FDA approves Rinvoq for moderate to severe ulcerative colitis
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Biopharmaceutical company AbbVie announced FDA approval for Rinvoq for the treatment of adults with moderately to severely active ulcerative colitis.
“This is a major development, as the degree of efficacy and the rapidity of response for [Rinvoq (upadacitinib, AbbVie)] are quite impressive,” Edward V. Loftus, Jr., MD, gastroenterologist at the Mayo Clinic in Rochester, Minnesota, and Healio Gastroenterology chief medical editor, told Healio. “It will be great to have another treatment option for our patients with ulcerative colitis.”
According to a press release, the approval was supported by efficacy and safety results from three phase 3 randomized, double-blind, placebo-controlled studies. In the U-Achieve and U-Accomplish induction trials, upadacitinib 45 mg once daily achieved the primary endpoint of clinical remission at 8 weeks (26% and 33%, respectively). During the maintenance U-Achieve trial, 42% and 52% of patients treated with upadacitinib 15 mg and 30 mg, respectively, achieved clinical remission at week 52 vs. 12% of patients who received placebo.
Further, 57% and 68% of patients receiving upadacitinib 15 mg and 30 mg, respectively, achieved corticosteroid-free remission. Endoscopic improvement and mucosal healing also were noted in all studies.
“Ulcerative colitis patients live with unpredictable symptoms such as increased stool frequency and bleeding, which can make daily activities difficult,” Maria T. Abreu, MD, professor of medicine, microbiology and immunology at the University of Miami Miller School of Medicine and director of the university’s Crohn's & Colitis Center, said in the release. “In clinical trials, Rinvoq showed its ability to rapidly control symptoms in just 8 weeks for many patients and sustained responses at one year. I believe these types of improvements can make a positive difference for my patients.”
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