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European Commission has approved Rinvoq for the treatment of moderately to severely active Crohn's disease


The European Commission ( EC ) has 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 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 Upadacitinib 45 mg in the induction studies and Upadacitinib 15 mg and 30 mg in the maintenance study compared to placebo.

Co-primary endpoint results from the phase 3 program has included:

Endoscopic response: In U-EXCEED and U-EXCEL, 35% and 46% of patients treated with Upadacitinib 45 mg have 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 Upadacitinib 15 mg and 30 mg have 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 Upadacitinib 45 mg have achieved clinical remission at 12 weeks, respectively, compared to 14% and 22% of patients receiving placebo. In U-ENDURE, 36% and 46% patients treated with Upadacitinib 15 mg and 30 mg have achieved clinical remission at 52 weeks, respectively, compared to 14% of patients receiving placebo.

Key secondary and additional endpoints have included:

Corticosteroid-free clinical remission: In U-EXCEED and U-EXCEL, 37% and 44% of patients treated with Upadacitinib 45 mg have 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 Upadacitinib 15 mg and 30 mg have achieved steroid-free remission at week 52, respectively, compared to 14% of patients receiving placebo.

Mucosal healing: in U-EXCEED and U-EXCEL, 17% and 25% of patients treated with Upadacitinib 45mg have 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 Upadacitinib 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 less than 0.001 ).

The safety profile of Upadacitinib in Crohn's disease was generally consistent with the known safety profile of Upadacitinib.
Similar rates of serious adverse events including serious infections, were observed between patients receiving Upadacitinib and placebo.
The most common adverse events included nasopharyngitis, acne and COVID-19 in the Upadacitinib treatment group.
Reports of malignancy, major cardiovascular events, venous thromboembolic events and gastrointestinal perforation were infrequently observed ( less than 1.0 Events / 100 Patient-Years ).

Upadacitinib is a selective and reversible JAK inhibitor. In human cellular assays, Upadacitinib preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.

Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain. It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients or may develop complications that require urgent medical care, including surgery.
Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease, not only physically, but also emotionally and economically. ( Xagena )

Source: Abbvie, 2023

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