Background Large scale data integration and comparison require standardised data collection. As part of the Health Outcomes Observatory (H2O) project, a core data set for IBD (including case-mix variables, biomarkers, clinical and patient-reported outcomes) that can uniformly be implemented across IBD centres was defined through an international, multi-stakeholder Delphi process. The next step was to identify the most appropriate instruments and minimum frequency to measure the patient-reported outcomes included in this core data set. Fierens L et al, UEG Week 2022. Methods A group of key stakeholders assessed potential instruments that were identified through a literature review. The literature review report included details on the development process, validation studies, extensiveness, required licenses and available translations of the identified instruments. The stakeholders were then asked to indicate in a survey which instrument(s) they considered most important to include in the core data set and at what minimum frequency they would collect these data. The collected insights were discussed at an online consensus meeting in Sept 2022 where a final selection of instruments and minimum frequency was agreed on. Results In total, 18 stakeholders from 10 different countries completed the survey (7 IBD specialists, 4 patient advocates, 3 pharma experts, 2 IBD nurses, 1 expert in patient-reported outcome measurements and 1 regulator). Also 18 stakeholders attended the consensus meeting (6 IBD specialists, 5 patient advocates, 3 academic researchers, 3 pharma experts and 1 IBD nurse from 11 different countries). The PRO-2 (both for UC and CD) and the IBD-Control were indicated as the most appropriate instruments to collect the IBD-specific outcomes, and the PROMIS Global Health and PROMIS Self-Efficacy short form to collect the generic patient-reported outcomes. At the consensus meeting it was additionally agreed to use the generic Health Monitor (disease acceptance and control) and to supplement the set with additional single items to measure bowel incontinence, bowel urgency, IBD medication adherence and the extent to which patients feel informed (Figure). It was agreed that the IBD-specific outcomes would be collected at every consultation with an IBD practitioner, and generic outcomes every 12 months. Conclusion This study recommends an instrument set and minimum frequency to measure the patient-reported outcomes included H2O core data set for IBD, agreed on by a group of key stakeholders. This set will initially be implemented in five European university clinics and subsequently in additional IBD clinics, enabling data integration and comparisons on a larger scale.

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Background Background: Vedolizumab (VDZ), an α47-integrin inhibitor, is approved for the treatment of moderate to severe Crohn’s disease (CD). Exposure-response relationship for VDZ is less evident in CD. Here, we are exploring associations between serum VDZ serum concentrations and clinical/biomarker-defined endpoints from a single center, real-world cohort. Methods Methods: Electronic health data records of CD patients during their first year of treatment with VDZ from January 2014 – July 2022 at our tertiary care center were obtained. Serum drug levels (TDL) and their correlation with outcomes were assessed at specified timepoints – weeks 12 (± 2), 26 (± 4) and 52 (± 6). Clinical remission was assessed by patient reported outcomes as suggested in STRIDE II guidelines (stool frequency ≤ 3 and abdominal pain ≤ 1). Fecal calprotectin (fCP) values ≤ 150 µg/g marked biomarker remission. Vedolizumab drug levels were measured with IDKmonitor Vedolizumab drug level ELISA kit (Immundiagnostik AG, Germany), In case of missing data patients were categorized as non-responders. For association modelling, multivariable fractional polynomials and generalised additive models were used (R statistical software, v4.1.2; R Core Team). Results Results: In total, 58 patients (females = 55.2%) with at least two available data points were included (Table 1). Sixteen individuals (16/58, 27.6%) were naive for biologics therapies. 98.3% (57/58) reached week 12 (± 2). Both at weeks 26 and 52 91.4% (53/58) subjects still were on drug. Clinical remission was achieved in 51.7% (30/58), 49.1% (26/53) and 45.2% (24/53) cases at weeks 12, 26 and 52, respectively, with biomarker remission rates of 24.1% (14/58), 35.8% (19/53) and 27.6% (16/53) patients reached biomarker remission. TDLs differed only between clinical remitters and non-remitters at week 26 (Mann-Whitney-U-test, p = 0.04). Also, there was no significant association between clinical and biomarker remission at defined timepoints and corresponding TDLs (for all p > 0.05). TDLs at week 2 and 6 were correlated with fCP values at the same time (rho: -0.327, p = 0.03 at week 2 and rho: -0.356, p = 0.02 at week 6). When TDLs at week 2 and week 6 were taken into consideration and associated separately with therapy outcomes in a univariate regression, only association between serum levels at week 6 and biomarker remission at weeks 26 and 52 was found (p = 0.02 and p = 0.03, respectively). Conclusion Conclusion: The only association between serum drug levels and remission was found between TDLs at week 6 and biomarker remission at weeks 26 and 52 suggesting a complex exposure-response relation for vedolizumab in CD patients.