Tuesday, July 16, 2024

Ulcerative Colitis Treatment Advances with FDA Approval of AbbVie’s Skyrizi

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

Edward V. Loftus, Jr., MD, Maxine, and Jack Zarrow Family professor of gastroenterology at Mayo Clinic, emphasized the importance of achieving both early and sustained clinical remission as well as endoscopic improvement in treating patients with ulcerative colitis. He stated, “This approval for Skyrizi is an important step toward addressing these treatment goals.”

The INSPIRE study was a multicenter, randomized, double-blind, placebo-controlled Phase III trial designed to evaluate the efficacy and safety of Skyrizi 1200 mg administered intravenously every four weeks in patients with moderately to severely active ulcerative colitis. 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.

Skyrizi Shows Promising Results in Phase III Trial for Ulcerative Colitis

The COMMAND Maintenance trial was a Phase III, multicenter, randomized, double-blind, controlled, 52-week study aimed at evaluating the efficacy and safety of Skyrizi 180 mg or 360 mg in adults with moderately to severely active ulcerative colitis. Participants who responded to the induction phase were randomly assigned to receive either 180 mg or 360 mg subcutaneously or to withdraw from Skyrizi treatment. The primary endpoint 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 treatment regimen for Skyrizi consists of an initial 12-week induction phase with three 1200 mg doses administered every four weeks, followed by maintenance therapy every eight weeks at doses of either 180 mg or 360 mg. Additionally, Skyrizi can be self-administered at home using an on-body injector.

Currently, between 600,000 to 900,000 people in the United States are diagnosed with UC. The disease predominantly affects individuals between the ages of 15 and 30, but it can also occur at a younger age. UC can lead to complications such as anemia, bone issues, growth and development problems in children, and an increased risk of colorectal cancer. In severe cases, UC can cause life-threatening complications like fulminant ulcerative colitis, perforation, severe rectal bleeding, and toxic megacolon. It can also result in extra-intestinal manifestations, including arthritis, and inflammation in the eyes, skin, liver, and bile ducts, leading to conditions like primary sclerosing cholangitis.

Ulcerative Colitis

Rising Ulcerative Colitis Cases in the US Highlight Need for New Treatments Like Skyrizi

The prevalence of ulcerative colitis is high in the United States, with the number of affected individuals continuing to rise annually. UC can cause significant damage to the colon lining, impacting the quality of life for those affected. Roopal Thakkar, MD, Senior Vice President and Chief Medical Officer of Global Therapeutics at AbbVie, commented on the approval, stating, “Today’s approval of Skyrizi for ulcerative colitis expands our IBD portfolio and demonstrates our commitment to help address the ongoing needs of patients. We will continue to invest in transforming the treatment landscape and the lives of people suffering from IBD.”

This approval of Skyrizi for ulcerative colitis marks a significant advancement in the treatment options available for patients with moderately to severely active ulcerative colitis. By targeting specific IL-23 pathways, Skyrizi offers a new therapeutic approach that can provide both early and sustained clinical remission and endoscopic improvement.

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The inclusion of Skyrizi in the treatment regimen for UC and Crohn’s disease, alongside its existing approvals for psoriatic arthritis and plaque psoriasis, underscores AbbVie’s commitment to addressing the diverse needs of patients with inflammatory diseases. As the understanding of UC and its complications continues to evolve, the development and approval of targeted therapies like Skyrizi play a crucial role in improving patient outcomes and quality of life.

 

Resource: Abbvie, June 19, 2024

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