FDA Expands Skyrizi’s Indications to Include Ulcerative Colitis

The FDA has approved Skyrizi (risankizumab-rzaa) to treat adults with moderate-to-severe active ulcerative colitis, making this the fourth indication for immune-mediated inflammatory diseases.

Ulcerative colitis is a chronic bowel disease. Between 600,000 and 900,000 people in the United States have ulcerative colitis, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Ulcerative colitis can lead to complications, including anemia, bone problems, and colorectal cancer.

Skyrizi blocks interleukin-23, a cytokine involved in inflammatory processes and is thought to be linked to a number of chronic immune-mediated diseases. It is the first IL-23 specific inhibitor approved for both moderate-to-severe ulcerative colitis and moderate-to-severe Crohn's disease.

Developed through a collaboration between Boehringer Ingelheim and AbbVie, Skyrizi is also available to treat patients with plaque psoriasis, psoriatic arthritis, and Crohn’s disease. The list price for one dose of Skyrizi is $21,017.36 as of January 2024.

Patients with commercial insurance may be eligible for a $0 copay card. The copay card assistance has a limit of $1,000, and patients whose PBM or insurance company includes an accumulator or maximizer program are not eligible for assistance. AbbVie indicates that Skyrizi is preferred on more 99% of national insurance coverage and 97% on Medicare Part D, as of January 2024.

The ulcerative colitis indication were supported by data from two phase 3 clinical trials: an induction study, INSPIRE, and a maintenance study, COMMAND. Significantly more patients treated with Skyrizi in the induction study and at week 52 in the maintenance study achieved the primary endpoint of clinical remission compared with patients receiving placebo.

Additionally, more Skyrizi-treated patients in both the induction and maintenance studies achieved the key secondary endpoints of endoscopic improvement.

In the COMMAND study, which was released in July 2023, 51% of patients treated with Skyrizi 180 mg and 48% of patients treated with Skyrizi 360 mg achieved endoscopic improvement at week 52 versus 32% of patients in the induction-only control group. Additionally, a significantly higher proportion of patients who received Skyrizi achieved steroid-free clinical remission compared with the induction-only control group at week 52.

In the INSPIRE study, which was released in March 2023, 36% of patients treated with Skyrizi achieved endoscopic improvement at week 12 compared with 12.1% in patients who received placebo. Additionally, 20.3% of patients receiving Skyrizi achieved clinical remission compared with 6.2% of patients receiving placebo.