Results on a pivotal Janssen Research & Development, LLC-commissioned Phase III clinical trial, called UNITI-2, on STELARA® (ustekinumab) for moderate to severe Crohn’s disease were recently reported and provided the first evidence of the drug’s ability to induce clinical response and remission in patients who were unresponsive to traditional treatments.
STELARA, a monoclonal antibody formulated to target interleukin (IL)-12 and IL-23 cytokines that is known to play major roles in autoimmune diseases, is more popularly prescribed for moderate to severe plaque psoriasis and active psoriatic arthritis.
The UNITI-2 trial was able to achieve its primary endpoint as demonstrated by the notably higher rates of patients’ clinical response after six weeks of treatment with STELARA, compared to those receiving a placebo. The study’s secondary endpoint was also achieved as patients with moderate to severe Crohn’s disease exhibited an improved clinical response and disease remission at week eight of treatment.
“The UNITI-2 study results show STELARA® induced clinical response and remission in patients with moderate to severe Crohn’s disease who had failed steroids and/or immunosuppressive therapy, but had not failed TNF [tumor necrosis factor] inhibitors,” Brian Feagan, MD, professor of Medicine, Chief Executive Officer and Senior Medical Director, Robarts Research Institute, University of Western Ontario, and study investigator, said in a press release. “Findings from this Phase 3 program provide an important first look into the efficacy and safety of STELARA® induction therapy in the treatment of inflammatory bowel disease — a disease where new therapeutic options are needed as the incidence continues to rise globally.”
Improvements in patient outcomes were measured using the Crohn’s Disease Activity Index (CDAI), Inflammatory Bowel Disease Questionnaire (IBDQ), and biomarkers of inflammation, including C-reactive protein (CRP), fecal lactoferrin, and calprotectin.
“The STELARA® Phase 3 UNITI-2 induction results are important findings, as induction of clinical response and clinical remission are important goals in the management of Crohn’s disease,” concluded Newman Yeilding, MD, Head of Immunology Development, Janssen Research & Development, LLC. “We look forward to filing applications this year seeking approval of STELARA® for the treatment of moderate to severe Crohn’s disease and remain committed to the continued development of this innovative medicine for the treatment of immune-mediated diseases.”