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Second Phase 3 Induction Study Confirms Upadacitinib (RINVOQ®) Improved Clinical and Endoscopic Outcomes in Patients with Crohn's Disease

Published: 2022-02-24 13:00:00 ET
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- In U-EXCEL, the second of two Phase 3 induction studies, a significantly higher proportion of patients with moderate to severe Crohn's disease treated with upadacitinib (45 mg once daily for induction) achieved both primary endpoints of clinical remission[a,b] and endoscopic response[c], compared to placebo at week 12[1]

- In this study, upadacitinib also met most key secondary endpoints, consistent with findings from the first Phase 3 induction study, U-EXCEED[1]

- The study showed that a significantly higher proportion of upadacitinib-treated patients achieved steroid-free clinical remission[d] at week 12 compared to placebo[1]

- Safety results were consistent with the known profile of upadacitinib, with no new safety risks observed[1-6]

- Upadacitinib, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is being studied as an oral therapy for moderate to severe Crohn's disease and several other immune-mediated inflammatory diseases[1],[6-14]

NORTH CHICAGO, Ill., Feb. 24, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive top-line results from U-EXCEL, a Phase 3 induction study, showing upadacitinib (45 mg once daily) achieved both primary endpoints of clinical remissiona,b and endoscopic responsec at week 12.1 U-EXCEL is the second of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe Crohn's disease who had an inadequate response or were intolerant to conventional or biologic therapy.1

"The results from this study reaffirm the data from U-EXCEED and demonstrate the potential impact that upadacitinib could have on clinical and endoscopic outcomes in patients with moderate to severe Crohn's disease," said Michael Severino, M.D., vice chairman and president, AbbVie. "Our decades of collaboration with the gastroenterology community demonstrates AbbVie's commitment to the discovery and development of multiple treatment options for patients with inflammatory bowel diseases."

U-EXCEL included the same primary and key secondary endpoints as U-EXCEED, with clinical remission measured by the Crohn's Disease Activity Index (CDAI) and by the patient-reported symptoms of stool frequency/abdominal pain (SF/AP).1 A significantly greater proportion of patients treated with a 12-week induction regimen of upadacitinib 45 mg daily achieved clinical remission per CDAI at week 12 compared to placebo (49 percent versus 29 percent; p