AbbVie said that RINVOQ (upadacitinib, 15 mg, once daily) has met the primary endpoint and key secondary endpoints in the SELECT-CHOICE phase 3 trial in a certain population of rheumatoid arthritis patients.
RINVOQ met the primary endpoint of non-inferiority compared to Bristol Myers Squibb’s ORENCIA (abatacept) on change from baseline in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) at week 12. Additionally, RINVOQ met the key secondary endpoints of superiority compared to ORENCIA on change from baseline in DAS28-CRP at week 12 and proportion of the participants reaching clinical remission at week 12 as measured by DAS28-CRP<2.6.
The SELECT-CHOICE clinical trial assessed RINVOQ in adults having moderate to severe active rheumatoid arthritis and prior inadequate response or intolerance to biologic disease-modifying anti-rheumatic drugs (DMARDs). It is the sixth and final phase 3 study from the SELECT rheumatoid arthritis clinical trial program.
RINVOQ, which is a selective and reversible JAK inhibitor, was discovered and developed by AbbVie. It has approvals in both the US and the European Union for the treatment of moderate to severe active rheumatoid arthritis in adults who have responded inadequately to, or who are intolerant to one or more DMARDs.
Michael Severino – vice chairman and president of AbbVie said: “Despite tremendous progress in the treatment of rheumatoid arthritis, about 70 percent of patients are still not achieving clinical remission with established therapies.
“We are pleased with the results as they add to our growing body of evidence that RINVOQ may offer more adult patients with rheumatoid arthritis a better chance at achieving clinical remission, including those who have already failed a prior biologic.”