Stelara ustekinumab: Phase III data

The double-blind, international Phase III IM-UNITI maintenance trial in 388 patients with moderate to severe CD who achieved a clinical response to Stelara in the 8-week Phase III UNITI-1 or UNITI-2 trials showed that 90 mg subcutaneous Stelara given every 8 weeks and every 12 weeks as maintenance therapy each met the primary endpoint of improving clinical remission rate, defined as a Crohn’s Disease Activity Index (CDAI) score of <=150 points, at week 44 vs. placebo (53% and 49%, respectively, vs. 36%, p=0.005 and p=0.04). Additionally, Stelara every 8 weeks and every 12 weeks each significantly improved clinical response rate, defined as an improvement in CDAI score of >=100 points, at week 44 vs. placebo (59% and 58%, respectively, vs. 44%, p=0.018 and p=0.033). Data were presented at the Digestive Disease Week meeting in San Diego (see BioCentury, Oct. 26, 2015 & March 28, 2016). ...