Results from the phase 3 SELECT-CHOICE study comparing treatment with upadacitinib (Rinvoq™; AbbVie), a Janus kinase inhibitor, to abatacept (Orencia™; Bristol Myers Squibb), a selective T cell costimulation modulator, in adults with moderate to severe active rheumatoid arthritis (RA) were recently presented at the 2020 Annual European E-Congress of Rheumatology (EULAR).
The multicenter, randomized, double-blind, active-controlled trial compared the efficacy and safety of upadacitinib to abatacept in combination with a stable dose of conventional synthetic DMARDs (csDMARDs) in adult patients with moderate to severe active RA who had an inadequate response to or intolerance to biologic DMARDs. Patients were randomized to receive either upadacitinib 15mg orally once daily (n=303) or abatacept intravenously (n=309) on day 1, then weeks 2, 4, 8, 12, 16 and 20.
The primary end point was noninferiority based on change from baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at week 12. Ranked secondary end points of superiority included the change from baseline in DAS28-CRP at week 12 and the proportion of patients achieving clinical remission, as defined by DAS28-CRP<2.6 at week 12.
Results showed that the change from baseline in DAS28-CRP at week 12 was -2.52 (95% CI, -2.66, -2.37) for upadacitinib vs -2.00 (95% CI, -2.14, -1.85) for abatacept (P <.001). At week 12, clinical remission was observed in a significantly greater proportion of patients treated with upadacitinib compared with those who received abatacept (30% vs 13%; P <.001). Moreover, patients treated with upadacitinib had higher American College of Rheumatology (ACR) 20/50/70 responses at week 12 compared with abatacept (76%/46%/22% vs 66%/34%/14%, respectively; nominal P <.05). Improvements in disease activity and clinical remission were maintained through week 24.
With regard to safety, upadacitinib demonstrated a profile consistent with that seen in previous studies for RA. The upadacitinib treatment arm reported 1 major adverse cardiovascular event (MACE) and 2 adjudicated cases of venous thromboembolic events (VTE) in patients with at least 1 risk factor for VTE, compared with no MACE and VTE events in the abatacept arm.
“These data show that upadacitinib was superior to abatacept with regard to the proportion of patients achieving remission,” said Professor Andrea Rubbert-Roth, MD, deputy director, Division of Rheumatology, Cantonal Hospital St. Gallen, Switzerland. “SELECT-CHOICE represents the first head-to-head study in rheumatoid arthritis patients who have failed biologic DMARDs and compares upadacitinib to a different biologic DMARD.”
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