NORTH CHICAGO, Ill., May 18, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Rinvoq® (upadacitinib) for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers. This is the seventh FDA approval for Rinvoq across rheumatology, dermatology, and gastroenterology, where it is now indicated in both ulcerative colitis and Crohn's disease.
AbbVie Official Commentary on the Approval
"AbbVie recognizes the need for more treatment options for Crohn's disease that can help address both rapid relief of symptoms along with the visible reduction of intestinal lining damage," said Thomas Hudson, M.D., senior vice president of research and development, chief scientific officer, AbbVie. "We're pleased that Rinvoq may provide this relief and is now available to treat Crohn's disease."
Clinical Trial Support for Approval
The approval is supported by data from two induction studies, U-EXCEED and U-EXCEL, and the U-ENDURE maintenance study. Statistical significance was achieved for the co-primary endpoints and key secondary endpoints with Rinvoq 45 mg in the induction studies and Rinvoq 15 mg and 30 mg in the maintenance study compared to placebo.
Endoscopic Response and Clinical Remission Data
Endoscopic Response
In the two induction studies, 34% and 46% of patients treated with Rinvoq 45 mg achieved endoscopic response (defined as a decrease of greater than 50% from the baseline Simplified Endoscopic Score for CD [SES-CD] or for patients with isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline) at week 12, respectively, compared to 3% and 13% of patients receiving placebo. In the maintenance study, 28% and 41% of patients treated with Rinvoq 15 mg and 30 mg achieved endoscopic response at week 52, respectively, compared to 7% of patients receiving placebo.
Clinical Remission
In the two induction studies, 36% and 46% of patients treated with Rinvoq 45 mg achieved clinical remission (defined as a Crohn's Disease Activity Index [CDAI] of less than 150) at 12 weeks, respectively, compared to 18% and 23% of patients receiving placebo. Additionally, in the maintenance trial, 42% and 55% of patients treated with Rinvoq 15 mg and 30 mg achieved clinical remission at 52 weeks, respectively, compared to 14% of patients receiving placebo.
Expert Commentary on Rinvoq's Efficacy
"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., M.D., professor of medicine in the division of gastroenterology and hepatology at Mayo Clinic in Rochester, Minnesota and U-EXCEL study investigator. "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."
Patient Experience with Rinvoq
"I started feeling better within a couple weeks. My symptoms lessened – less cramping, firmer stools, and the bleeding stopped. When I stopped bleeding, I had more energy," said Danielle, who is living with Crohn's disease and received Rinvoq in an open-label treatment arm in one of the clinical trials.
