FDA Approves Stelara for Adults with Moderate-to-Severe Active Crohn’s Disease

FDA Approves Stelara for Adults with Moderate-to-Severe Active Crohn’s Disease

Janssen Biotech recently announced that the company’s Stelara (ustekinumab) for the treatment of moderate-to-severe active Crohn’s disease in adults, has been approved by the U.S. Food and Drug Administration (FDA).

Stelara is the first approved biologic treatment for Crohn’s that targets interleukin (IL)-12 and IL-23 cytokines — which are known to play a critical role in immune and inflammatory responses.

Use is restricted to patients who either failed completion or were intolerant to treatment with immunomodulators or corticosteroids – but who never failed treatment with tumor necrosis factor (TNF) blockers or, who failed completion or were intolerant to treatment with one or more TNF blockers.

The approval was based on results from a clinical trial program that included three pivotal clinical studies in 1,300 patients:

  • The UNITI-1 induction study (NCT01369329) found that Stelara was capable of inducing clinical response and remission in patients who had previously failed or were intolerant to treatment with one or more TNF blockers. Study results showed that 34% of patients reported relief from Crohn’s disease symptoms six weeks after receiving a one-time intravenous (IV) infusion of Stelara.
  • The UNITI-2 induction study (NCT01369342) showed that Stelara induced remission in patients who had previously failed or were intolerant to conventional therapy with immunomodulators or corticosteroids, the majority of whom had never received treatment with TNF blockers. Relief from Crohn’s symptoms was reported in 56 percent of patients six weeks after the IV infusion.
  • The IM-UNITI maintenance study (NCT01369355) evaluated patients who achieved clinical response eight weeks after a single IV infusion of Stelara in the two UNITI-1 and UNITI-2 Phase 3 trials. Over 50% of patients receiving Stelara by injection every eight weeks were in clinical remission after almost one year after beginning treatment.

Stelara was developed to treat Crohn’s disease starting with a weight-based, single-time IV infusion induction dose (260mg/55kg or less, 390mg/55kg to 85kg, and 520mg/85kg or more) to help reduce symptoms. The dosage was followed by 90mg maintenance injections every eight weeks. Janssen recommends that the first dose be administered by a healthcare professional but maintenance injections that follow can be self-administered.

“Crohn’s disease is a complex condition to treat, and not all therapies work for every patient,” said Dr. William J. Sandborn,  the study investigator who is chief of division of gastroenterology, and a professor of Medicine at University of California San Diego School of Medicine, in a press release. “The FDA approval of Stelara represents an important advancement in treating patients with Crohn’s disease, as this therapy offers an alternate mechanism of action to induce and maintain clinical remission over time.”

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