title: One-year maintenance outcomes among patients with moderately-to-severely active ulcerative colitis who responded to induction therapy with adalimumab: subgroup analyses from ULTRA 2.
abstract: BACKGROUND
  Patients with moderately-to-severely active ulcerative colitis (UC) are unlikely to continue anti-TNF therapy in the absence of early therapeutic response.
  
  
  OBJECTIVE
  To assess week 52 efficacy, safety and benefit/risk balance of adalimumab treatment in patients with moderately-to-severely active UC failing conventional therapy who achieved clinical response at week 8 in the 52-week ULTRA 2 trial.
  
  
  METHODS
  Patients randomised to adalimumab (160/80 mg, week 0/2; 40 mg, every other week thereafter) in ULTRA 2 who achieved clinical response at week 8 per partial Mayo score (Mayo score without endoscopy subscore) were assessed for week 52 clinical remission, clinical response, mucosal healing, steroid-free remission and steroid discontinuation rates, overall and by prior anti-TNF use. Benefit/risk balance for the overall ITT population (regardless of week 8 responder status) was assessed using 'net efficacy adjusted for risk' (NEAR) odds ratios. Safety was assessed using adverse event rates.
  
  
  RESULTS
  Of 248 adalimumab-treated patients, 123 (49.6%) achieved clinical response at week 8. Of these, 30.9%, 49.6%, and 43.1% achieved clinical remission, clinical response, and mucosal healing, respectively, at week 52. Of the week 8 responders using corticosteroids at baseline (N = 90), 21.1% achieved steroid-free remission and 37.8% were steroid-free at week 52. NEAR odds ratios indicated a positive benefit/risk balance for achievement of week 8 and week 52 response or remission without serious adverse events or serious infections. No safety concerns were identified.
  
  
  CONCLUSIONS
  Adalimumab treatment was associated with a positive benefit/risk balance in the overall population of patients with moderately-to-severely active ulcerative colitis in ULTRA 2; early response was predictive of a positive outcome at 1 year (NCT00408629).
authors.affiliation: University of California San Diego, La Jolla, CA 92093-0956, USA. wsandborn@ucsd.edu
authors.forename: W J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: J-F
authors.initials: JF
authors.lastname: Colombel
authors.forename: G
authors.initials: G
authors.lastname: D'Haens
authors.forename: G
authors.initials: G
authors.lastname: Van Assche
authors.forename: D
authors.initials: D
authors.lastname: Wolf
authors.forename: M
authors.initials: M
authors.lastname: Kron
authors.forename: A
authors.initials: A
authors.lastname: Lazar
authors.forename: A M
authors.initials: AM
authors.lastname: Robinson
authors.forename: M
authors.initials: M
authors.lastname: Yang
authors.forename: J D
authors.initials: JD
authors.lastname: Chao
authors.forename: R
authors.initials: R
authors.lastname: Thakkar
mesh_terms: D000068879:Adalimumab; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012074:Remission Induction; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors* / Q000627:therapeutic use
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab