medwireNews: The Janus kinase (JAK)1 selective inhibitor upadacitinib improves disease activity to a greater degree than abatacept in rheumatoid arthritis (RA) patients with previous biologic exposure, show data presented at the EULAR 2020 E-Congress.
“SELECT-CHOICE is the first study demonstrating the superiority of a selective JAK inhibitor compared to a standard of care biologic in a population of RA patients with a prior inadequate response [IR] to a biologic therapy, and adds to the understanding of the benefit:risk profile of [upadacitinib] for the treatment of RA,” said Andrea Rubbert-Roth (Cantonal Clinic St Gallen, Switzerland) and co-authors in a poster presentation.
They found that the 303 patients with prior IR or intolerance to biologic DMARDs who were randomly assigned to receive once-daily oral upadacitinib 15 mg had an average 2.52-point reduction in DAS28-CRP after 12 weeks of treatment.
By comparison, the reduction was a significantly lower 2.00 points among the 309 patients randomly assigned to receive abatacept on day 1 and weeks 2, 4, 8, 12, 16, and 20 at a dose based on their weight (<60 kg: 500 mg; 60–100 kg: 750 mg; >100 kg: 1000 mg).
The 95% confidence intervals for the between-group difference of 0.52 points met the criteria for both non-inferiority and superiority, suggesting that upadacitinib is superior to abatacept in this setting, said the investigators.
In addition, significantly more participants achieved clinical remission (DAS28-CRP <2.6 points) with upadacitinib than with abatacept at week 12 (30 vs 13%) and week 24 (46 vs 31%).
The researchers also recorded significantly greater improvements in some patient-reported outcomes in the upadacitinib versus abatacept arms. This included a higher proportion of patients achieving clinically meaningful change in HAQ-DI at week 12 and a greater improvement from baseline in the physical component summary of the SF-36 at weeks 12 and 24.
Of note, all study participants continued stable background treatment with conventional DMARDs, and from week 12 onward, those who did not achieve at least a 20% improvement from baseline in both tender and swollen joint counts at two consecutive visits had background medication adjusted or initiated.
Approximately two-thirds of patients had received one prior biologic DMARD, approximately 22% had received two, and around 10% had received three or more prior biologics.
Safety analyses did not identify any new risks associated with upadacitinib, but people receiving the JAK1 inhibitor had a higher incidence of serious treatment-emergent adverse events (AEs; 3.3 vs 1.6%), AEs leading to discontinuation (4.6 vs 2.9%), and hepatic disorders (7.6 vs 1.6%) thank those receiving abatacept.
There was one treatment-emergent death in the upadacitinib arm due to cardiac arrest after an initial hospitalization with pneumonia.
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