Phase III SELECT-CHOICE trial of Rinvoq meets primary endpoint in rheumatoid arthritis.- AbbVie

AbbVie announced new Phase III data from the SELECT-CHOICE clinical trial in adult patients with moderate to severe active rheumatoid arthritis and prior inadequate response or intolerance to biologic disease-modifying anti-rheumatic drugs (DMARDs), shows that Rinvoq (upadacitinib, 15 mg, once daily) met the primary endpoint of non-inferiority versus Orencia (abatacept) on change from baseline in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) at week 12. In addition, Rinvoq met the key secondary endpoints of superiority versus Orencia on change from baseline in DAS28-CRP at week 12 and proportion of patients achieving clinical remission at week 12 as measured by DAS28-CRP<2.6.

The study evaluated Rinvoq . In this study, Rinvoq met both the primary (non-inferiority) and secondary (superiority) endpoints, with a change from baseline in DAS28-CRP at week 12 of -2.52 compared to -2.00 in patients treated with Orencia. In addition, 30 percent of patients receiving Rinvoq achieved clinical remission at week 12 (DAS28-CRP<2.6) compared to 13 percent of patients receiving Orencia (p<0.001). ACR20/50/70 responses were also higher in the Rinvoq group compared to the Orencia group (76/46/22 percent versus 66/34/14 percent, respectively, nominal p<0.05) at week 12.

Improvements in disease activity and remission rates were maintained through 24 weeks. The safety profile of Rinvoq (15 mg) was consistent with that observed in previously reported studies in rheumatoid arthritis, with no new safety risks detected. Full results were presented at the 2020 Annual European E-Congress of Rheumatology (EULAR).

Comment: SELECT-CHOICE is the sixth and final Phase III study from the robust SELECT rheumatoid arthritis clinical trial program. Rinvoq, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is approved for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs.