Janssen says its Stelara maintained clinical remission in Crohn’s disease in Phase III trials
pharmafile | May 26, 2016 | News story | Research and Development, Sales and Marketing | Crohn’s disease, Janssen, Stelara, crohn's disease, drug trial
Janssen said its maintenance therapy for Crohn’s disease showed remission for patients in late-stage trials.
The company said a significant number of patients with Crohn’s disease receiving its Stelara (ustekinumab) were in clinical remission at one year in Phase III trials.
Study investigator, William Sandborn, said: “The totality of the induction and maintenance data over the course of one year show the potential of this biologic therapy in inducing and maintaining a clinically relevant therapeutic effect in patients with moderate to severe Crohn’s disease. The results of this comprehensive Phase III programme—which included anti-tumor necrosis factor (TNF)-alpha naïve, exposed and failure patients—demonstrate the potential of ustekinumab to provide significant benefit for patients in need of an effective therapy.”
Applications seeking approval of Stelara to treat Crohn’s disease are currently under review in the US and Europe. Stelara, approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in many countries, is a novel biologic therapy 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 said: “These maintenance data complement the induction data previously presented and provide important insights into the efficacy and safety profile of ustekinumab for the treatment of moderately to severely active Crohn’s disease.”
Crohn’s disease is a long-term condition that causes inflammation of the lining of the digestive system. Inflammation can affect any part of the digestive system, from the mouth to the back passage, but most commonly occurs in the last section of the small intestine (ileum) or the large intestine (colon).
Anjali Shukla
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