Janssen’s Stelara shows improvement in Crohn’s symptoms within one week, new findings reveal

pharmafile | October 30, 2017 | News story | Manufacturing and Production, Research and Development Crohn’s disease, Janssen, Stelara, crohn's disease, pharma 

Janssen has unveiled new data on Stelara (ustekinumab) in the treatment of patients with moderately to severely active Crohn’s disease at the 25th United European Gastroenterology Week. The findings showed a patient-reported improvement in symptoms of the disease within one week of an intravenous infusion dose of Stelara, beginning as early as day one and remaining consistent until day eight and beyond when compared to placebo.

The UNITI-1 trial examined patients with moderately to severely active Crohn’s disease who were intolerant or refractory to anti-TNF treatment, with participants administered with either a 130mg or 6mg/kg IV infusion of Stelara, or given placebo. Symptom improvements were determined using patient-reported outcomes from the Crohn’s Disease Activity Index (CDAI), measuring three elements of the condition: abdominal pain (AP), daily frequency of loose stools (SF), and general wellbeing (GWB).   

It was found that 19.6% of those receiving the 6mg/kg dose and 17.6% of those receiving the 130mg dose reported symptom improvement within the first seven days following administration, as determined by at least a 50 point CDAI improvement in AP and SF scores. These figures rose to 29.3% and 31.4% respectively after 14 days.

Additionally, it was reported that while 219 patients administered with the 6mg/kg dose did not respond to treatment by the eighth week in the UNITI-1 and UNITI-2 trials, 37.6% and 60.5% respectively responded by week 16.

Commenting on the new data, the University of California, San Diego’s Professor William Sandborn remarked: “The symptoms of Crohn’s disease can cause significant distress to many patients, which is why it’s important to find a treatment that can act rapidly to reduce the impact of the disease. These new results from the UNITI-1 trial are encouraging because they demonstrate that treatment with ustekinumab may begin to reduce patient reported symptoms of Crohn’s disease within just 1-2 weeks for a number of patients.”

Matt Fellows

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