Janssen Pharmaceutical said 79% of patients in a late-stage trial showed a clinical response to the medication and 67% were in clinical remission.
Treatment with Stelara is resulting in positive outcomes for patients with Crohn’s disease. Janssen Pharmaceutical said 79% of patients in a late-stage trial showed a clinical response to the medication and 67% were in clinical remission.
Janssen, a division of Johnson & Johnson, presented data from the Phase IIIb STARDUST trial at the 15th Congress of the European Crohn’s & Colitis Organization (ECCO). The company said the results were achieved following one 6 mg/kg intravenous dose followed by one 90 mg subcutaneous dose of Stelara (ustekinumab). Intestinal ultrasound (IUS) responses were assessed and were detected as early as week four, the company said.
The primary endpoint of the 48-week STARDUST study is comparative endoscopic response among adult patients with Crohn’s disease receiving Stelara as maintenance therapy. At 16 weeks, Janssen said patients who achieved a greater than 70 point decrease in Crohn’s Disease Activity Index were randomized into treat-to-target or routine standard of care treatment groups. Of the 220 CDAI70 responders randomized to the treat-to-target arm, 37% achieved an 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, Janssen said. The STARDUST trial is the first study of a treat-to-target strategy in Crohn’s disease using endoscopic response to guide treatment.
Jan Wehkamp, vice president and Gastroenterology Disease Area Leader at Janssen Research & Development, said STARDUST is a significant milestone in the company’s commitment to helping patients with Crohn’s disease.
“The data from this study may provide us with key clinical insights which may inform future treatment strategies,” Wehkamp said in a statement.
Crohn’s disease, a chronic inflammatory condition of the gastrointestinal tract, is one of the two main forms of Irritable Bowel Disorder, which affects an estimated 3 million Americans. Crohn’s is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet or other environmental factors. Symptoms of CD can vary but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss and fever. Stelara is currently approved for the treatment of adults with moderately to severely active Crohn’s disease in the U.S., Canada, the European Union and Japan.
IUS is a complementary method of assessing CD activity, based upon measuring transmural bowel features, like thickness of the bowel wall and presence of hypervascularization. STARDUST is the first study to use IUS for monitoring CD patients in an interventional setting, the company said. Future studies need to confirm whether early IUS response at week 4 is predictive of longer-term clinical and endoscopic outcomes for Crohn’s patients.
