Stelara ustekinumab: Phase III data

The double-blind, international Phase III UNITI-2 trial in 628 patients with moderate to severe CD who had previously failed conventional therapy showed that a single infusion of 6 mg/kg and 130 mg IV Stelara each met the primary endpoint of improving clinical response rate, defined as a >=100-point reduction in CDAI score, at week 6, vs. placebo (56% and 52%, respectively, vs. 29%, p<0.001 for both). Low- and high-dose Stelara also met the secondary endpoints of improving clinical response rate at week 8 (58% and 47%, respectively, vs. 32%, p<0.001 for both) and clinical remission rate, defined as a CDAI score of <150 points, at week 8 (40% and 31%, respectively, vs. 20%, p<0.001 and p=0.009) vs. placebo. Stelara also significantly improved the Inflammatory Bowel Disease Questionnaire (IBDQ) scores vs. placebo. Data were presented at the American College of Gastroenterology meeting in Honolulu. ...