–  Seventh approved indication for RINVOQ in the European Union (EU) and the first and only oral Janus Kinase (JAK) inhibitor approved to treat adult patients with moderately to severely active Crohn's disease

–  Third gastroenterology indication approved across AbbVie's Inflammatory Bowel Disease portfolio in less than a year

–  A significantly higher proportion of patients treated with RINVOQ achieved the co-primary endpoints of endoscopic response and clinical remission and the key secondary endpoint of corticosteroid-free clinical remission at weeks 12 and 52 compared to placebo1-4; safety results in Crohn's disease were generally consistent with the known safety profile of RINVOQ1,5-9

–  Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract and is progressive, potentially producing complications that require urgent medical care, including surgery10,11

NORTH CHICAGO, Ill., April 17, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the European Commission (EC) approved RINVOQ® (upadacitinib, 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) as the first oral Janus Kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.1-4

"The EC approval of RINVOQ in Crohn's disease is a significant milestone in offering patients the first and only once-daily oral treatment that can provide endoscopic improvement, and sustained symptom relief, making a difference in their daily lives," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "With existing therapies, not all patients are able to achieve adequate disease control to meet their treatment goals, which is why we continue to embrace the challenge of expanding our IBD portfolio with new treatment options."

The EC approval is supported by data from two induction studies, U-EXCEED and U-EXCEL, and the U-ENDURE maintenance study.1 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.1-4

Co-Primary Endpoint Results from the Phase 3 program include1-4:

• Endoscopic response*: In U-EXCEED and U-EXCEL, 35% and 46% of patients treated with RINVOQ 45 mg achieved endoscopic response at week 12, respectively, compared to 4% and 13% of patients receiving placebo.1 In U-ENDURE, 28% and 40% of patients treated with RINVOQ 15 mg and 30 mg achieved endoscopic response at week 52, respectively, compared to 7% of patients receiving placebo.1  
• Clinical remission†: In U-EXCEED and U-EXCEL, 40% and 51% of patients treated with RINVOQ 45 mg achieved clinical remission at 12 weeks, respectively, compared to 14% and 22% of patients receiving placebo.1 Additionally, in U-ENDURE, 36% and 46% patients treated with RINVOQ 15 mg and 30 mg achieved clinical remission at 52 weeks, respectively, compared to 14% of patients receiving placebo.1

Key Secondary and Additional Endpoints include:

• Corticosteroid-free clinical remission‡: In U-EXCEED and U-EXCEL, 37% and 44% of patients treated with RINVOQ 45 mg achieved steroid-free remission at week 12, respectively, compared to 7% and 13% of patients receiving placebo. In U-ENDURE, 35% and 45% of patients treated with RINVOQ 15 mg and 30 mg achieved steroid-free remission at week 52, respectively, compared to 14% of patients receiving placebo.1   
• Mucosal healing§: Additionally, in U-EXCEED and U-EXCEL, 17% and 25% of patients treated with RINVOQ 45mg achieved SES-CD ulcerated surface subscore of 0 at week 12, respectively, compared to 0% and 5% of patients receiving placebo. In U-ENDURE, 13% and 24% of patients treated with RINVOQ 15 mg and 30 mg achieved SES-CD ulcerated surface subscore of 0 at week 52 compared to 4% of patients receiving placebo (all with nominal p-value50% from baseline (or at least a 2-point reduction from baseline in patients with a baseline score of 4) of the induction.    † Clinical remission per SF/AP is defined as average daily very soft or liquid stool frequency ≤2.8 AND abdominal pain score ≤1.0 and neither greater than baseline.‡ Corticosteroid-free clinical remission is defined as discontinuation of corticosteroid and achievement of clinical remission among subjects on corticosteroid at baseline in the induction studies and is defined as without corticosteroid use for 90 days and achievement of clinical remission in the maintenance study.§ Mucosal healing is defined as SES-CD ulcerated surface subscore of 0 in patients with SES-CD ulcerated surface subscore ≥ 1 at baseline. Mucosal healing was a prespecified endpoint, not controlled for multiplicity.

   

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  SOURCE AbbVie