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.
Article first published online 9 May 2013
*Department of Internal Medicine III, Medical University Vienna, Vienna, Austria;
†Division of Gastroenterology, University of California, San Diego, La Jolla, California;
‡Gastroenterology Research, University of Calgary, Calgary, Canada;
§AbbVie Inc., North Chicago, Illinois; and
‖AbbVie Deutschland GmbH & Co, KG, Ludwigshafen, Germany.
Reprints: Walter Reinisch, MD, Clinic Internal Medicine III, Department of Gastroenterology and Hepatology, Medical University of Vienna, Währinger Gürtel 18-20, A-1090 Vienna, Austria (e-mail: email@example.com).
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Supported by AbbVie Inc.
Author disclosures are available in the Acknowledgments.
Received September 28, 2012
Accepted November 19, 2012