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Rinvoq meets primary and important secondary endpoints in Phase 3 Crohn’s disease study

By Brian Buntz | December 8, 2021

AbbVieAbbVie (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.

Rinvoq

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.


Filed Under: clinical trials, Drug Discovery, Gastroenterology
Tagged With: AbbVie, Crohn's disease, Rinvoq, U-EXCEED
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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