Patients with moderately‐to‐severely active ulcerative colitis (UC) are unlikely to continue anti‐TNF therapy in the absence of early therapeutic response.

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.

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.

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.

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).