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P391. Rates of “patient-defined” remission with adalimumab in patients with ulcerative colitis: subanalysis of ULTRA 1 and ULTRA 2

J. Lewis1, S. Ghosh2, W. Sandborn3, G. Van Assche4, G. D'Haens5, A. Lazar6, S. Eichner7, B. Huang7, A. Robinson7, R. Thakkar7, 1University of Pennsylvania Perelman School of Medicine, Philadelphia, United States, 2University of Calgary, Calgary, Canada, 3University of California San Diego, La Jolla, United States, 4University of Toronto, Toronto, Canada, 5Academic Medical Center, Amsterdam, Netherlands, 6AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, 7Abbott Laboratories, Abbott Park, United States

Background

The Mayo score is commonly used to measure disease activity in clinical trials of patients (pts) with ulcerative colitis (UC). Although a Mayo score ≤2 is frequently used to define clinical remission, this cut-off is not standardised and data regarding the clinical relevance of this cut-off from a patient's perspective are limited [1,2]. It was recently shown that pt-reported disease activity of “perfect” or “very good” was best identified by a full Mayo score cut-off of 4.5 [3]. Rates of remission were analysed based on this cutpoint in moderate to severe UC pts from 2 pivotal, controlled trials, ULTRA 1 [4] and ULTRA 2 [5].

Methods

In ULTRA 1, pts were randomised to placebo (PBO) for 8 weeks (wks), or ADA 160/80 mg, or 80/40 mg at wks 0/2, followed by ADA 40 mg every other week (eow) to wk 8. In ULTRA 2, pts were randomised to PBO or ADA 160/80 mg at wks 0/2 followed by PBO or ADA 40 mg eow to wk 52. Pts could move to open-label (OL) ADA (40 mg eow) for inadequate response after wk 12, and to 40 mg weekly (ew) for continued non-response. Prior anti-TNF exposure was allowed in ULTRA 2. “Pt-defined remission” (full Mayo score ≤4, Mayo scores were collected as whole numbers since pt reported subscores were captured as worst vs average values) was assessed in the ITT population at wk 8 (ULTRA 1) and wks 8 and 52 (ULTRA 2). Subgroup analysis by prior anti-TNF use (ULTRA 2) was also performed. Non-responder imputation (whereby pts were considered non-remitters) was used for missing data or for that obtained after move to OL dosing.

Results

Significantly more pts randomized to ADA 160/80 mg achieved “pt-defined remission” at wks 8, 52, and at both time points than PBO (Table). The greatest rates of pt-defined remission were observed in anti-TNF naïve pts.

Table: Pt-defined remission (Mayo score ≤4)
 ULTRA1ULTRA2
    All patientsAnti-TNF NaivePrior Anti-TNF
 PBO N = 130ADA 80/40 N = 130ADA 160/80 N = 130PBO N = 246ADA 160/80 N = 248PBO N = 145ADA 160/80 N = 150PBO N = 101ADA 160/80 N = 98
Wk 8, %28.533.844.6**22.035.1***24.843.3***17.822.4
Wk 52, %n/an/an/a15.025.8**20.732.7*6.915.3
Wk 8 & 52, %n/an/an/a8.917.3**12.422.7*4.09.2
*p ≤ 0.05, **p ≤ 0.01, ***p ≤ 0.001 vs. PBO.

Conclusion

ADA induction and maintenance therapy demonstrated clinically relevant efficacy in UC using a definition consistent with pt-reported perfect or very good symptom control.

1. D'Haens G, et al. 2007. Gastroenterology 132: 763.

2. Higgins PDR, et al. 2005. Gastroenterology 100: 355.

3. Lewis JD, et al. 2008. Inflamm Bowel Dis 14: 1660.

4. Reinisch W, et al. 2011. Gut 60: 780.

5. Sandborn J, et al. 2012. Gastroenterology 142: 257.