FDA Approves Upadacitinib for Ulcerative Colitis

Megan Brooks


March 17, 2022

The US Food and Drug Administration (FDA) has approved upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who do not respond adequately to or can't tolerate antitumor necrosis factor (TNF) agents.

It marks the first FDA approval for the selective Janus kinase (JAK) inhibitor in gastroenterology and is supported by efficacy and safety data from three phase 3 randomized, double-blind, placebo-controlled clinical studies.

In clinical trials, upadacitinib achieved the primary endpoints of clinical remission, per modified Mayo Score, at 8 and 52 weeks.

In addition, a greater proportion of patients who received upadacitinib achieved clinical response as early as the second week of treatment and steroid-free clinical remission at 1 year, as well as key endoscopic and histologic improvement endpoints at 8 and 52 weeks.

"Ulcerative colitis patients live with unpredictable symptoms such as increased stool frequency and bleeding, which can make daily activities difficult," Maria T. Abreu, MD, director, Crohn's and Colitis Center, University of Miami Health System, said in a news release issued by AbbVie.

Upadacitinib has been shown to "rapidly control symptoms," said Abreu, adding, "I believe these types of improvements can make a positive difference for my patients."

Upadacitinib is also approved in the United States to treat adults with moderate to severe rheumatoid arthritis, moderate to severe atopic dermatitis, and active psoriatic arthritis.

Overall, the safety profile observed in patients with UC who were treated with upadacitinib was generally similar to the safety profile in patients with rheumatoid arthritis and atopic dermatitis.

Full prescribing information and medication guide are available online.

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