The approval is the fourth indication for the anti–interleukin 23 monoclonal antibody after approval for Crohn's disease, psoriatic arthritis, and plaque psoriasis.
The safety and efficacy of Skyrizi for ulcerative colitis is supported by data from two phase 3 clinical trials: a 12-week induction study and a 52-week maintenance study .
The data showed that clinical remission, the primary endpoint in both the induction and maintenance studies, was achieved along with endoscopic improvement, which was a key secondary endpoint. "When treating patients with ulcerative colitis, it's important to prioritize both early and sustained clinical remission as well as endoscopic improvement," Edward V. Loftus, Jr., MD, gastroenterologist at Mayo Clinic in Rochester, Minnesota, said in aFor the treatment of ulcerative colitis, dosing includes a 12-week induction period with three 1200-mg doses delivered every 4 weeks followed by maintenance therapy of either 180 mg or 360 mg delivered every 8 weeks.
After the induction period, Skyrizi treatment can be maintained at home using an on-body injector ."The OBI is a hands-free device designed with patients in mind that adheres to the body and takes about 5 minutes to deliver the medication following preparation steps," according to the news release. Drugmakers to Raise Prices on at Least 350 Drugs in US in JanuaryAll material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
Ulcerative Colitis (UC) UC - Ulcerative Colitis Colitis Inflammatory Bowel Disease IBD - Inflammatory Bowel Disease IBD Psoriatic Arthritis Arthropathic Psoriasis Psoriatic Arthropathy Psa Biologic Therapy Biologics Crohn's Disease Crohn Disease Regional Enteritis Crohn Crohn’S Psoriasis Arthritis Joint Inflammation Interleukins Monoclonal Antibody Cetuximab
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