Rinvoq met primary and all ranked secondary endpoints in SELECT-AXIS 2 a phase III study in ankylosing spondylitis.
In this study, Rinvoq met its primary endpoint of Assessment in SpondyloAthritis International Society (ASAS) 40 response and all ranked secondary endpoints at week 14. Significantly more Rinvoq-treated patients achieved ASAS40 response at week 14 compared to placebo (45 percent versus 18 percent; p<0.0001).></0.0001).>
The results of SELECT-AXIS 1, a Phase II/III study in adult patients with ankylosing spondylitis who were naïve to bDMARDs and had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs), were used to support the European Commission approval of Rinvoq for the treatment of active ankylosing spondylitis in January 2021. AbbVie will also announce the positive results of the second study of SELECT-AXIS 2 in adults with non-radiographic axial spondyloarthritis (nr-axSpA).
Treatment with Rinvoq resulted in statistically significant reductions in signs and symptoms of AS, including back pain and inflammation, as well as improvements in physical function and disease activity at week 14. Significantly more patients treated with Rinvoq achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Low Disease Activity compared to those treated with placebo (44 percent versus 10 percent). A statistically significantly greater improvement in Magnetic Resonance Imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) Score (Spine) as measured by mean change from baseline was reported in the Rinvoq group versus the placebo group (-3.95 versus -0.04). Patients on Rinvoq experienced a significantly greater mean decrease from baseline in Patient's Assessment of Total Back Pain at week 14 than those on placebo (-3.00 versus -1.47). Additionally, patients treated with Rinvoq experienced significantly greater improvement in physical function as assessed by mean change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) compared to patients on placebo (-2.26 versus -1.09). All ranked secondary endpoints achieved p-values of <0.0001 versus placebo.></0.0001>
Safety data were consistent with SELECT-AXIS 1, previous Phase III studies in other indications, and the known safety profile of Rinvoq, with no new risks identified. Through week 14, the most common adverse events ( greater than 3 percent of patients) for Rinvoq were COVID-19 and headache. The proportion of patients with adverse events leading to discontinuation, serious adverse events and serious infections were 0 percent/2.8 percent/2.4 percent for Rinvoq and 1.4 percent/0.5 percent/0 percent for placebo, respectively. Serious infections included four events of COVID-19 and one of uveitis with Rinvoq; two patients on Rinvoq developed non-serious, mild or moderate herpes zoster limited to one dermatome. One patient treated with placebo developed a malignancy (tonsil cancer). No adjudicated major adverse cardiovascular events, venous thromboembolic events or deaths were reported in either group through week 14.
Full results from the SELECT-AXIS-2 trial will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal.
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