Encouraging late-stage results for Stelara in Crohn’s disease
pharmafile | October 21, 2015 | News story | Research and Development, Sales and Marketing | Crohn’s disease, Janssen, Stelera, crohn's disease, ustekinumab
Janssen is planning new regulatory submissions for Stelera after Phase III data found it improved responses and remission rates in patients with moderate to severe Crohn’s disease.
The study found Stelara (ustekinumab) achieved its primary endpoint, demonstrating significantly higher rates of clinical response at week six when compared with the placebo group.
The study looked at people who had previously failed conventional therapy, the majority of whom were naïve to treatment with anti-tumour necrosis factor (TNF)-alpha therapy.
The major secondary endpoints of clinical response and clinical remission at week eight were also significantly higher among patients receiving Stelara – a monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines- compared to the placebo group.
Patients participating in the Phase III UNITI-2 study received a single intravenous infusion of placebo, high- or low-dose Stelara. At week six, 52% of patients receiving high-dose Stelara and 56% of patients receiving low-dose Stelara achieved clinical response, as defined by a reduction from baseline in the Crohn’s Disease Activity Index (CDAI) score of at least 100 points. This compared with 29% of patients receiving placebo.
CDAI is a symptom-based disease assessment tool commonly used in clinical trials to quantify Crohn’s disease activity.
At week eight, 47% and 58% of patients receiving high- and low-dose Stelara, respectively, achieved clinical response, compared with 32% of patients receiving placebo.
In addition, 31% of patients receiving high-dose Stelara 130 mg and 40% of patients receiving low-dose Stelara achieved clinical remission at week eight, as defined by a CDAI score of less than 150 points, compared with 20% of patients receiving placebo.
Commenting on the results, Professor Brian Feagan, senior medical director at Robarts Research Institute at the University of Western Ontario, and study investigator, says: “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 inhibitors.
“Findings from this Phase III 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.”
In addition to significant improvements in signs and symptoms as measured by CDAI, Janssen said both doses of Stelara resulted in statistically-significant improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ), a health-related quality of life measure for patients with IBD.
“The Stelara Phase III 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,” says Newman Yeilding, head of immunology development at Janssen. “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.”
More than five million people worldwide are living with Crohn’s disease and ulcerative colitis—collectively known as inflammatory bowel disease (IBD). The cause of the condition is unknown, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition or diet and other environmental factors.
Stelara is already widely used as a treatment for psoriatic arthritis. UK regulator NICE, having initially rejected J&J’s Stelara submission in March 2014 for this indication, claimed it ‘appeared less effective’ than TNF alpha inhibitors and was not a cost-effective option for the NHS. The watchdog, made a U-turn in December 2014, approving the drug after agreeing a patient access scheme with the Department of Health.
The latest trial results will give J&J hope of an additional approval, opening the drug up to a large new customer base.
Joel Levy
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