AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Moderately to Severely Active Crohn’s Disease
AbbVie has 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.
“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. 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.
Co-Primary Endpoint Results from the Phase 3 program include:
- 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. 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.
- 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. 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.
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.
- 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-value<0.001).
“Crohn’s disease is a burden that can present patients with daily, often uncomfortable challenges,” said Laurent Peyrin-Biroulet, M.D., Ph.D., professor of gastroenterology and head of the Inflammatory Bowel Disease group at the Gastroenterology Department, University Hospital of Nancy, France. “These studies demonstrated RINVOQ’s ability to achieve key treatment targets, including endoscopic outcomes and symptomatic relief, that are critical for patients and beneficial for long-term care.”
The safety profile of RINVOQ in Crohn’s disease was generally consistent with the known safety profile of RINVOQ. Similar rates of serious adverse events including serious infections, were observed between patients receiving RINVOQ and placebo. The most common adverse events included nasopharyngitis, acne and COVID-19 in the RINVOQ treatment group. Reports of malignancy, major cardiovascular events, venous thromboembolic events and gastrointestinal perforation were infrequently observed (<1.0 Events/100 Patient-Years).
RINVOQ is approved in the EU for the treatment of adults with radiographic axial spondyloarthritis, non-radiographic axial spondyloarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, adults and adolescents with atopic dermatitis and now Crohn’s disease.
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