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P552. Association between Week 8 Mayo subscores and hospitalisation rates in adalimumab-treated patients with ulcerative colitis from ULTRA 1 and ULTRA 2

W. Reinisch1, W.J. Sandborn2, B. Feagan3, S. Ghosh4, A. Robinson5, M. Skup5, J. Petersson5, B. Huang5, A. Lazar6, R. Thakkar5, 1McMaster University, Department of Medicine, Hamilton, Canada, 2University of California San Diego, Division of Gastroenterology, La Jolla, United States, 3Robarts Clinical Trials Inc., Robarts Research Institute, Western University, London, Ontario, Canada, 4University of Calgary, Department of Medicine, Calgary, Canada, 5AbbVie Inc, GPRD, North Chicago, United States, 6AbbVie Deutschland GmbH & Co, KG, GPRD, Ludwigshafen, Germany

Background

To determine the association between week (wk) 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 1 [1] and ULTRA 2 [2].

Methods

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 wks 0/2, followed by 40 mg ADA every other week (eow) to wk 52. ULTRA 1 had an 8-wk double-blind (DB) phase followed by an open-label (OL) phase to wk 52, during which pts could move to weekly (ew) ADA for inadequate response. In the 52-wk DB trial ULTRA 2, pts with inadequate response could receive OL 40 mg eow beginning at wk 12 followed by 40 mg ew. All hospitalisations occurring during DB or OL were analysed. Hospitalisation IR (the number of pts with hospitalisations over pt-yrs at risk) was 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.

Results

The table shows IRs for all-cause and UC-related hospitalisations by wk 8 MS category. Significant correlations were seen for SF subscores and all-cause hospitalisations and for RB and PGA subscores with UC-related hospitalisations. Wk 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 wk 8 endoscopy subscore of 0 or 1.

Table: Incidence rates for All-cause and UC-related hospitalisations for ADA-treated pts by Mayo subscores at wk 8
SubscoreSF (N = 433)RB (N = 433)PGA (N = 433)Endoscopy (N = 422)
valueAll-cause*UC-relatedAll-causeUC-related*All-causeUC-related*All-causeUC-related*
00.080.050.130.060.110.050.140.06
10.110.050.130.100.110.060.110.06
20.150.110.220.130.200.140.160.10
30.220.160.290.290.230.190.270.21
ADA, adalimumab; SF, stool frequency; RB, rectal bleeding; PGA, physician's global assessment.
*Spearman R2 = 1, p < 0.001; † Spearman R2 = 0.64, p = 0.20.

Conclusion

For ADA-treated pts with moderately to severely active UC, SF subscore at wk 8 was strongly correlated with all-cause hospitalisation risk, whereas wk 8 endoscopy subscore trended to correlate with hospitalisation risk.

1. Reinisch W, et al. 2011. Gut; 60: 780.

2. Sandborn WJ, et al. 2012. Gastroenterology; 142: 257.