P-141 Association Between Week 8 Mayo Subscores and Hospitalisation Rates in Adalimumab-treated Patients with Ulcerative Colitis from ULTRA1 and ULTRA2

Abstract

To determine the association between week 8 Mayo subscore (MS) values for rectal bleeding (RB), stool frequency (SF), endoscopy, and physicians global assessment (PGA) and hospitalisation incidence rates (IR) for adalimumab (ADA)-treated patients (pts) with moderately to severely active ulcerative colitis (UC) enrolled in ULTRA 11 and ULTRA 2.2 All-cause and UC-related hospitalisations occurring from wks 8 to 52 were examined for 160/80 mg-ADA randomised pts in ULTRA 1 and ULTRA 2. ADA-treated pts received 160/80 mg ADA at weeks 0/2, followed by 40 mg ADA every other week (eow) to week 52. ULTRA 1 had an 8-week double-blind (DB) phase followed by an open-label (OL) phase to week 52, during which pts could move to weekly (ew) ADA for inadequate response. In the 52-week DB trial ULTRA 2, pts with inadequate response could receive OL 40 mg eow beginning at week 12 followed by 40 mg ew. All hospitalisations occurring during DB or OL were analyzed. Hospitalisation IR (the number of pts with hospitalisations over pt-yrs at risk) were calculated for each MS value as assessed at wk 8. Spearman correlation coefficients were calculated between the MS and IR for each category. Pts were censored at first hospitalisation. The table shows IRs for all-cause and UC-related hospitalisations by week 8 MS category. Significant correlations were seen for SF subscores and all-cause hospitalisations and for RB and PGA subscores with UC-related hospitalisations. Week 8 endoscopy subscores were not significantly correlated with hospitalisation IRs (R2 = 0.64, P = 0.20 for each category). The IRs for both categories of hospitalisations were similar for pts with a week 8 endoscopy subscore of 0 or 1. For ADA-treated pts with moderately to severely active UC, SF subscore at week 8 was strongly correlated with all-cause hospitalisation risk, whereas week 8 endoscopy subscore trended to correlate with hospitalisation risk.