Janssen has presented new data showing that a single dose of its biologic Stelara induced clinical remission and response in patients with moderate to severe ulcerative colitis.
Eight-week induction data from the pivotal Phase III UNIFI study showed that 15.6% of patients receiving Stelara (ustekinumab) 130mg and 15.5% of those receiving the drug at a dose of 6mg/kg achieved clinical remission compared with 5.3% in the placebo arm.
Also, 51.3% and 61.8% of patients in the Stelara arms achieved clinical response versus 31.3% in the placebo group, while the figures for those experiencing endoscopic healing were 26.3%, 27% and 13.8%, respectively.
According to Janssen, both doses of Stelara resulted in statistically significant improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ), a health-related measure of quality of life, as well as markers of inflammation.
“Stelara is the first biologic approved for any indication that targets interleukin (IL)-12 and IL-23 cytokines, which are believed to play a role in immune-mediated diseases, like ulcerative colitis,” said Philippe Szapary, vice president, Clinical Development, Janssen Research & Development.
“These induction data from the Phase III UNIFI study underscore the potential for this pathway in the treatment of UC, which may lead to a new effective and safe treatment option for UC patients in the future.”
Stelara is currently approved in the US for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn’s disease.
Clearance for use to treat ulcerative colitis would significantly expand the drug’s scope, given that the condition affects nearly 907,000 people in the US alone, with around 38,000 new cases diagnosed each year.