J&J says psoriasis drug Stelara shows positive results in trials for Crohn’s disease
pharmafile | March 18, 2016 | News story | Medical Communications, Research and Development | Crohn’s disease, J&J, JJ, Stelara, crohn's disease
Johnson & Johnson (NYSE: JNJ) on Friday said a second late-stage trial of its psoriasis drug Stelara (ustekinumab) has shown effectiveness against Crohn’s disease.
The Phase III study showed Stelara induced remissions in moderate to severe Crohn’s disease patients who had previously failed to benefit from TNF inhibitorsm, the company said in a statement.
Paul Rutgeerts, Crohn’s disease steering committee member, says: “Results from the UNITI-1 study show that ustekinumab therapy induced clinical response and remission in patients with moderate to severe Crohn’s disease who had previously failed treatment with TNF inhibitors. With two Phase III induction studies demonstrating the efficacy and safety of ustekinumab in anti-TNF-alpha naïve, exposed and failure patient populations, we look forward to the forthcoming maintenance study findings. The need to induce and maintain control of disease symptoms is paramount in the treatment of Crohn’s disease.”
The company presented the data at the 11th Congress of the European Crohn’s and Colitis Organization in Amsterdam.
Stelara is now seeking US and European regulatory approval as a treatment for the condition.
The drug is approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in many countries, is a monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, which are believed to play a role in immune-mediated diseases, including Crohn’s disease.
Newman Yeilding, head of immunology development, Janssen Research & Development, says: “We are pleased to share these important results from the Phase III UNITI-1 induction study, which complement Phase III results from the UNITI-2 study and further support regulatory applications submitted seeking approval of Stelara for the treatment of moderately to severely active Crohn’s disease. Janssen Immunology remains committed to the continued development of Stelara and the discovery of innovative medicines for the treatment of immune-mediated diseases.”
Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract that affects approximately 700,000 Americans and nearly 250,000 Europeans.
Anjali Shukla
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