Janssen’s biologic therapy Stelara (ustekinumab) has shown new efficacy in the treatment of moderate to severe ulcerative colitis in two dosage groups, with both reporting “statistically significant improvements” as measured on the Inflammatory Bowel Disease Questionnaire (IBDQ).
The drug has already secured approval in the US for a range of conditions including active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderate to severe plaque psoriasis.
In eight-week induction data derived at Phase 2, 15.6% and 15.5% of patients taking 130mg doses or 6mg/kg doses respectively achieved clinical remission, as opposed to just 5.3% of those taking placebo.
Clinical response stood at 51.3% and 61.8% for the same dosage groups, compared to 31.3% for placebo, while 26.3% and 27% experienced endoscopic healing, versus 13.8% for placebo.
“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 at Janssen Research & Development. “These induction data from the Phase 3 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.”
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