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Results from a Phase 3 clinical trial, UNIFI, on Janssen Pharmaceuticals (NYSE: JNJ) STELARA (ustekinumab) from Johnson & Johnson (NYSE: JNJ) in adult patients with moderate to severe ulcerative colitis who Had not responded correctly the treatments showed a therapeutic effect after an intravenous dose. The data is presented today at the plenary session devoted to recent abstracts at the Scientific Congress of the American College of Gastroenterology in Philadelphia.
Clinical remission was observed in 15.6% of patients receiving 130 mg of STELARA and in 15.5% of patients receiving a dose of ~ 6 mg / kg versus 5.3% for placebo (p <0.001).
The overall response rates were 51.3% and 61.8%, respectively, versus 31.3% for placebo (p <0.001).
Endoscopic healing rates were 26.3% and 27.0%, respectively, versus 13.8% for control (p <0.001).
The mucosal healing rates were respectively 20.3% and 18.4% against 8.9% for the controls (p <0.001).
STELARA is currently approved in the United States for plaque psoriasis, Crohn's disease and psoriatic arthritis.
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