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.