The approval is based on the Phase III UNIFI study that showed that after eight weeks of taking a single intravenous dose of Stelara, patients saw “clinical remission in a significantly greater proportion of UC patients.”
The U.S. Food and Drug Administration (FDA) green-lit Janssen’s Stelara for the treatment of adult patients with moderately to severely active ulcerative colitis after clinical trials demonstrated the drug helped patients achieve “clinical remission.”
The approval is based on the Phase III UNIFI study that showed that after eight weeks of taking a single intravenous dose of Stelara (ustekinumab), patients saw “clinical remission in a significantly greater proportion of UC patients.” Not only did treatment with Stelara bring about clinical remission of ulcerative colitis, it also helped a significantly greater proportion of patients maintain that remission.
Janssen also said at the time the UNIFI data was released that at Week 8, the trial data showed Stelara hit some of its major secondary endpoints, which includes the proportion of patients in clinical response, endoscopic healing, as well as health-related quality of life scores. In addition, Janssen said that at least 50 percent of study participants were considered biologically refractory, and 17 percent had a history of inadequate response or intolerance to any anti-TNF antibody and Takeda’s Entyvio (vedolizumab).
Ulcerative colitis is a debilitating inflammatory bowel disease in adults and children, with limited therapeutic management options for many patients. It is estimated that close to 1 million patients with ulcerative colitis live in the United States. Stelara, Janssen said, is the first and only approved biologic therapy for UC that targets the interleukin (IL)-12 and IL-23 cytokines. The IL-12 and IL-23 cytokines have been shown to play an important role in inflammatory and immune responses.
The UNIFI trial includes an initial induction study and was followed by a maintenance study eight weeks later where patients received subcutaneous injections of Stelara every 8 weeks for 44 weeks. In the Induction study, 19% of patients receiving Stelara achieved clinical remission in 8 weeks. Janssen also noted that Stelara provided rapid relief of symptoms as 58 percent of patients experienced a clinical response at Week 8.
In the maintenance study, 45% of patients who received Stelara remained in remission after one year. Stelara also helped patients achieve clinical remission without the use of corticosteroids, the company noted. At the end of the first year, 43% of patients treated with Stelara were in clinical remission and not receiving steroids, Janssen said.
David Lee, therapeutic area head of immunology at Janssen Research & Development, said the division of Johnson & Johnson has a longstanding commitment to addressing unmet needs for patients with immune-mediated diseases.
“With today’s milestone, Stelara has received its fifth FDA approval since 2009, a testament to our unwavering focus on delivering treatments for patients who have limited therapeutic options,” Lee said in a statement.
In addition to the latest approval from the FDA, Stelara has been approved as a treatment for adults living with moderate to severe plaque psoriasis, adolescent patients with moderate to severe plaque psoriasis, adults with active psoriatic arthritis and adults with moderately to severely active Crohn’s disease. The drug brings in about $4 billion in annual sales.
