Positive Phase III data for Janssen's Stelara in Crohn's disease

Stelara (ustekinumab) from Johnson & Johnson’s (NYSE: JNJ) Janssen unit induced clinical response and remission in the treatment of patients with moderate and severe Crohn’s disease.

Phase III data, presented at the American College of Gastroenterology (ACG) Annual Meeting in Hawaii, showed that treatment with Stelara induced clinical response and remission in patients with moderate to severe Crohn’s disease who had previously failed conventional therapy, the majority of whom were treatment-naive with anti-tumor necrosis factor(TNF)-alpha therapy.

The UNITI-2 study achieved its primary endpoint with Stelara treatment groups demonstrating significantly higher rates of clinical response at week 6 when compared with the placebo arm. At week six, 52% of patients receiving Stelara 130mg and 56% of patients receiving Stelara ~6mg/kg achieved clinical response, as defined by a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of at least 100 points, compared with 29% of patients receiving placebo. There were also good results in secondary endpoints.