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The treatment has previously been approved by the FDA for the treatment of ulcerative colitis.
In a late-breaking abstract presented at 2022 Digestive Disease Week Annual Meeting in San Diego, investigators found upadacitinib resulted in clinical remission, endoscopic response, and corticosteroid-free clinical remission during induction therapy in patients with moderate to severely active Crohn’s disease in patients who failed 1 or more biologics.
In the update to the U-EXCEED study, the investigators found the treatment was superior to placebo for all co-primary endpoints of clionical remission and endoscopic response and most of the ranked secondary endpoints
In an interview with HCPLive®, Jean-Frederic Colombel, MD, Professor of Medicine, Mount Sinai Medical Center, NY, and Director of the Susan & Leonard Feinstein IBD Clinical Center and The Leona M. & Harry B. Helmsley IBD Research Center, Icahn School of Medicine at Mount Sinai, explained how the positive results could pave the way for upadacitinib to be a top of the line option for patients with Crohn’s disease.
The treatment was also well-tolerated, with the most common adverse events being nasopharyngitis, headache, and upper respiratory tract infections in the upadacitinib group.
The treatment has gained US Food and Drug Administration (FDA) approval for ulcerative colitis and the positive data could result in an approval for patients with Crohn’s disease.