P135 Real-world effectiveness and safety of ustekinumab for the treatment of crohn’s: the Scottish ustekinumab cohort

Abstract

and colitis patients across >100 participating hospitals with a long-standing goal of fostering IBD Research to expedite clinical translation. For each patient recruited, clinical and selfreported phenotype data are collected, alongside plasma, serum and DNA samples for genetic analyses. The resulting data-rich panel is open to any investigators wishing to access data/samples or recall genotype-selected participants to donate further samples or trial novel therapies. Methods Building the IBD BioResource panel: Patients' clinical data are collected at recruitment by the IBD team through a clinical data sheet based on the Montreal classification while health and lifestyle information are obtained via a patient questionnaire. All include demographics, smoking habits, general and IBD specific health questions, family history of IBD and non-IBD conditions, medication, treatment, surgery history and co-morbidities. The IBD BioResource panel also holds Whole Genome/Exome sequencing and GWAS data derived from its detailed biological samplings.Accessing the IBD BioResource panel: The built-in panel of patients and their data is open to any investigators from science or industry. Following feasibility checks, submitted research applications are reviewed by the NIHR BioResource Scientific Advisory Board (SAB) based on scientific merits and projected benefit to patients. Upon study approval, patients meeting inclusion criteria are contacted by the NIHR BioResource team with a letter of invitation and a patient information leaflet. For volunteers willing to participate, appropriate arrangements are then made to gather information, collect fresh biological samples or engage patients in intervention studies. Results To date 26 'Stage 2 studies' applied to utilise the IBD BioResource, 18 of which are currently active, 4 completed and 4 pending approval. Of the 26 applications, ~20% requested access to anonymised samples/data while the remaining ~80% required involvement of participants. Applications