Johnson & Johnson reports positive results for Stelara using "treat-to-target" approach in Phase III Crohn's disease trial

Johnson & Johnson announced interim data Friday from a Phase IIIb trial of Stelara (ustekinumab), the first that it says explored a so-called "treat-to-target" (T2T) strategy in Crohn's disease that uses endoscopy to guide dose adjustment. According to the company, findings from the STARDUST study demonstrated that two-thirds of patients achieved clinical remission after two doses of the IL-12 and -23 antagonist.

Jan Wehkamp, gastroenterology disease area leader at the company's Janssen R&D unit, said "the data from this study may provide us with key clinical insights which may inform future treatment strategies." The findings were presented at the European Crohn's and Colitis Organisation (ECCO) annual meeting.

The trial includes 500 adults with moderately-to-severely active Crohn's disease who all received an intravenous induction dose of Stelara, followed by a subcutaneous injection of the drug at week eight. At the 16-week mark, those who achieved a decrease of 70 points or more on the Crohn's Disease Activity Index (CDAI70) were randomised into the T2T or routine care arms, and will be followed through to the end of the study.

In the T2T arm, Stelara maintenance treatment is based on centrally-read colonoscopy, with outcomes such as endoscopic response, biomarkers and clinical symptoms guiding use of the medication. For the routine care arm, assessment visits are scheduled according to the timing of maintenance treatment injections up to week 48, with EU guidelines recommending dosing every 12 weeks. The primary outcome measure is endoscopic response, defined as at least a 50% reduction from baseline in simple endoscopic score for Crohn's disease (SES-CD) at week 48, among patients receiving Stelara maintenance therapy.

Johnson & Johnson said the interim analysis showed that at week 16, 79% of patients achieved clinical response and 67% were in clinical remission after receiving the intravenous dose followed by the subcutaneous dose of Stelara. In addition, intestinal ultrasound (IUS) responses were assessed and detected as early as week four. The company noted that STARDUST is the first study to use IUS for monitoring Crohn's disease patients in an interventional setting, but more testing is required to see whether "early IUS response…is predictive of longer-term clinical and endoscopic outcomes."

"Crohn's disease patients may respond to treatment while continuing to experience internal inflammation that can cause irreversible damage," commented principal investigator Silvio Danesei, adding "these patients may benefit from a more proactive, robust treatment approach [such as T2T] and less invasive monitoring methods…[like IUS] in helping guide treatment."

Stelara was approved in the US and Europe in 2016 for the treatment of moderately-to-severely active Crohn's disease in adults. Sales of the drug in the fourth quarter came of 2019 in at $1.7 billion, shy of analyst estimates of $1.8 billion, driven by strong uptake in Crohn's disease.

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