Janssen announced interim data from the phase 3b STARDUST study of ustekinumab for the treatment of moderately to severely active Crohn disease.
STARDUST is a randomized, multicenter, interventional study that evaluated the efficacy of ustekinumab using either a treat to target or standard of care approach to achieve endoscopic response, defined as a ≥50% reduction from baseline in simple endoscopic score for Crohn disease. Patients (N=500) with moderately to severely active Crohn disease received an intravenous (IV) induction dose of ustekinumab 6mg/kg, followed by ustekinumab 90mg subcutaneous (SC) injection at week 8.
At week 16, patients with a Crohn Disease Activity Index reduction of ≥70 points (CDAI70 responders) were randomized 1:1 to a treat to a target maintenance treatment strategy (treatment guided by endoscopic response) or a standard of care arm. Endoscopic response at week 48 was designated as the primary end point of the study.
At week 16, results showed that 79% of patients achieved clinical response and 67% were in clinical remission after the initial 2 doses of ustekinumab. Responses were also assessed using intestinal ultrasound (IUS), a complimentary method of assessing Crohn disease activity; IUS responses were detected as early as week 4. Additionally, of the 220 CDAI70 responders randomized to the treat to target arm, 37% achieved endoscopic response at week 16. The safety profile for ustekinumab was consistent with that seen in previous clinical trials.
Week 16 data and IUS response data from STARDUST will be presented at the 15th Congress of the European Crohn’s & Colitis Organization (ECCO).
“Crohn disease patients may respond to treatment while continuing to experience internal inflammation that can cause irreversible damage. These patients may benefit from a more proactive, robust treatment approach and less invasive monitoring methods,” said Professor Silvio Danesei, Head of the Inflammatory Bowel Diseases Centre at Humanitas Research Hospital, Milan, Italy and principal investigator. “I am encouraged by these data, that demonstrate the potential clinical utility of the noninvasive IUS method in helping guide treatment of Crohn disease and look forward to forthcoming data that may help us better understand the possible benefits of a treat-to-target strategy.”
Ustekinumab is marketed under the trade name Stelara and is currently indicated for the treatment of moderately to severely active Crohn disease or ulcerative colitis; active psoriatic arthritis in adults, alone or in combination with methotrexate; and moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy.
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