Journal of Crohn's and Colitis最新文献

{"title":"P524 Etrasimod shows low risk of adverse events following concomitant use with opioids or antidepressants in patients with ulcerative colitis","authors":"A Afzali, M Regueiro, A J Yarur, Y Zabana, S C Ng, S S Menon, A McDonnell, K Lazin, M Keating, A Bhattacharjee, D Branquinho, E Bananis, L Peyrin-Biroulet","doi":"10.1093/ecco-jcc/jjad212.0654","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0654","url":null,"abstract":"Background Etrasimod is an oral, once-daily (QD), selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). Unlike the other S1P receptor modulator approved for UC, etrasimod and its metabolites do not have a molecular structure to inhibit monoamine oxidase (MAO).1 Coadministration of drugs that inhibit MAO with opioids and antidepressants may increase the risk of adverse events (AEs), including hypertension.2 This post hoc analysis evaluated the incidence of AEs potentially related to serotonin syndrome in patients taking etrasimod and concomitant opioids or antidepressants in the phase 3 ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369) trials. Methods Safety data pooled from both trials were analysed in patients receiving etrasimod 2 mg QD (up to 52 weeks of exposure) with/without concomitant opioids or antidepressants. We report the proportions of patients who had ≥1 concurrent AE potentially related to serotonin syndrome, consisting of one standardised MedDRA Query, one query based on the Hunter Criteria and supplemental preferred terms (pyrexia, tachycardia and hypertension-related AEs).3 Results Among 527 patients receiving etrasimod, 77 (14.6%) and 35 (6.6%) patients were taking concomitant opioids or antidepressants, respectively. Most patients on concomitant opioids or antidepressants were White (80.0–88.3%); male (50.6–51.4%); their median age was 35.0 (18.0–70.0) and 41.0 (19.0–74.0) years, respectively. More patients with vs without concomitant opioids or antidepressants, respectively, consumed alcohol (40.3% vs 24.7% and 48.6% vs 25.4%) and used tobacco (40.3% vs 20.9% and 34.3% vs 23.0%). The incidence of other AEs potentially related to serotonin syndrome was low and generally comparable in all subgroups; reported rates of pyrexia and tachycardia were similar in patients with/without concomitant opioids or antidepressants (Table). Hypertension-related AEs were infrequent and generally balanced. No AEs per the Hunter Criteria were reported in patients on concomitant opioids or antidepressants (Table). No reported AEs were serious or led to treatment discontinuation among patients taking these concomitant medications. Conclusion The incidence of AEs was low and comparable in patients receiving etrasimod with or without concomitant opioids or antidepressants. This analysis supports the low likelihood of clinically relevant drug–drug interactions between etrasimod and medications commonly prescribed to patients with UC, such as opioids or antidepressants. References 1. Lee CA et al. Clin Pharmacol Drug Dev 2023; 12: 553–571. 2. Sands BE et al. J Crohns Colitis 2023; online ahead of print. 3. Dunkley EJC et al. QJM 2003; 96: 635–642.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"P459 The prevalence and characteristics of inflammatory bowel disease-related ocular involvement in children","authors":"A Ben-Tov, T Achler, T Patalon, S Gazit, H Yanai, S Shulman, A Assa","doi":"10.1093/ecco-jcc/jjad212.0589","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0589","url":null,"abstract":"Background Ocular manifestations (OM) in patients with inflammatory bowel disease (IBD) are uncommon, particularly in children. We aimed to explore the prevalence, characteristics and risk factors of IBD associated OM in a large epidemiologic cohort-based study. Methods A cross-sectional study was performed using the Maccabi Healthcare Services (MHS) database. The eligible population included all patients diagnosed with IBD as children (<18 years) between January 2005 and July 2023. An additional analysis was conducted on patients diagnosed with ocular disease during childhood (<18 years) and IBD during childhood or adulthood. Results Out of 2,567 children with IBD (males 55%, Crohn’s disease 64%), 78 (3%) were diagnosed with OM at any time during disease course. In 54 patients (69%), the OM occurred after IBD diagnosis with a median time of 2.6 (0.47-7) years between the two events, whereas in 24 patients (31%) OM preceded IBD diagnosis with a median time of 2.1 (0.6-5.7) years. OM was significantly associated with Crohn’s disease, compared with ulcerative colitis (78.2% vs. 63.6% in the entire cohort; p=0.03). The presence of OM was associated with increased usage of systemic corticosteroids (p<0.001), biologic agents (p=0.04) and longer duration since IBD diagnosis (p=0.04). There were 55 patients with OM during childhood who were ever diagnosed with IBD. In this population OM was also associated with increased usage of systemic corticosteroids (p<0.001) and increased hospitalization rate per year (p=0.048). The annual prevalence of OM increased gradually from 10/1000 patients in 2005 to 22/1000 patients in 2022 (p=0.55). Conclusion Ocular involvement in children with IBD is rare and more common in patients with Crohn’s disease with a stable prevalence rate. It is associated with a longer duration of disease, greater usage of systemic corticosteroids and biologic agents and with a higher rate of hospitalizations, potentially representing a more severe disease course.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"40 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"P1123 Social isolation, loneliness, and incident inflammatory bowel disease: results from a large prospective cohorts and Mendelian randomization","authors":"J Zhao, M Zhang, J Ye, X Li","doi":"10.1093/ecco-jcc/jjad212.1253","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.1253","url":null,"abstract":"Background Background Social isolation and loneliness pose significant public health challenges globally. The objective of this study is to investigate the association between social isolation, loneliness, and the risk of inflammatory bowel disease (IBD), ulcerative colitis (UC) and Crohn's disease (CD). Methods Methods 275,157 UK adults from the UK Biobank (UKB) was analyzed. The exposures of interest were social isolation and loneliness. Social isolation was measured by the frequency of meeting family/friends, leisure and social activity, and communal/solitary living. Loneliness was evaluated by the subjective feeling of loneliness and the willingness to confide in others. The primary endpoint was incident IBD, including UC and CD. The twosample Mendelian randomization (MR) analysis was based on the genome-wide association studies of UKB and the a nonoverlapping European ancestry GWAS study. Results Results The UKB cohort study documented 1,565 IBD (1063 UC and 492 CD) cases during a mean follow-up of 13.49 years. Social isolation and loneliness showed significant associations with an elevated risk of IBD in UKB (social isolation [moderate vs least]: aHR 1.13, 95% CI 1.02-1.26; social isolation [most vs least]: aHR 1.31, 95% CI 1.01-1.70; loneliness [yes vs no]: aHR 1.29, 95% CI 1.04-1.60). These associations were evident among moderate genetic susceptibility to IBD. Social isolation and loneliness jointly increase the risk of IBD onset, with an aHR of 1.60 (95% CI 1.21-2.12). Two-sample MR analyses determined that engaging in fewer leisure/social activities (OR 3.42, 95% CI 1.55-7.58; 3.32, 95% CI 1.29-8.55; 3.09, 95% CI 1.35-7.07) were associated with increased IBD, UC and CD risk, whereas more activities-sports club or gym (OR 0.37, 95% CI 0.15-0.88) was associated with reduced IBD risk. Conclusion Conclusion Social isolation and loneliness are each associated with an elevated risk of IBD especially for individuals with a moderate genetic risk for IBD, with MR analyses suggesting potential causal links. The findings highlight the importance of promoting initiatives to address social isolation and loneliness as part of IBD prevention strategies.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"233 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"P1101 Patient-reported physical activity of IBD patients is of concern when weighed with the international physical activity questionnaire regardless of disease activity and IBD phenotype: barriers and facilitators emerged from the extended \"BE-FIT-IBD\" cross-sectional study","authors":"A G Gravina, R Pellegrino, G Palladino, G Imperio, R D'Onofrio, G Arboretto, M Romeo, P Ciamarra, M Dallio, A Federico","doi":"10.1093/ecco-jcc/jjad212.1231","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.1231","url":null,"abstract":"Background As the World Health Organization recommends, regular physical activity (PA) determines quality of life. The qualitative/quantitative characteristics of ideal PA to be suggested for inflammatory bowel diseases (IBD) nor the relationship with disease activity are not yet well defined. This study aimed to weigh PA levels and barriers/facilitators to PA in a cross-sectional group of patients with IBD. Methods Consecutive Italian non-severe IBD patients (assessed with partial Mayo score for and Harvey-Bradshaw index) received an anonymous online questionnaire to assess PA levels using the International Physical Activity Questionnaire (IPAQ), disease activity as Patient-Reported Outcomes 2 (PRO-2), and finally habits, beliefs, and barriers in conducting regular PA. Clinical, anthropometric, and demographic data were also collected. PA was processed as continuous units of resting metabolic rate in minutes/week (Met min/wk). Three PA groups were identified: inactive (< 700 Met min/wk), sufficiently active (700-2500 Met min/wk) and Health Enhancing PA (i.e., HEPA active, > 2500 Met min/wk) patients. Results The 219 patients enrolled exhibited overall PA levels of 834.5 Met min/wk, with a large proportion (94, 42.9%) classified as inactive. Only a minority (9, 4.1%) resulted as health-enhancing PA. Patients with a non-dyslipidaemia metabolic profile (p < 0.0001) or on biologics therapy (p=0.022) showed better IPAQ scores in moderate activities. PRO-2 correlated negatively with IPAQ intense activities scores (τ= -0.156, p=0.038) in ulcerative colitis patients. PRO-2 did not show notable sensitivity/specificity in predicting IPAQ inactivity (AUC < 0.6). IPAQ showed no notable differences when related to disease activity categories according to PRO-2 (p > 0.05). Physically active patients were more willing to discuss their PA with their IBDologists. Several barriers (e.g., diagnosis of IBD and fear of flare-ups after PA) are firmly rooted in physically inactive patients. Evacuation urgency (rectal syndrome) is the IBD-related barrier most physically inactive patients reported. Some fears about PA were worse felt in the absence of a stable partner (i.e., fear of worsening or recurrence of IBD, p < 0.05). Conclusion Many Italian IBD patients show a worrying rate of physical inactivity, depriving themselves of the multidimensional benefits that regular PA can bring. There is a need for IBDologists to act by removing barriers to PA and engaging in a regular discussion on the importance of PA with IBD patients. IPAQ has shown good feasibility and patient acceptance in this setting.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"163 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"P310 Intestinal ultrasound as a tool to assess treatment response in patients with Inflammatory Bowel Diseases","authors":"M Katsaros, A Katsoula, M Kalogirou, P Paschos, P Papagiannakis, T Tsionis, O Giouleme","doi":"10.1093/ecco-jcc/jjad212.0440","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0440","url":null,"abstract":"Background The assessment of treatment response in patients with Inflammatory Bowel Disease (IBD) is often based on clinical indices [Harvey Bradshaw index (HBI), Partial Mayo score (PMS)] and biomarkers [C - reactive protein (CRP)]. Intestinal ultrasound (IUS) has been proposed as a modality capable of objectively evaluating therapeutic response. We investigated the utility of the IUS as a tool to assess treatment response, as well as its association with HBI, PMS and CRP. Methods We included patients with an established diagnosis of IBD who initiated biologic agent (infliximab, adalimumab, ustekinumab, vedolizumab) or tofacitinib. Active disease on IUS was defined as an increase in bowel wall thickness (BWT) >3 mm in the most affected bowel segment, while the presence of a Doppler signal (CDS) in the bowel wall was also assessed. Treatment response on IUS was defined according to the International Bowel Ultrasound Group (IBUS) criteria: reduction in bowel wall thickness (in continuous measurements) >25% or >2.0 mm or >1.0 mm with concomitant reduction in CDS by 1 unit at week 14 ± 2 from the initiation of treatment. Results A total of 19 patients (11 men, 11 with Crohn's disease) underwent IUS at week 0 and week 14 ± 2, while CRP, HBI and PMS were calculated at the same time points. We included bio-naïve as well bio experienced patients (table 1). At week 0, 84.2% of patients exhibited clinical activity (HBI ≥5, PMS ≥2), median CRP was 24.7 mg /L (IQR 18.6-42.8) and median BWT was 7.1mm (IQR 6.5-7.6). At week 14 ± 2, 42.1% of patients remained clinically active, median CRP was 6.8 mg/L (IQR 4.6-20.7) and median BWT was 5.2 mm (IQR 4.6- 6.4). Overall 10/19 patients fulfilled the criteria of treatment response on IUS at week 14 ± 2. Clinical remission was observed in 8/10 patients who demonstrated therapeutic response on IUS and 3/9 patients who did not (p=0.07). Normalization of CRP value (<6mg/L) was observed in 8/10 patients who exhibited treatment response on IUS and in none of the patients who did not (p<0.001). Among the IUS parameters at baseline, a statistically significant difference was found only in the presence of fat wrapping between treatment responders and treatment non-responders (table 2). Finally, median CRP was 4.9 mg/L (IQR 2.6-6.2) in IUS treatment responders and 20.7 mg/L (IQR 10.5-28.5) in IUS treatment non-responders. (p<0.001), with median BWT being 4.7mm (IQR 3.3-5.1) and 6.4mm (IQR 6.1-6.9) respectively (p<0.001). Conclusion IUS represents an objective tool for evaluating treatment response in patients with IBD, which demonstrates a significant correlation with CRP but not with clinical indices of activity.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"155 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559385","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}

{"title":"P1069 One-year clinical outcomes of switching to subcutaneous infliximab in patients with inflammatory bowel disease on maintenance of intravenous infliximab therapy with or without remission: A multicentre cohort study","authors":"J H Bae, J B Park, J E Baek, Y J Lee, K O Kim, E S Kim, H H Jo, S W Hong, S H Park, D H Yang, B D Ye, J S Byeon, S J Myung, S K Yang, E Y Kim, S W Hwang","doi":"10.1093/ecco-jcc/jjad212.1199","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.1199","url":null,"abstract":"Background An elective switching to the subcutaneous (SC) formulation of infliximab (IFX) has shown effectiveness and safety in patients with inflammatory bowel disease (IBD) on intravenous (IV) IFX maintenance therapy. However, data on long-term outcomes in patients not in clinical remission during maintenance therapy is limited. This study aims to evaluate the long-term outcomes of SC switching in patients who were in clinical remission and not in remission during IV IFX maintenance therapy. Methods This retrospective multicentre study was conducted from January 2021 to October 2023. Clinical remission was defined as Crohn’s Disease Activity Index (CDAI) <150 for Crohn’s disease (CD) and partial Mayo score <2 for ulcerative colitis. Biological remission was defined as faecal calprotectin (FC) <250 µg/g and C-reactive protein (CRP) <0.5 mg/dL. The primary outcome measure was 1-year treatment persistence of SC IFX. Results Among 127 patients included in the study, 80 (62.9%) had CD, and 47 (37.1%) had UC. At the time of switching, 90 patients (70.9 %) were in clinical remission; whereas, 37 (29.1 %) were in a non-remission state. The treatment persistence rate at 1 year was high at 92.9%. Treatment persistence rates between the clinical remission and non-remission groups did not differ significantly (94.4% vs. 89.2%, p=0.287). In both groups, IFX pharmacokinetics and biomarkers between baseline and 12 months (p<0.01) significantly improved. The median infliximab levels increased from a baseline of 3.3 µg/mL (interquartile range [IQR] 1.3–5.1) to 14.4 µg/mL (IQR 9.4–23.0, p<0.001) at 12 months. Disease activity index was stable in the remission group, and decreased in the non-remission group (partial Mayo score, p<0.001; CDAI, p=0.063). At the one-year follow-up, clinical remission and biological remission were achieved in 86.6% and 60.6%, respectively, an increase from baseline (70.9% and 48.0%, respectively). Biologics exposure before IFX was the only significant variable associated with treatment persistence (odds ratio 5.138, 95% confidence interval 1.150–22.951, p=0.032). The concomitant use of immunomodulators was not associated. The incidence of IFX-related adverse events was 14.2%, with only three patients discontinuing treatment. Conclusion Switching to SC IFX from IV IFX maintenance therapy demonstrated high treatment persistence and favourable safety profiles, irrespective of remission status at the time of switching. Patients in both remission or non-remission states showed significant improvement in pharmacokinetics and biomarkers, and/or stable disease activity indices.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"23 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":"139559423","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}

{"title":"P696 Initiation of Vedolizumab did not provoke new-onset spondylarthritis in patients with inflammatory bowel disease: A Prospective Study Including Rheumatological and Blinded Imaging Assessments","authors":"S Rohekar, T Boyd, R Lambert, M Beaton, N Chande, J Gregor, H Lennox, K McIntosh, T Ponich, A Rahman, T Sharma, M Sey, M Tauqir, V Jairath","doi":"10.1093/ecco-jcc/jjad212.0826","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0826","url":null,"abstract":"Background Prior case series indicated a temporal relationship between use of vedolizumab and new-onset spondyloarthritis. Methods We aimed to evaluate the relationship between initiation of vedolizumab and development of new-onset spondyloarthritis in patients with inflammatory bowel disease, through serial clinical evaluation and magnetic resonance imaging. A single-centre prospective observational study of 24 patients with inflammatory bowel disease. Patients were eligible if they had active ulcerative colitis or Crohn’s disease and initiating vedolizumab, had no prior history of arthritis or spondyloarthritis and suitable for undergoing serial magnetic resonance imaging. Clinical evaluation was performed by a rheumatologist prior to first dose of vedolizumab and at weeks 8 and 24 weeks after administration. Axial magnetic resonance imaging was performed at baseline, weeks 8 and 24 and evaluated by a blinded central reader. Results Nine tumour necrosis factor inhibitor-naïve patients (4 male; mean age 53.2 yrs; 6 ulcerative colitis; 3 Crohn’s disease) and eight tumour necrosis factor inhibitor-experienced patients (7 male; mean age 48 yrs; 3 ulcerative colitis; 5 Crohn’s disease) completed all assessments. No patients developed new features of axial arthritis either on clinical or blinded radiological assessment at weeks 8 or 24, nor any features of peripheral spondyloarthritis including inflammatory oligoarthritis, enthesitis, dactylitis, or psoriasis (nail, body, or scalp). Both the tumour necrosis factor inhibitor-naive and tumour necrosis factor inhibitor-experienced patients demonstrated good intestinal response to vedolizumab. Conclusion Initiation of vedolizumab did not induce new features of axial or peripheral spondyloarthritis in tumour necrosis factor inhibitor-experienced or tumour necrosis factor inhibitor-naive patients with inflammatory bowel disease.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"163 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559435","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}

{"title":"DOP63 Mortality in Pediatric-onset Immune-Mediated Inflammatory Disease – A Nationwide Study","authors":"M Malham, S Jansson, H A S Ingels, M H Jørgensen, N Roed, A V Wewer, M P Fox","doi":"10.1093/ecco-jcc/jjad212.0103","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.0103","url":null,"abstract":"Background Patients with pediatric-onset immune-mediated inflammatory diseases (pIMID) show more aggressive phenotypes compared to patients diagnosed as adults. Despite this, data on mortality is extrapolated from patients diagnosed in adulthood, which might underestimate the actual risk. We aim to estimate the effect of pIMID compared to reference individuals from the general population on the long-term risk of all-cause mortality. Methods A population-based cohort study using the nationwide Danish health care registers. We included all patients diagnosed with pIMID in Denmark from 1980 to 2018 and matched them to up to ten reference individuals from the general population (with no recorded IMID) based on sex, age at diagnosis, and area of residence. Exposure was pIMID, defined as ICD codes indicative of autoimmune hepatitis, primary sclerosing cholangitis, Crohn’s disease, ulcerative colitis, juvenile idiopathic arthritis, system lupus erythematosus, or vasculitis registered before age 18. The primary outcome was all-cause mortality. The secondary outcome was cause-specific mortality. Cox survival analysis was used to estimate hazard ratios (HR) and Aalen survival analysis to estimate rate differences with corresponding 95% confidence intervals (CI) adjusted for the year of diagnosis and family income. Denmark has universal free health care, and health care data can be accessed through the nationwide health registers, continuously updated since 1980. Results We included 11,581 individuals diagnosed with pIMID, and 99,665 matched reference individuals, accounting for 1,371,994 person-years of follow-up. Median age at pIMID diagnosis was 12.6 years (IQR: 7.9 – 15.9). During follow-up, 152 pIMID patients and 316 reference individuals died, resulting in an all-cause mortality adjusted HR (aHR) of 3.8 (95% confidence interval [CI]: 3.1-4.7) compared to reference individuals without pIMID. This corresponded to 7.8 (95%CI: 6.1-9.5) additional deaths per 10,000 person-years. The strongest associations were found for gastrointestinal disorders (aHR 22.8 [95%CI: 9.6-64.1]), gastrointestinal cancers (aHR 19.2 [95%CI: 5.0-74.2]), and lymphoproliferative diseases (aHR 6.8 [95%CI: 2.8-16.8]). The aHR of suicide was 2.9 (95%CI: 1.6-5.0). Conclusion Patients diagnosed with pIMID have a four-fold increased risk of mortality when followed into adulthood. This underlines the severe disease course of pIMID and highlights the need for lifelong multidisciplinary care.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559644","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}

{"title":"P886 Ustekinumab concentrations in induction are associated with mid-term endoscopic outcomes in patients with inflammatory bowel disease","authors":"X Serra-Ruiz, E Céspedes Martínez, L Mayorga Ayala, C Herrera de-Guise, V Robles Alonso, Z Pérez Martínez, E Oller, N Borruel Sainz","doi":"10.1093/ecco-jcc/jjad212.1016","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.1016","url":null,"abstract":"Background It is unclear whether ustekinumab (UST) concentrations can predict the clinical course of inflammatory bowel disease (IBD) and guide treatment algorithms during the induction phase. The aim of our study was to assess the association between serum UST concentrations during the induction phase and clinical outcomes at week 24 and to determine the validity of a UST threshold for guiding intensification strategies. Methods We conducted a retrospective study including Crohn's disease (CD) and ulcerative colitis (UC) patients who started UST treatment between June 2022 and February 2023. Intensification strategies were determined according to standard clinical practice. UST concentrations were collected at weeks 8, 16, and 24. Quartile analysis and logistic regression were performed to evaluate the association between UST concentrations and treatment targets. Definitions are clinical steroid-free remission as a Harvey-Bradshaw index <5 and a partial Mayo score <2; endoscopic remission as a simple endoscopic score (SES-CD) ≤2 and Mayo endoscopic score (EMS) ≤1; and endoscopic response as a ≥50% reduction in SES-CD and ≥1 point in EMS. Results We included 42 patients (CD: 24). At week 24, clinical remission rates of 67% and endoscopic response and remission rates of 57% and 28%, respectively, were achieved. At week 24, the majority of patients continued intensified treatment: 90 mg subcutaneously every 4 weeks in 55% and 130 mg intravenously every 4 weeks in 36%. Patients who achieved an endoscopic response at week 24 had higher UST levels at week 8 (4.1 vs. 2.9 µg/ml, p=0.029). No significant differences between endoscopic remission rates and UST levels at any week were observed. The differences observed in the quartile analysis between the UST concentrations at week 8 and the endoscopic response were not statistically significant (p=0.451). The area under the ROC curve value for UST levels at week 8 to predict endoscopic response was 0.734 (p=0.012). Logistic regression analysis identified prior exposure to vedolizumab and absence of perianal disease as predictors of endoscopic response and remission at week 24 in univariate analysis, but not in multivariate analysis. No association was observed between UST levels and drug persistence rates. Conclusion In this real-world cohort, higher UST concentrations at week 8 were associated with higher rates of endoscopic response at week 24. A reliable concentration threshold for predicting endoscopic response and treatment intensification could not be determined, probably due to the insufficient number of patients included in the study and the relatively poor performance of the ROC curve. Prospective, randomized studies are needed to validate these results.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"23 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559198","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}

{"title":"N03 Flexibility & Accessibility, e-Literacy, Resourcing and The Human Factor: Early Lessons from EIBD, a UK Qualitative Interview Study","authors":"P Avery, K Kemp, L Dibley, S Green","doi":"10.1093/ecco-jcc/jjad212.1375","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjad212.1375","url":null,"abstract":"Background Since the COVID-19 pandemic, the use of health tools (video/phone consultations, patient portals, and digital applications) has increased in the clinical management of patients with Inflammatory Bowel Disease (PIBD). We aimed to evidence the acceptability of eHealth tools by investigating the shared experience of PIBD and healthcare professionals (HCPs) in using eHealth to carry out follow-up appointments and support self-management. Methods An exploratory qualitative method was used. Participants were recruited via professional networks, social media platforms, Crohn's and Colitis UK website and newsletters. Semi-structured interviews were conducted remotely in April/May 2023 using MS Teams or Zoom. Transcripts were analysed using a thematic analysis. Results Fifteen HCPs (13 female) participated: IBD specialist nurses (n=9); gastroenterologists (n=2), pharmacists (n=2) and Dieticians (n=2). The 16 PIBD (10 female) participants were living with Crohn’s Disease (n=9), Ulcerative Colitis (n=6), and Inflammatory Bowel Disease Unclassified (n=1); age was reported in ranges 18 -24 (n=3), 24-34 (n=1), 35-54 (n=8), and 55-65 (n=2) and 75-85 (n=1). Time since IBD diagnosis ranged from < 6 months - 43 years (mean time 18.7 years). Some participants had pre-diagnosis symptoms for at least one year (81%) to over five years (25%). Four themes emerged: • Flexibility and Accessibility: PIBD appreciated the ease of virtual appointments and access to test results and information but wanted flexibility and a personal approach to their care; eHealth connected them to their IBD team more easily. • Resource: HCPs wanted better digital training since remote assessment skills differ from in-person assessment skills. They also identified the need for admin support when planning to implement eHealth tools. HCPs and PIBD wondered whether eHealth was primarily a cost-savings exercise, whilst the need for resource efficiencies across the health service was recognised. • e-Literacy: HCPs were concerned that some older PIBD might be excluded from accessing eHealth due to e-literacy and capability issues, perceiving that eHealth is for the younger generation. • The Human Factor: PIBD and HCPs wanted to have already met in person anyone they engaged with later virtually. For PIBD, in-person consultations meant they felt seen or understood, and they described the importance of hands-on abdominal examinations in reassuring them about their health status. Conclusion There is an acceptability of eHealth to support the care of PIBD, but HCPs and PIBD still value the Human factor. Concerns over Resourcing, Flexibility and Accessibility and e-Literacy may need addressing to avoid these becoming barriers to the benefits of virtual healthcare in supporting PIBD.","PeriodicalId":15453,"journal":{"name":"Journal of Crohn's and Colitis","volume":"33 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139559254","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}