertension-related AEs were infrequent and generally balanced. No AEs per the Hunter Criteria were reported in patients on concomitant opioids or antidepressants (Table). No reported AEs were serious or led to treatment discontinuation among patients taking these concomitant medications. Conclusion The incidence of AEs was low and comparable in patients receiving etrasimod with or without concomitant opioids or antidepressants. This analysis supports the low likelihood of clinically relevant drug–drug interactions between etrasimod and medications commonly prescribed to patients with UC, such as opioids or antidepressants. References 1. Lee CA et al. Clin Pharmacol Drug Dev 2023; 12: 553–571. 2. Sands BE et al. J Crohns Colitis 2023; online ahead of print. 3. Dunkley EJC et al. QJM 2003; 96: 635–642.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-24DOI: 10.1093/ecco-jcc/jjad212.0589
A Ben-Tov, T Achler, T Patalon, S Gazit, H Yanai, S Shulman, A Assa
Background Ocular manifestations (OM) in patients with inflammatory bowel disease (IBD) are uncommon, particularly in children. We aimed to explore the prevalence, characteristics and risk factors of IBD associated OM in a large epidemiologic cohort-based study. Methods A cross-sectional study was performed using the Maccabi Healthcare Services (MHS) database. The eligible population included all patients diagnosed with IBD as children (<18 years) between January 2005 and July 2023. An additional analysis was conducted on patients diagnosed with ocular disease during childhood (<18 years) and IBD during childhood or adulthood. Results Out of 2,567 children with IBD (males 55%, Crohn’s disease 64%), 78 (3%) were diagnosed with OM at any time during disease course. In 54 patients (69%), the OM occurred after IBD diagnosis with a median time of 2.6 (0.47-7) years between the two events, whereas in 24 patients (31%) OM preceded IBD diagnosis with a median time of 2.1 (0.6-5.7) years. OM was significantly associated with Crohn’s disease, compared with ulcerative colitis (78.2% vs. 63.6% in the entire cohort; p=0.03). The presence of OM was associated with increased usage of systemic corticosteroids (p<0.001), biologic agents (p=0.04) and longer duration since IBD diagnosis (p=0.04). There were 55 patients with OM during childhood who were ever diagnosed with IBD. In this population OM was also associated with increased usage of systemic corticosteroids (p<0.001) and increased hospitalization rate per year (p=0.048). The annual prevalence of OM increased gradually from 10/1000 patients in 2005 to 22/1000 patients in 2022 (p=0.55). Conclusion Ocular involvement in children with IBD is rare and more common in patients with Crohn’s disease with a stable prevalence rate. It is associated with a longer duration of disease, greater usage of systemic corticosteroids and biologic agents and with a higher rate of hospitalizations, potentially representing a more severe disease course.
{"title":"P459 The prevalence and characteristics of inflammatory bowel disease-related ocular involvement in children","authors":"A Ben-Tov, T Achler, T Patalon, S Gazit, H Yanai, S Shulman, A Assa","doi":"10.1093/ecco-jcc/jjad212.0589","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0589","url":null,"abstract":"Background Ocular manifestations (OM) in patients with inflammatory bowel disease (IBD) are uncommon, particularly in children. We aimed to explore the prevalence, characteristics and risk factors of IBD associated OM in a large epidemiologic cohort-based study. Methods A cross-sectional study was performed using the Maccabi Healthcare Services (MHS) database. The eligible population included all patients diagnosed with IBD as children (&lt;18 years) between January 2005 and July 2023. An additional analysis was conducted on patients diagnosed with ocular disease during childhood (&lt;18 years) and IBD during childhood or adulthood. Results Out of 2,567 children with IBD (males 55%, Crohn’s disease 64%), 78 (3%) were diagnosed with OM at any time during disease course. In 54 patients (69%), the OM occurred after IBD diagnosis with a median time of 2.6 (0.47-7) years between the two events, whereas in 24 patients (31%) OM preceded IBD diagnosis with a median time of 2.1 (0.6-5.7) years. OM was significantly associated with Crohn’s disease, compared with ulcerative colitis (78.2% vs. 63.6% in the entire cohort; p=0.03). The presence of OM was associated with increased usage of systemic corticosteroids (p&lt;0.001), biologic agents (p=0.04) and longer duration since IBD diagnosis (p=0.04). There were 55 patients with OM during childhood who were ever diagnosed with IBD. In this population OM was also associated with increased usage of systemic corticosteroids (p&lt;0.001) and increased hospitalization rate per year (p=0.048). The annual prevalence of OM increased gradually from 10/1000 patients in 2005 to 22/1000 patients in 2022 (p=0.55). Conclusion Ocular involvement in children with IBD is rare and more common in patients with Crohn’s disease with a stable prevalence rate. It is associated with a longer duration of disease, greater usage of systemic corticosteroids and biologic agents and with a higher rate of hospitalizations, potentially representing a more severe disease course.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-24DOI: 10.1093/ecco-jcc/jjad212.1253
J Zhao, M Zhang, J Ye, X Li
Background Background Social isolation and loneliness pose significant public health challenges globally. The objective of this study is to investigate the association between social isolation, loneliness, and the risk of inflammatory bowel disease (IBD), ulcerative colitis (UC) and Crohn's disease (CD). Methods Methods 275,157 UK adults from the UK Biobank (UKB) was analyzed. The exposures of interest were social isolation and loneliness. Social isolation was measured by the frequency of meeting family/friends, leisure and social activity, and communal/solitary living. Loneliness was evaluated by the subjective feeling of loneliness and the willingness to confide in others. The primary endpoint was incident IBD, including UC and CD. The twosample Mendelian randomization (MR) analysis was based on the genome-wide association studies of UKB and the a nonoverlapping European ancestry GWAS study. Results Results The UKB cohort study documented 1,565 IBD (1063 UC and 492 CD) cases during a mean follow-up of 13.49 years. Social isolation and loneliness showed significant associations with an elevated risk of IBD in UKB (social isolation [moderate vs least]: aHR 1.13, 95% CI 1.02-1.26; social isolation [most vs least]: aHR 1.31, 95% CI 1.01-1.70; loneliness [yes vs no]: aHR 1.29, 95% CI 1.04-1.60). These associations were evident among moderate genetic susceptibility to IBD. Social isolation and loneliness jointly increase the risk of IBD onset, with an aHR of 1.60 (95% CI 1.21-2.12). Two-sample MR analyses determined that engaging in fewer leisure/social activities (OR 3.42, 95% CI 1.55-7.58; 3.32, 95% CI 1.29-8.55; 3.09, 95% CI 1.35-7.07) were associated with increased IBD, UC and CD risk, whereas more activities-sports club or gym (OR 0.37, 95% CI 0.15-0.88) was associated with reduced IBD risk. Conclusion Conclusion Social isolation and loneliness are each associated with an elevated risk of IBD especially for individuals with a moderate genetic risk for IBD, with MR analyses suggesting potential causal links. The findings highlight the importance of promoting initiatives to address social isolation and loneliness as part of IBD prevention strategies.
背景 社会隔离和孤独是全球面临的重大公共卫生挑战。本研究旨在调查社会隔离、孤独与炎症性肠病（IBD）、溃疡性结肠炎（UC）和克罗恩病（CD）风险之间的关联。方法 对英国生物库（UKB）中的 275,157 名英国成年人进行了分析。研究对象为社会隔离和孤独感。社会隔离通过与家人/朋友会面的频率、休闲和社交活动以及集体/独居生活来衡量。孤独感通过主观孤独感和向他人倾诉的意愿来评估。主要终点是IBD事件，包括UC和CD。双样本孟德尔随机化（MR）分析基于UKB的全基因组关联研究和一项非重叠的欧洲血统GWAS研究。结果 UKB队列研究记录了1565例IBD病例（1063例UC和492例CD），平均随访时间为13.49年。在 UKB 中，社会隔离和孤独与 IBD 风险升高有显著关联（社会隔离[中度 vs 最小]：aHR 1.13，95% CI 1.02-1.26；社会隔离[最大 vs 最小]：aHR 1.31，95% CI 1.01-1.70；孤独[有 vs 无]：aHR 1.29，95% CI 1.04-1.60）。这些关联在中度遗传性 IBD 易感人群中非常明显。社会隔离和孤独感共同增加了 IBD 的发病风险，aHR 为 1.60（95% CI 1.21-2.12）。双样本 MR 分析表明，参与较少的休闲/社交活动（OR 3.42，95% CI 1.55-7.58；3.32，95% CI 1.29-8.55；3.09，95% CI 1.35-7.07）与 IBD、UC 和 CD 风险增加有关，而参与较多的活动--体育俱乐部或健身房（OR 0.37，95% CI 0.15-0.88）则与 IBD 风险降低有关。结论 社会隔离和孤独都与 IBD 风险的升高有关，特别是对于具有中度 IBD 遗传风险的个体，MR 分析表明两者之间存在潜在的因果关系。研究结果突出表明，作为 IBD 预防策略的一部分，推动解决社会隔离和孤独问题的措施非常重要。
{"title":"P1123 Social isolation, loneliness, and incident inflammatory bowel disease: results from a large prospective cohorts and Mendelian randomization","authors":"J Zhao, M Zhang, J Ye, X Li","doi":"10.1093/ecco-jcc/jjad212.1253","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.1253","url":null,"abstract":"Background Background Social isolation and loneliness pose significant public health challenges globally. The objective of this study is to investigate the association between social isolation, loneliness, and the risk of inflammatory bowel disease (IBD), ulcerative colitis (UC) and Crohn's disease (CD). Methods Methods 275,157 UK adults from the UK Biobank (UKB) was analyzed. The exposures of interest were social isolation and loneliness. Social isolation was measured by the frequency of meeting family/friends, leisure and social activity, and communal/solitary living. Loneliness was evaluated by the subjective feeling of loneliness and the willingness to confide in others. The primary endpoint was incident IBD, including UC and CD. The twosample Mendelian randomization (MR) analysis was based on the genome-wide association studies of UKB and the a nonoverlapping European ancestry GWAS study. Results Results The UKB cohort study documented 1,565 IBD (1063 UC and 492 CD) cases during a mean follow-up of 13.49 years. Social isolation and loneliness showed significant associations with an elevated risk of IBD in UKB (social isolation [moderate vs least]: aHR 1.13, 95% CI 1.02-1.26; social isolation [most vs least]: aHR 1.31, 95% CI 1.01-1.70; loneliness [yes vs no]: aHR 1.29, 95% CI 1.04-1.60). These associations were evident among moderate genetic susceptibility to IBD. Social isolation and loneliness jointly increase the risk of IBD onset, with an aHR of 1.60 (95% CI 1.21-2.12). Two-sample MR analyses determined that engaging in fewer leisure/social activities (OR 3.42, 95% CI 1.55-7.58; 3.32, 95% CI 1.29-8.55; 3.09, 95% CI 1.35-7.07) were associated with increased IBD, UC and CD risk, whereas more activities-sports club or gym (OR 0.37, 95% CI 0.15-0.88) was associated with reduced IBD risk. Conclusion Conclusion Social isolation and loneliness are each associated with an elevated risk of IBD especially for individuals with a moderate genetic risk for IBD, with MR analyses suggesting potential causal links. The findings highlight the importance of promoting initiatives to address social isolation and loneliness as part of IBD prevention strategies.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-24DOI: 10.1093/ecco-jcc/jjad212.1231
A G Gravina, R Pellegrino, G Palladino, G Imperio, R D'Onofrio, G Arboretto, M Romeo, P Ciamarra, M Dallio, A Federico
Background As the World Health Organization recommends, regular physical activity (PA) determines quality of life. The qualitative/quantitative characteristics of ideal PA to be suggested for inflammatory bowel diseases (IBD) nor the relationship with disease activity are not yet well defined. This study aimed to weigh PA levels and barriers/facilitators to PA in a cross-sectional group of patients with IBD. Methods Consecutive Italian non-severe IBD patients (assessed with partial Mayo score for and Harvey-Bradshaw index) received an anonymous online questionnaire to assess PA levels using the International Physical Activity Questionnaire (IPAQ), disease activity as Patient-Reported Outcomes 2 (PRO-2), and finally habits, beliefs, and barriers in conducting regular PA. Clinical, anthropometric, and demographic data were also collected. PA was processed as continuous units of resting metabolic rate in minutes/week (Met min/wk). Three PA groups were identified: inactive (< 700 Met min/wk), sufficiently active (700-2500 Met min/wk) and Health Enhancing PA (i.e., HEPA active, > 2500 Met min/wk) patients. Results The 219 patients enrolled exhibited overall PA levels of 834.5 Met min/wk, with a large proportion (94, 42.9%) classified as inactive. Only a minority (9, 4.1%) resulted as health-enhancing PA. Patients with a non-dyslipidaemia metabolic profile (p < 0.0001) or on biologics therapy (p=0.022) showed better IPAQ scores in moderate activities. PRO-2 correlated negatively with IPAQ intense activities scores (τ= -0.156, p=0.038) in ulcerative colitis patients. PRO-2 did not show notable sensitivity/specificity in predicting IPAQ inactivity (AUC < 0.6). IPAQ showed no notable differences when related to disease activity categories according to PRO-2 (p > 0.05). Physically active patients were more willing to discuss their PA with their IBDologists. Several barriers (e.g., diagnosis of IBD and fear of flare-ups after PA) are firmly rooted in physically inactive patients. Evacuation urgency (rectal syndrome) is the IBD-related barrier most physically inactive patients reported. Some fears about PA were worse felt in the absence of a stable partner (i.e., fear of worsening or recurrence of IBD, p < 0.05). Conclusion Many Italian IBD patients show a worrying rate of physical inactivity, depriving themselves of the multidimensional benefits that regular PA can bring. There is a need for IBDologists to act by removing barriers to PA and engaging in a regular discussion on the importance of PA with IBD patients. IPAQ has shown good feasibility and patient acceptance in this setting.
背景 正如世界卫生组织所建议的那样，经常进行体育锻炼（PA）可提高生活质量。炎症性肠病（IBD）理想的体力活动的定性/定量特征以及与疾病活动的关系尚未明确。本研究旨在权衡 IBD 患者的 PA 水平和 PA 的障碍/促进因素。方法 连续的意大利非重度 IBD 患者（以部分梅奥评分和哈维-布拉德肖指数进行评估）接受匿名在线问卷调查，使用国际体育锻炼问卷 (IPAQ) 评估体育锻炼水平，以患者报告结果 2 (PRO-2) 评估疾病活动情况，并最终评估定期进行体育锻炼的习惯、信念和障碍。此外，还收集了临床、人体测量和人口统计学数据。运动量以静息代谢率的连续单位进行处理，单位为分钟/周（Met min/wk）。研究确定了三组热能锻炼人群：不活跃人群（< 700 Met min/wk）、充分活跃人群（700-2500 Met min/wk）和健康增强型热能锻炼人群（即 HEPA 活跃人群，> 2500 Met min/wk）。结果 219 名入选患者的总体活动量为 834.5 Met min/wk，其中很大一部分（94 人，42.9%）被归类为不活动。只有少数患者（9 人，占 4.1%）的活动量达到了增进健康的水平。患有非血脂异常代谢病（p< 0.0001）或接受生物制剂治疗（p=0.022）的患者在中度活动中的 IPAQ 得分更高。PRO-2与溃疡性结肠炎患者的IPAQ剧烈活动评分呈负相关（τ= -0.156，p=0.038）。PRO-2在预测IPAQ活动不足方面没有显示出明显的敏感性/特异性（AUC < 0.6）。IPAQ与根据PRO-2划分的疾病活动类别没有明显差异（p> 0.05）。身体活跃的患者更愿意与他们的 IBD 专家讨论他们的 PA。一些障碍（如 IBD 诊断和对 PA 后复发的恐惧）在身体不活跃的患者中根深蒂固。排便紧迫感（直肠综合征）是大多数不运动患者报告的与 IBD 相关的障碍。在没有稳定伴侣的情况下，对 PA 的某些恐惧感会更加强烈（即担心 IBD 恶化或复发，p < 0.05）。结论 许多意大利 IBD 患者缺乏体育锻炼的比例令人担忧，他们无法享受定期体育锻炼带来的多方面益处。因此，IBD 患者需要定期与 IBD 专家讨论 PA 的重要性，消除 PA 的障碍。在这种情况下，IPAQ 已显示出良好的可行性和患者接受度。
{"title":"P1101 Patient-reported physical activity of IBD patients is of concern when weighed with the international physical activity questionnaire regardless of disease activity and IBD phenotype: barriers and facilitators emerged from the extended \"BE-FIT-IBD\" cross-sectional study","authors":"A G Gravina, R Pellegrino, G Palladino, G Imperio, R D'Onofrio, G Arboretto, M Romeo, P Ciamarra, M Dallio, A Federico","doi":"10.1093/ecco-jcc/jjad212.1231","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.1231","url":null,"abstract":"Background As the World Health Organization recommends, regular physical activity (PA) determines quality of life. The qualitative/quantitative characteristics of ideal PA to be suggested for inflammatory bowel diseases (IBD) nor the relationship with disease activity are not yet well defined. This study aimed to weigh PA levels and barriers/facilitators to PA in a cross-sectional group of patients with IBD. Methods Consecutive Italian non-severe IBD patients (assessed with partial Mayo score for and Harvey-Bradshaw index) received an anonymous online questionnaire to assess PA levels using the International Physical Activity Questionnaire (IPAQ), disease activity as Patient-Reported Outcomes 2 (PRO-2), and finally habits, beliefs, and barriers in conducting regular PA. Clinical, anthropometric, and demographic data were also collected. PA was processed as continuous units of resting metabolic rate in minutes/week (Met min/wk). Three PA groups were identified: inactive (&lt; 700 Met min/wk), sufficiently active (700-2500 Met min/wk) and Health Enhancing PA (i.e., HEPA active, &gt; 2500 Met min/wk) patients. Results The 219 patients enrolled exhibited overall PA levels of 834.5 Met min/wk, with a large proportion (94, 42.9%) classified as inactive. Only a minority (9, 4.1%) resulted as health-enhancing PA. Patients with a non-dyslipidaemia metabolic profile (p &lt; 0.0001) or on biologics therapy (p=0.022) showed better IPAQ scores in moderate activities. PRO-2 correlated negatively with IPAQ intense activities scores (τ= -0.156, p=0.038) in ulcerative colitis patients. PRO-2 did not show notable sensitivity/specificity in predicting IPAQ inactivity (AUC &lt; 0.6). IPAQ showed no notable differences when related to disease activity categories according to PRO-2 (p &gt; 0.05). Physically active patients were more willing to discuss their PA with their IBDologists. Several barriers (e.g., diagnosis of IBD and fear of flare-ups after PA) are firmly rooted in physically inactive patients. Evacuation urgency (rectal syndrome) is the IBD-related barrier most physically inactive patients reported. Some fears about PA were worse felt in the absence of a stable partner (i.e., fear of worsening or recurrence of IBD, p &lt; 0.05). Conclusion Many Italian IBD patients show a worrying rate of physical inactivity, depriving themselves of the multidimensional benefits that regular PA can bring. There is a need for IBDologists to act by removing barriers to PA and engaging in a regular discussion on the importance of PA with IBD patients. IPAQ has shown good feasibility and patient acceptance in this setting.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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