Janssen has announced interim data from its Phase IIIb STARDUST study, demonstrating that at week 16, 79% of patients with moderately to severely active Crohn’s disease (CD) achieved clinical response and 67% were in clinical remission.
Study participants received one ~6 mg/kg intravenous (IV) dose of Stelara (ustekinumab), followed by one 90 mg subcutaneous (SC) dose, and Janssen says that responses were assessed and were detected as early as week four.
Also, of the 220 patients randomised in the treat-to-target arm, 37% achieved endoscopic response at week 16.
Janssen, a Johnson & Johnson company, reminds that the ultimate primary endpoint of the 48-week STARDUST study is comparative endoscopic response among adult patients with CD receiving maintenance therapy.
“STARDUST represents a significant milestone in our commitment to helping Crohn’s disease patients and the physicians who treat them,” said Jan Wehkamp, vice president, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. “The data from this study may provide us with key clinical insights which may inform future treatment strategies.”
Last month the National Institute for Health and Care Excellence (NICE) released a draft guidance not recommending the drug for moderately to severely active ulcerative colitis in adults.
Despite there being an unmet need for new, non-surgical treatment options because many people have an inadequate response to current therapies or they stop working, the organisation said there is considerable uncertainty about the cost-effectiveness estimates for the drug.
If recommended by NICE, Stelara would be available for routine use within its marketing authorisation when conventional therapy or a biological agent cannot be tolerated or the disease has responded inadequately or lost response to treatment.
The annual treatment costs are £14,482 in the induction year, and £9,304 per year for maintenance treatment, but the company has agreed a confidential pricing arrangement for the drug with the Commercial Medicines Unit.
However, NICE already recommends several treatment options for when conventional therapy or a biological agent cannot be tolerated, or the disease has responded inadequately or lost response to treatment.