Janssen Research & Development drug candidate Stelara (ustekinumab) demonstrated positive results in the IM-UNITI maintenance study investigating clinical remission effects in patients with moderate to severe Crohn’s disease.
The results showed that a significantly greater proportion of patients receiving Stelara subcutaneous (SC) maintenance therapy were in clinical remission after one year when compared to those on placebo.
The positive clinical data was presented at the Digestive Disease Week 2016 May 21-24 in San Diego, California.
Stelara is a monoclonal antibody antagonist of human interleukin-12 and interleukin-23, molecules that are believed to play a role in the autoimmunity that leads to disorders such as Crohn’s disease.
Janssen launched a comprehensive Phase 3 UNITI clinical program which included three studies: UNITI-1, UNITI-2 and IM-UNITI. Data from the UNITI-2 study, which evaluated Stelara for the treatment of patients who had failed conventional therapy but were mostly naive to treatment with anti-TNF-alpha, was presented at the 2015 American College of Gastroenterology Annual Meeting and United European Gastroenterology Week.
Efficacy and safety results from the UNITI-1 clinical trial were recently presented at the 11th Congress of the European Crohn’s and Colitis Organization.
The Phase 3 IM-UNITI maintenance study evaluated 388 patients who had achieved clinical response at week 8 after a single intravenous infusion of Stelara in the UNITI-1 and UNITI-2 Phase 3 induction studies. The patients were randomized to Stelara 90 mg SC every eight weeks) Stelara 90 mg SC every 12 weeks, or placebo, and were followed for a combined one year of treatment. At their entry into the IM-UNITI study, approximately 60 percent of patients were in clinical remission.
The study’s primary endpoint was clinical remission at week 44, defined by a Crohn’s Disease Activity Index (CDAI) score of less than 150 points. Secondary endpoints included clinical response, clinical remission among patients in remission after induction, corticosteroid-free remission, and clinical remission in patients refractory or intolerant to anti-TNF-alpha therapies (UNITI-1 subpopulation), all at week 44.
Key results showed that 53 percent of the patients receiving a Stelara 90 mg SC injection every eight weeks, and 49 percent receiving Stelara 90 mg SC injection every 12 weeks, achieved clinical remission, compared to the 36 percent in clinical remission after treatment with placebo.
“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 Prof. William Sandborn, M.D., in a press release.
“The results of this comprehensive Phase 3 program — which included anti-tumor necrosis factor (TNF)-alpha naïve exposed and failure patients — demonstrate the potential of Stelara to provide significant benefit for patients in need of an effective therapy.”
Serious adverse events occurred in 10 percent, 12 percent, and 15 percent of patients receiving Stelara 90 mg SC every eight weeks, Stelara 90 mg SC every 12 weeks, and placebo, respectively. Moreover, 2 percent, 5 percent, and 2 percent of patients in the respective groups reported serious infections.
Janssen has submitted applications, currently under review, with the U.S. FDA and the European Medicines Agency (EMA) seeking approval of Stelara for the treatment of moderate to severe Crohn’s disease.