Interim data from phase IIIb STARDUST study of Stelara shows clinical response in Crohns disease.- J&J Janssen Cilag

The Janssen Pharmaceutical Companies of Johnson & Johnson announced interim data from the Phase IIIb STARDUST study of Stelara (ustekinumab) in patients with moderately to severely active Crohn's disease (CD). At week 16, 79 percent of patients achieved clinical response and 67 percent were in clinical remission after receiving one approx 6 mg/kg intravenous (IV) dose followed by one 90 mg subcutaneous (SC) dose of ustekinumab, open label. Intestinal ultrasound (IUS) responses were assessed and were detected as early as week 4. The primary endpoint of the 48-week STARDUST study is comparative endoscopic response among adult patients with CD receiving Stelara maintenance therapy. At week 16, patients who achieved a minimum 70 point decrease in Crohn's Disease Activity Index score (CDAI70 responders) were randomized into treat-to-target or routine standard of care treatment groups at a 1:1 ratio. Of the 220 CDAI70 responders randomized to the treat-to-target arm, 37 percent achieved endoscopic response at week 16. Endoscopy at week 16 was measured only in the treat-to-target group. Treat-to-target is a proactive treatment strategy where frequently monitored outcomes, like endoscopic response, biomarkers and clinical symptoms, guide use of the medication. STARDUST is the first study of a treat-to-target strategy in CD using endoscopic response to guide treatment. At week 16, the safety profile for Stelara in STARDUST was consistent with the established safety profile observed in Phase III inflammatory bowel disease (IBD) clinical trials, as well as that seen in other indications. Week 16 data (digital oral presentation, or DOP 13) and IUS response data (DOP 10) from STARDUST are being presented as digital oral presentations at the 15th Congress of the European Crohn's & Colitis Organization (ECCO).