Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved upadacitinib (RINVOQ) for the treatment of adult patients with moderately to severely active Crohn’s disease who had an inadequate response or intolerance to 1 or more anti-TNF medications.¹

The approval is based on a pair of induction studies called the U-EXCEED and U-EXCEL studies, as well as the U-Endure maintenance study.

The results show upadacitinib 45 mg resulted in a 34% and 46% endoscopic response rate at week 12 in the 2 induction studies, compared to 3% and 15% of patients in the placebo group.

The maintenance study results patients treated with upadacitinib 15 mg and 30 mg had a 28% and 41% endoscopic response rate at week 52, compared to 7% of the placebo group.

In the clinical remission analysis, the study drug resulted in 36% and 46% of patients achieving clinical remission at week 12, compared to 18% and 23% of patients in the placebo group.

For the maintenance trial, 42% and 55% of patients treated with upadacitinib 15 mg and 30 mg achieved clinical remission at week 52, compared to 14% of the placebo group.

The onset of clinical response was identified as early as week 2 in the induction studies.

“Symptoms of moderately to severely active Crohn’s disease can be disruptive and uncomfortable for patients, so relief as early as possible is key. Given the progressive nature of the disease, endoscopic response is just as important,” said Edward V. Loftus, Jr., MD, professor of medicine in the division of gastroenterology and hepatology at Mayo Clinic in Rochester, Minnesota and U-EXCEL study investigator, in a statement. “Based on the clinical trial results, treatment with RINVOQ shows both early and long-term symptom relief along with evidence of a visible reduction of damage to the intestinal lining caused by excess inflammation.”

Upadacitinib is also approved for ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ankylosing spondylitis, and non-radiographic axial spondylarthritis.

References:

1. MultiVu. (n.d.). U.S. FDA approves RINVOQ® (upadacitinib) as a once-daily pill for moderately to severely active crohn’s disease in adults. MultiVu. https://www.multivu.com/players/English/9145751-abbvie-fda-crohns-disease/