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P213. Benefit–risk assessment of adalimumab as maintenance treatment for ulcerative colitis: Near analysis of week 8 responders in ULTRA 2

J.‑F. Colombel1, W. Sandborn2, G. Van Assche3, G. D'Haens4, D. Wolf5, M. Kron6, A. Lazar7, A. Robinson8, J. Chao8, R. Thakkar8

1Centre Hospitalier Universitaire de Lille, Hôpital Claude Huriez, Lille, France; 2University of California, San Diego, La Jolla, United States; 3University Hospital of Gasthuisberg, Leuven, Belgium; 4Academic Medical Center, Amsterdam, Netherlands; 5Atlanta Gastroenterology Associates, Atlanta, United States; 6Abbott GmbH & Co. KG, Ludwigshafen, Germany; 7Abbott GmbH & Co. KG, Ludwigshafen, United States; 8Abbott Laboratories, Abbott Park, United States

Background: The “Net Efficacy Adjusted for Risk” (NEAR) model is a method for expressing the benefit/risk balance of a therapeutic intervention as a single value [1]. The NEAR odds ratio (OR) expresses the likelihood of a patient achieving adverse event (AE)-free treatment success with a therapeutic intervention versus a control. We calculated NEAR ORs for adalimumab (ADA) maintenance treatment of ulcerative colitis (UC) compared with placebo (PBO) for Week (Wk) 8 responders in ULTRA 2.

Methods: Data from randomization through Wk 52 (study end) of ULTRA 2, a randomized, double-blind, pbo-controlled trial of ADA for moderate to severe UC, were analyzed. ADA-treated patients achieving response per partial Mayo score at Wk 8 (score decrease of ≥2 points and ≥30% from baseline and decrease in rectal bleeding score [RBS] ≥1 or absolute RBS of 0 or 1) were compared to all PBO-treated patients. ORs (ADA/PBO) for efficacy were calculated based on proportions of patients with clinical remission (full Mayo score ≤2; no subscore >1) or clinical response (full Mayo score decrease of ≥3 points and ≥30% from baseline and decrease in RBS ≥1 or absolute RBS of 0 or 1) at Wk 52. Safety ORs (PBO/ADA) were calculated based on serious adverse events (SAEs), AEs leading to discontinuation, and serious infections (a subset of SAEs). NEAR ORs (ADA/PBO) were calculated for AE-free treatment success based on response/remission per full Mayo and the AE classes defined above. Efficacy ORs >1 favor ADA over PBO for achieving efficacy; safety ORs >1 indicate lower risk with ADA vs. PBO for the AE analyzed. NEAR ORs >1 favor ADA over PBO for AE-free treatment success.

Results: For each AE of interest, the NEAR ORs indicate a significantly greater likelihood of achieving AE-free clinical remission and response at Wk 52 with ADA as compared with PBO (Figure).

Conclusions: This NEAR analysis demonstrates that adalimumab has a favorable benefit/risk profile as maintenance treatment through 52 weeks for moderate to severe UC patients who achieve clinical response at week 8.

1. Boada JN et al. PLoS One 2008;3:e3580.