Stelara (ustekinumab), a drug produced by Janssen, is an approved treatment for a type of inflammatory bowel disease (IBD) called Crohn’s disease (CD) when the patient has failed or was intolerant to treatment by immunomodulators, corticosteroids and TNF blockers. Stelara is administered as an injection.
Crohn’s disease is an autoimmune condition where the body’s immune system overreacts to small or non-existent threats in the digestive system. This results in persistent inflammation (swelling) of the gastrointestinal tract.
How Stelara works
Stelara works by reducing the level of inflammation in the digestive tract, leading to the remission of CD.
It is a monoclonal antibody — a protein designed to target and block specific proteins. It inhibits the action of two proteins, human interleukin (IL)-12 and IL-23, which are inflammatory cytokines (a type of protein that is involved in the inflammation response as part of our immune system).
Levels of both IL-12 and IL-23 are increased in Crohn’s, and both proteins have been associated with Crohn’s disease. It is believed that by blocking these proteins, Stelara pushes CD into remission.
History of Stelara approval
Janssen has extensively studied the safety and effectiveness of Stelara on Crohn’s patients through a series of Phase 3 clinical trials: UNITI-1 (NCT01369329), UNITI-2 (NCT01369342), and IM-UNITI (NCT01369355). The results from these three studies have been published in The New England Journal of Medicine.
UNITI 1 and 2 have both been completed. Patients were given a single injection at the start of the trial, and the response, measured by the Crohn’s Disease Activity Index, CDAI, was recorded after three, six, and eight weeks. In both trials, a significant response was observed as early as the third week.
In the UNITI-1 trial, 38 percent of patients had a clinical response by week 8, compared with 20 percent taking the placebo. In addition, a significantly higher number of Crohn’s patients treated with Stelara went into remission compared to placebo (21 percent vs. 7 percent).
The UNITI-2 trial also saw positive results, with 40 percent of patients achieving clinical remission of the disease, compared to 20 percent in the placebo group, within eight weeks after the injection.
The IM-UNITI trial is currently ongoing, and is assessing the long-term response of patients who showed a clinical response in the UNITI-1 and UNITI-2 trials over two years. In this trial, patients were randomized to receive either Stelara or placebo every eight or 12 weeks. By week 44, the rate of remission continued to be significantly high in both Stelara-treated groups compared to placebo. The rates were at 53 percent in the eight-week Stelara-treatment group and 49 percent in the 12-week group, compared to 36 percent in the placebo group.
In September 2016, Stelara received final approval from the U.S. Food and Drug Administration (FDA) as a treatment for Crohn’s disease. This was closely followed by European Commission (EC) marketing approval in November 2016 for Stelara in the European Union.
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