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P571. Adalimumab maintains remission for up to 4 years in patients with ulcerative colitis

J.-F. Colombel1, W.J. Sandborn2, S. Ghosh3, D. Wolf4, R. Panaccione3, B. Feagan5, W. Reinisch6, A.M. Robinson7, A. Lazar8, M. Kron8, B. Huang7, R.B. Thakkar7, 1Icahn School of Medicine at Mount Sinai, Division of Gastroenterology, New York, United States, 2University of California, San Diego, Division of Gastroenterology, La Jolla, United States, 3University of Calgary, Department of Medicine, Calgary, Canada, 4Atlanta Gastroenterology Associates, Atlanta, United States, 5Robarts Research Institute, London, Canada, 6McMaster University, Department of Medicine, Hamilton, Canada, 7AbbVie Inc, GPRD, North Chicago, United States, 8AbbVie Deutschland GmbH & Co, KG, GPRD, Ludwigshafen, Germany

Background

Results from the clinical trials ULTRA 1 [1] and ULTRA 2 [2] demonstrated the efficacy of adalimumab (ADA) induction and maintenance therapy in the treatment of ulcerative colitis (UC) through week (wk) 52. The long-term efficacy and safety of ADA continues to be evaluated in the ongoing open-label (OL) extension, ULTRA 3.

Methods

Patients (pts) who completed ULTRA 1 or 2 could enter ULTRA 3. Pts entering ULTRA 3 from blinded therapy received ADA 40 mg every other week (eow) and those entering from OL ADA, either eow or weekly (ew), continued on the same dosing regimen. Escalation to ew dosing was allowed for flare or non-response during ULTRA 3. Partial Mayo score (PMS), Mayo score without endoscopy subscore, was calculated at every study visit. Endoscopies were performed every 48 wks in ULTRA 3. Remission (PMS ≤2 with no subscore >1) and mucosal healing (MH) (endoscopy subscore ≤1) at year 4 after lead-in study baseline (BL) was assessed in the ITT pts who entered ULTRA 3 from ULTRA 1 and 2. Maintenance of remission per PMS and maintenance of MH in year 4 was assessed in pts who entered ULTRA 3 in remission per full Mayo score (Mayo score ≤2 with no subscore >1) and with MH, respectively. Efficacy endpoints were measured, using a data cut-off of April 15, 2013, from ULTRA 3 entry (wk 0) through wk 156 (representing 208 wks from lead-in study BL), for remission, and through wk 144 (representing 196 wks from lead-in study BL), for MH. Missing data were handled using last observation carried forward and non-responder imputation (NRI).

Results

More than half of the pts from ULTRA 1 and 2 were followed in ULTRA 3 (588/1094, 53.7%). Of these pts, 52.2% (307/588, NRI) were in remission per PMS and 69.6% (409/588, NRI) had MH upon entry into ULTRA 3. At year 4 from lead-in study BL, remission per PMS and MH rates were 46.4% (273/588, NRI) and 50.7% (298/588, NRI), respectively. A majority of the pts entering ULTRA 3 with remission per full Mayo score or MH maintained remission per PMS and MH, respectively, over time (Table). Adverse event rates were stable over time and no new safety signals were observed.

Table: Maintenance of remission per PMS and MH during ULTRA 3
Week 48Week 96Week 144Week 156
LOCFNRILOCFNRILOCFNRILOCFNRI
Remission per PMS (%)78.575.681.873.178.164.978.563.6
Mucosal healing (%)81.473.380.466.381.759.9N/AN/A
N/A, not available due to the timing of endoscopies in ULTRA 3.

Conclusion

Long-term ADA therapy maintains remission and MH for up to four years in pts with UC, with a stable safety profile and no new safety signals.

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

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