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."