AbbVie (NYSE:ABBV) has released positive top-line results from U-EXCEED, which showed that Rinvoq (upadacitinib) hit both primary endpoints of clinical remission and endoscopic response at week 12 of a Phase 3 induction study focused on patients with Crohn’s disease.
Upadacitinib is a selective and reversible JAK inhibitor first FDA approved in 2019 for treating adults with moderate to severe rheumatoid arthritis. It is now also marketed for ankylosing spondylitis and psoriatic arthritis.
The U-EXCEED is the first of two Phase 3 induction studies testing upadacitinib in adults with moderate to severe Crohn’s disease.
The multicenter study was randomized, double-blind and placebo-controlled.
Image courtesy of AbbVie
The patients in the U-EXCEED enrolled patients with Crohn’s disease who had a poor response or were intolerant to biologics. In the patient pool, more than 60% had failed two or more biologics.
The data “suggest upadacitinib may help address the needs of patients suffering from [Crohn’s] disease, as demonstrated in stringent endpoints such as endoscopic response,” said Dr. Michael Severino, vice chairman and president, AbbVie, in a news release.
In October, the company announced positive top-line results from a Phase 3 trial involving patients with active ankylosing spondylitis.