Interim results from the Phase IIIb STARDUST clinical trial have revealed that Janssen Pharmaceutical’s Stelara (ustekinumab) led to clinical remission in moderately to severely active Crohn’s disease (CD) patients.
Stelara is a human IL-12 and IL-23 antagonist. In the US, the drug has approvals to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease or ulcerative colitis in certain patients.
The randomised, international, multi-centre, interventional Phase IIIb trial assessed a 6mg/kg intravenous dose of Stelara, followed by a 90mg subcutaneous injection at week eight in a total of 500 patients.
At week 16, patients with a Crohn’s Disease Activity Index score (CDAI) decrease of ≥70 points (CDAI70) were randomly assigned to treat-to-target or standard of care treatment groups.
The primary objective of the study is to measure patients’ endoscopic response, determined as a ≥50% decrease in simple endoscopic score for Crohn’s disease (SES-CD) from baseline to week 48.
Results showed that 79% of participants experienced clinical response and 67% were in clinical remission at week 16.
Of the 220 CDAI70 responders assigned to the treat-to-target arm at week 16, 37% achieved an endoscopic response.
During the study, intestinal ultrasound (IUS) responses were measured and detected at week four. STARDUST is said to be the first trial to use IUS for assessing CD patients in an interventional setting.
Additional studies are required to validate if early IUS response at week four indicates longer-term clinical and endoscopic outcomes in this patient population.
Janssen Research & Development vice-president Jan Wehkamp said: “STARDUST represents a significant milestone in our commitment to helping Crohn’s disease patients and the physicians who treat them. The data from this study may provide us with key clinical insights, which may inform future treatment strategies.”
In March last year, the company reported positive data from the Phase III UNIFI trial of Stelara as maintenance therapy in adults with moderate to severe ulcerative colitis.