Ensayo Clínico de Upadacitinib o Abatacept en Artritis Reumatoide
In patients with refractory RA to bDMARDs, upadacitinib was found to be superior to abatacept in DAS28-CRP change from baseline and the achievement of remission at week 12.
612 bDMARD-IR patients were randomised 1:1 to UPA 15 mg QD or ABA, each in combination with stable synthetic DMARDs. At Week 12, patients with <20% decrease in TJC and Swollen joint count (SJC) had background medication adjusted or added. All patients completing Week 24 were eligible to remain in an open-label, long-term extension for 5 years. The primary endpoint, change from baseline in DAS28-CRP at Week 12, was assessed for noninferiority; with key secondary endpoints, superiority over abatacept in DAS28-CRP change from baseline and percentage of patients in clinical remission.
Demographics, disease characteristics and severity in the modified intention-to-treat population did not differ substantially between the two treatment groups. UPA was superior to abatacept in mean change from baseline in DAS28-CRP at Week 12. The incidence of SAEs and AEs leading to discontinuation were numerically higher with UPA than abatacept.
In conclusion, UPA achieved superiority for achievement of remission over 24 weeks. However, longer, and larger trials are required, to determine the effect and safety of UPA in patients with RA.