AbbVie recently announced that the U.S. FDA has approved the expanded indication of Skyrizi (risankizumab) for the treatment of adult patients with moderately to severely active ulcerative colitis. The press release stated that this approval makes it the first IL-23 specific inhibitor approved for the treatment of moderate to severe ulcerative colitis and moderate to severe Crohn’s disease . Skyrizi is currently approved for the treatment of four immune-mediated inflammatory diseases.
Ulcerative colitis is a type of inflammatory bowel disease (IBD) that causes inflammation of the digestive tract and can damage the colon lining. Patients typically experience a range of unpredictable symptoms that impact their daily lives, such as abdominal pain, bloody stools, and an urgent need to have a bowel movement. The course of ulcerative colitis varies from patient to patient and in some cases may lead to surgery or complications, including cancer or death. With more than 1 million people living with ulcerative colitis, the United States has one of the highest numbers of people affected by the disease, and that number continues to rise.
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Risankizumab is a humanized, IgG1 subtype monoclonal antibody that selectively antagonizes IL-23 by binding to the p19 subunit of IL-23. IL-23 is an inflammation-related cytokine that is thought to be involved in many chronic immune diseases. Previously, Skyrizi has been approved by the FDA for three indications, including Crohn’s disease, moderate to severe plaque psoriasis, and active psoriatic arthritis in adults.
The results of the Phase 3 clinical trial previously released showed that a significantly higher proportion of patients treated with 180 mg and 360 mg of risankizumab achieved clinical remission at 52 weeks: 40% and 38%, respectively, compared with 25% in the control group (p<0.01). Among patients treated with 180 mg and 360 mg of risankizumab, 51% and 48% achieved endoscopic improvement, respectively, while only 32% of patients in the control group achieved improvement (p<0.001). In addition, 43% and 42% of patients treated with risankizumab 180 mg and 360 mg, respectively, achieved histological endoscopic mucosal improvement, which was significantly higher than that of patients in the control group (23%, p<0.001). In addition, a significantly higher proportion of patients treated with risankizumab 180 mg and 360 mg achieved corticosteroid-free clinical remission at week 52 (p<0.01).
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