Stelara Biologic Approved for Crohn's Disease

The FDA recently approved Janssen’s ustekinumab (Stelara) for the treatment of moderate to severe active Crohn’s disease in adults who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, as well as those who failed or were intolerant to treatment with one or more TNF blockers.

Stelara is the first biologic approved for Crohn’s disease targeting interleukin (IL)-12 and IL-23 cytokines, which play a key role in inflammatory and immune responses. It is the only treatment for Crohn’s disease that starts with a weight-based, one-time intravenous (IV) infusion induction dose (260 mg [55 kg or less], 390 mg [more than 55 kg to 85 kg], or 520 mg [more than 85 kg]) to help reduce symptoms, followed by 90 mg subcutaneous maintenance injections every 8 weeks to help keep the symptoms under control.

The first dose of Stelara is an induction dose administered intravenously under the supervision of a health care professional. Subsequent maintenance doses are administered as a subcutaneous injection every 8 weeks, either by a health care professional or self-injected by the patient after proper training.

In clinical studies involving patients who were new to, experienced with, or had failed previous TNF blocker therapy, between 34% and 56% of subjects experienced relief from their Crohn’s disease symptoms within 6 weeks of receiving a one-time IV infusion of Stelara, and noticeable improvement was seen as early as 3 weeks. The majority of participants who responded to their first Stelara dose and continued treatment through subcutaneous maintenance doses every 8 weeks were in remission by the end of 44 weeks.

“Crohn’s disease is a complex condition to treat, and not all therapies work for every patient,” said William J. Sandborn, MD, chief of the Division of Gastroenterology at UC 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. Based on the results of the clinical development program, Stelara has the potential to benefit many adults living with Crohn’s disease.”