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P207. One-year response and remission rates in ulcerative colitis patients with week 8 response to adalimumab: Subanalysis of ULTRA 2


W. Sandborn1, G. D'Haens2,3, J.‑F. Colombel4, G. Van Assche5, D. Wolf6, M. Kron7, A. Lazar7, A. Robinson8, J. Chao8, R. Thakkar8

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



Background: Physicians are unlikely to continue anti‑TNF therapy for ulcerative colitis (UC) patients (pts) not exhibiting early therapeutic response. We evaluated Week (Wk) 52 clinical remission and response rates in moderate to severe UC pts failing conventional therapy and achieving Wk 8 clinical response in ULTRA 2.

Methods: In the 52-wk ULTRA 2 trial, pts were randomized 1:1 to adalimumab (ADA; 160/80 mg at Wk 0/2, 40 mg every other wk [eow] thereafter) or placebo (PBO). Pts with inadequate response could switch to open-label (OL) ADA (40 mg eow, followed by 40 mg weekly) from Wk 12. Wk 52 clinical remission (Mayo score ≤2; no subscore >1) and clinical response (Mayo score decrease of ≥3 points and ≥30% from baseline and decrease in rectal bleeding score [RBS] ≥1 or absolute RBS of 0 or 1) rates were assessed in all PBO pts, in ADA pts achieving clinical response by full Mayo score, and in ADA pts achieving clinical response by partial Mayo score (decrease of ≥2 points and ≥30% from baseline and above RBS criteria) at Wk 8. Subgroup analyses by prior anti‑TNF use were also performed. Non-responder imputation (NRI) was used for missing data or that collected on/after move to OL for PBO and ADA. ADA subgroups were also analyzed using modified NRI (mNRI); only missing data were imputed as non-response/remission. Response and remission were compared between ADA (NRI or mNRI) and PBO (NRI only) groups.

Results: Significantly more ADA-treated pts in each response group achieved Wk 52 remission or response as compared with PBO pts (Table; all comparisons P < 0.01). A similar pattern of results was seen regardless of prior anti‑TNF status (Table).

a Wk 8 responder per full Mayo score; b Wk 8 responder per partial Mayo score; *P < 0.01, ADA vs. PBO (CMH test for all, chi square test for anti-TNF subgroups).
Week 52 results in ADA Week 8 responders (by full or partial Mayo Score) and All PBO Pts
 AllAnti-TNF naïveAnti-TNF exposed
 ADA FMSaADA PMSbPboADA FMSaADA PMSbPboADA FMSaADA PMSbPbo
N12512324689881453635101
Remission, %         
 NRI28.8*30.9*8.531.5*33.0*12.422.2*25.7*3.0
 mNRI35.2*37.4*n/a38.2*39.8*n/a27.8*31.4*n/a
Response, %         
 NRI47.2*49.6*18.349.4*51.1*24.141.7*45.7*9.9
 mNRI63.2*63.4*n/a65.2*64.8*n/a58.3*60.0*n/a

Conclusions: In moderate to severe UC pts in ULTRA 2, clinically meaningful long-term efficacy with ADA was seen at Wk 52 in pts with Wk 8 full or partial Mayo score response.