Positive results from phase III SELECT-AXIS 2 trials of Rinvoq in patients with axial spondyloarthritis presented at EULAR 2022.- AbbVie
AbbVie announced the presentation of full results from two studies from the Phase III SELECT-AXIS 2 program evaluating upadacitinib (Rinvoq) , an oral therapy, in adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) and patients with treatment-refractory active ankylosing spondylitis (AS) with an inadequate response (IR) to biologic disease-modifying antirheumatic drugs (bDMARDs).
Both studies met the primary endpoint of Assessment of SpondyloArthritis international Society 40 percent response criteria (ASAS40) at week 14 versus placebo.
In the SELECT-AXIS 2 nr-axSpA study , significantly more nr-axSpA patients achieved the primary endpoint of ASAS40 at week 14 with upadacitinib versus placebo (45 percent versus 23 percent; p<0.0001). statistical significance was also achieved in the first 12 of 14 multiplicity-controlled secondary endpoints compared to placebo at week 14 including change from baseline in patient's assessment of total back pain, bath ankylosing spondylitis functional index (basfi), ankylosing spondylitis disease activity score (asdas) low disease activity, ankylosing spondylitis quality of life (asqol), and mri spondyloarthritis research consortium of canada (sparcc) score for si joints.></0.0001).>
These findings, for which AbbVie disclosed topline results in 2021, were submitted as part of the regulatory applications to the FDA and the European Medicines Agency (EMA) to treat adults with active nr-axSpA with objective signs of inflammation who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
"Non-radiographic axial spondyloarthritis is a progressive and disabling inflammatory disease, with limited treatment options. It often affects young adults, causing spinal inflammation that leads to back pain and stiffness and can significantly decrease quality of life," said Filip Van den Bosch, M.D., SELECT-AXIS 2 investigator and professor in the Department of Rheumatology at the University Hospital of Ghent University. "These data suggest the potential of upadacitinib to help counter inflammation, relieve pain and improve function, helping patients living with nr-axSpA take control of their disease."
In the SELECT-AXIS 2 AS bDMARD-IR study , significantly more patients achieved the primary endpoint of ASAS40 at week 14 with upadacitinib versus placebo (45 percent versus 18 percent; p<0.0001). statistical significance was also achieved in all multiplicity-controlled secondary endpoints compared to placebo at week 14, including change from baseline in patient's assessment of total back pain, basfi, asdas low disease activity, asqol, and mri sparcc score for spine.no new safety risks were identified with upadacitinib when compared with its known safety profile.>
Through week 14 in the nr-axSpA study, the proportion of patients who experienced an adverse event (AE) was similar between both treatment groups (upadacitinib at 48 percent and placebo at 46 percent). Serious AEs were reported in four patients on upadacitinib and in two patients on placebo. Through week 14 in the AS bDMARD-IR study, the proportion of patients who experienced an adverse event was also similar (upadacitinib at 41 percent and placebo at 37 percent). In both the nr-axSpA study and the AS bDMARD-IR study, there were no reports of malignancy, major adverse cardiovascular events, venous thromboembolic events or death in patients receiving upadacitinib.
The full results for both studies will be presented at the EULAR 2022 Congress. The SELECT-AXIS 2 nr-axSpA study results was presented in an oral presentation on 1 June, 4:35 – 4:45pm (CEST) (OP0016) and the SELECT-AXIS 2 AS bDMARD-IR study results will be presented in a poster tour on 4 June, 11:37 – 11:45am (CEST) (POS0306).Use of upadacitinib in nr-axSpA is not approved in the U.S. or EU, and its efficacy and safety are currently under review by the respective regulatory authorities.
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