Phase III data shows that Stelara (ustekinumab) offers remission benefits in moderate to severe Crohn's disease- Janssen

Janssen Research & Development has presented Phase III data showing that a significantly greater proportion of adult patients with moderate to severe Crohn's disease receiving Stelara (ustekinumab) subcutaneous (SC) maintenance therapy were in clinical remission at one year. The Phase III IM-UNITI maintenance study, which evaluated 388 patients who achieved clinical response eight weeks after a single intravenous infusion of Stelara in the UNITI-1 and UNITI-2 Phase III induction studies, showed that 53 percent of patients receiving a Stelara 90 mg SC injection every eight weeks (Q8W) and 49 percent of patients receiving a Stelara 90 mg SC injection every 12 weeks (Q12W) were in clinical remission at week 44, the study's primary endpoint, compared with 36 percent of patients receiving placebo. Clinical remission was defined by a Crohn's Disease Activity Index (CDAI) score of less than 150 points.

Through week 44 (placebo-controlled period), adverse events (AEs) were reported in similar proportions across Stelara and placebo treatment groups. Serious AEs occurred in 10 percent, 12 percent and 15 percent of patients receiving a Stelara 90 mg SC Q8W, Stelara 90 mg SC Q12W and placebo, respectively; 2 percent, 5 percent and 2 percent of patients reported serious infections in these respective groups. In the placebo controlled period, no deaths or major adverse cardiovascular events (MACE) were reported. The results were presented at Digestive Disease Week 2016.