Janssen publishes positive Crohn’s disease data for Stelara

Janssen has announced the publication of clinical trial data that demonstrates the benefits that Stelara can offer in the treatment of Crohn's disease.

Results from three pivotal phase III studies have been published in the New England Journal of Medicine, showing how treatment with Stelara was able to induce and maintain clinical responses and remission in a greater proportion of adult patients with moderately to severely active Crohn's disease compared to placebo.

The UNITI phase III development programme consisted of two eight-week induction studies, with the UNITI-1 trial enrolling patients who had previously failed or were intolerant to treatment with anti-TNF therapies, while the UNITI-2 study targeted patients who had previously failed conventional therapy.

Patients then continued into a 44-week maintenance study  called IM-UNITI, with all three of these trials demonstrating a consistent safety and efficacy performance.

Results from these studies were recently used to support the regulatory approval of Stelara for the treatment of Crohn's disease in the US and Europe.

Dr Newman Yeilding, head of immunology development for Janssen Research and Development, said: "Inflammatory bowel disease, which includes Crohn's disease and ulcerative colitis, is a disease area where we are committed to bringing forward novel therapeutic approaches to benefit patients and support healthcare professionals."

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