AbbVie's Upadacitinib Shows Clinical Benefit In Second Late-Stage Ulcerative Colitis Study

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.