Janssen's biologic Stelara has hit targets in a Phase III trial testing its ability to maintain clinical remission in patients with Crohn's disease.
A significantly greater proportion of adult patients with moderate to severe Crohn's disease receiving Stelara (ustekinumab) subcutaneous maintenance therapy were in clinical remission at one year compared to those taking a placebo.
The Phase III IM-UNITI maintenance study, which evaluated 388 patients who achieved clinical response eight weeks after a single infusion of Stelara in the prior UNITI-1 and UNITI-2 Phase III induction studies, showed that 53 percent taking a 90mg SC injection every eight weeks and 49 percent of those receiving the injection every 12 weeks were in clinical remission at week 44, compared with 36 percent in the placebo group.
"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," said study investigator William Sandborn, chief, Division of Gastroenterology, and Professor of Medicine, University of California, San Diego.
"The results of this comprehensive Phase III program - 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," he noted.
Stelara is currently being reviewed by European regulators as a treatment for moderately-to-severely active Crohn's disease. The drug, which targets interleukin (IL)-12 and IL-23 cytokines, believed to play a role in immune-mediated illnesses, is already approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.