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IntroductionAnti-tumour necrosis factor (TNF) therapy has greatly improved treatment outcomes in patients with inflammatory bowel disease (IBD), but long-term use is associated with cutaneous reactions, susceptibility to infections and frequent injections or hospital visits. Several non-controlled studies have demonstrated that dose reduction is feasible for a subset of patients, provided that early detection of a disease flare is possible. Here, we aim to compare the effectiveness of interval lengthening with standard dosing in maintaining remission in young patients with IBD.Methods and analysisIn this international, prospective, non-inferiority, partially randomised patient preference trial, we aim to recruit 148 patients aged 12–25 years with luminal Crohn’s disease or ulcerative colitis in sustained remission (ie, three consecutive in-range faecal calprotectin (FC) results or recently confirmed endoscopic remission). In the interventional arm, the dosing interval will be lengthened from 8 to 12 weeks for infliximab users and from 2 to 3 weeks for adalimumab users. In the control group, standard dosing will be continued. Rapid tests will be performed for FC every 4 weeks and for anti-TNF trough levels every 12 weeks. The primary outcome is the cumulative incidence of out-of-range FC results at 48-week follow-up. Secondary endpoints include time to get out-of-range FC results, cumulative incidence of adverse effects, proportion of patients progressing to loss of response and identification of predictors of successful interval lengthening.Ethics and disseminationThe protocol has been approved by the Medical Ethics Review Committee of the University Medical Centre Groningen and is pending at the other participating centres. Results will be disseminated in peer-reviewed journals and presented at scientific meetings.Trial registration numberEudraCT number: 2020-001811-26; ClinicalTrials.gov Identifier: NCT04646187. Protocol version 4, date 17 September 2021.

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Background The IBD-disk is a 10-item visual tool assessing inflammatory bowel diseases (IBD)-related disability. It could be a valuable tool in daily practice but it has not been validated. In a cohort of patients with IBD, we aimed to determine the correlation between the IBD-disk and each of its components with the IBD daily-life burden. Methods A 1-week cross-sectional study has been conducted in 42 centres affiliated to the GETAID in France and Belgium in November 2018. Patients were asked to fulfil the IBD-disk questionnaire and an IBD daily-life burden visual analogic scale (VAS: 0 = no burden; 10 = maximal burden). The validation included for internal consistency, correlation analysis and diagnostic performance assessment. In addition, we evaluated the completion rate as well as patient satisfaction for IBD-disk. Multivariate analysis was performed to determine predictors of moderate-to-severe IBD-related disability. Results Among the 2011 IBD outpatients who responded to the survey (67.8% of patients with Crohn’s disease), 49.9% were in clinical remission. The full completion rate of the IBD-disk was 73.8%. It was considered easy to fulfil by 88.4% of patients. The mean IBD-disk score was 39.0 ± 23.2 (best score 0, worst 100). The IBD-disk score was well correlated with IBD daily-life burden VAS (r = 0.62; p < 0.001). With the optimal IBD-disk cut-off of 40, AUROC for high IBD daily-life burden was 0.81 (CI95%: 0.79–0.83; p < 0.001). Using multiple logistic regression, a shortened IBD-disk score using only 5 items (abdominal pain + regulating defecation x2 + work and education x3 + emotions + energy) of the IBD-disk had similar correlation and diagnosis performance than the complete IBD-disk score (AUROC=0.82 [0.79–0.83]; p < 0.001) for assessing IBD daily-life burden. In multivariate analysis, moderate-to-severe disability (overall IBD-disk score > 40) was significantly increased in patients with frequent sick leave > 0.3 per year, with general practitioner appointment > 2 per year, with concerns about the lack of efficacy of their current treatment, perceived need of psychotherapist or IBD-nurse whereas it was decreased in patients with clinical remission assessed by patient global assessment and employed or student occupational status. Conclusion The IBD-disk had a good completion rate and demonstrated a close correlation with daily-life IBD burden and good internal consistency, in a large multicentre cohort of IBD patients. Our results suggest that the IBD-disk could be a valuable tool in routine practice to assess daily-life IBD burden. Although a simplified 5-item IBD-disk demonstrated better performance to assess IBDdaily-life burden, the overall score, the IBD-disk allows exploring all dimensions of IBD daily-life burden.

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S38 Poster PresentationsOnly 3 cases (0.5%) had colon cancer among 612 UC patients. Adenomatous polyp was not found in cases with colon cancer. Conclusion: In our cases with UC, adenomatous polyp rate was 3.2%, dysplasia 2.1%, and colon cancer rate was 0.5%. Patients with tonsillectomy revealed a higher rate of dysplasia P069 The CARE trial: adalimumab improves work productivity and quality of life in patients with Crohn's disease

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