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News

Adalimumab induction improves ulcerative colitis outcomes

A study published ahead of print in the Alimentary Pharmacology & Therapeutics reports on 1-year maintenance outcomes among patients with moderately-to-severely active ulcerative colitis who responded to induction therapy with adalimumab.

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

Dr Sandborn and colleagues from California, USA assessed week 52 efficacy, safety and benefit/risk balance of adalimumab treatment in patients with moderately-to-severely active ulcerative colitis failing conventional therapy who achieved clinical response at week 8 in the 52-week ULTRA 2 trial.

The team randomized patients to adalimumab in ULTRA 2 who achieved clinical response at week 8 per partial Mayo score 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 was assessed using ‘net efficacy adjusted for risk’ odds ratios.

38% were steroid-free at week 52
Alimentary Pharmacology & Therapeutics

The doctors assessed safety using adverse event rates.

Of 248 adalimumab-treated patients, 123 achieved clinical response at week 8.

Of these, 31%, 50%, and 43% achieved clinical remission, clinical response, and mucosal healing, respectively, at week 52.

Of the week 8 responders using corticosteroids at baseline, the team found that 21% achieved steroid-free remission, and 38% were steroid-free at week 52.

The research team found that 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.

The researchers identified no safety concerns.

Dr Sandborn and his team comment, "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."

Aliment Pharmacol Ther 2013: DOI: 10.1111/apt.12145
20 December 2012

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