Janssen shows off Phase 3b interim data for Stelara in Crohn’s disease
Janssen has revealed new interim Phase 3b data from a study investigating the efficacy of Stelara (ustekinumab) in the treatment of moderate to severe Crohn’s disease (CD).
Patients were given a 6mg/kg intravenous dose followed by a 90mg subcutaneous dose of Janssen’s drug. It was found that, after 16 weeks, 67% of patients achieved clinical remission, while intestinal ultrasound responses were detected as early as four weeks following initial treatment; Novartis noted that further studies will be needed to confirm the longer-term benefit in these metrics.
As part of the study, after 16 weeks of treatment, patients who scored a decrease of at least 70 points on the Crohn’s Disease Activity Index were randomised to receive either standard of care or were placed in a treat-to-target group, where frequently reported outcomes such as biomarkers and clinical symptoms were used to inform treatment.
In total, 220 participants were placed in this latter group, of whom 37% achieved comparative endoscopic response after 16 weeks of treatment, the study’s primary endpoint. The study was the first of the treat-to-target variety to utilise endoscopic response measures to determine treatment.
“Crohn’s 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,” explained Professor Silvio Danesei, principal investigator on the study and Head of the Inflammatory Bowel Diseases Centre at Humanitas Research Hospital in Italy. “I am encouraged by these data that demonstrate the potential clinical utility of the noninvasive IUS method in helping guide treatment of CD and look forward to forthcoming data that may help us better understand the possible benefits of a treat-to-target strategy.”
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