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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.

AbstractBACKGROUND:
Patients with moderately-to-severely active ulcerative colitis (UC) are unlikely to continue anti-TNF therapy in the absence of early therapeutic response.
AIM:
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).
AuthorsW J Sandborn, J-F Colombel, G D'Haens, G Van Assche, D Wolf, M Kron, A Lazar, A M Robinson, M Yang, J D Chao, R Thakkar
JournalAlimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 37 Issue 2 Pg. 204-13 (Jan 2013) ISSN: 1365-2036 [Electronic] England
PMID23173821 (Publication Type: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't)
Copyright© 2012 Blackwell Publishing Ltd.
Chemical References
  • Anti-Inflammatory Agents
  • Antibodies, Monoclonal, Humanized
  • Tumor Necrosis Factor-alpha
  • Adalimumab
Topics
  • Adalimumab
  • Anti-Inflammatory Agents (therapeutic use)
  • Antibodies, Monoclonal, Humanized (therapeutic use)
  • Colitis, Ulcerative (drug therapy)
  • Humans
  • Randomized Controlled Trials as Topic
  • Remission Induction
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha (antagonists & inhibitors, therapeutic use)

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