(ABBV) – AbbVie’s Upadacitinib Shows Clinical Benefit In Second Late-Stage Ulcerative Colitis Study

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  • AbbVie Inc (NYSE: ABBV) announces data from the second Phase 3 study, U-ACCOMPLISH, evaluating upadacitinib in patients with moderate to severe ulcerative colitis. The study met the primary and secondary endpoints.
  • 33% of patients receiving upadacitinib achieved clinical remission at week eight compared to 4% of patients receiving placebo.
  • 74% of upadacitinib-treated patients achieved clinical response at week eight versus 25% of patients receiving placebo on secondary endpoints. At week 2, 63% of patients in the upadacitinib arm achieved clinical response versus 26% in placebo.
  • At week 8, 44% of patients treated with upadacitinib achieved endoscopic improvement versus 8% of patients receiving placebo.
  • 37% of upadacitinib-treated patients achieved histologic-endoscopic mucosal improvement at week eight compared to 6% patients receiving placebo.
  • On the safety front, upadacitinib was safe, with no new safety risks observed.
  • AbbVie will present full results from the U-ACCOMPLISH study at a future medical meeting and submitted for publication in a peer-reviewed journal.
  • In December last year, the first Phase 3 induction study (U-ACHIEVE) in ulcerative colitis also met its primary endpoint of clinical remission as well as secondary endpoints.
  • Last month, RINVOQ (upadacitinib) received the European Commission’s approval to treat psoriatic arthritis and ankylosing spondylitis.
  • Price Action: ABBV is up 1.81% at $106.91 in market trading hours on the last check Monday.