The FDA has approved the first biologic therapy for patients with moderate to severe Crohn’s disease who have failed, or were intolerant to, one or more treatments containing immunomodulators, corticosteroids or tumor necrosis factor (TNF) blockers. 

Ustekinumab (Stelara, Janssen Biotech) is the only treatment for Crohn’s disease that consists of a one-time intravenous induction injection (250, 390 or 520 mg) that helps reduce symptoms, and a dosage of 90 mg every eight weeks to help keep symptoms under control, according to 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,” William Sandborn, MD, lead study investigator and chief of the Division of Gastroenterology at the University of California, San Diego, said in a press release. 

Three pivotal Phase III studies included 1,300 patients who were new to, experienced with or failed biologic TNF therapy, and tested whether their symptoms would decrease over time. The studies found that between 34% and 56% of the patients experienced relief from their Crohn’s disease symptoms just six weeks after receiving the first injection. Patients who responded well to the first dose of ustekinumab and continued their injections every eight weeks experienced remission of their symptoms by the end of 44 weeks. 

Janssen Biotech Inc. is working to make ustekinumab easily accessible and affordable for patients. The company offers a copay card for patients with commercial insurance that would reduce their out-of-pocket cost to about $5 per dose, according to a press release.

“We are confident STELARA® will improve the lives of many people living with Crohn’s disease and are committed to ensuring that it is accessible to patients who qualify for this new therapeutic option,” Andrew Greenspan, MD, vice president of medical affairs at Janssen Biotech, said in a press release. 

—GEN Staff