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P568. Sustained efficacy in patients with ulcerative colitis treated with adalimumab: results from ULTRA 2

S. Ghosh1, D. Wolf2, W. Sandborn3, J.-F. Colombel4, A. Lazar5, S. Eichner6, A. Robinson7, R. Thakkar7, 1University of Calgary, Calgary, Canada, 2Atlanta Gastroenterology Associates, Atlanta, United States, 3University of California, San Diego, La Jolla, United States, 4Centre Hospitalier Universitaire de Lille, Hôpital Claude Huriez, Lille, France, 5AbbVie Deutschland GmBH & Co. KG, Ludwigshafen, Germany, 6Abbott Laboratories, United States, 7Abbott Laboratories, Abbott Park, United States

Background

The efficacy and safety of adalimumab (ADA) for induction and maintenance of remission in patients with moderately to severely active ulcerative colitis (UC) was demonstrated in ULTRA 2 [1]. Sustained efficacy at weeks 8, 32, and 52 with ADA treatment has not been reported.

Methods

Adults with UC for >3 months (Mayo score 6–12; endoscopy subscore 2–3) failing corticosteroid or immunosuppressant therapy were randomised to placebo (PBO) or ADA (160/80 mg, week 0/2; 40 mg every other week [eow] from week 4). Anti-TNF-exposed patients were eligible. Patients with inadequate response could move to open-label (OL) ADA (40 mg eow) from week 12. Endoscopy was performed and full Mayo score was calculated at weeks 8, 32, and 52, using the worst rectal bleeding and stool frequency scores from the previous 3 days. Remission (Mayo score ≤2, no subscore >1), response (Mayo score decrease ≥3 points and ≤30% from baseline, and rectal bleeding subscore ≤1 or decreased by ≥1), and mucosal healing (endoscopy subscore ≤1) were assessed at each timepoint. The proportion of patients with efficacy at all three timepoints was determined (non-responder imputation: patients who moved to OL ADA or with missing data were considered not to have achieved the endpoint). Results were compared for ADA- vs PBO-treated patients (ITT, Cochran–Mantel–Haenszel test) and in subgroups by prior anti-TNF use (chi-squared or Fisher's exact test).

Results

ADA-treated patients were significantly more likely than PBO-treated patients to achieve sustained remission, response, and mucosal healing (Table). Anti-TNF-naïve ADA-treated patients were significantly more likely than PBO-treated patients to achieve each of the sustained efficacy endpoints. Anti-TNF-exposed ADA-treated patients had significantly greater rates of response, while remission or mucosal healing rates were numerically but not statistically greater, compared with PBO-treated patients.

 ITTAnti-TNF-naiveAnti-TNF-exposed
 PBOADAPBOADAPBOADA
 N = 246N = 248N = 145N = 150N = 101N = 98
Sustained remission, %2.48.1**3.410.7*1.04.1
Sustained response, %11.421.8**16.626.7*4.014.3*
Sustained mucosal healing, %9.318.1**13.123.34.010.2
*P < 0.05 vs PBO; **P < 0.01 vs PBO.

Conclusion

In ULTRA 2, ADA treatment resulted in statistically significantly greater rates of sustained efficacy at weeks 8, 32, and 52 than PBO treatment, with anti-TNF-naïve patients deriving the largest treatment benefit.

1. Sandborn, et al. Gastroenterology. 2012: 142.