FDA Approves AbbVie’s Skyrizi for the Treatment of Adults with Moderate to Severely Active Ulcerative Colitis

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The FDA has approved AbbVie’s Skyrizi (risankizumab-rzaa) for the treatment for adults with moderately to severely active ulcerative colitis (UC). According to the company, this approval makes Skyrizi the first IL-23 specific inhibitor to be approved for both UC and Crohn disease classified as moderate-to-severe. The approval was based on results from the INSPIRE Induction study and the COMMAND Maintenance study. In addition to the approved indications for UC and Crohn disease, Skyrizi also has been approved for active psoriatic arthritis and plaque psoriasis.¹

"When treating patients with ulcerative colitis, it's important to prioritize both early and sustained clinical remission as well as endoscopic improvement," said Edward V. Loftus, Jr., MD, Maxine and Jack Zarrow Family professor of gastroenterology, division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minnesota, in a press release. "This approval for Skyrizi is an important step toward addressing these treatment goals."

INSPIRE was a multicenter, randomized, double-blind, placebo-controlled Phase III trial aimed at evaluating the efficacy and safety of Skyrizi 1200 mg administered intravenously every four weeks in patients with moderately to severely active UC. The primary endpoint of the study was clinical remission (per Adapted Mayo Score, defined as SFS ≤1 and not greater than baseline, RBS of 0 and endoscopic subscore ≤1 without friability) after 12 weeks of treatment.

The Phase III multicenter, randomized, double-blind, controlled, 52-week COMMAND maintenance trial was designed to evaluate the efficacy and safety of Skyrizi 180 mg or 360 mg in adults with moderately to severely active UC. In this study, all participants received an induction, with those who responded being randomly assigned to receive either 180 mg or 360 mg subcutaneously or withdrawal from Skyrizi treatment. The primary endpoint of this trial was clinical remission (per Adapted Mayo Score, defined as SFS ≤1 and not greater than baseline, RBS of 0 and endoscopic subscore ≤1 without evidence of friability) after 52 weeks of treatment.

As a result of both studies, the drug’s treatment regimen consists of an initial 12-week induction phase with three 1200 mg doses administered every four weeks, followed by maintenance therapy either every eight weeks at doses of 180 mg or 360 mg. Additionally, it can be self-administered at home using an on-body injector.¹

Anywhere from 600,000 to 900,000 people in the United States are currently diagnosed with UC. For the most part, the disease manifests in people between the ages of 15-30 years, but it can also occur at a younger age. UC can result in anemia, bone issues, problems with growth and development in children, and it can lead to colorectal cancer.

In other cases, UC can cause complications that could develop much quicker, with the possibility to be life-threatening. This includes fulminant UC, perforation, severe rectal bleeding, and toxic megacolon. It can also cause arthritis due to joint issues, inflammation in the eyes, skin, liver, and bile ducts, resulting in conditions such as primary sclerosing cholangitis.²

Reportedly, the United States has one of the largest populations affected by UC, with rates continuing to rise on an annual basis. It can also cause damage to the colon lining.¹

"Today's approval of Skyrizi for ulcerative colitis expands our IBD portfolio and demonstrates our commitment to helping address ongoing needs of patients," said Roopal Thakkar, MD, SVP, chief medical officer, global therapeutics, AbbVie, in the press release. "We will continue to invest in transforming the treatment landscape and the lives of people suffering from lBD."

References

1. U.S. FDA Approves SKYRIZI® (risankizumab-rzaa) for Ulcerative Colitis, Expanding AbbVie's Portfolio Across Inflammatory Bowel Disease. AbbVie. June 18, 2024. Accessed June 19, 2024. https://news.abbvie.com/2024-06-18-U-S-FDA-Approves-SKYRIZI-R-risankizumab-rzaa-for-Ulcerative-Colitis,-Expanding-AbbVies-Portfolio-Across-Inflammatory-Bowel-Disease 

2. Definition & Facts of Ulcerative Colitis. National Institute of Diabetes and Digestive and Kidney Diseases. Accessed June 19, 2024. https://www.niddk.nih.gov/health-information/digestive-diseases/ulcerative-colitis/definition-facts#:~:text=How%20common%20is%20ulcerative%20colitis,United%20States%20have%20ulcerative%20colitis.