by Elana Gotkine

Upadacitinib superior to placebo in moderate-to-severe crohn disease

For patients with moderate-to-severe Crohn disease, upadacitinib induction and maintenance treatment are superior to placebo, according to a study published in the May 25 issue of the New England Journal of Medicine.

Edward V. Loftus Jr., M.D., from the Mayo Clinic College of Medicine and Science in Rochester, Minnesota, and colleagues examined upadacitinib in three trials involving patients with moderate-to-severe Crohn disease. In U-EXCEL and U-EXCEED, patients were randomly assigned to 45 mg upadacitinib or placebo once daily for 12 weeks.

Those with a clinical response to upadacitinib induction therapy were randomly assigned to 15 mg or 30 mg upadacitinib or placebo for 52 weeks in the U-ENDURE maintenance trial. The primary end points for induction and maintenance were clinical remission and endoscopic response at 12 and 52 weeks. Data were included for 526 patients in U-EXCEL, 495 in U-EXCEED, and 502 in U-ENDURE.

The researchers found that clinical remission occurred in a significantly higher percentage of patients receiving 45 mg upadacitinib compared with those receiving placebo (U-EXCEL: 49.5 versus 29.1 percent; U-EXCEED: 38.9 versus 21.1 percent), and more patients receiving upadacitinib had an endoscopic response (U-EXCEL: 45.5 versus 13.1 percent; U-EXCEED: 34.6 versus 3.5 percent). In U-ENDURE, a higher percentage of patients had clinical remission with 15 mg and 30 mg upadacitinib than placebo (37.3 and 47.6 percent, respectively, versus 15.1 percent), with similar findings seen for endoscopic response (27.6 and 40.1 percent, respectively, versus 7.3 percent) at 52 weeks.

"Upadacitinib was effective in achieving and maintaining clinical remission and endoscopic response in patients with moderate-to-severe Crohn's disease, regardless of previous failure of biologic therapy," the authors write.

Several authors disclosed ties to industry.

More information: Edward V. Loftus et al, Upadacitinib Induction and Maintenance Therapy for Crohn's Disease, New England Journal of Medicine (2023). DOI: 10.1056/NEJMoa2212728

Journal information: New England Journal of Medicine 

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