medwireNews: Findings from the SELECT-AXIS 2 trial, presented at the EULAR 2022 Congress in Copenhagen, Denmark, provide further support for the benefits of upadacitinib across the spectrum of axial spondyloarthritis (axSpA).
The phase 3 trial was separated into two studies according to whether patients had ankylosing spondylitis (AS) with an inadequate response to biologic DMARDs or nonradiographic axSpA with objective signs of inflammation. Participants in both studies were randomly assigned to receive oral upadacitinib 15 mg/day or placebo.
Reporting the results of the AS study in a poster presentation, Désirée van der Heijde (Leiden University Medical Center, the Netherlands) said that SELECT-AXIS 2 “is the first dedicated clinical trial to assess the efficacy and safety of a JAK [Janus kinase] inhibitor in an active AS population with an inadequate response to [biologic] DMARDs.”
She noted that upadacitinib was previously shown to have a favorable efficacy and safety profile in the SELECT-AXIS 1 trial, which evaluated the JAK inhibitor in biologic-naïve patients with active AS. SELECT-AXIS 2 included participants with prior exposure to tumor necrosis factor inhibitors or interleukin-17 inhibitors.
In SELECT-AXIS 2, the primary endpoint of ASAS40 response rate at week 14 was significantly higher among AS patients given upadacitinib (n=211) than those given placebo (n=209), at 45% versus 18%. Analysis of secondary endpoints also favored the JAK inhibitor, with upadacitinib-treated patients having significantly better outcomes based on measures such as ASDAS, BASFI, and sacroiliac joint inflammation on magnetic resonance imaging.
van der Heijde said that rates of treatment-emergent adverse events from baseline to week 14 were similar in the upadacitinib and placebo arms groups (41 vs 37%), and “no new safety risks were identified compared to the known safety profile of upadacitinib.”
She concluded that the SELECT-AXIS 2 findings in the biologic-refractory AS patient population “are consistent with and complementary to those of SELECT-AXIS 1.”
The nonradiographic axSpA part of the SELECT-AXIS 2 trial was presented by Filip van den Bosch (Ghent University, Belgium) and included 313 participants, approximately a third of whom had previously received a biologic DMARD.
In accordance with the findings from the AS study, van den Bosch said that people with active nonradiographic axSpA given upadacitinib (n=156) were significantly more likely to achieve an ASAS40 response at week 14 than those given placebo (n=157), at rates of 45% and 23%, respectively.
Moreover, the proportion of patients who met the criteria for an ASAS20 response, ASAS partial remission, or at least a 50% improvement in BASDAI score, as well as various measures of response according to ASDAS, was significantly higher in the upadacitinib than the placebo group.
Adverse events were reported in 48% and 46% of participants in the upadacitinib and placebo arms, respectively. van den Bosch noted that there were no deaths or major adverse cardiovascular events during 14 weeks of treatment with the JAK inhibitor.
“This is the first study […] showing that the JAK inhibitor upadacitinib might be a therapeutic option in patients with active nonradiographic spondyloarthritis,” he concluded.
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