Skip Navigation LinksHome > July 2013 - Volume 19 - Issue 8 > 52-Week Efficacy of Adalimumab in Patients with Moderately t...
Inflammatory Bowel Diseases:
doi: 10.1097/MIB.0b013e318281f2b7
Original Clinical Articles

52-Week Efficacy of Adalimumab in Patients with Moderately to Severely Active Ulcerative Colitis Who Failed Corticosteroids and/or Immunosuppressants

Reinisch, Walter MD*; Sandborn, William J. MD; Panaccione, Remo MD; Huang, Bidan PhD§; Pollack, Paul F. MD§; Lazar, Andreas MD; Thakkar, Roopal B. MD§

Supplemental Author Material
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Abstract

Background:

The results of an open-label follow-up until week 52 of patients with moderately to severely active ulcerative colitis who participated in a double-blind placebo-controlled adalimumab induction trial (ULTRA 1, NCT00385736) are reported.

Methods:

The study included adult anti–tumor necrosis factor–naive patients who completed double-blind adalimumab induction under an amended protocol (intent-to-treat [ITT]-A3 population) or any version of the protocol (ITT-E). Patients randomized to placebo received adalimumab beginning at week 8; patients randomized to adalimumab continued every other week dosing. Weekly dosing was allowed beginning at week 14 (original protocol) or week 12 (amended protocol). Clinical remission (Mayo score ≤2, no subscore >1), clinical response (decrease in Mayo score ≥3 points and ≥30% from baseline, plus decrease in rectal bleeding subscore ≥1 or absolute rectal bleeding subscore ≤1), mucosal healing (endoscopy subscore ≤1), escalation to weekly dosing, and reduction in corticosteroid use were assessed at week 52 in the pooled ITT-A3 and pooled ITT-E populations, using modified nonresponder imputation.

Results:

Rates of clinical remission, clinical response, and mucosal healing at week 52 for the ITT-A3 population (N = 390) were 29.5%, 53.6%, and 46.7%, respectively; 38.8% of week 8 responders achieved clinical remission at week 52. Of patients using baseline corticosteroids (N = 234), 56.0% were corticosteroid-free at week 52 (26.1% in clinical remission). Results of the ITT-E population were similar. No new safety issues were identified.

Conclusions:

In this open-label study, adalimumab was effective for maintaining clinical remission in anti–tumor necrosis factor–naive patients with moderately to severely active ulcerative colitis who did not adequately respond to conventional therapy.

Copyright © 2013 Crohn's & Colitis Foundation of America, Inc.

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