NEW YORK (Reuters Health) - Results of the three phase-3 trials that led to recent U.S. approval of the selective Janus kinase 1 (JAK1) inhibitor upadacitinib for ulcerative colitis have now been published in The Lancet.
The two induction trials randomly assigned 660 patients with moderate-to-severely active ulcerative colitis to oral upadacitinib 45 mg daily or placebo for eight weeks.
In the maintenance trial, the 415 responders were again randomly assigned to maintenance doses of oral upadacitinib 15 mg or 30 mg daily or placebo for an additional 52 weeks.
In the two induction studies, patients taking upadacitinib were significantly more likely to achieve clinical remission (26% and 34%) compared with placebo (5% and 4%, respectively).
Similarly, during maintenance treatment, there were higher rates of clinical remission after 52 weeks with both the 15 mg and 30 mg daily dose of upadacitinib (42% and 52%, respectively) compared with placebo (12%).
"There is a great unmet need for advanced therapies that provide rapid, robust and sustained disease control for patients with ulcerative colitis," write Dr. Silvio Danese with IRCCS Ospedale San Raffaele, in Milan, Italy, and colleagues.
"In this phase 3 program in patients with moderately to severely active ulcerative colitis, upadacitinib induction and maintenance therapy met the primary endpoint of clinical remission and all secondary endpoints, including clinical, endoscopic, histological, and QOL outcomes," they report.
"Upadacitinib induction (45 mg) followed by upadacitinib maintenance (15 mg or 30 mg) was generally well tolerated, and no new important safety risks were observed compared with its known safety profile," they add.
In a linked comment, Dr. Ashwin Ananthakrishnan of Massachusetts General Hospital and Harvard Medical School says upadacitinib is "a welcome addition to our expanding treatment armamentarium for ulcerative colitis."
"Although more data are needed to accurately position drugs within treatment algorithms, the promise of expanding the arsenal means more patients will be able to achieve normalization of their bowel function and restoration of their quality of life," Dr. Ananthakrishnan adds.
SOURCE: https://bit.ly/3NgkSQc and https://bit.ly/3M9bufu The Lancet, online May 26, 2022.
Reuters Health Information © 2022