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Rinvoq met primary and most ranked secondary endpoints in SELECT-AXIS 2.

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Last updated:13th Oct 2021
Published:13th Oct 2021
AbbVie has announced positive top-line results from Study 2 of the Phase III SELECT-AXIS 2 clinical trial in adults with active non-radiographic axial spondyloarthritis (nr-axSpA), showing upadacitinib (Rinvoq; 15 mg, once daily) met the primary endpoint of Assessment in SpondyloArthritis International Society (ASAS) 40 response and the majority of ranked secondary endpoints at week 14.

Significantly more upadacitinib-treated patients achieved ASAS40 response at week 14 compared to placebo (45 percent versus 23 percent; p<0.0001). select-axis 2 is the first trial to evaluate the efficacy and safety of upadacitinib in adult patients with non-radiographic axial spondyloarthritis. abbvie has announced positive results from study 1 of select-axis 2 in adults with active ankylosing spondylitis (as) and inadequate response to biologic disease-modifying antirheumatic drugs (bdmards).></0.0001).>

Treatment with upadacitinib resulted in reductions in signs and symptoms of non-radiographic axial spondyloarthritis, including back pain and inflammation, as well as improvements in physical function and disease activity at week 14. Significantly more patients treated with upadacitinib achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Low Disease Activity compared to those treated with placebo (42 percent versus 18 percent; p<0.0001). a statistically significantly improvement in magnetic resonance imaging (mri) spondyloarthritis research consortium of canada (sparcc) score (si joints) as measured by mean change from baseline was reported in the upadacitinib group versus the placebo group (-2.49 versus 0.57; p><0.0001). patients on upadacitinib experienced significantly greater decrease from baseline in patient's assessment of total back pain at week 14 than those on placebo (-2.91 versus -2.00; p="0.0004)." additionally, patients treated with upadacitinib 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 (-2.61 versus -1.47; p><0.0001).></0.0001).></0.0001).></0.0001).>

Safety data were consistent with SELECT-AXIS 1, previous Phase III studies in other indications, and the known safety profile of upadacitinib, with no new risks identified. Through week 14, the most common adverse events ( greater than 3 percent of patients) with upadacitinib were headache, COVID-19, nasopharyngitis and nausea. The proportion of patients with adverse events leading to discontinuation, serious adverse events and serious infections were 2.6 percent/2.6 percent/1.3 percent for upadacitinib and 1.3 percent/1.3 percent/0.6 percent for placebo, respectively. Serious infections included COVID-19 induced pneumonia and pyelonephritis in two patients on upadacitinib and hemorrhagic fever with renal syndrome in one patient on placebo. Two patients treated with upadacitinib and one treated with placebo developed non-serious, mild or moderate herpes zoster limited to one dermatome. One patient treated with placebo developed a malignancy (basal cell carcinoma). 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. Use of upadacitinib in non-radiographic axial spondyloarthritis is not approved, and its safety and efficacy have not been evaluated by regulatory authorities.

Condition: Axial Spondyloarthritis
Type: drug

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