Pub Date : 2024-01-24DOI: 10.1093/ecco-jcc/jjad212.0348
A Singh, C Kakkar, A Bhardwaj, P A Bonaffini, M Goyal, M Marwah, A Sachdeva, N Bansal, R Mahajan, V Midha, A Sood
Background Magnetic resonance imaging (MRI) is the standard for evaluating perianal fistulae. Perianal fistula can be the first manifestation of CD, and needs to be differentiated from non-CD associated perianal fistula. This study sought to identify the variations in MRI characteristics of perianal fistulas in patients with and without inflammatory bowel disease (IBD), considering the potential implications for treatment decisions. Methods This was a single-center cross-sectional analysis of patients who underwent pelvic MRI for assessment of perianal fistula between January 2021 and June 2022 at Dayanand Medical College and Hospital (DMCH), Ludhiana, India. Patients who underwent dedicated MRI fistula protocol were included. Patients with prior anal resection or anastomosis, anorectal tumor, or equivocal imaging findings that could not be definitely assessed as a fistula were excluded. The following features were assessed: anatomic type of fistula (Parks classification), luminal origin (hour clock position), anal verge distance, signs of acute inflammation, circumference of anus involved by inflammation, presence of rectal inflammation, and abscess. Results Between January 2022 and December 2022, a total of 287 MRI scans were conducted to assess for perianal fistulae. Out of these, 119 MRI scans met the eligibility criteria and 32(26.89%) were associated with an established clinical diagnosis of CD. A higher proportion of females had CD-associated perianal fistula compared to non-CD perianal fistula. A significantly greater percentage of CD-associated perianal fistulas exhibited supra-levator extension, multiple and branched fistula tracts, and ≥2 internal and external openings. Patients with CD had higher prevalence of concurrent perianal abscess, proctitis, anorectal strictures, and a greater number of clock hours of inflamed anal circumference, compared to patients with cryptoglandular fistula. (Table 1) On multivariate logistic regression analysis, female sex, ≥2 internal openings, proctitis and height of the mucosal origin of the fistula from the anal verge >1.85 cm independently predicted the perianal fistula to be associated with CD. We constructed the DMCH index as follows: DMCH index: (3xfemale sex) + (3x≥2 internal openings of the fistula tract) + (6xrectal wall thickening) + (2xheight of mucosal origin of the fistula from anal verge >1.85 cm) The DMCH index greater than 7 identified the perianal fistulae associated with CD with a sensitivity of 84% and specificity of 91% [Area under curve 0.91; 95% CI 0.85-0.97; P< 0.0001].(Figure 1) Conclusion The DMCH index identifies CD associates perianal fistula with a high level of accuracy. These findings require validation and confirmation in independent, multi-reader studies.
{"title":"P218 Development of Magnetic Resonance Imaging based index to differentiate Crohn’s disease associated perianal fistula and cryptoglandular perianal fistula","authors":"A Singh, C Kakkar, A Bhardwaj, P A Bonaffini, M Goyal, M Marwah, A Sachdeva, N Bansal, R Mahajan, V Midha, A Sood","doi":"10.1093/ecco-jcc/jjad212.0348","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0348","url":null,"abstract":"Background Magnetic resonance imaging (MRI) is the standard for evaluating perianal fistulae. Perianal fistula can be the first manifestation of CD, and needs to be differentiated from non-CD associated perianal fistula. This study sought to identify the variations in MRI characteristics of perianal fistulas in patients with and without inflammatory bowel disease (IBD), considering the potential implications for treatment decisions. Methods This was a single-center cross-sectional analysis of patients who underwent pelvic MRI for assessment of perianal fistula between January 2021 and June 2022 at Dayanand Medical College and Hospital (DMCH), Ludhiana, India. Patients who underwent dedicated MRI fistula protocol were included. Patients with prior anal resection or anastomosis, anorectal tumor, or equivocal imaging findings that could not be definitely assessed as a fistula were excluded. The following features were assessed: anatomic type of fistula (Parks classification), luminal origin (hour clock position), anal verge distance, signs of acute inflammation, circumference of anus involved by inflammation, presence of rectal inflammation, and abscess. Results Between January 2022 and December 2022, a total of 287 MRI scans were conducted to assess for perianal fistulae. Out of these, 119 MRI scans met the eligibility criteria and 32(26.89%) were associated with an established clinical diagnosis of CD. A higher proportion of females had CD-associated perianal fistula compared to non-CD perianal fistula. A significantly greater percentage of CD-associated perianal fistulas exhibited supra-levator extension, multiple and branched fistula tracts, and ≥2 internal and external openings. Patients with CD had higher prevalence of concurrent perianal abscess, proctitis, anorectal strictures, and a greater number of clock hours of inflamed anal circumference, compared to patients with cryptoglandular fistula. (Table 1) On multivariate logistic regression analysis, female sex, ≥2 internal openings, proctitis and height of the mucosal origin of the fistula from the anal verge &gt;1.85 cm independently predicted the perianal fistula to be associated with CD. We constructed the DMCH index as follows: DMCH index: (3xfemale sex) + (3x≥2 internal openings of the fistula tract) + (6xrectal wall thickening) + (2xheight of mucosal origin of the fistula from anal verge &gt;1.85 cm) The DMCH index greater than 7 identified the perianal fistulae associated with CD with a sensitivity of 84% and specificity of 91% [Area under curve 0.91; 95% CI 0.85-0.97; P&lt; 0.0001].(Figure 1) Conclusion The DMCH index identifies CD associates perianal fistula with a high level of accuracy. These findings require validation and confirmation in independent, multi-reader studies.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559271","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/jjad212.1119
B Gros, N Manceñido Marcos, J Guardiola, I Alonso Abreu, I Rodríguez Lago, R Alvarado, Á Ponferrada, J Orobitg Bernades, F Argüelles-Arias, F Mesonero, I Guerra, F Cañete, L Madero, P Borràs, G E Rodríguez, M Iborra, J Castro, A Caballero Mateos, M Barreiro-de Acosta, J M Huguet Malavés, E Brunet-Mas, F López Romero-Salazar, B Caballol, Y Zabana, C Suria Bolufer, P Soto, B Castro, S Marín, S Porto-Silva, J M Benítez, A Gutierrez, E Iglesias-Flores
Background Despite the established use of intravenous (IV) vedolizumab for treating inflammatory bowel disease (IBD), there's growing interest in exploring the advantages of the novel subcutaneous (SC) administration route. However, comprehensive real-world evidence regarding the extended safety and effectiveness of this approach remains scarce. The aim of the study was to evaluate the effectiveness and safety of vedolizumab SC among IBD patients in clinical remission. Methods Multicenter, observational, retrospective study. IBD patients on IV vedolizumab treatment across 24 Spanish hospitals who were in clinical remission were given the option to switch to SC injections or continue with IV treatment. Data encompassing clinical disease activity (assessed through partial Mayo score, and Harvey-Bradshaw Index), biochemical markers (C-reactive protein and fecal calprotectin), adverse events and treatment persistence were retrospectively gathered from prospectively maintained clinical records at baseline, and at weeks 12, 24, and 48. Non-parametric tests were used for comparisons and Kaplan-Meier for survival. Results We identified 166 patients, with 19 excluded due to not being in clinical remission and 8 excluded due to absence of follow-up data, resulting in a final inclusion of 139 patients for analysis. Of these, 36 (25.9%) remained on IV vedolizumab, while 103 (74.1%) switched to SC vedolizumab. Both groups exhibited comparable demographic characteristics including age, gender, disease type, disease duration and extension, previous therapy, presence of extra intestinal manifestations and comorbidities (Table 1). However, there were differences in Crohn’s disease behavior among groups (p=0.013). There were not significant differences in clinical, biochemical and fecal calprotectin remission at week 12, 24 and 48 neither in the overall cohort nor assessing Crohn’s disease or ulcerative colitis separately (Figure 1). At the end of follow-up, median duration 47 weeks (29-49), persistence on the same formulation was 85%,1 (2.8%) patient on IV and 4 (3.9%) on SC withdrew the drug (p=0.810), 5 (4.8%) switched back to IV from SC. Adverse events were reported in 1 (2.8%) IV vs 11 (10.7%) SC vedolizumab (p=0.292), most of them being mild skin reactions to SC injection 3 (2.9%). Conclusion In our study we found that transitioning from IV to SC vedolizumab in patients with IBD in remission showed comparable effectiveness in maintaining disease remission. Switching to SC formulation appears safe with no new safety signals identified and most adverse events being mild.
{"title":"P989 Switching from intravenous to subcutaneous vedolizumab in patients with inflammatory bowel disease in clinical remission: a multicenter study from GETECCU","authors":"B Gros, N Manceñido Marcos, J Guardiola, I Alonso Abreu, I Rodríguez Lago, R Alvarado, Á Ponferrada, J Orobitg Bernades, F Argüelles-Arias, F Mesonero, I Guerra, F Cañete, L Madero, P Borràs, G E Rodríguez, M Iborra, J Castro, A Caballero Mateos, M Barreiro-de Acosta, J M Huguet Malavés, E Brunet-Mas, F López Romero-Salazar, B Caballol, Y Zabana, C Suria Bolufer, P Soto, B Castro, S Marín, S Porto-Silva, J M Benítez, A Gutierrez, E Iglesias-Flores","doi":"10.1093/ecco-jcc/jjad212.1119","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.1119","url":null,"abstract":"Background Despite the established use of intravenous (IV) vedolizumab for treating inflammatory bowel disease (IBD), there's growing interest in exploring the advantages of the novel subcutaneous (SC) administration route. However, comprehensive real-world evidence regarding the extended safety and effectiveness of this approach remains scarce. The aim of the study was to evaluate the effectiveness and safety of vedolizumab SC among IBD patients in clinical remission. Methods Multicenter, observational, retrospective study. IBD patients on IV vedolizumab treatment across 24 Spanish hospitals who were in clinical remission were given the option to switch to SC injections or continue with IV treatment. Data encompassing clinical disease activity (assessed through partial Mayo score, and Harvey-Bradshaw Index), biochemical markers (C-reactive protein and fecal calprotectin), adverse events and treatment persistence were retrospectively gathered from prospectively maintained clinical records at baseline, and at weeks 12, 24, and 48. Non-parametric tests were used for comparisons and Kaplan-Meier for survival. Results We identified 166 patients, with 19 excluded due to not being in clinical remission and 8 excluded due to absence of follow-up data, resulting in a final inclusion of 139 patients for analysis. Of these, 36 (25.9%) remained on IV vedolizumab, while 103 (74.1%) switched to SC vedolizumab. Both groups exhibited comparable demographic characteristics including age, gender, disease type, disease duration and extension, previous therapy, presence of extra intestinal manifestations and comorbidities (Table 1). However, there were differences in Crohn’s disease behavior among groups (p=0.013). There were not significant differences in clinical, biochemical and fecal calprotectin remission at week 12, 24 and 48 neither in the overall cohort nor assessing Crohn’s disease or ulcerative colitis separately (Figure 1). At the end of follow-up, median duration 47 weeks (29-49), persistence on the same formulation was 85%,1 (2.8%) patient on IV and 4 (3.9%) on SC withdrew the drug (p=0.810), 5 (4.8%) switched back to IV from SC. Adverse events were reported in 1 (2.8%) IV vs 11 (10.7%) SC vedolizumab (p=0.292), most of them being mild skin reactions to SC injection 3 (2.9%). Conclusion In our study we found that transitioning from IV to SC vedolizumab in patients with IBD in remission showed comparable effectiveness in maintaining disease remission. Switching to SC formulation appears safe with no new safety signals identified and most adverse events being mild.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"43 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559386","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/jjad212.0873
A Croft, S Okano, G Hartel, A Lord, G Walker, G Radford-Smith
Background An episode of acute ulcerative colitis (UC) represents an important watershed moment in a patient’s disease course. Foreknowledge of a patient's likely response to intravenous corticosteroid therapy has significant clinical utility. Using a large prospectively collected acute UC patient database and machine learning-based techniques we aimed to derive and validate a personalised algorithm for identifying patients at high risk of corticosteroid therapy failure from variables available at hospital presentation. Methods A prospectively collected database of 600 consecutive presentations of acute UC was collated at a single referral centre between 1996 and 2022. An AIC-based Elastic Net model was used to select variables on the 419 earliest presentations of acute UC (1996-2017). Two risk-scoring algorithms, with and without utilising additional endoscopic variables, were constructed using logistic regression models. These risk scores were then validated on a separate cohort of 181 acute UC presentations (2018-2022). Results The partial risk of rescue (ROR) score included the admission indices of oral corticosteroid treatment; bowel frequency ≥6/24 hours; albumin; CRP ≥12mg/ml and log10CRP. The full ROR score incorporates the same variables with the addition of the Mayo endoscopic subscore and disease extent. The ROC AUCs in the validation cohort were 0.76 (95% CI: 0.69-0.83) and 0.78 (95% CI: 0.71-0.85) for the partial and full ROR scores, respectively. When incomplete cases were excluded, the full ROR score validation cohort ROC AUC increased from 0.78 to 0.80. Conclusion These pragmatic personalised risk scores (available at www.severecolitis.com) have comparably strong performance characteristics and usability enabling the identification of individuals at high risk of corticosteroid treatment failure before or after endoscopic assessment. These patients may be suitable for consideration of early treatment escalation or screening for participation in clinical trials.
{"title":"P743 A personalised algorithm predicting the risk of intravenous corticosteroid failure in acute ulcerative colitis","authors":"A Croft, S Okano, G Hartel, A Lord, G Walker, G Radford-Smith","doi":"10.1093/ecco-jcc/jjad212.0873","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0873","url":null,"abstract":"Background An episode of acute ulcerative colitis (UC) represents an important watershed moment in a patient’s disease course. Foreknowledge of a patient's likely response to intravenous corticosteroid therapy has significant clinical utility. Using a large prospectively collected acute UC patient database and machine learning-based techniques we aimed to derive and validate a personalised algorithm for identifying patients at high risk of corticosteroid therapy failure from variables available at hospital presentation. Methods A prospectively collected database of 600 consecutive presentations of acute UC was collated at a single referral centre between 1996 and 2022. An AIC-based Elastic Net model was used to select variables on the 419 earliest presentations of acute UC (1996-2017). Two risk-scoring algorithms, with and without utilising additional endoscopic variables, were constructed using logistic regression models. These risk scores were then validated on a separate cohort of 181 acute UC presentations (2018-2022). Results The partial risk of rescue (ROR) score included the admission indices of oral corticosteroid treatment; bowel frequency ≥6/24 hours; albumin; CRP ≥12mg/ml and log10CRP. The full ROR score incorporates the same variables with the addition of the Mayo endoscopic subscore and disease extent. The ROC AUCs in the validation cohort were 0.76 (95% CI: 0.69-0.83) and 0.78 (95% CI: 0.71-0.85) for the partial and full ROR scores, respectively. When incomplete cases were excluded, the full ROR score validation cohort ROC AUC increased from 0.78 to 0.80. Conclusion These pragmatic personalised risk scores (available at www.severecolitis.com) have comparably strong performance characteristics and usability enabling the identification of individuals at high risk of corticosteroid treatment failure before or after endoscopic assessment. These patients may be suitable for consideration of early treatment escalation or screening for participation in clinical trials.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"134 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559437","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/jjad212.0146
I Jacobs, J Cremer, M Ferrante, J Sabino, S Vermeire, C Breynaert, T Vanuytsel, B Verstockt
Background Patients with ulcerative colitis (UC) are often treated with biological therapies or small molecules. Knowledge about the impact of these therapies on the intestinal and peripheral blood immune cell composition is scarce. Therefore, we investigated how advanced therapies modulate immune cell distribution in UC patients. Methods We included 30 UC patients (53% male, median age 42 years) who started a biological or small molecule. Before the first drug administration, mucosal colonic biopsies and a peripheral blood sample were obtained. At the end of induction, colonic biopsies and peripheral blood were sampled again. Patients starting adalimumab (n=2), infliximab (n=3), vedolizumab (n=11), ustekinumab (n=6), ozanimod (n=2) and the JAK inhibitors filgotinib (n=3) and tofacitinib (n=3) were included. Endoscopic improvement was defined as a Mayo endoscopic subscore of 0-1 at the end of induction. From the biopsies, a single-cell suspension was made. Intestinal and circulating immune cells were characterized via flow cytometry. Statistical analysis was performed using a paired t-test. Results Independent of the mechanism of action (MOA), patients responding to therapy showed a decrease of colonic granulocytes (neutrophils (p<0.0001) (Figure 1A), basophils (p<0.0001) (Figure 1B) and eosinophils (p=0.008) (Figure 1C)), active eosinophils (p=0.002) (Figure 1D)), B cells (p=0.05) (Figure 1E), regulatory T cells (p<0.0001) (Figure 1F) and T helper (Th) 2 cells (p=0.02) (Figure 1G), balanced with an increase of Th1 cells (p=0.03) (Figure 1H). In peripheral blood, eosinophils increased in patients not responding to therapy (p=0.05) (Figure 1I). Furthermore, we observed that only patients starting vedolizumab (n=11) showed a decrease in colonic eosinophils (p=0.02) (Figure 1J), active eosinophils (p=0.002) (Figure 1K), B cells (p=0.03) (Figure 1L) and T cells (p=0.004) (Figure 1M). Considering only non-vedolizumab patients (n=19), we did not observe this effect. Conclusion UC patients responding to advanced therapies showed a different intestinal immune cell distribution compared to non-responders, regardless of MOA. Vedolizumab therapy furthermore decreased several mucosal immune cell subsets that migrate to the gut through α4β7-MAdCAM-1 binding. While the effect of vedolizumab on B cells and T cells was previously described, we have now potentially identified an additional eosinophil-reducing effect in the colon.
背景溃疡性结肠炎（UC）患者通常接受生物疗法或小分子药物治疗。有关这些疗法对肠道和外周血免疫细胞组成的影响的知识很少。因此，我们研究了先进疗法如何调节 UC 患者的免疫细胞分布。方法 我们纳入了 30 名开始接受生物或小分子药物治疗的 UC 患者（53% 为男性，中位年龄 42 岁）。首次用药前，我们采集了结肠粘膜活检样本和外周血样本。在诱导治疗结束时，再次采集结肠活检和外周血样本。开始使用阿达木单抗（2例）、英夫利昔单抗（3例）、维多珠单抗（11例）、乌司他珠单抗（6例）、奥扎尼莫德（2例）以及JAK抑制剂非格替尼（3例）和托法替尼（3例）的患者均被纳入其中。内镜改善的定义是在诱导结束时梅奥内镜子评分为0-1。从活检组织中提取单细胞悬液。通过流式细胞术鉴定肠道和循环免疫细胞。统计分析采用配对 t 检验。结果 与作用机制（MOA）无关，对治疗有反应的患者结肠粒细胞（中性粒细胞（p<0.0001）（图 1A）、嗜碱性粒细胞（p<0.0001）（图 1B）和嗜酸性粒细胞（p=0.008）（图 1C））、活性嗜酸性粒细胞（p=0.002）（图 1D））、B 细胞（p=0.05）（图 1E）、调节性 T 细胞（p<0.0001）（图 1F）和 T 辅助（Th）2 细胞（p=0.02）（图 1G），与 Th1 细胞的增加（p=0.03）（图 1H）相平衡。在外周血中，对治疗无反应的患者嗜酸性粒细胞增加（p=0.05）（图 1I）。此外，我们还观察到，只有开始使用维多利珠单抗的患者（n=11）的结肠嗜酸性粒细胞（p=0.02）（图 1J）、活性嗜酸性粒细胞（p=0.002）（图 1K）、B 细胞（p=0.03）（图 1L）和 T 细胞（p=0.004）（图 1M）有所减少。仅考虑非韦多珠单抗患者（n=19），我们没有观察到这种效应。结论 对晚期疗法有反应的 UC 患者的肠道免疫细胞分布与无反应者不同，与 MOA 无关。维多珠单抗疗法进一步减少了通过α4β7-MAdCAM-1结合迁移到肠道的多个粘膜免疫细胞亚群。虽然维多珠单抗对 B 细胞和 T 细胞的作用之前已有描述，但我们现在可能又发现了一种减少结肠中嗜酸性粒细胞的作用。
{"title":"P016 Reduction of mucosal (active) eosinophils, B cells and T cells after vedolizumab therapy in patients with ulcerative colitis","authors":"I Jacobs, J Cremer, M Ferrante, J Sabino, S Vermeire, C Breynaert, T Vanuytsel, B Verstockt","doi":"10.1093/ecco-jcc/jjad212.0146","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0146","url":null,"abstract":"Background Patients with ulcerative colitis (UC) are often treated with biological therapies or small molecules. Knowledge about the impact of these therapies on the intestinal and peripheral blood immune cell composition is scarce. Therefore, we investigated how advanced therapies modulate immune cell distribution in UC patients. Methods We included 30 UC patients (53% male, median age 42 years) who started a biological or small molecule. Before the first drug administration, mucosal colonic biopsies and a peripheral blood sample were obtained. At the end of induction, colonic biopsies and peripheral blood were sampled again. Patients starting adalimumab (n=2), infliximab (n=3), vedolizumab (n=11), ustekinumab (n=6), ozanimod (n=2) and the JAK inhibitors filgotinib (n=3) and tofacitinib (n=3) were included. Endoscopic improvement was defined as a Mayo endoscopic subscore of 0-1 at the end of induction. From the biopsies, a single-cell suspension was made. Intestinal and circulating immune cells were characterized via flow cytometry. Statistical analysis was performed using a paired t-test. Results Independent of the mechanism of action (MOA), patients responding to therapy showed a decrease of colonic granulocytes (neutrophils (p&lt;0.0001) (Figure 1A), basophils (p&lt;0.0001) (Figure 1B) and eosinophils (p=0.008) (Figure 1C)), active eosinophils (p=0.002) (Figure 1D)), B cells (p=0.05) (Figure 1E), regulatory T cells (p&lt;0.0001) (Figure 1F) and T helper (Th) 2 cells (p=0.02) (Figure 1G), balanced with an increase of Th1 cells (p=0.03) (Figure 1H). In peripheral blood, eosinophils increased in patients not responding to therapy (p=0.05) (Figure 1I). Furthermore, we observed that only patients starting vedolizumab (n=11) showed a decrease in colonic eosinophils (p=0.02) (Figure 1J), active eosinophils (p=0.002) (Figure 1K), B cells (p=0.03) (Figure 1L) and T cells (p=0.004) (Figure 1M). Considering only non-vedolizumab patients (n=19), we did not observe this effect. Conclusion UC patients responding to advanced therapies showed a different intestinal immune cell distribution compared to non-responders, regardless of MOA. Vedolizumab therapy furthermore decreased several mucosal immune cell subsets that migrate to the gut through α4β7-MAdCAM-1 binding. While the effect of vedolizumab on B cells and T cells was previously described, we have now potentially identified an additional eosinophil-reducing effect in the colon.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"79 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559500","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/jjad212.0655
K Kim, S W Hong, S W Hwang, S H Park, B D Ye, J S Byeon, S J Myung, S K Yang, D H Yang
Background Endoscopic submucosal dissection (ESD) has gained traction as an effective therapy for ulcerative colitis (UC)-associated dysplasia, yet identifying fitting ESD candidates is challenging by substantial submucosal (SM) fibrosis from chronic inflammation. We report our experience utilising endoscopic ultrasonography (EUS) to assess ESD eligibility by measuring SM cushion thickness. Methods Retrospective case-series includes nine patients who were diagnosed or referred to as UC-associated dysplasia in surveillance colonoscopies between August 2017 and October 2023. After scanning dysplastic lesions (Fig A-B), hyaluronic acid solution was injected into the SM layer (Fig C). EUS with a mini-probe quantified SM cushion beneath the dysplastic lesion (Fig D), and ESD was performed in cases with at least 2.0 mm of SM cushion thickness (Fig E-F). Results Among ten cases from nine patients, eight cases met the criteria and underwent ESD, while two cases (Patient 3, Patient 7) were regarded as unsuitable for ESD with SM cushion thickness less than 2.0 mm. Median disease duration was 19 years, and median age at diagnosis of UC-associated dysplasia was 50 years. Median SM cushion thickness ranged from 4.2 to 6.9 mm. Median procedure time was 50 minutes, and median size of resected specimens and lesions were 31.5 x 24.5 mm and 16.0 x 12.5 mm, respectively. en bloc resection was achieved in all cases, with an 87.5% R0 resection rate. No perforation occurred; only one required post-discharge endoscopic bleeding control after four days post-discharge. Conclusion EUS-measured SM cushion thickness may be a valid approach that provides an objective criterion for determining ESD eligibility in UC-associated dysplasia. This would help guide individualised treatment in UC-associated dysplasia, reducing unnecessary procedures or surgery.
背景内镜黏膜下剥离术（ESD）作为治疗溃疡性结肠炎（UC）相关性发育不良的有效疗法已受到广泛关注，但由于慢性炎症导致黏膜下（SM）大量纤维化，确定合适的 ESD 候选者具有挑战性。我们报告了利用内镜超声波成像（EUS）测量粘膜下纤维垫厚度来评估ESD资格的经验。方法 回顾性病例系列包括 2017 年 8 月至 2023 年 10 月期间在监测结肠镜检查中被诊断为或转诊为 UC 相关性发育不良的九名患者。扫描发育不良病灶后（图 A-B），向 SM 层注射透明质酸溶液（图 C）。用微型探头对增生异常病变下的 SM 垫进行 EUS 定量（图 D），对 SM 垫厚度至少为 2.0 mm 的病例进行 ESD（图 E-F）。结果 在来自 9 名患者的 10 个病例中，8 个病例符合标准并接受了 ESD，2 个病例（患者 3 和患者 7）因 SM 衬垫厚度小于 2.0 毫米而被视为不适合 ESD。中位病程为19年，确诊UC相关发育不良的中位年龄为50岁。SM垫厚度中位数为4.2至6.9毫米。中位手术时间为50分钟，切除标本和病灶的中位尺寸分别为31.5 x 24.5 mm和16.0 x 12.5 mm。所有病例均实现了全切，R0切除率为87.5%。无穿孔发生；仅有一例患者在出院四天后需要内镜止血。结论 EUS 测量的 SM 衬垫厚度可能是一种有效的方法，为确定 UC 相关发育不良是否符合 ESD 条件提供了客观标准。这将有助于指导 UC 相关性发育不良的个体化治疗，减少不必要的程序或手术。
{"title":"P525 Utilisation of endoscopic ultrasonography for submucosal cushion measurement to determine eligibility for endoscopic submucosal dissection in ulcerative colitis-associated dysplasia: A case series","authors":"K Kim, S W Hong, S W Hwang, S H Park, B D Ye, J S Byeon, S J Myung, S K Yang, D H Yang","doi":"10.1093/ecco-jcc/jjad212.0655","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0655","url":null,"abstract":"Background Endoscopic submucosal dissection (ESD) has gained traction as an effective therapy for ulcerative colitis (UC)-associated dysplasia, yet identifying fitting ESD candidates is challenging by substantial submucosal (SM) fibrosis from chronic inflammation. We report our experience utilising endoscopic ultrasonography (EUS) to assess ESD eligibility by measuring SM cushion thickness. Methods Retrospective case-series includes nine patients who were diagnosed or referred to as UC-associated dysplasia in surveillance colonoscopies between August 2017 and October 2023. After scanning dysplastic lesions (Fig A-B), hyaluronic acid solution was injected into the SM layer (Fig C). EUS with a mini-probe quantified SM cushion beneath the dysplastic lesion (Fig D), and ESD was performed in cases with at least 2.0 mm of SM cushion thickness (Fig E-F). Results Among ten cases from nine patients, eight cases met the criteria and underwent ESD, while two cases (Patient 3, Patient 7) were regarded as unsuitable for ESD with SM cushion thickness less than 2.0 mm. Median disease duration was 19 years, and median age at diagnosis of UC-associated dysplasia was 50 years. Median SM cushion thickness ranged from 4.2 to 6.9 mm. Median procedure time was 50 minutes, and median size of resected specimens and lesions were 31.5 x 24.5 mm and 16.0 x 12.5 mm, respectively. en bloc resection was achieved in all cases, with an 87.5% R0 resection rate. No perforation occurred; only one required post-discharge endoscopic bleeding control after four days post-discharge. Conclusion EUS-measured SM cushion thickness may be a valid approach that provides an objective criterion for determining ESD eligibility in UC-associated dysplasia. This would help guide individualised treatment in UC-associated dysplasia, reducing unnecessary procedures or surgery.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"8 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559192","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/jjad212.0791
L J Barkai, L Gonczi, K Farkas, B Farkas, T Molnar, T Szamosi, E Schafer, P Golovics, M Juhasz, A Patai, A Vincze, P Sarlos, A Farkas, Z Dubravcsik, T G Toth, P Miheller, P L Lakatos, A Ilias
Background While randomized controlled trials have shown ustekinumab (UST) as an effective therapeutic option for Crohn’s disease (CD), there is a lack of long-term observational data in real-world CD patient settings. This prospective study seeks to evaluate the clinical effectiveness, sustainability, and safety of UST in a nationwide multicentre cohort of CD patients over three years. The aim is to bridge the gap in our understanding of UST's real-world implications for long-term CD management. Methods CD patients undergoing ustekinumab (UST) treatment were consecutively enrolled at nine Hungarian Inflammatory Bowel Disease centers from January 2019 to May 2020. Over a three-year period, comprehensive data on patient demographics, disease characteristics, treatment history, clinical disease activity (measured by the Harvey Bradshaw Index (HBI)), biomarkers, and endoscopic activity (evaluated using the Simple Endoscopic Score for Crohn’s Disease (SES-CD)) were systematically collected. Results Involving 148 patients, the cohort comprised 48.9% with complex behavior of CD and 97.2% with previous anti-TNF exposure. Pre-induction remission rates were observed at 12.2% (HBI) and 5.1% (SES-CD). Clinical remission rates (HBI) at the end of the first, second, and third years were 52.2%, 55.6%, and 50.9%, respectively. Criteria for endoscopic remission were met in 14.3%, 27.5%, and 35.3% of subjects at the end of the first, second, and third years. Dose intensification was notable, with 84.0% of patients on an 8-weekly and 29.9% on a 4-weekly regimen by the end of year 3. Throughout the follow-up period, drug sustainability stood at 76.9%, and no serious adverse events were observed. Conclusion Our study confirms that ustekinumab is a sustainable, effective, and safe long-term treatment for Crohn's disease patients with a severe disease phenotype and a history of high anti-TNF failure, with the need for frequent dose adjustments.
背景 虽然随机对照试验显示乌司他单抗（UST）是治疗克罗恩病（CD）的有效方法，但目前还缺乏在真实世界中对 CD 患者进行长期观察的数据。这项前瞻性研究旨在评估 UST 在全国多中心 CD 患者队列中三年的临床有效性、可持续性和安全性。目的是弥补我们在了解 UST 对 CD 长期管理的实际影响方面的差距。方法 从 2019 年 1 月到 2020 年 5 月，接受乌司替尼（UST）治疗的 CD 患者在匈牙利九家炎症性肠病中心连续登记。在为期三年的时间里，系统收集了有关患者人口统计学、疾病特征、治疗史、临床疾病活动性（通过哈维-布拉德肖指数（HBI）测量）、生物标志物和内镜活动性（通过克罗恩病简易内镜评分（SES-CD）评估）的全面数据。结果 共有148名患者，其中48.9%患有复杂的克罗恩病，97.2%曾接触过抗-TNF。诱导前缓解率分别为12.2%（HBI）和5.1%（SES-CD）。第一年、第二年和第三年年底的临床缓解率（HBI）分别为 52.2%、55.6% 和 50.9%。在第一、第二和第三年结束时，分别有 14.3%、27.5% 和 35.3% 的受试者达到了内镜缓解标准。患者的剂量明显增加，到第三年年底，84.0%的患者采用了8周一次的治疗方案，29.9%的患者采用了4周一次的治疗方案。在整个随访期间，用药持续率为 76.9%，未发现严重不良反应。结论 我们的研究证实，对于疾病表型严重、抗肿瘤坏死因子治疗失败率高且需要频繁调整剂量的克罗恩病患者来说，乌司替尼是一种可持续、有效且安全的长期治疗药物。
{"title":"P661 Ustekinumab in Crohn’s disease: A three-year multicentre prospective study from Hungary - Assessing efficacy, drug sustainability, and safety","authors":"L J Barkai, L Gonczi, K Farkas, B Farkas, T Molnar, T Szamosi, E Schafer, P Golovics, M Juhasz, A Patai, A Vincze, P Sarlos, A Farkas, Z Dubravcsik, T G Toth, P Miheller, P L Lakatos, A Ilias","doi":"10.1093/ecco-jcc/jjad212.0791","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0791","url":null,"abstract":"Background While randomized controlled trials have shown ustekinumab (UST) as an effective therapeutic option for Crohn’s disease (CD), there is a lack of long-term observational data in real-world CD patient settings. This prospective study seeks to evaluate the clinical effectiveness, sustainability, and safety of UST in a nationwide multicentre cohort of CD patients over three years. The aim is to bridge the gap in our understanding of UST's real-world implications for long-term CD management. Methods CD patients undergoing ustekinumab (UST) treatment were consecutively enrolled at nine Hungarian Inflammatory Bowel Disease centers from January 2019 to May 2020. Over a three-year period, comprehensive data on patient demographics, disease characteristics, treatment history, clinical disease activity (measured by the Harvey Bradshaw Index (HBI)), biomarkers, and endoscopic activity (evaluated using the Simple Endoscopic Score for Crohn’s Disease (SES-CD)) were systematically collected. Results Involving 148 patients, the cohort comprised 48.9% with complex behavior of CD and 97.2% with previous anti-TNF exposure. Pre-induction remission rates were observed at 12.2% (HBI) and 5.1% (SES-CD). Clinical remission rates (HBI) at the end of the first, second, and third years were 52.2%, 55.6%, and 50.9%, respectively. Criteria for endoscopic remission were met in 14.3%, 27.5%, and 35.3% of subjects at the end of the first, second, and third years. Dose intensification was notable, with 84.0% of patients on an 8-weekly and 29.9% on a 4-weekly regimen by the end of year 3. Throughout the follow-up period, drug sustainability stood at 76.9%, and no serious adverse events were observed. Conclusion Our study confirms that ustekinumab is a sustainable, effective, and safe long-term treatment for Crohn's disease patients with a severe disease phenotype and a history of high anti-TNF failure, with the need for frequent dose adjustments.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"45 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559194","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/jjad212.1088
S Steiner, S Shehzad, J Adler, R B Colletti, R Strauss, J Heile, O Adedokun, A Sheahan, R Zhang, K H Lo, L Kim, Y Xiao, S Volger
Background Few approved treatment options exist for paediatric patients (pts) with Crohn’s disease (CD). Paediatric inflammatory bowel disease (IBD) medication approvals are delayed nearly 7 years after adult approvals,1 resulting in off-label use and potential for incorrect dosing. The REALITI Study evaluated the effectiveness and safety of ustekinumab (UST) in routine clinical care in paediatric pts (age 2-<18) and young adults (age 18-25) with moderately to severely active CD (Short Paediatric CD activity [sPCDAI] score ≥30) using data from the ImproveCareNow (ICN) Registry. Methods Effectiveness data from pts with CD treated with UST were extracted from the ICN Registry between 10 January 2010 and 29 February 2020. A supplemental, retrospective chart review was conducted to collect data not in the ICN Registry. The primary endpoint was clinical remission (sPCDAI≤10) at Week (Wk) 52. All data were summarized descriptively, and the proportion of pts achieving clinical remission and associated 2-sided 95% confidence interval were calculated across multiple populations. Rates of discontinuations, IBD-related hospitalizations, surgeries, and serious infections were also calculated. Results A total of 479 CD pts in ICN were treated with UST, including 348 paediatric pts and 131 young adults. We report an analysis of 114 paediatric pts who weighed >40 kg and had a sPCDAI ≥30. All pts were treatment refractory; 99.1% had not responded to prior biologic therapies, with less than 1% biologic naïve. Results were compared to 51 ICN young adults with moderately to severely active CD, a population for which UST is approved. Clinical remission at Wk 52 was achieved in 22.8% (26/114; 95% CI: 16.1%, 31.3%) of paediatric pts vs 21.6% (11/51; 95% CI:12.5%, 34.6%) of young adults (Figure 1A). Discontinuation rates through Wk 52 were similar between paediatric pts (25.4%) and young adults (25.5%; Figure 1B). Overall, 36.0% of paediatric pts and 21.6% of young adults had IBD-related hospitalizations. IBD-related surgery was reported in 14.0% of paediatric pts and 11.8% of young adults. Serious infections occurred in 9.6% of paediatric pts and 3.9% of young adults. Opportunistic infections occurred in 1.8% of paediatric pts and 0% of young adults. No events of tuberculosis, malignancy, or anaphylaxis requiring UST discontinuation occurred in either group. No deaths were reported. Conclusion This study of real-world data from the ICN Registry found similar remissions rates in paediatric pts and young adults with CD treated with UST, suggesting comparable effectiveness of UST in both age groups. No new safety signals were identified. (Crowley E, et al. J Crohns Colitis. 2022 Feb 23;16(2):331-335.)
{"title":"P958 Comparison of Paediatric Patients and Young Adults with Moderately to Severely Active Crohn’s Disease Treated with Ustekinumab in the REALITI Real-World Evidence Effectiveness Study","authors":"S Steiner, S Shehzad, J Adler, R B Colletti, R Strauss, J Heile, O Adedokun, A Sheahan, R Zhang, K H Lo, L Kim, Y Xiao, S Volger","doi":"10.1093/ecco-jcc/jjad212.1088","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.1088","url":null,"abstract":"Background Few approved treatment options exist for paediatric patients (pts) with Crohn’s disease (CD). Paediatric inflammatory bowel disease (IBD) medication approvals are delayed nearly 7 years after adult approvals,1 resulting in off-label use and potential for incorrect dosing. The REALITI Study evaluated the effectiveness and safety of ustekinumab (UST) in routine clinical care in paediatric pts (age 2-&lt;18) and young adults (age 18-25) with moderately to severely active CD (Short Paediatric CD activity [sPCDAI] score ≥30) using data from the ImproveCareNow (ICN) Registry. Methods Effectiveness data from pts with CD treated with UST were extracted from the ICN Registry between 10 January 2010 and 29 February 2020. A supplemental, retrospective chart review was conducted to collect data not in the ICN Registry. The primary endpoint was clinical remission (sPCDAI≤10) at Week (Wk) 52. All data were summarized descriptively, and the proportion of pts achieving clinical remission and associated 2-sided 95% confidence interval were calculated across multiple populations. Rates of discontinuations, IBD-related hospitalizations, surgeries, and serious infections were also calculated. Results A total of 479 CD pts in ICN were treated with UST, including 348 paediatric pts and 131 young adults. We report an analysis of 114 paediatric pts who weighed &gt;40 kg and had a sPCDAI ≥30. All pts were treatment refractory; 99.1% had not responded to prior biologic therapies, with less than 1% biologic naïve. Results were compared to 51 ICN young adults with moderately to severely active CD, a population for which UST is approved. Clinical remission at Wk 52 was achieved in 22.8% (26/114; 95% CI: 16.1%, 31.3%) of paediatric pts vs 21.6% (11/51; 95% CI:12.5%, 34.6%) of young adults (Figure 1A). Discontinuation rates through Wk 52 were similar between paediatric pts (25.4%) and young adults (25.5%; Figure 1B). Overall, 36.0% of paediatric pts and 21.6% of young adults had IBD-related hospitalizations. IBD-related surgery was reported in 14.0% of paediatric pts and 11.8% of young adults. Serious infections occurred in 9.6% of paediatric pts and 3.9% of young adults. Opportunistic infections occurred in 1.8% of paediatric pts and 0% of young adults. No events of tuberculosis, malignancy, or anaphylaxis requiring UST discontinuation occurred in either group. No deaths were reported. Conclusion This study of real-world data from the ICN Registry found similar remissions rates in paediatric pts and young adults with CD treated with UST, suggesting comparable effectiveness of UST in both age groups. No new safety signals were identified. (Crowley E, et al. J Crohns Colitis. 2022 Feb 23;16(2):331-335.)","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"11 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559257","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/jjad212.0465
L Fierens, C Liefferinckx, J Sabino, E de Dycker, V Wambacq, K Vanhaecht, F Rademakers, P Bossuyt, F Baert, D Baert, M Ferrante
Background Quality indicators are standardized, evidence-based measures of health care quality, categorised as structure (to assess the care setting), process (to assess high-quality care actions by healthcare professionals) or outcome indicators (results of actions undertaken by healthcare professionals). Several quality indicator sets have been developed to standardise, measure and optimise IBD care. Our aim was to develop and validate a set to assess IBD care in Belgium and to select a subset of indicators with room for improvement that can be used to implement and improve care in clinical practice. Methods The importance of 221 quality indicators (49 structure, 135 process and 37 outcome) identified through literature was scored on a 10-point Likert scale in a two-round modified Delphi exercise by IBD experts. In a third round, the experts indicated and ranked their top 10 indicators with most room for improvement benefitting the patient in the Belgian healthcare system to agree on an improvement subset. In parallel, patient perspectives were collected through two linguistic patient focus groups, one in Flemish (6 participants) and one in French (4 participants). A final consensus meeting was organised to discuss 1) the patient perspectives gained through the focus groups, 2) the results of two Delphi scoring rounds and 3) the results of the additional ranking round. Indicators scoring ≥7 by ≥80% of the participants during the second scoring round, or based on agreement during the consensus meeting, were included in the final set. Results Thirty-two experts (11 IBD nurses and 21 clinicians including 2 paediatricians) participated in all three voting rounds, of which 19 also participated in the consensus meeting (6 IBD nurses and 13 IBD clinicians including 2 IBD paediatricians). In total, 199 quality indicators were agreed upon to assess IBD care in Belgium (41 structure, 123 process and 35 outcome). Eighteen (3 structure, 14 process and 1 outcome; Table) were retained in the improvement subset, related to patient characteristics, endoscopy guidelines, infection prevention, steroid use, the IBD care team, services provided in the IBD clinic, the documentation of patient characteristics, the care pathway and the monitoring of disease activity. The decision to include the latter five themes was driven by the importance to patients, which was evident from the patient focus groups. Conclusion An evidence and consensus based set of quality indicators was developed and validated - including an improvement subset - allowing Belgian IBD centres to evaluate quality of provided care, set up quality improvement projects and potentially launch a benchmarking study.
{"title":"P335 Development and validation of a Belgian set of quality indicators for inflammatory bowel diseases","authors":"L Fierens, C Liefferinckx, J Sabino, E de Dycker, V Wambacq, K Vanhaecht, F Rademakers, P Bossuyt, F Baert, D Baert, M Ferrante","doi":"10.1093/ecco-jcc/jjad212.0465","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0465","url":null,"abstract":"Background Quality indicators are standardized, evidence-based measures of health care quality, categorised as structure (to assess the care setting), process (to assess high-quality care actions by healthcare professionals) or outcome indicators (results of actions undertaken by healthcare professionals). Several quality indicator sets have been developed to standardise, measure and optimise IBD care. Our aim was to develop and validate a set to assess IBD care in Belgium and to select a subset of indicators with room for improvement that can be used to implement and improve care in clinical practice. Methods The importance of 221 quality indicators (49 structure, 135 process and 37 outcome) identified through literature was scored on a 10-point Likert scale in a two-round modified Delphi exercise by IBD experts. In a third round, the experts indicated and ranked their top 10 indicators with most room for improvement benefitting the patient in the Belgian healthcare system to agree on an improvement subset. In parallel, patient perspectives were collected through two linguistic patient focus groups, one in Flemish (6 participants) and one in French (4 participants). A final consensus meeting was organised to discuss 1) the patient perspectives gained through the focus groups, 2) the results of two Delphi scoring rounds and 3) the results of the additional ranking round. Indicators scoring ≥7 by ≥80% of the participants during the second scoring round, or based on agreement during the consensus meeting, were included in the final set. Results Thirty-two experts (11 IBD nurses and 21 clinicians including 2 paediatricians) participated in all three voting rounds, of which 19 also participated in the consensus meeting (6 IBD nurses and 13 IBD clinicians including 2 IBD paediatricians). In total, 199 quality indicators were agreed upon to assess IBD care in Belgium (41 structure, 123 process and 35 outcome). Eighteen (3 structure, 14 process and 1 outcome; Table) were retained in the improvement subset, related to patient characteristics, endoscopy guidelines, infection prevention, steroid use, the IBD care team, services provided in the IBD clinic, the documentation of patient characteristics, the care pathway and the monitoring of disease activity. The decision to include the latter five themes was driven by the importance to patients, which was evident from the patient focus groups. Conclusion An evidence and consensus based set of quality indicators was developed and validated - including an improvement subset - allowing Belgian IBD centres to evaluate quality of provided care, set up quality improvement projects and potentially launch a benchmarking study.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559272","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/jjad212.0504
J E Baek, E S Kim, K O Kim, H H Jo, S W Hwang, S H Park, B I Jang, E Y Kim, S K Yang, S K Kim, B D Ye
Background The real-life data on ustekinumab (UST) for Asian patients with ulcerative colitis (UC) are limited. We aimed to assess effectiveness and safety of UST for Korean patients with UC. Methods This was a multicenter retrospective study on patients with UC who received UST at 4 academic centers in Korea between January 2021 and April 2023. The primary endpoint was clinical remission defined as partial Mayo score (PMS) ≤2 and no subscore >1 at week (W) 8 of therapy. Secondary endpoints included clinical remission (W16–20 and W52–56), corticosteroid-free clinical remission (W8, W16–20 and W52–56), clinical response defined as reduction of PMS ≥3 and at least 30% from baseline with either a decrease in rectal bleeding subscore ≥1 or an absolute rectal bleeding subscore ≤1 (W8, W16–20 and W52–56), endoscopic remission defined as Mayo endoscopic subscore 0–1 (W16–20 and W52–56), durability of UST at W52–56 and adverse events. Results A total of 55 patients were included and 54 were analyzed excluding one in clinical remission at baseline (Male, 66.7%; Median age at UST initiation, 44.5 years; Disease duration at UST initiation, 7.5 years; Previous exposure to biologics/small molecules, 70.4%; Extensive colitis, 64.8%; Median baseline Mayo score, 8; Concomitant use of systemic corticosteroids, 48.1%; Concomitant use of immunomodulators, 38.9%). Out of 54 patients, 27 patients (50%) reached to W52–56 or stopped UST, while remained 27 patients still under maintenance UST therapy, not reaching W52–56. At W8, W16–20, and W52–56, 53.7% (29/54), 63% (34/54), and 44.4% (12/27) achieved clinical remission and 68.5% (37/54), 70.4% (38/54), and 51.9% (14/27) showed clinical response, respectively (Figure 1). Endoscopic remission rates at W16–20 and W52–56 were 57.4% (31/54) and 37% (10/27), respectively (Figure 1). The durability of UST at W52–56 was 74.1% (20/27). Multivariable analysis revealed that previous exposure to biologics/small molecules was negatively associated with clinical remission at W8 (OR: 0.10; 95% confidence interval [CI] 0.02–0.57; p=0.01) and W16–20 (OR: 0.18; 95% CI 0.04–0.91; p=0.04), whereas the concomitant use of immunomodulators showed a positive association with clinical remission at W8 (OR: 4.19; 95% CI 1.11–15.77; p=0.03). Adverse events occurred in 23 patients (42.6%) and serious adverse event in one patient (1.9%) (Table 1). Conclusion UST was effective with an acceptable safety profile for Korean patients with UC. Previous exposure to biologics/small molecules was negatively associated with clinical remission at both W8 and W16–20. Financial Support This work was supported by the National Research Foundation of Korea(NRF) grant funded by the Korea government(MSIT) (NRF-2021R1A2C2095096).
{"title":"P374 Real-life effectiveness and safety of ustekinumab treatment in patients with ulcerative colitis: An Asan-Crohn’s and Colitis Association in Daegu-Gyeongbuk (CCAiD) multicenter cohort study","authors":"J E Baek, E S Kim, K O Kim, H H Jo, S W Hwang, S H Park, B I Jang, E Y Kim, S K Yang, S K Kim, B D Ye","doi":"10.1093/ecco-jcc/jjad212.0504","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0504","url":null,"abstract":"Background The real-life data on ustekinumab (UST) for Asian patients with ulcerative colitis (UC) are limited. We aimed to assess effectiveness and safety of UST for Korean patients with UC. Methods This was a multicenter retrospective study on patients with UC who received UST at 4 academic centers in Korea between January 2021 and April 2023. The primary endpoint was clinical remission defined as partial Mayo score (PMS) ≤2 and no subscore &gt;1 at week (W) 8 of therapy. Secondary endpoints included clinical remission (W16–20 and W52–56), corticosteroid-free clinical remission (W8, W16–20 and W52–56), clinical response defined as reduction of PMS ≥3 and at least 30% from baseline with either a decrease in rectal bleeding subscore ≥1 or an absolute rectal bleeding subscore ≤1 (W8, W16–20 and W52–56), endoscopic remission defined as Mayo endoscopic subscore 0–1 (W16–20 and W52–56), durability of UST at W52–56 and adverse events. Results A total of 55 patients were included and 54 were analyzed excluding one in clinical remission at baseline (Male, 66.7%; Median age at UST initiation, 44.5 years; Disease duration at UST initiation, 7.5 years; Previous exposure to biologics/small molecules, 70.4%; Extensive colitis, 64.8%; Median baseline Mayo score, 8; Concomitant use of systemic corticosteroids, 48.1%; Concomitant use of immunomodulators, 38.9%). Out of 54 patients, 27 patients (50%) reached to W52–56 or stopped UST, while remained 27 patients still under maintenance UST therapy, not reaching W52–56. At W8, W16–20, and W52–56, 53.7% (29/54), 63% (34/54), and 44.4% (12/27) achieved clinical remission and 68.5% (37/54), 70.4% (38/54), and 51.9% (14/27) showed clinical response, respectively (Figure 1). Endoscopic remission rates at W16–20 and W52–56 were 57.4% (31/54) and 37% (10/27), respectively (Figure 1). The durability of UST at W52–56 was 74.1% (20/27). Multivariable analysis revealed that previous exposure to biologics/small molecules was negatively associated with clinical remission at W8 (OR: 0.10; 95% confidence interval [CI] 0.02–0.57; p=0.01) and W16–20 (OR: 0.18; 95% CI 0.04–0.91; p=0.04), whereas the concomitant use of immunomodulators showed a positive association with clinical remission at W8 (OR: 4.19; 95% CI 1.11–15.77; p=0.03). Adverse events occurred in 23 patients (42.6%) and serious adverse event in one patient (1.9%) (Table 1). Conclusion UST was effective with an acceptable safety profile for Korean patients with UC. Previous exposure to biologics/small molecules was negatively associated with clinical remission at both W8 and W16–20. Financial Support This work was supported by the National Research Foundation of Korea(NRF) grant funded by the Korea government(MSIT) (NRF-2021R1A2C2095096).","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"19 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559273","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/jjad212.0828
R Parra, J M F Chebli, M Freitas Cardoso de Azevedo, L A Chebli, G P Zabot, O S Cassol, R D S B Fróes, G O Santana, M Lubini, D O Magro, M Imbrizi, A C S Moraes, F V Teixeira, A J T Alves Jr, N L T Gasparetti Junior, S D C Ferreira, N S F Queiroz, P G Kotze, O Féres
Background Real-world data on the effectiveness and safety of ustekinumab (UST) in ulcerative colitis (UC) are lacking in Latin America. In this study, we aimed to describe the effectiveness and safety of UST in a real-world multicentre cohort of Brazilian patients with UC. Methods We conducted a multicentre retrospective observational cohort study, including patients with moderate to severe UC (Total Mayo score 6-12, with an endoscopic subscore of 2 or 3) who received UST. The co-primary endpoints were clinical remission, defined as a total Mayo score ≤2 at 1 year, with a combined rectal bleeding and stool frequency subscore of ≤1, and endoscopic remission (endoscopic Mayo subscore of zero) within one year from baseline. Secondary endpoints included clinical response between weeks 12-16, endoscopic response within one year of starting UST, steroid-free clinical remission at week 52, and biochemical remission at week 52. We also evaluated UST treatment persistence and safety. Results A total of 50 patients were included (female, n=36, 72.0%), with a median disease duration of 9.2 years (1-27). Most patients had extensive colitis (n=38, 76.0%), and 43 (86.0%) were steroid-dependent at baseline. Forty patients (80.0%) were previously exposed to biologics (anti-TNF drugs, n=31; vedolizumab [VDZ], n=27). The co-primary endpoints of clinical remission and endoscopic remission at 1 year were achieved by 50.0% and 36.0% of patients, respectively. Clinical response at weeks 12-16 was 56.0%, endoscopic response, steroid-free clinical remission, and biochemical remission at week 52 were 68.0%, 67.4%, and 50.0%, respectively. The UST treatment persistence rates at 24 months was 73.7%. During the follow-up, 10 patients (20.0%) were hospitalized, mostly due to disease progression, and three patients required colectomy. Nine patients (18.0%) discontinued the drug mainly due to a lack of effectiveness. Twenty-six adverse events (AEs) were reported, 15 of which were considered as serious AEs. Conclusion This is the first real-world experience study to report the effectiveness and safety of UST specifically in a Latin American population. In this real-world cohort of difficult-to-treat UC patients, UST was associated with improvements in clinical, biochemical, and endoscopic outcomes. The safety profile was favorable, consistent with the known profile of UST.
{"title":"P698 Effectiveness and Safety of Ustekinumab for Ulcerative Colitis: A Brazilian Multicentre Real-World Observational Study","authors":"R Parra, J M F Chebli, M Freitas Cardoso de Azevedo, L A Chebli, G P Zabot, O S Cassol, R D S B Fróes, G O Santana, M Lubini, D O Magro, M Imbrizi, A C S Moraes, F V Teixeira, A J T Alves Jr, N L T Gasparetti Junior, S D C Ferreira, N S F Queiroz, P G Kotze, O Féres","doi":"10.1093/ecco-jcc/jjad212.0828","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0828","url":null,"abstract":"Background Real-world data on the effectiveness and safety of ustekinumab (UST) in ulcerative colitis (UC) are lacking in Latin America. In this study, we aimed to describe the effectiveness and safety of UST in a real-world multicentre cohort of Brazilian patients with UC. Methods We conducted a multicentre retrospective observational cohort study, including patients with moderate to severe UC (Total Mayo score 6-12, with an endoscopic subscore of 2 or 3) who received UST. The co-primary endpoints were clinical remission, defined as a total Mayo score ≤2 at 1 year, with a combined rectal bleeding and stool frequency subscore of ≤1, and endoscopic remission (endoscopic Mayo subscore of zero) within one year from baseline. Secondary endpoints included clinical response between weeks 12-16, endoscopic response within one year of starting UST, steroid-free clinical remission at week 52, and biochemical remission at week 52. We also evaluated UST treatment persistence and safety. Results A total of 50 patients were included (female, n=36, 72.0%), with a median disease duration of 9.2 years (1-27). Most patients had extensive colitis (n=38, 76.0%), and 43 (86.0%) were steroid-dependent at baseline. Forty patients (80.0%) were previously exposed to biologics (anti-TNF drugs, n=31; vedolizumab [VDZ], n=27). The co-primary endpoints of clinical remission and endoscopic remission at 1 year were achieved by 50.0% and 36.0% of patients, respectively. Clinical response at weeks 12-16 was 56.0%, endoscopic response, steroid-free clinical remission, and biochemical remission at week 52 were 68.0%, 67.4%, and 50.0%, respectively. The UST treatment persistence rates at 24 months was 73.7%. During the follow-up, 10 patients (20.0%) were hospitalized, mostly due to disease progression, and three patients required colectomy. Nine patients (18.0%) discontinued the drug mainly due to a lack of effectiveness. Twenty-six adverse events (AEs) were reported, 15 of which were considered as serious AEs. Conclusion This is the first real-world experience study to report the effectiveness and safety of UST specifically in a Latin American population. In this real-world cohort of difficult-to-treat UC patients, UST was associated with improvements in clinical, biochemical, and endoscopic outcomes. The safety profile was favorable, consistent with the known profile of UST.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"25 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559401","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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