Pub Date : 2024-01-01DOI: 10.1093/ecco-jcc/jjad212.1225
C. Eriksson, J. Sun, M. Bryder, G. Bröms, Å. H. Everhov, A. Forss, T. Jernberg, J. Ludvigsson, O. Olén
There are conflicting data on the risk of acute coronary syndrome (ACS) in patients with inflammatory bowel disease (IBD) and only a few previous reports include patients diagnosed in the last decade. The aim of this study was to assess the risk of ACS in a modern population of IBD patients vs general population comparators. In this cohort study, we used nationwide registers to identify patients diagnosed with IBD in Sweden 2003-2021. Every patient was matched by birth year, sex, calendar year of diagnosis, and area of residence with up to ten general population comparators. The primary outcome was incident ACS (i.e. ST-segment elevation myocardial infarction [MI], non–ST-segment elevation MI, unspecific MI and unstable angina). Cox proportional hazard models were used to estimate hazard ratios (HRs). Overall, 76,517 patients with IBD (Crohn's disease (CD), N=22,732; ulcerative colitis (UC), N=42,194 and IBD-unclassified, N=11,591) and 757,141 comparators were identified (Table 1). During a median follow-up of 8 years, 2546 patients with IBD (37.5/10,000 person-years) were diagnosed with ACS as compared with 19,598 (28.0/10,000 person-years) in the general population comparators. This corresponded to an HR of 1.30 (95% confidence interval [CI]: 1.24-1.35) after adjustings for potential confounders, and approximately 1 extra case of ACS in 100 IBD patients followed for 10 years. HRs for ACS were higher during the first year of follow-up but remained increased even after 5 years of follow-up (Figure 1). The highest HRs for ACS were observed in patients with elderly onset IBD (≥60 years; HR: 1.35; 95% CI: 1.28-1.43) and in patients with CD and UC with extra-intestinal manifestations (HR in CD: 1.58; 95% CI: 1.20-2.09; HR in UC: 1.98; 95% CI: 1.63-2.40). When restricting analyes to patients with elderly onset IBD, the absolute risk increase corresponded to 1 additional case of ACS for every 30 IBD-patient followed for 10 years. In contrast, no increased HRs were observed in patients diagnosed with IBD before the age of 40. But of note, just a few of the patients diagnosed with IBD before 40 years of age were followed-up beyond 50 years of age. HRs for ACS were stable during the whole study period 2003-2021 with no signs of leveling off during recent years. In this contemporary cohort of patients with IBD, exposed to modern IBD-care, an increased risk for ACS was observed as compared with individuals of the general population. The highest HRs were observed in patients with elderly onset IBD and in patients with CD and UC with extra-intestinal manifestations.
{"title":"P1095 Impact of inflammatory bowel disease on the risk of acute coronary syndrome: A Swedish Nationwide cohort study 2003-2021","authors":"C. Eriksson, J. Sun, M. Bryder, G. Bröms, Å. H. Everhov, A. Forss, T. Jernberg, J. Ludvigsson, O. Olén","doi":"10.1093/ecco-jcc/jjad212.1225","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.1225","url":null,"abstract":"\u0000 \u0000 \u0000 There are conflicting data on the risk of acute coronary syndrome (ACS) in patients with inflammatory bowel disease (IBD) and only a few previous reports include patients diagnosed in the last decade. The aim of this study was to assess the risk of ACS in a modern population of IBD patients vs general population comparators.\u0000 \u0000 \u0000 \u0000 In this cohort study, we used nationwide registers to identify patients diagnosed with IBD in Sweden 2003-2021. Every patient was matched by birth year, sex, calendar year of diagnosis, and area of residence with up to ten general population comparators. The primary outcome was incident ACS (i.e. ST-segment elevation myocardial infarction [MI], non–ST-segment elevation MI, unspecific MI and unstable angina). Cox proportional hazard models were used to estimate hazard ratios (HRs).\u0000 \u0000 \u0000 \u0000 Overall, 76,517 patients with IBD (Crohn's disease (CD), N=22,732; ulcerative colitis (UC), N=42,194 and IBD-unclassified, N=11,591) and 757,141 comparators were identified (Table 1). During a median follow-up of 8 years, 2546 patients with IBD (37.5/10,000 person-years) were diagnosed with ACS as compared with 19,598 (28.0/10,000 person-years) in the general population comparators. This corresponded to an HR of 1.30 (95% confidence interval [CI]: 1.24-1.35) after adjustings for potential confounders, and approximately 1 extra case of ACS in 100 IBD patients followed for 10 years. HRs for ACS were higher during the first year of follow-up but remained increased even after 5 years of follow-up (Figure 1). The highest HRs for ACS were observed in patients with elderly onset IBD (≥60 years; HR: 1.35; 95% CI: 1.28-1.43) and in patients with CD and UC with extra-intestinal manifestations (HR in CD: 1.58; 95% CI: 1.20-2.09; HR in UC: 1.98; 95% CI: 1.63-2.40). When restricting analyes to patients with elderly onset IBD, the absolute risk increase corresponded to 1 additional case of ACS for every 30 IBD-patient followed for 10 years. In contrast, no increased HRs were observed in patients diagnosed with IBD before the age of 40. But of note, just a few of the patients diagnosed with IBD before 40 years of age were followed-up beyond 50 years of age. HRs for ACS were stable during the whole study period 2003-2021 with no signs of leveling off during recent years.\u0000 \u0000 \u0000 \u0000 In this contemporary cohort of patients with IBD, exposed to modern IBD-care, an increased risk for ACS was observed as compared with individuals of the general population. The highest HRs were observed in patients with elderly onset IBD and in patients with CD and UC with extra-intestinal manifestations.\u0000 \u0000 \u0000","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139632825","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 : 2024-01-01DOI: 10.1093/ecco-jcc/jjad212.1389
K. King, C. Norton, T. Chalder, W. Czuber-dochan
Inflammatory bowel disease (IBD) has recognised medications to maintain remission and prevent relapse. Yet between 53–75% of people with IBD do not take medications as prescribed. Identifying and improving medication adherence in IBD is a primary treatment goal to keep symptoms quiescent. This systematic review aims to identify why people are adherent and non-adherent to IBD medications. Studies exploring medication adherence for IBD conducted between 2012-2022, were identified in six electronic databases. The quality of quantitative and qualitative studies was assessed using a scoring system or the Critical Appraisal Skills Programme, respectively. 39,603 participants were included across 79 studies investigating IBD medication adherence, mainly from single outpatient clinic populations, using cross-sectional surveys. Most data were quantitative, rated medium quality. Few studies were based around a theory to explain adherence. Non-adherence was most typically measured using a version of the Morisky Medication Adherence Scale or the study’s own self-report questionnaire, with non-adherence ranging from 4.3%-88.9%. In multivariable analysis of quantitative data, younger age and female gender were usually associated with non-adherence. The presence of smoking, psychological issues (depression, treatment concerns, anxiety) or lower social status were also significant non-adherence risk factors. Most typically investigated were clinical variables, many being significantly related with non-adherence, including medication type (specifically 5-ASA), route (oral, rectal, subcutaneous, intravenous), high and low disease activity and poor disease/medication knowledge. Significant results were often contradictory between studies, as was the relationship direction with non-adherence. Forgetting medication was the main reason for non-adherence in qualitative interviews, with side effects, costs, medication concerns and busy lifestyle also variables. Cohort-specific factors were reported for non-adherence in pregnant women, adolescents and patients during COVID.Conclusion Adherence to treatment is essential in IBD. Yet a large and confusing literature exists regarding factors underpinning non-adherence. Clinicians should be aware of those non-modifiable factors, to help identify relevant patients and support their treatment programme. Potentially modifiable factors including medication regimes, route and patient knowledge, could be targeted to improve adherence in IBD. Theoretically informed interventions need to be developed. A successful evidence-based intervention supporting medication adherence could help improve quality of life for patients living with IBD, whilst providing patient-centred care and minimising health costs.
{"title":"N17 Exploration of medication non-adherence in Inflammatory Bowel Disease patients: A systematic review","authors":"K. King, C. Norton, T. Chalder, W. Czuber-dochan","doi":"10.1093/ecco-jcc/jjad212.1389","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.1389","url":null,"abstract":"\u0000 \u0000 \u0000 Inflammatory bowel disease (IBD) has recognised medications to maintain remission and prevent relapse. Yet between 53–75% of people with IBD do not take medications as prescribed. Identifying and improving medication adherence in IBD is a primary treatment goal to keep symptoms quiescent.\u0000 This systematic review aims to identify why people are adherent and non-adherent to IBD medications.\u0000 \u0000 \u0000 \u0000 Studies exploring medication adherence for IBD conducted between 2012-2022, were identified in six electronic databases.\u0000 The quality of quantitative and qualitative studies was assessed using a scoring system or the Critical Appraisal Skills Programme, respectively.\u0000 \u0000 \u0000 \u0000 39,603 participants were included across 79 studies investigating IBD medication adherence, mainly from single outpatient clinic populations, using cross-sectional surveys.\u0000 Most data were quantitative, rated medium quality. Few studies were based around a theory to explain adherence.\u0000 Non-adherence was most typically measured using a version of the Morisky Medication Adherence Scale or the study’s own self-report questionnaire, with non-adherence ranging from 4.3%-88.9%.\u0000 In multivariable analysis of quantitative data, younger age and female gender were usually associated with non-adherence. The presence of smoking, psychological issues (depression, treatment concerns, anxiety) or lower social status were also significant non-adherence risk factors. Most typically investigated were clinical variables, many being significantly related with non-adherence, including medication type (specifically 5-ASA), route (oral, rectal, subcutaneous, intravenous), high and low disease activity and poor disease/medication knowledge. Significant results were often contradictory between studies, as was the relationship direction with non-adherence.\u0000 Forgetting medication was the main reason for non-adherence in qualitative interviews, with side effects, costs, medication concerns and busy lifestyle also variables.\u0000 Cohort-specific factors were reported for non-adherence in pregnant women, adolescents and patients during COVID.Conclusion\u0000 Adherence to treatment is essential in IBD. Yet a large and confusing literature exists regarding factors underpinning non-adherence.\u0000 Clinicians should be aware of those non-modifiable factors, to help identify relevant patients and support their treatment programme.\u0000 Potentially modifiable factors including medication regimes, route and patient knowledge, could be targeted to improve adherence in IBD.\u0000 Theoretically informed interventions need to be developed. A successful evidence-based intervention supporting medication adherence could help improve quality of life for patients living with IBD, whilst providing patient-centred care and minimising health costs.\u0000","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139632835","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 : 2024-01-01DOI: 10.1093/ecco-jcc/jjad212.1349
W. C. Tai, C. C. Yao, Y. -. Tsai
Inflammatory bowel disease (IBD), comprising the predominant forms Crohn’s disease (CD) and ulcerative colitis (UC), is associated with compositional and metabolic changes in the intestinal dysbiosis. The aim of this study is to evaluate the composition in the microbiota of IBD patients who received biologic therapy This is a prospective study recruited 14 patients with IBD received biologic therapy and 13 IBD controls who received conventional treatment . The taxonomic composition of the gut microbiota was determined by 16S ribosomal RNA gene sequencing of stool samples. The stool samples at baseline, weeks 6 and 48 after biologic therapy initiation were assessed. We also evaluated the level of inflammation and treatment response of biologics by BD activity score (CD patient by Crohn’s disease activity index [CDAI] and in UC patient by Mayo score). In CD group, we recruited 7 CD patients receiving biologic therapy (Anti-tumor Necrosis Factor for 4 and anti-integrin for 3) and 6 controls.In UC group, we recruited 7 UC patient receiving biological therapy (Anti-tumor Necrosis Factor for 2 and anti-integrin for 5) and 7 controls. Community α-diversity was lower in patients at baseline of biologics group compare to controls significantly but increase abundance and richness after achieving remission in trend at week 6 and week 48, respectively. In Top 10 taxon bacterial distribution, the Firmicutes were increase its abundances gradually ( relative abundance in biologics W0,W6,W48 and controls were 46.3%, 51.7%,62.0%, and 66.4%, respectively). Conversely, the Bacteroidetes were decrease its abundances ( relative abundance in biologics W0,W6,W48 and controls were18.3%, 18.8%, 10.2% and 6.4%, respectively). Increased F/B ratio significantly after biologics therapy also found in our study. (F/B ratio were 9.4, 12.5,64.0,and 84.3,respectively). Patients in control group had higher abundance of Firmicutes of the phylum.By contrast, Enterobacteriaceae and Bacteroidaceae were significantly more abundant in patients of biologics group at W0 . Treatment with biologic therapy induced improvement of community diversity and increased F/B ratio in IBD patients which seemed correlate the level of clinical inflammation. The dysbiosis-representative bacteria, such as Enterobacteriaceae, could induce colonic inflammation,were more abundant in patients who had higher activity of IBD. Further larger prospective studies are needed to determine whether the biologic therapy could induce long-term changes of intestinal microbiome.
{"title":"P1219 Changes in gut microbiota of patients with inflammatory bowel disease receiving biologic therapy","authors":"W. C. Tai, C. C. Yao, Y. -. Tsai","doi":"10.1093/ecco-jcc/jjad212.1349","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.1349","url":null,"abstract":"\u0000 \u0000 \u0000 Inflammatory bowel disease (IBD), comprising the predominant forms Crohn’s disease (CD) and ulcerative colitis (UC), is associated with compositional and metabolic changes in the intestinal dysbiosis. The aim of this study is to evaluate the composition in the microbiota of IBD patients who received biologic therapy\u0000 \u0000 \u0000 \u0000 This is a prospective study recruited 14 patients with IBD received biologic therapy and 13 IBD controls who received conventional treatment . The taxonomic composition of the gut microbiota was determined by 16S ribosomal RNA gene sequencing of stool samples. The stool samples at baseline, weeks 6 and 48 after biologic therapy initiation were assessed. We also evaluated the level of inflammation and treatment response of biologics by BD activity score (CD patient by Crohn’s disease activity index [CDAI] and in UC patient by Mayo score).\u0000 \u0000 \u0000 \u0000 In CD group, we recruited 7 CD patients receiving biologic therapy (Anti-tumor Necrosis Factor for 4 and anti-integrin for 3) and 6 controls.In UC group, we recruited 7 UC patient receiving biological therapy (Anti-tumor Necrosis Factor for 2 and anti-integrin for 5) and 7 controls.\u0000 Community α-diversity was lower in patients at baseline of biologics group compare to controls significantly but increase abundance and richness after achieving remission in trend at week 6 and week 48, respectively. In Top 10 taxon bacterial distribution, the Firmicutes were increase its abundances gradually ( relative abundance in biologics W0,W6,W48 and controls were 46.3%, 51.7%,62.0%, and 66.4%, respectively). Conversely, the Bacteroidetes were decrease its abundances ( relative abundance in biologics W0,W6,W48 and controls were18.3%, 18.8%, 10.2% and 6.4%, respectively). Increased F/B ratio significantly after biologics therapy also found in our study. (F/B ratio were 9.4, 12.5,64.0,and 84.3,respectively).\u0000 Patients in control group had higher abundance of Firmicutes of the phylum.By contrast, Enterobacteriaceae and Bacteroidaceae were significantly more abundant in patients of biologics group at W0 .\u0000 \u0000 \u0000 \u0000 Treatment with biologic therapy induced improvement of community diversity and increased F/B ratio in IBD patients which seemed correlate the level of clinical inflammation. The dysbiosis-representative bacteria, such as Enterobacteriaceae, could induce colonic inflammation,were more abundant in patients who had higher activity of IBD. Further larger prospective studies are needed to determine whether the biologic therapy could induce long-term changes of intestinal microbiome.\u0000","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139632886","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 : 2024-01-01DOI: 10.1093/ecco-jcc/jjad212.0812
Y. Uchitel, N. A. Cohen, A. Hirsch, H. Tulchinsky, M. Zemel, N. Maharshak
Chronic pouchitis affects ~30% of patients post total colectomy with ileal pouch anal anastomosis (IPAA) surgery. Treatment with anti-TNF, anti-integrin α4β7, anti-IL-12/23, or Crohn's disease exclusion diet (CDED), have shown promise in different studies. We aimed to compare the efficacy of these treatments in a real-world context and to detect factors that can aid in treatment choices. A retrospective cohort study encompassing demographic, clinic, endoscopic, histologic and lab values of adult ulcerative colitis (UC) patients post-IPAA surgery with chronic pouchitis, treated with biologics or CDED at the Tel Aviv Medical Center. Data were collected at baseline, 12, 26, and 52 weeks of treatment. Primary outcomes were assessed using the modified Pouchitis Disease Activity Index (mPDAI). mPDAI response was defined as a reduction from baseline of ≥2 points, while mPDAI remission was defined as mPDAI response in addition to mPDAI score ≤4. Therapeutic interventions among 51 patients included CDED (n=10), vedolizumab (n=21), ustekinumab (n=7) and adalimumab (n=13) [Table 1]. At 12 and 26 weeks, overall mPDAI response rates were 52% and 48%, respectively, with no significant difference between groups. At 52 weeks, mPDAI response rates were significantly higher for ustekinumab and vedolizumab (60% and 55%, respectively) compared with adalimumab and CDED (27.3% and 0%, respectively), p=0.043. Fecal calprotectin reduction at week-26 was greatest for ustekinumab (93%), followed by vedolizumab (73%), adalimumab (55%), and CDED (-13%), p=0.003. Treatment persistence over 150 weeks was significantly higher for ustekinumab (100%) compared with adalimumab (46%), vedolizumab (33%), and CDED (20%), p<0.001 [Figure 1]. The predominant cause for treatment discontinuation was secondary loss of response (50%), followed by primary non-response and surgical complications (14.7% each), poor compliance (11.8%), side-effects (5.9%), and development of antibodies (2.9%). Patients without prior biologic or immunomodulator treatment for pouchitis had significantly higher mPDAI response rates at 12 weeks (90%, p=0.016 and 73.3%, p=0.03, respectively). Patients with surgical pouch complications showed a trend towards lower mPDAI-defined response rates at 12 weeks (25% vs. 64.7%; p = 0.064). Ustekinumab and vedolizumab demonstrate higher likelihood of maintaining long-term clinical and endoscopic response, along with greater reduction in fecal calprotectin compared with adalimumab and CDED. Biologic and immunomodulator therapy-naïve patients achieved higher induction response rates.
{"title":"P682 A Retrospective Comparison of Different Treatment Modalities in Patients with Chronic Pouchitis","authors":"Y. Uchitel, N. A. Cohen, A. Hirsch, H. Tulchinsky, M. Zemel, N. Maharshak","doi":"10.1093/ecco-jcc/jjad212.0812","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0812","url":null,"abstract":"\u0000 \u0000 \u0000 Chronic pouchitis affects ~30% of patients post total colectomy with ileal pouch anal anastomosis (IPAA) surgery. Treatment with anti-TNF, anti-integrin α4β7, anti-IL-12/23, or Crohn's disease exclusion diet (CDED), have shown promise in different studies. We aimed to compare the efficacy of these treatments in a real-world context and to detect factors that can aid in treatment choices.\u0000 \u0000 \u0000 \u0000 A retrospective cohort study encompassing demographic, clinic, endoscopic, histologic and lab values of adult ulcerative colitis (UC) patients post-IPAA surgery with chronic pouchitis, treated with biologics or CDED at the Tel Aviv Medical Center. Data were collected at baseline, 12, 26, and 52 weeks of treatment. Primary outcomes were assessed using the modified Pouchitis Disease Activity Index (mPDAI). mPDAI response was defined as a reduction from baseline of ≥2 points, while mPDAI remission was defined as mPDAI response in addition to mPDAI score ≤4.\u0000 \u0000 \u0000 \u0000 Therapeutic interventions among 51 patients included CDED (n=10), vedolizumab (n=21), ustekinumab (n=7) and adalimumab (n=13) [Table 1].\u0000 At 12 and 26 weeks, overall mPDAI response rates were 52% and 48%, respectively, with no significant difference between groups. At 52 weeks, mPDAI response rates were significantly higher for ustekinumab and vedolizumab (60% and 55%, respectively) compared with adalimumab and CDED (27.3% and 0%, respectively), p=0.043. Fecal calprotectin reduction at week-26 was greatest for ustekinumab (93%), followed by vedolizumab (73%), adalimumab (55%), and CDED (-13%), p=0.003.\u0000 Treatment persistence over 150 weeks was significantly higher for ustekinumab (100%) compared with adalimumab (46%), vedolizumab (33%), and CDED (20%), p<0.001 [Figure 1]. The predominant cause for treatment discontinuation was secondary loss of response (50%), followed by primary non-response and surgical complications (14.7% each), poor compliance (11.8%), side-effects (5.9%), and development of antibodies (2.9%).\u0000 Patients without prior biologic or immunomodulator treatment for pouchitis had significantly higher mPDAI response rates at 12 weeks (90%, p=0.016 and 73.3%, p=0.03, respectively). Patients with surgical pouch complications showed a trend towards lower mPDAI-defined response rates at 12 weeks (25% vs. 64.7%; p = 0.064).\u0000 \u0000 \u0000 \u0000 Ustekinumab and vedolizumab demonstrate higher likelihood of maintaining long-term clinical and endoscopic response, along with greater reduction in fecal calprotectin compared with adalimumab and CDED. Biologic and immunomodulator therapy-naïve patients achieved higher induction response rates.\u0000 \u0000 \u0000","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139632904","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 : 2024-01-01DOI: 10.1093/ecco-jcc/jjad212.1049
L. Scarallo, S. Pochesci, L. Fioretti, M. Paci, S. Renzo, S. Naldini, L. Lacitignola, J. Barp, E. Banci, A. De Blasi, P. Lionetti
Despite the accumulating body of evidence of the efficacy and tolerability of Crohn’s disease exclusion diet (CDED) combined with partial enteral nutrition (PEN), there is still a paucity data regarding its use in combination with other medical treatments. We aimed at assessing its efficacy in re-inducing remission in pediatric CD patients experiencing disease relapse while on other maintenance therapies. This was a single-center, retrospective, observational study conducted at an Italian national referral pediatric IBD center. Incident patients who received CDED coupled with PEN in the setting of the loss of response to other maintenance therapies from January 1st, 2020 to June 30th 2023 were included. Clinical remission at the end of each phase was defined by a weighted Pediatric Crohn’s Disease Activity Index (wPCDAI) below 12.5. Biochemical remission was defined by a c-reactive protein (CRP) lower than 0.5 mg/dL. A FC lower than 150 mg/kg was used as a surrogate of mucosal improvement (MI). 25 patients (52% males) met inclusion criteria and were included in the analysis. Median disease duration at CDED+PEN initiation was 31 months (Q1-Q3: 8.4-13.8). The most frequent disease location was ileocolonic (64%), 3 (12%) patients had isolated colonic involvement. 9 (36%) patients had stricturing/penetrating phenotype. 16 patients (68%) were being treated with an anti-TNF-alpha agent, whereas 5 (20%) patients were receiving ustekinumab (Table 1). wPCDAI, CRP and FC significantly decreased after the firs 8 weeks of treatment (22.5 vs 2.5, 1 vs 0.2, 640 vs 360, p<0.001, p=0.019 and p=0.007, respectively). At the end of phase I, 19/25 (76%) of the patients achieved clinical remission, 15 (60%) patients had CRP levels within normal range and 7 (28%) of them had normalized FC. 18/25 patients (72%) had received Exclusive Enteral Nutrition (EEN) for the induction of remission at diagnosis. Patients who achieved clinical remission with the EEN course (i.e.: a wPCDAI of < 12.5 after a complete course of EEN) were more likely to achieve clinical remission when receiving CDED + PEN (11/13 vs 1/5, p=0.022). CDED coupled with PEN is a valid treatment strategy in the setting of secondary loss of response to maintenance treatments in children with CD. A previous successful course of EEN was associated with higher rates of clinical remission at the end of phase I, thereby possibly identifying a subset of “nutritional responder” patients.
尽管越来越多的证据表明克罗恩病排除饮食（CDED）与部分肠内营养（PEN）相结合具有疗效和耐受性，但有关其与其他药物治疗联合使用的数据仍然很少。我们的目的是评估 CDED 对正在接受其他维持性治疗但病情复发的儿童 CD 患者重新获得缓解的疗效。 这是一项在意大利国家儿科 IBD 转诊中心进行的单中心、回顾性、观察性研究。研究对象包括在 2020 年 1 月 1 日至 2023 年 6 月 30 日期间接受 CDED 和 PEN 治疗，但对其他维持疗法无效的患者。每个阶段结束时的临床缓解定义为加权小儿克罗恩病活动指数（wPCDAI）低于 12.5。生化缓解的定义是 c 反应蛋白（CRP）低于 0.5 毫克/分升。FC 低于 150 毫克/千克被用作粘膜改善（MI）的替代指标。 25名患者（52%为男性）符合纳入标准并被纳入分析。CDED+PEN 开始治疗时的中位病程为 31 个月（Q1-Q3：8.4-13.8）。最常见的疾病部位是回结肠（64%），3 名（12%）患者有孤立的结肠受累。9名患者（36%）有狭窄/穿透表型。16名患者（68%）正在接受抗肿瘤坏死因子-α药物治疗，5名患者（20%）正在接受乌斯特库单抗治疗（表 1）。治疗最初 8 周后，wPCDAI、CRP 和 FC 显著下降（分别为 22.5 vs 2.5、1 vs 0.2、640 vs 360，p<0.001、p=0.019 和 p=0.007）。第一阶段结束时，19/25（76%）名患者实现了临床缓解，15（60%）名患者的 CRP 水平在正常范围内，其中 7（28%）名患者的 FC 恢复正常。18/25（72%）名患者在确诊时接受了肠外营养（EEN）以诱导病情缓解。接受肠内营养治疗后获得临床缓解的患者（即：在接受一个完整疗程的肠内营养治疗后，wPCDAI<12.5）更有可能在接受CDED+PEN治疗后获得临床缓解（11/13 vs 1/5，P=0.022）。 CDED+PEN是CD患儿对维持治疗继发失效时的一种有效治疗策略。在第一阶段结束时，曾成功接受过EEN治疗的患者临床缓解率较高，因此可能会确定 "营养应答 "患者的子集。
{"title":"P919 Crohn’s Disease Exclusion Diet as add-on therapy in refractory pediatric patients","authors":"L. Scarallo, S. Pochesci, L. Fioretti, M. Paci, S. Renzo, S. Naldini, L. Lacitignola, J. Barp, E. Banci, A. De Blasi, P. Lionetti","doi":"10.1093/ecco-jcc/jjad212.1049","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.1049","url":null,"abstract":"\u0000 \u0000 \u0000 Despite the accumulating body of evidence of the efficacy and tolerability of Crohn’s disease exclusion diet (CDED) combined with partial enteral nutrition (PEN), there is still a paucity data regarding its use in combination with other medical treatments. We aimed at assessing its efficacy in re-inducing remission in pediatric CD patients experiencing disease relapse while on other maintenance therapies.\u0000 \u0000 \u0000 \u0000 This was a single-center, retrospective, observational study conducted at an Italian national referral pediatric IBD center. Incident patients who received CDED coupled with PEN in the setting of the loss of response to other maintenance therapies from January 1st, 2020 to June 30th 2023 were included. Clinical remission at the end of each phase was defined by a weighted Pediatric Crohn’s Disease Activity Index (wPCDAI) below 12.5. Biochemical remission was defined by a c-reactive protein (CRP) lower than 0.5 mg/dL. A FC lower than 150 mg/kg was used as a surrogate of mucosal improvement (MI).\u0000 \u0000 \u0000 \u0000 25 patients (52% males) met inclusion criteria and were included in the analysis. Median disease duration at CDED+PEN initiation was 31 months (Q1-Q3: 8.4-13.8). The most frequent disease location was ileocolonic (64%), 3 (12%) patients had isolated colonic involvement. 9 (36%) patients had stricturing/penetrating phenotype. 16 patients (68%) were being treated with an anti-TNF-alpha agent, whereas 5 (20%) patients were receiving ustekinumab (Table 1). wPCDAI, CRP and FC significantly decreased after the firs 8 weeks of treatment (22.5 vs 2.5, 1 vs 0.2, 640 vs 360, p<0.001, p=0.019 and p=0.007, respectively). At the end of phase I, 19/25 (76%) of the patients achieved clinical remission, 15 (60%) patients had CRP levels within normal range and 7 (28%) of them had normalized FC. 18/25 patients (72%) had received Exclusive Enteral Nutrition (EEN) for the induction of remission at diagnosis. Patients who achieved clinical remission with the EEN course (i.e.: a wPCDAI of < 12.5 after a complete course of EEN) were more likely to achieve clinical remission when receiving CDED + PEN (11/13 vs 1/5, p=0.022).\u0000 \u0000 \u0000 \u0000 CDED coupled with PEN is a valid treatment strategy in the setting of secondary loss of response to maintenance treatments in children with CD. A previous successful course of EEN was associated with higher rates of clinical remission at the end of phase I, thereby possibly identifying a subset of “nutritional responder” patients.\u0000 \u0000","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139632917","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 : 2024-01-01DOI: 10.1093/ecco-jcc/jjad212.1308
P. Ladrón Abia, B. Sicilia Aladrén, J. Hernández Bernad, R. Quiñones Castro, A. Martín Izquierdo, C. Villar Lucas, M. Ibañez García, L. Hernández Villalba, B. Burgueño Gómez, M. Antona Herranz, M. Cimavilla Román, L. Aguilar Argeñal, J. Gómez Camarero
Investigation of liver disease is recommended in the ECCO Guidelines for Extraintestinal Manifestations in Inflammatory Bowel Disease (IBD). The aim of this study was to analyse the prevalence of liver disease in IBD patients, to examine the frequency of different aetiologies, and to investigate a possible correlation between the severity of liver disease and IBD. Cross-sectional descriptive study including all patients with inflammatory bowel disease (IBD) of nine hospitals in Spain. The study of liver disease was carried out in two phases: patients with FIB-4 greater than 1.3 (greater than 2 in those aged 65 years or more), as well as those with APRI greater than 0.5 and/or elevated transaminases were selected as those at risk of liver disease. In the second phase, these patients underwent a medical history, comprehensive blood tests, abdominal ultrasound with SWE elastography and Fibroscan® (including transitional elastography (TE) and Controlled Attenuation Parameter (CAP)). In total, 5302 patients were enrolled and 1640 (31%) were identified as at risk for liver disease. The University Hospital of Burgos has completed the second phase of the study in patients diagnosed with IBD between 2010 and 2021 (n=151). Of these patients, 72.2% were male and the median age was 61 years. Ulcerative colitis (57%) was the most common type of IBD and 62% of the patients were overweight or obese, while 12% of the patients had high-risk alcohol consumption. Metabolic hepatic steatosis was the most frequent cause of liver disease (35%). Moderate/severe steatosis was detected in 44.3% of patients by CAP and 24% by ultrasound. The prevalence of advanced fibrosis was 10.6% and 12% when assessed by ET and SWE, respectively. Notably, 12.6% displayed ultrasound signs of chronic liver disease. A positive correlation was found between the ET and the SWE for liver fibrosis, with a correlation coefficient of ĸ = 0.663. On univariate analysis, an increased risk of significant fibrosis (p=0.011) and moderate/severe steatosis (p=0.00) was found only in those who were overweight or obese. However, no association with severity of liver disease was found for perianal disease, use of immunosuppressants or history of previous surgery. The incidence of unrecognised liver disease in IBD patients is substantial, with metabolic hepatic steatosis being the most common cause. The severity of liver disease in these patients cannot be ignored, with one in ten patients having advanced fibrosis. In the univariate study, only obesity was found to correlate with the severity of steatosis and fibrosis, while IBD severity showed no significant association with liver disease severity.
炎症性肠病（IBD）肠道外表现 ECCO 指南建议对肝病进行调查。本研究旨在分析 IBD 患者中肝脏疾病的患病率，检查不同病因的发生频率，并研究肝脏疾病的严重程度与 IBD 之间可能存在的相关性。 横断面描述性研究包括西班牙九家医院的所有炎症性肠病（IBD）患者。肝病研究分两个阶段进行：FIB-4大于1.3（65岁或以上者大于2）以及APRI大于0.5和/或转氨酶升高的患者被选为肝病高危人群。在第二阶段，这些患者接受了病史、全面的血液检查、腹部超声波 SWE 弹性成像和 Fibroscan®（包括过渡弹性成像 (TE) 和受控衰减参数 (CAP)）检查。 共有 5302 名患者参与了这项研究，其中 1640 人（31%）被确定为肝病高危人群。布尔戈斯大学医院已完成了第二阶段的研究，研究对象为 2010 年至 2021 年期间确诊的 IBD 患者（人数=151）。在这些患者中，72.2%为男性，年龄中位数为61岁。溃疡性结肠炎（57%）是最常见的 IBD 类型，62% 的患者超重或肥胖，12% 的患者高危饮酒。代谢性肝脂肪变性是最常见的肝病病因（35%）。44.3% 的患者通过 CAP 检测出中度/重度脂肪变性，24% 的患者通过超声波检测出中度/重度脂肪变性。通过 ET 和 SWE 评估，晚期纤维化的发生率分别为 10.6% 和 12%。值得注意的是，12.6%的患者显示出慢性肝病的超声征象。肝纤维化的 ET 和 SWE 呈正相关，相关系数为 ĸ = 0.663。通过单变量分析，发现只有超重或肥胖者发生明显肝纤维化（p=0.011）和中度/重度脂肪变性（p=0.00）的风险才会增加。不过，肛周疾病、使用免疫抑制剂或既往手术史与肝病严重程度没有关联。 IBD 患者未被发现的肝病发病率很高，其中最常见的原因是代谢性肝脂肪变性。这些患者肝病的严重程度不容忽视，每十名患者中就有一人患有晚期肝纤维化。在单变量研究中，只发现肥胖与脂肪变性和肝纤维化的严重程度相关，而 IBD 的严重程度与肝病严重程度无明显关联。
{"title":"P1178 Detection of occult liver disease in patients with Inflammatory Bowel Disease","authors":"P. Ladrón Abia, B. Sicilia Aladrén, J. Hernández Bernad, R. Quiñones Castro, A. Martín Izquierdo, C. Villar Lucas, M. Ibañez García, L. Hernández Villalba, B. Burgueño Gómez, M. Antona Herranz, M. Cimavilla Román, L. Aguilar Argeñal, J. Gómez Camarero","doi":"10.1093/ecco-jcc/jjad212.1308","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.1308","url":null,"abstract":"\u0000 \u0000 \u0000 Investigation of liver disease is recommended in the ECCO Guidelines for Extraintestinal Manifestations in Inflammatory Bowel Disease (IBD). The aim of this study was to analyse the prevalence of liver disease in IBD patients, to examine the frequency of different aetiologies, and to investigate a possible correlation between the severity of liver disease and IBD.\u0000 \u0000 \u0000 \u0000 Cross-sectional descriptive study including all patients with inflammatory bowel disease (IBD) of nine hospitals in Spain. The study of liver disease was carried out in two phases: patients with FIB-4 greater than 1.3 (greater than 2 in those aged 65 years or more), as well as those with APRI greater than 0.5 and/or elevated transaminases were selected as those at risk of liver disease. In the second phase, these patients underwent a medical history, comprehensive blood tests, abdominal ultrasound with SWE elastography and Fibroscan® (including transitional elastography (TE) and Controlled Attenuation Parameter (CAP)).\u0000 \u0000 \u0000 \u0000 In total, 5302 patients were enrolled and 1640 (31%) were identified as at risk for liver disease. The University Hospital of Burgos has completed the second phase of the study in patients diagnosed with IBD between 2010 and 2021 (n=151). Of these patients, 72.2% were male and the median age was 61 years. Ulcerative colitis (57%) was the most common type of IBD and 62% of the patients were overweight or obese, while 12% of the patients had high-risk alcohol consumption. Metabolic hepatic steatosis was the most frequent cause of liver disease (35%).\u0000 Moderate/severe steatosis was detected in 44.3% of patients by CAP and 24% by ultrasound. The prevalence of advanced fibrosis was 10.6% and 12% when assessed by ET and SWE, respectively. Notably, 12.6% displayed ultrasound signs of chronic liver disease.\u0000 A positive correlation was found between the ET and the SWE for liver fibrosis, with a correlation coefficient of ĸ = 0.663.\u0000 On univariate analysis, an increased risk of significant fibrosis (p=0.011) and moderate/severe steatosis (p=0.00) was found only in those who were overweight or obese. However, no association with severity of liver disease was found for perianal disease, use of immunosuppressants or history of previous surgery.\u0000 \u0000 \u0000 \u0000 The incidence of unrecognised liver disease in IBD patients is substantial, with metabolic hepatic steatosis being the most common cause. The severity of liver disease in these patients cannot be ignored, with one in ten patients having advanced fibrosis. In the univariate study, only obesity was found to correlate with the severity of steatosis and fibrosis, while IBD severity showed no significant association with liver disease severity.\u0000","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139632983","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 : 2024-01-01DOI: 10.1093/ecco-jcc/jjad212.1440
R. I. Comoretto, E. Tavazzi, M. Martinato, D. Azzolina
The aim of this project is to model Inflammatory Bowel Diseases (IBD) progression using an innovative approach that considers the manifestation of the disease from a dynamic and multifactorial point of view, with a focus on model explainability. With the aim of modelling the course of IBD in the study population of the UR-CARE registry, an innovative approach will be applied consisting of the combined use of two different data-driven Artificial Intelligence techniques, namely dynamic Bayesian networks and Process Mining. Specifically, these two approaches will be jointly used to model IBD progression trajectories, providing a broader overview of the disease through the description of its patterns of progression (including clinical events, treatments and/or outcomes) and the interactions between clinical variables. The potential of the proposed methodology to address the predictive needs of chronic IBD progression, such as the forecasting of the next relapse, the effect of a therapy, or the impact of a risk factor, will also be explored. On the one side, IBD patients experience constant uncertainty regarding disease progression, while clinicians, on the other hand, need tools that can support them in understanding the multidimensionality of disease progression. In this scenario, AI can be the key to successfully satisfy these needs, effectively investigating the disease processes, allowing to describe pathological evolution over time, handling and capturing patients’ inter-variability, and providing tools to forecast disease evolution. By adopting an ad-hoc developed analytic approach, this project can help in better understanding IBD mechanisms and best care strategies, defining the relationships among the patient characteristics and the sequence of experienced clinical events, evaluating the impact of key elements on disease’s prognosis. These results would be useful not only to better manage the disease from a clinical and care point of view, but also in economic terms.
{"title":"IIS Registry Grant Modelling Inflammatory Bowel Diseases trajectories combining dynamic, multifactorial, Artificial Intelligence-based approaches","authors":"R. I. Comoretto, E. Tavazzi, M. Martinato, D. Azzolina","doi":"10.1093/ecco-jcc/jjad212.1440","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.1440","url":null,"abstract":"\u0000 \u0000 \u0000 The aim of this project is to model Inflammatory Bowel Diseases (IBD) progression using an innovative approach that considers the manifestation of the disease from a dynamic and multifactorial point of view, with a focus on model explainability.\u0000 \u0000 \u0000 \u0000 With the aim of modelling the course of IBD in the study population of the UR-CARE registry, an innovative approach will be applied consisting of the combined use of two different data-driven Artificial Intelligence techniques, namely dynamic Bayesian networks and Process Mining. Specifically, these two approaches will be jointly used to model IBD progression trajectories, providing a broader overview of the disease through the description of its patterns of progression (including clinical events, treatments and/or outcomes) and the interactions between clinical variables. The potential of the proposed methodology to address the predictive needs of chronic IBD progression, such as the forecasting of the next relapse, the effect of a therapy, or the impact of a risk factor, will also be explored.\u0000 \u0000 \u0000 \u0000 On the one side, IBD patients experience constant uncertainty regarding disease progression, while clinicians, on the other hand, need tools that can support them in understanding the multidimensionality of disease progression. In this scenario, AI can be the key to successfully satisfy these needs, effectively investigating the disease processes, allowing to describe pathological evolution over time, handling and capturing patients’ inter-variability, and providing tools to forecast disease evolution. By adopting an ad-hoc developed analytic approach, this project can help in better understanding IBD mechanisms and best care strategies, defining the relationships among the patient characteristics and the sequence of experienced clinical events, evaluating the impact of key elements on disease’s prognosis. These results would be useful not only to better manage the disease from a clinical and care point of view, but also in economic terms.\u0000","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139632984","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 : 2024-01-01DOI: 10.1093/ecco-jcc/jjad212.0914
Ž. Šubic, G. Novak
In recent years, there are several new treatment options for inflammatory bowel disease (IBD). Tumour necrosis factor α inhibitors have been joined by novel advanced therapies (vedolizumab, ustekinumab (UST) and Janus kinase inhibitors). These drugs are mostly used as second-line treatments after tumor necrosis factor α inhibitors, with subsequent poorer efficacy. There are few data available on the efficacy of first-line treatment with UST. The aim of our study was to assess efficacy of UST in biologically naïve patients with IBD. All patients older than 18 years who had a confirmed diagnosis of IBD, treated in a tertiary IBD centre (University Medical Centre Ljubljana, Slovenia), who started first-line treatment with UST, were included in this retrospective cross-sectional cohort study. Demographics, clinical characteristics of patients, treatment persistence of UST, clinical disease activity scores, C-reactive protein (CRP), faecal calprotectin (FC), UST concentrations, and endoscopic scores were collected retrospectively in medical files. We determined a Kaplan-Meier curve of treatment persistence. We included 71 patients, 11 of which had ulcerative colitis and 60 had Crohn’s disease. Persistence of treatment with UST in biologically naïve patients is 88% at one year (Figure 1). Clinical remission was achieved in 57.7% of patients. Biochemical remission was achieved in 77.6% (CRP<5mg/ml) and 71.1% (FC<100mg/kg) of patients. Endoscopic remission (Mayo endoscopic score <2 in ulcerative colitis or absence of ulcers in Crohn’s disease) was achieved in 50.0% of patients. There was no significant difference (P>0.05) between the median serum concentrations of UST in the group of patients who achieved remission (clinical (5.86μg/ml), biochemical (5.93μg/ml based on CRP, 5.63μg/ml based on FC) and endoscopic (7.14μg/ml)) and who did not achieve remission (5.31μg/ml, 3.25μg/ml, 4.47μg/ml and 4.64μg/ml, respectively). Treatment of UST in biologically naïve IBD patients shows high treatment persistence with high biochemical and endoscopic remission rates. It appears that UST is more efficacious if used as first-line therapy compared to the use after other advanced therapies. Further prospective data are needed to confirm our findings.
{"title":"P784 Efficacy of ustekinumab in biologically naïve patients with Inflammatory Bowel Disease","authors":"Ž. Šubic, G. Novak","doi":"10.1093/ecco-jcc/jjad212.0914","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0914","url":null,"abstract":"\u0000 \u0000 \u0000 In recent years, there are several new treatment options for inflammatory bowel disease (IBD). Tumour necrosis factor α inhibitors have been joined by novel advanced therapies (vedolizumab, ustekinumab (UST) and Janus kinase inhibitors). These drugs are mostly used as second-line treatments after tumor necrosis factor α inhibitors, with subsequent poorer efficacy. There are few data available on the efficacy of first-line treatment with UST. The aim of our study was to assess efficacy of UST in biologically naïve patients with IBD.\u0000 \u0000 \u0000 \u0000 All patients older than 18 years who had a confirmed diagnosis of IBD, treated in a tertiary IBD centre (University Medical Centre Ljubljana, Slovenia), who started first-line treatment with UST, were included in this retrospective cross-sectional cohort study. Demographics, clinical characteristics of patients, treatment persistence of UST, clinical disease activity scores, C-reactive protein (CRP), faecal calprotectin (FC), UST concentrations, and endoscopic scores were collected retrospectively in medical files. We determined a Kaplan-Meier curve of treatment persistence.\u0000 \u0000 \u0000 \u0000 We included 71 patients, 11 of which had ulcerative colitis and 60 had Crohn’s disease. Persistence of treatment with UST in biologically naïve patients is 88% at one year (Figure 1). Clinical remission was achieved in 57.7% of patients. Biochemical remission was achieved in 77.6% (CRP<5mg/ml) and 71.1% (FC<100mg/kg) of patients. Endoscopic remission (Mayo endoscopic score <2 in ulcerative colitis or absence of ulcers in Crohn’s disease) was achieved in 50.0% of patients. There was no significant difference (P>0.05) between the median serum concentrations of UST in the group of patients who achieved remission (clinical (5.86μg/ml), biochemical (5.93μg/ml based on CRP, 5.63μg/ml based on FC) and endoscopic (7.14μg/ml)) and who did not achieve remission (5.31μg/ml, 3.25μg/ml, 4.47μg/ml and 4.64μg/ml, respectively).\u0000 \u0000 \u0000 \u0000 Treatment of UST in biologically naïve IBD patients shows high treatment persistence with high biochemical and endoscopic remission rates. It appears that UST is more efficacious if used as first-line therapy compared to the use after other advanced therapies. Further prospective data are needed to confirm our findings.\u0000","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139633146","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 : 2024-01-01DOI: 10.1093/ecco-jcc/jjad212.0043
A. Walsh, C. Fidalgo, M. Adamina, M. Barreiro de Acosta, J. Burisch, D. Drobne, O. Faiz, M. Ferrante, L. Godny, M. Iacucci, S. Jäghult, S. Restellini, F. Rosini, D. Shouval, H. Yanai, G. Fiorino
The European Crohn’s and Colitis Organisation (ECCO) Position Paper on Quality-of-Care (QoC) proposed essential standards on process and outcomes for units that manage patients with inflammatory bowel disease (IBD). The E-QUALITY taskforce investigated whether gaps between these standards and real-world practice exist. A 74-question web survey accessible to all institutions affiliated with ECCO was developed. One delegate per institution was requested to respond. A descriptive analysis was done. From March to October 2023, 166 centres from 28 different countries replied to the survey (Fig.1). At diagnosis, disease extent is assessed by colonoscopy in 96% and completed by small bowel (SB) evaluation in 43%. At least 2 biopsies from each segment are obtained in 55%. SB investigation for Crohn’s disease (CD) takes place in 60%. 54% of centres provide access to endoscopy with deep sedation for the majority of patients. To assess treatment response, faecal calprotectin is used in 65%, endoscopy in 54%, cross-sectional imaging for CD in 36%. In the case of primary failure of any drug, therapeutic decisions are based on objective measures of inflammation in 98%. A scheduled monitoring protocol for asymptomatic patients is followed in 42%. Patients with prolonged use of corticosteroids are being switched to a steroid-sparing treatment in 84%, but there is no protocol to track or act upon high steroid exposure in 43% of centres. 72% centres monitor metabolic bone health. Only 51% of units screen IBD patients for colorectal cancer, but screening is done with high-definition endoscopy in 92%. Chromoendoscopy with targeted biopsies is performed in only 47% units. Patients with perianal fistula are managed by combined medical and surgical approach in 67%, and reassessment by clinical and endoscopy and/or pelvic MRI is done in 62%. Laparoscopic approach for intra-abdominal surgery is used in 76%, and preoperative nutritional assessment in 62%. Patients receive therapies to prevent post-operative recurrence based on risk factors in 70%, standard endoscopy within 6-12 months after surgery is done only in 52% of centres. Although only 8% of centres lack a defined protocol to manage acute severe ulcerative colitis flares, 13% lack a standard algorithm, and 36% do not involve the surgeon in this setting from day 1. 38% of centres have a paediatric to adult transition clinic. The main reason for not adhering to ECCO standards are difficulty of providing tests in a timely fashion in up to 83% of centres. Our survey has revealed significant gaps between ECCO standards and real-world practice. These results will help ECCO improve initiatives to help institutions to provide standard QoC. 1) Fiorino et al. JCC 2020;14:1037-48
{"title":"DOP03 Gaps between ECCO quality standards of care and the real world: the E-QUALITY survey on processes and outcomes","authors":"A. Walsh, C. Fidalgo, M. Adamina, M. Barreiro de Acosta, J. Burisch, D. Drobne, O. Faiz, M. Ferrante, L. Godny, M. Iacucci, S. Jäghult, S. Restellini, F. Rosini, D. Shouval, H. Yanai, G. Fiorino","doi":"10.1093/ecco-jcc/jjad212.0043","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0043","url":null,"abstract":"\u0000 \u0000 \u0000 The European Crohn’s and Colitis Organisation (ECCO) Position Paper on Quality-of-Care (QoC) proposed essential standards on process and outcomes for units that manage patients with inflammatory bowel disease (IBD). The E-QUALITY taskforce investigated whether gaps between these standards and real-world practice exist.\u0000 \u0000 \u0000 \u0000 A 74-question web survey accessible to all institutions affiliated with ECCO was developed. One delegate per institution was requested to respond. A descriptive analysis was done.\u0000 \u0000 \u0000 \u0000 From March to October 2023, 166 centres from 28 different countries replied to the survey (Fig.1).\u0000 At diagnosis, disease extent is assessed by colonoscopy in 96% and completed by small bowel (SB) evaluation in 43%. At least 2 biopsies from each segment are obtained in 55%. SB investigation for Crohn’s disease (CD) takes place in 60%. 54% of centres provide access to endoscopy with deep sedation for the majority of patients. To assess treatment response, faecal calprotectin is used in 65%, endoscopy in 54%, cross-sectional imaging for CD in 36%. In the case of primary failure of any drug, therapeutic decisions are based on objective measures of inflammation in 98%. A scheduled monitoring protocol for asymptomatic patients is followed in 42%. Patients with prolonged use of corticosteroids are being switched to a steroid-sparing treatment in 84%, but there is no protocol to track or act upon high steroid exposure in 43% of centres. 72% centres monitor metabolic bone health. Only 51% of units screen IBD patients for colorectal cancer, but screening is done with high-definition endoscopy in 92%. Chromoendoscopy with targeted biopsies is performed in only 47% units. Patients with perianal fistula are managed by combined medical and surgical approach in 67%, and reassessment by clinical and endoscopy and/or pelvic MRI is done in 62%. Laparoscopic approach for intra-abdominal surgery is used in 76%, and preoperative nutritional assessment in 62%. Patients receive therapies to prevent post-operative recurrence based on risk factors in 70%, standard endoscopy within 6-12 months after surgery is done only in 52% of centres. Although only 8% of centres lack a defined protocol to manage acute severe ulcerative colitis flares, 13% lack a standard algorithm, and 36% do not involve the surgeon in this setting from day 1. 38% of centres have a paediatric to adult transition clinic.\u0000 The main reason for not adhering to ECCO standards are difficulty of providing tests in a timely fashion in up to 83% of centres.\u0000 \u0000 \u0000 \u0000 Our survey has revealed significant gaps between ECCO standards and real-world practice. These results will help ECCO improve initiatives to help institutions to provide standard QoC.\u0000 1) Fiorino et al. JCC 2020;14:1037-48\u0000 \u0000","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139633175","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 : 2024-01-01DOI: 10.1093/ecco-jcc/jjad212.0838
J. Hou, C. Pham, A. Xu, S. Sansgiry, V. Modi, A. Waljee
Infliximab (IFX) biosimilars are available for inflammatory bowel disease (IBD). Many options of IFX biosimilars exist, however there is a paucity of data on the safety and efficacy of switching between multiple IFX biosimilars. The goal of this study is to evaluate the safety and outcomes in patients who received multiple IFX biosimilars in a National U.S. Cohort of patients with IBD. We conducted a retrospective cohort study of IBD patients on maintenance IFX originator from 2017- 2019 in the national Veterans Affairs (VA) healthcare system. Crohn’s disease (CD) and ulcerative colitis (UC) patients were identified using a previously validated algorithm. Cases, exposures and outcomes were confirmed by chart review. Patents on IFX originator were identified by dispensed medication from the VA Corporate Data Warehouse. Patients were classified as no-switch (NS)- receiving originator but no biosimilar during study period, Single Switch (SS)- switch from originator to one biosimilar, or Double Switch (DS)-switch from IFX originator to two different biosimilars. Primary outcome was IBD flare, defined as escalation of steroid, IBD-related Emergency department visit or hospitalization within 12 months. Secondary outcomes were immunogenicity, serious infection, and infusion reaction. Event rates of the DS group were compared to NS and SS groups using univariate and multivariate (MV) logistic regression models adjusting for patient and non-patient factors. 789 patients (487 CD, 298 UC) on maintenance IFX originator were identified. Of these, 410 patients were categorized as NS, 249 as SS, and 130 as DS. Overall, the rate of flare within 12 months was 19.9% (22.2% NS, 15.3% SS, 21.5% DS, p= 0.08), rate of infection was 11.2% (11.5% NS, 8% SS, 16.2% DS, p= 0.056). No statistically significant differences in rates of immunogenicity or infusion reaction were identified between the DS and NS or SS groups. In MV logistic regression including age, race, gender, medication, comorbidity and VA priority status, no significant differences in flares at 12 months was observed between DS (ref) and NS (aOR 1.12, 95% CI 0.68-1.84), or SS groups (aOR 0.64, 95% CI 0.36-1.12). In MV analyses, SS was associated with lower rate of infection compared to DS (aOR 0.41, 95% CI 0.21-0.82). In a national U.S. cohort of patients with IBD, multiple IFX biosimilar switching was not associated with flare at 12 months compared to patients continued on IFX originator or with a single IFX biosimilar switch. However, DS was associated with increased odds of infection compared to single switch. These findings provide reassurance that multiple IFX biosimilar switching for IBD is effective but further study on infection risks may be warranted.
{"title":"P708 Multiple Biosimilar Infliximab Switching is Not Associated with Adverse Outcomes in Inflammatory Bowel Disease: A Real-World Effectiveness Analysis in a National U.S. Cohort","authors":"J. Hou, C. Pham, A. Xu, S. Sansgiry, V. Modi, A. Waljee","doi":"10.1093/ecco-jcc/jjad212.0838","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0838","url":null,"abstract":"\u0000 \u0000 \u0000 Infliximab (IFX) biosimilars are available for inflammatory bowel disease (IBD). Many options of IFX biosimilars exist, however there is a paucity of data on the safety and efficacy of switching between multiple IFX biosimilars. The goal of this study is to evaluate the safety and outcomes in patients who received multiple IFX biosimilars in a National U.S. Cohort of patients with IBD.\u0000 \u0000 \u0000 \u0000 We conducted a retrospective cohort study of IBD patients on maintenance IFX originator from 2017- 2019 in the national Veterans Affairs (VA) healthcare system. Crohn’s disease (CD) and ulcerative colitis (UC) patients were identified using a previously validated algorithm. Cases, exposures and outcomes were confirmed by chart review. Patents on IFX originator were identified by dispensed medication from the VA Corporate Data Warehouse. Patients were classified as no-switch (NS)- receiving originator but no biosimilar during study period, Single Switch (SS)- switch from originator to one biosimilar, or Double Switch (DS)-switch from IFX originator to two different biosimilars. Primary outcome was IBD flare, defined as escalation of steroid, IBD-related Emergency department visit or hospitalization within 12 months. Secondary outcomes were immunogenicity, serious infection, and infusion reaction. Event rates of the DS group were compared to NS and SS groups using univariate and multivariate (MV) logistic regression models adjusting for patient and non-patient factors.\u0000 \u0000 \u0000 \u0000 789 patients (487 CD, 298 UC) on maintenance IFX originator were identified. Of these, 410 patients were categorized as NS, 249 as SS, and 130 as DS. Overall, the rate of flare within 12 months was 19.9% (22.2% NS, 15.3% SS, 21.5% DS, p= 0.08), rate of infection was 11.2% (11.5% NS, 8% SS, 16.2% DS, p= 0.056). No statistically significant differences in rates of immunogenicity or infusion reaction were identified between the DS and NS or SS groups. In MV logistic regression including age, race, gender, medication, comorbidity and VA priority status, no significant differences in flares at 12 months was observed between DS (ref) and NS (aOR 1.12, 95% CI 0.68-1.84), or SS groups (aOR 0.64, 95% CI 0.36-1.12). In MV analyses, SS was associated with lower rate of infection compared to DS (aOR 0.41, 95% CI 0.21-0.82).\u0000 \u0000 \u0000 \u0000 In a national U.S. cohort of patients with IBD, multiple IFX biosimilar switching was not associated with flare at 12 months compared to patients continued on IFX originator or with a single IFX biosimilar switch. However, DS was associated with increased odds of infection compared to single switch. These findings provide reassurance that multiple IFX biosimilar switching for IBD is effective but further study on infection risks may be warranted.\u0000","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139633241","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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