Patients with moderate to severe ulcerative colitis are more likely to achieve clinical remission and a range of other outcomes on ustekinumab than placebo, according to the results of a phase 3 trial.

In the pharma-company funded trial (known as UNIFI), 961 patients from 244 international sites were randomised to one of two different intravenous doses of a single, induction infusion of the drug or IV placebo.

Eight weeks later, clinical remission was achieved in 15.5% of those who had a 130mg dose of ustekinumab, in 15.6% of those administered a weight-based dose that approximated to 6mg/kg of the biologic, compared with just 5.3% of those given placebo.

More than half the patients had experienced treatment failure with a biologic before the trial, for the most part anti-TNF therapies, the authors reported in the New England Journal of Medicine.