P083 CREATION OF A PROSPECTIVE, LONGITUDINAL ADULT INFLAMMATORY BOWEL DISEASE COHORT COMBINING HIGH-RESOLUTION PHENOTYPING WITH BIOSAMPLE COLLECTION TO FACILITATE PRECISION MEDICINE: SPARC IBD
Authors: Saha Sumona , Caldera Freddy , Bohm Matthew , Fischer Monika , Sagi Sashi , Kaur Manreet , Shukla Richa , Snapper Scott , Korzenik Joshua , Perera Lilani , Yarur Andres , Cross Raymond , Wong Uni , Pekow Joel , Dalal Sushila , Higgins Peter , Bishu Shrinivas , Reynolds Gorman , Ciorba Matthew , Deepak Parakkal , Scoville Elizabeth , Wilson Keith , Hudesman David , Loke P’ng , Dassapoulos Themistocles , Wells Katerina , Norris Cecile , Bewtra Meena , Raffals Laura , Lewis James 
Published: January 2020

Abstract

Background
Disease location, behavior, and average activity over time vary significantly amongst patients with inflammatory bowel disease (IBD). Despite this heterogeneity patients are often subjected to a “one size fits all” treatment plan. Clinical and multi-omic profiles which predict responsiveness to treatment are needed given the expanding range of therapeutic options for IBD.

Methods
The Study of Prospective Adult Research Cohort of IBD (SPARC IBD) is a prospective, longitudinal cohort study of patients with IBD ages 18 and older managed according to local standards at 17 academic medical centers in the US. Demographic data, disease-related data, and patient-reported outcomes are collected at baseline, during routine GI office visits, and quarterly by data abstraction from the electronic health record, patient surveys, and highly structured electronic case report forms (eCRF) created with Epic Systems (IBD SmartForm). Biosamples are collected at baseline (blood and stool), at the time colonoscopy (stool and tissue), and after key medication changes (blood and stool). Clinical data is transferred from sites on a periodic basis and stored in the Crohn’s & Colitis Foundation’s exchange platform called IBD Plexus. A portion of the biosamples are analyzed and the rest are banked for future use.

Results
Between November 2016 and October 2019, 2582 patients have enrolled in SPARC IBD (66% Crohn’s disease [CD], 33% ulcerative colitis (UC), and 1% IBD-U). Females comprise 52.5% of the cohort. Median age at enrollment is 37 years (range18-85). The majority of patients are white (80.5%) and non-Hispanic or Latino (84.5%). Median disease duration is 12 years (range 0–53). Distribution of disease location in the CD sub-group is 44% with small bowel and colonic disease, 28% with isolated small bowel disease, and 15% with isolated colonic disease. In the UC sub-group, 50.5% of patients have extensive colitis, followed by 23.5% with left-sided colitis, and 8.8% with proctitis. Among CD patients, 17.6% have stricturing disease, 12.5% have penetrating disease, 5.8% have both stricturing and penetrating disease and 16.2% have perianal involvement. At time of study enrollment 60% of CD patients, 41% of UC patients and 37% of IBD-U patients were on a biologic. The majority of patients with CD (88%) and UC (89%) were in remission.

Conclusions
SPARC IBD is a prospective cohort study of adult IBD patients which combines high-resolution phenotyping with biosample collection at multiple points in time. The unique aspects of this study including the multiple modalities for clinical data collection, the geographic diversity of patients enrolled, as well as the biosample procurement at multiple time points position SPARC IBD to aid in the discovery of novel biomarkers which can predict therapeutic responsiveness.