title: 52-week efficacy of adalimumab in patients with moderately to severely active ulcerative colitis who failed corticosteroids and/or immunosuppressants.
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.
authors.affiliation: Department of Internal Medicine III, Medical University Vienna, Vienna, Austria. walter.reinisch@meduniwien.ac.at
authors.forename: Walter
authors.initials: W
authors.lastname: Reinisch
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Remo
authors.initials: R
authors.lastname: Panaccione
authors.forename: Bidan
authors.initials: B
authors.lastname: Huang
authors.forename: Paul F
authors.initials: PF
authors.lastname: Pollack
authors.forename: Andreas
authors.initials: A
authors.lastname: Lazar
authors.forename: Roopal B
authors.initials: RB
authors.lastname: Thakkar
mesh_terms: D000068879:Adalimumab; D000305:Adrenal Cortex Hormones / Q000009:adverse effects*; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000150:complications* / Q000188:drug therapy; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000139:chemically induced / Q000188:drug therapy*; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D008297:Male; D011379:Prognosis; D012074:Remission Induction; D016879:Salvage Therapy; D012720:Severity of Illness Index; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab