Stelara Leads to High Clinical Response, Remission in Severely Active Crohn’s, Phase 3 Study Shows

Stelara Leads to High Clinical Response, Remission in Severely Active Crohn’s, Phase 3 Study Shows
Almost 80% of patients with severely active Crohn's disease (CD) responded to treatment with Stelara (ustekinumab) and two-thirds achieved clinical remission, according to 16-week results from a Phase 3 clinical trial. The results were presented at the 15th Congress of the European Crohn's & Colitis Organization (ECCO) in an he abstract titled, "Intestinal ultrasound response and transmural healing after ustekinumab induction in Crohn’s disease: Week 16 interim analysis of the STARDUST trial substudy." Stelera, developed by Janssen Pharmaceuticals, part of Johnson & Johnson, is approved in the U.S. for the treatment of adults patients with moderately to severely active CD and moderately to severely active ulcerative colitis, the main types of inflammatory bowel disease (IBD), as well as other inflammatory diseases. The biologic agent works by inhibiting two pro-inflammatory proteins, interleukin (IL)-12 and IL-23, both of which are highly expressed in IBD. The Phase 3b STARDUST (NCT03107793) study is a randomized, international, clinical trial designed to evaluate the effectiveness of two treatment strategies: treat-to-target (T2T) maintenance treatment strategy and standard of care. T2T is a proactive treatment strategy in which frequently monitored outcomes — such as endoscopic response, biomarkers and clinical symptoms — help guide use of the medication. The primary endpoint was the proportion of patients that had an endoscopic response — defined as a greater than or equal to 50% reduction in simple endoscopic score for Crohn's disease (SES-CD) — after 48 weeks. The clinical trial was conducted with 500 participants, each of whom received one intravenous (IV) dose of 6 mg/kg of Stelara, followed by a 90 mg Stelara injection
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