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Upadacitinib (RINVOQ™) Meets Primary and All Ranked Secondary Endpoints in First Phase 3 Induction Study in Ulcerative Colitis

Published: 2020-12-09 13:45:00 ET
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- Significantly more upadacitinib-treated (45 mg) patients achieved clinical remission (primary endpoint per Adapted Mayo Score) at week 8 compared to placebo in adults with moderate to severe ulcerative colitis[1]

- All ranked secondary endpoints, including clinical, endoscopic and histologic outcomes, were met[1]

- The safety results in this study were consistent with the known profile of upadacitinib, with no new safety risks observed[1-5]

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

- Ulcerative colitis is a chronic, systemic, inflammatory disease caused by inflammation of the large intestine[15-17]

NORTH CHICAGO, Ill., Dec. 9, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive results from the Phase 3 induction study, U-ACHIEVE, which showed upadacitinib (45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 8, as well as all ranked secondary endpoints, in adult patients with moderate to severe ulcerative colitis.1 In the study, 26 percent of patients receiving upadacitinib achieved clinical remission compared to 5 percent of patients receiving placebo (p