Crohn’s Disease Patients See Promising Results in Stelara (Ustekinumab) Phase 3 Clinical Studies, Janssen Reports

Crohn’s Disease Patients See Promising Results in Stelara (Ustekinumab) Phase 3 Clinical Studies, Janssen Reports
Janssen Research & Development drug candidate Stelara (ustekinumab) demonstrated positive results in the IM-UNITI maintenance study investigating clinical remission effects in patients with moderate to severe Crohn's disease. The results showed that a significantly greater proportion of patients receiving Stelara subcutaneous (SC) maintenance therapy were in clinical remission after one year when compared to those on placebo. The positive clinical data was presented at the Digestive Disease Week 2016 May 21-24 in San Diego, California. Stelara is a monoclonal antibody antagonist of human interleukin-12 and interleukin-23, molecules that are believed to play a role in the autoimmunity that leads to disorders such as Crohn’s disease. Janssen launched a comprehensive Phase 3 UNITI clinical program which included three studies: UNITI-1, UNITI-2 and IM-UNITI. Data from the UNITI-2 study, which evaluated Stelara for the treatment of patients who had failed conventional therapy but were mostly naive to treatment with anti-TNF-alpha, was presented at the 2015 American College of Gastroenterology Annual Meeting and United European Gastroenterology Week. Efficacy and safety results from the UNITI-1 clinical trial were recently presented at the 11th Congress of the European Crohn’s and Colitis Organization. The Phase 3 IM-UNITI maintenance study evaluated 388 patients who had achieved clinical response at week 8 after a single intravenous infusion of Stelara in the UNITI-1 and UNITI-2 Phase 3 induction studies. The patients
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