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Upadacitinib (RINVOQ®) Achieved Primary and Key Secondary Endpoints in First Phase 3 Induction Study in Patients with Crohn's Disease

Published: 2021-12-06 13:30:00 ET

- In U-EXCEED, 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]

- 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]

- The safety results in this study 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., Dec. 6, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive top-line results from U-EXCEED, 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 The U-EXCEED study enrolled patients with moderate to severe Crohn's disease who had an inadequate response or were intolerant to biologic therapy, with over 60 percent having previously failed two or more biologics.1 U-EXCEED is the first of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe Crohn's disease.1

"The data from this first Phase 3 induction study in Crohn's disease suggest upadacitinib may help address the needs of patients suffering from this disease, as demonstrated in stringent endpoints such as endoscopic response," said Michael Severino, M.D., vice chairman and president, AbbVie. "We continue to leverage our expertise in IBD by driving research and development that help shape the IBD landscape and elevate standards of care for patients."

In U-EXCEED, clinical remission was 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 (39 percent, versus 21 percent; p

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.