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. 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).
|
Authors | W 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 |
Journal | Alimentary pharmacology & therapeutics
(Aliment Pharmacol Ther)
Vol. 37
Issue 2
Pg. 204-13
(Jan 2013)
ISSN: 1365-2036 [Electronic] England |
PMID | 23173821
(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)
|