S1453 Disease Characteristics Associated With Bowel Urgency in Crohn’s Disease: Results From the Phase 3 VIVID-1 Trial

Introduction: Data on bowel urgency (BU) in Crohn’s disease (CD) are limited, and associated factors are not well identified. Here we evaluate the association of BU with baseline (BL) disease characteristics in patients with moderately to severely active CD in the randomized, double-blind, double-dummy, treat-through design Phase 3 VIVID-1 trial. Methods: BU was assessed using the average Urgency Numeric Rating Scale (UNRS) (range 0-10) from 7 days prior to the visit. Adults having UNRS ≥3 and no missing values at BL were included. The association of UNRS with Crohn’s Disease Activity Index (CDAI), abdominal pain (AP), stool frequency (SF), Simple Endoscopic Score for CD (SES-CD) total score, disease location, count of inflamed intestinal segments, rectal involvement, presence of narrowing, presence of perianal fistulae, number of bowel resections and inflammatory biomarkers were primarily analyzed. Random forest method (RFM) was applied to rank variables by importance associated with BU score at BL. Pearson correlation coefficients (r value) were calculated for continuous BL variables. Results: At BL, 73.4% (782/1065) patients randomized to placebo (n=141), MIRI (n=433), or ustekinumab (n=208) reported UNRS ≥3 (median UNRS 7.0). Among BL disease characteristics, CDAI total score and AP were the top 2 important factors based on RFM and had moderate positive correlations with UNRS (Table 1). Notably, disease characteristics such as SF, SES-CD total score, age at diagnosis, age, fecal calprotectin, and C-reactive protein had weak correlations with UNRS. Also, count of inflamed segments (RFM=0.021; r=0.069), duration of CD (RFM=0.015; r=-0.007), presence of perianal fistula (RFM=0.009; r=0.090), and number of bowel resections (RFM=0.000; r=-0.036) had weak correlations with UNRS. BL corticosteroid (RFM=0.015) and immunomodulator (RFM=0.007) use, disease location (RFM=-0.005), rectal involvement (RFM=0.011), presence of narrowing (RFM=0.007), prior biologic failure (RFM=0.003), and sex (RFM=0.007) had weak correlations with UNRS implied by RFM. Conclusion: Most patients reported BU ≥3 at BL. Moderate positive correlations were observed only between BU, clinical disease severity (CDAI) and AP. Though the association of BU with other disease characteristics such as extent and severity of endoscopic inflammation, rectal involvement, presence of active perianal disease, disease location, previous resection and duration of CD were weak, they potentially interact and contribute together resulting in BU. Table 1. - Correlation of highest ranked baseline variables with UNRS Patient baseline variables Importance value based on random forest Pearson correlation coefficient (r) CDAI Total Score 0.701 0.479 Abdominal pain score 0.398 0.384 Stool frequency score 0.236 0.286 SES-CD total score 0.056 0.118 Age at diagnosis 0.037 -0.018 Age 0.033 -0.022 Faecal calprotectin 0.029 0.031 C-reactive protein 0.028 0.050 Correlation strength defined as: r >0.5=strong, 0.5≥r≥0.3 =moderate, 0.3 >r≥0.1 =weak, r< 0.1=insubstantial.2RFM is used to rank the relative importance of the patient baseline variables to UNRS. The higher values mean more important with a stronger association with UNRS.Abbreviations: CDAI=Crohn’s Disease Activity Index; CI=confidence interval; RFM = random forest method; SES-CD=Simple Endoscopic Score for Crohn’s Disease; UNRS = Urgency Numeric Rating Scale.

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