FDA Expanded Approval of Skyrizi for Treatment of Crohn’s Disease

The FDA recently approved Skyrizi as a treatment for moderate to severely active Crohn’s disease. Crohn’s disease is an inflammatory bowel disease (IBD) with many painful symptoms that can impact patients’ quality of life. Abbvie stated in the press release that Skyrizi is the only new therapy for Crohn’s disease in the past 6 years.  

According to the CDC, in 2015, 3.1 billion adults in the United States suffered from IBD. That number is nearly double that of 1999.  

Symptoms of Crohn’s disease and their severity vary from person to person but can include diarrhea, fever, abdominal pain, fistulas, and kidney stones. The Mayo Clinic summarizes how complications of Crohn’s disease can be fatal. Having Crohn’s disease may be associated with a higher risk of colon cancer. 

While there is no known cause of Crohn’s disease, researchers have identified multiple risk factors for its development, such as age, familial history, smoker status, and ethnicity.  

Skyrizi — generically known as risankizumab — has already been approved to treat plaque psoriasis and psoriatic arthritis. This new FDA approval marks just one of the drug’s multiple uses.  

Skyrizi is an injectable selective p19 anti-interleukin (IL)-23 inhibitor.  

Three different trials were conducted on Skyrizi for use in Crohn’s disease. First, two 12 week induction studies were done. Endoscopic response and clinical remission were used to measure efficacy at these stages. 

A successful endoscopic response was classified by a minimum 50% reduction in the Simple Endoscopic Score in CD (SES-CD). Meanwhile, clinical remission was considered a Crohn's Disease Activity Index (CDAI) lower than 150. 

The induction phases of Skyrizi found that patients taking the drug were more likely to have an improved endoscopic response and be in clinical remission. Changes in clinical response began for Skyrizi patients as early as 4 weeks into the study.  

The final year-long maintenance trial for Skyrizi saw a similar trend in results.  

The intended treatment schedule for Skyrizi is 3 doses given via infusion at weeks 0, 4, and 8. After week 8, patients use an on-body injector to administer doses at week 12 and every 8 weeks from that point.  

Currently, the approved dosing consists of the 3 initial doses at 600 mg and the self-administered doses at 360 mg. However, the Abbvie press release states that a lower self-administered dose is under review.  

Skyrizi must be prescribed by a licensed physician because, despite its clinical success, there are chances of adverse side effects. Nevertheless, the additional approval of this treatment option has provided some hope for Crohn’s providers and patients.  

"This approval provides healthcare professionals with a greatly needed additional option for treating the disruptive symptoms of Crohn's disease,” said Marla Dubinsky, MD, chief of the division of pediatric gastroenterology for the Mount Sinai Health System, co-director of the Susan and Leonard Feinstein IBD Center at Mount Sinai in the Abbvie statement.