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P356 Durable Clinical Remission and Response in Adalimumab-Treated Patients with Ulcerative Colitis

R. Panaccione*1, J.-F. Colombel2, W.J. Sandborn3, W. Reinisch4, 5, G. D'Haens6, D. Hommes7, S. Ghosh1, B. Pappalardo8, J. Petersson8, A.M. Robinson8, A. Lazar9, Q. Zhou8, R.B. Thakkar8

1University of Calgary, Department of Medicine, Calgary, Canada, 2Icahn School of Medicine at Mount Sinai, Gastroenterology, New York City, United States, 3University of California San Diego, Gastroenterology, La Jolla, CA, United States, 4McMaster University, Gastroenterology, Hamilton, Canada, 5Medical University of Vienna, Dept. for Gastroenterology and Hepatology, Vienna, Austria, 6Academic Medical Centre, Department of Gastroenterology, Amsterdam, Netherlands, 7University of California, Gastroenterology, Los Angeles, CA, United States, 8AbbVie Inc., Global Pharmaceutical Research & Development, North Chicago, United States, 9AbbVie Deutschland GmbH & Co, KG, GPRD, Ludwigshafen, Germany

Background

Achievement of remission with adalimumab (ADA) treatment in patients (pts) with moderate to severe ulcerative colitis was demonstrated in ULTRA 11 and ULTRA 2.2 Sustained efficacy was shown through week (wk) 52 in ULTRA 2 and up to 4 years in ULTRA 3.2,3,4 Durable remission/response rates have not yet been reported for pts in ULTRA 2.

Methods

ULTRA 2 was a 52-wk double-blind (DB) trial in which pts were randomized to placebo or ADA [160/80 mg at wks 0/2, 40 mg every other wk (eow) from wk 4). Pts with inadequate response could move to open-label (OL) ADA (40 mg eow and then 40 mg wkly if necessary) from wk 12. In post-hoc analyses, durable remission (partial Mayo score [PMS] ≤2, no subscore >1), and durable response [PMS decrease ≥2 points and ≥30% from baseline, and rectal bleeding subscore (RBS) decrease ≥1 from baseline or RBS ≤1] were assessed in ADA wk 8 responders (by PMS, N=123) at multiple time points over 9 visits (wks 8, 12, 16, 20, 26, 32, 38, 44, 52): (1) at wks 32 and 52 and (2) at 100%, 89%, 78%, and 67% of all visits. Response and remission were also reported at each of the 9 visits. Missing data were handled using nonresponder imputation (NRI), whereby pts with missing data or those who received OL ADA were considered nonresponders, by modified NRI (mNRI) whereby only pts with missing data were considered nonresponders, and by last observation carried forward (LOCF).

Durable remission/response in ADA-treated patients who responded to therapy at week 8.

Durable remission/response in ADA-treated patients who responded to therapy at week 8.

Remission (% of patients)Remission (% of patients)Response (% of patients)Response (% of patients)
NRImNRINRImNRI
Weeks 32 and 5232.536.644.751.2
% of visits (n/N)
−- 100% (9/9)18.7N/A37.4N/A
−- 89% (8/9)30.131.750.454.5
−- 78% (7/9)36.639.852.058.5
−- 67% (6/9)41.548.856.962.6

 

Results

Remission was observed in 58% of ADA-treated wk 8 responders and was maintained through wk 52 (Figure). Response and remission were maintained at wks 32 and 52 in 44.7% and 32.5% (NRI) of wk 8 responders, respectively (mNRI: 51.2% and 36.6%, respectively) (Table). At 2/3 of all study visits, response and remission were maintained in 56.9% and 41.5% (NRI) of wk 8 responders, respectively (mNRI: 62.6% and 48.8%, respectively) (Table). For all analyses, greater numerical rates of remission and response were observed in TNF-naïve v. anti-TNF-experienced pts (data not shown).

Conclusion

Maintenance ADA treatment in pts with response to ADA induction treatment led to durable remission and response through wk 52.

Reference:

1) Reinisch et al Gut, 2011;60:780 2) Sandborn et al Gastroenterol, 2012;142:257 3) Sandborn et al Aliment Pharmacol Ther, 2013;37:204 4) Colombel et al Am J Gastroenterol 2014;109:1771

 

ECCOJC jju027 P356 F0001

“Remission Rates Over Time in Week 8 Responders”