Efficacy and safety of etanercept in patients from Latin America, Central Europe and Asia with early non‐radiographic axial spondyloarthritis

<jats:title>Abstract</jats:title><jats:sec><jats:title>Aim</jats:title><jats:p>To evaluate etanercept in patients from Latin America, Central/Eastern Europe, and Asia with non‐radiographic axial spondyloarthritis (nr‐axSpA).</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>A subset analysis was performed on nr‐axSpA patients from Argentina, Colombia, the Czech Republic, Hungary, Russia and Taiwan who were enrolled in <jats:styled-content style="fixed-case">EMBARK</jats:styled-content> (<jats:styled-content style="fixed-case">NCT</jats:styled-content>01258738). Patients received either etanercept 50 mg or placebo once weekly. The primary endpoint was proportion of patients achieving 40% improvement from baseline based on Assessment of SpondyloArthritis International Society (<jats:styled-content style="fixed-case">ASAS</jats:styled-content>) criteria. Secondary endpoints included other efficacy assessments, health‐related quality of life (<jats:styled-content style="fixed-case">HRQ</jats:styled-content>oL) and safety.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of the 117 patients in this subset, 59 were treated with etanercept and 58 received placebo. At week 12, numerically greater improvements from baseline were observed for all efficacy endpoints in etanercept‐treated patients compared with those receiving placebo. Statistically significant differences between the two treatment groups were observed for proportion of patients achieving <jats:styled-content style="fixed-case">ASAS</jats:styled-content>40 (<jats:italic>P</jats:italic> = 0.0413, at week 8), <jats:styled-content style="fixed-case">ASAS</jats:styled-content>5/6 (<jats:italic>P</jats:italic> = 0.0126), Ankylosing Spondylitis Disease Activity Score ‐ C‐reactive protein (<jats:styled-content style="fixed-case">CRP</jats:styled-content>) inactive disease (<jats:italic>P</jats:italic> = 0.0093), Spondyloarthritis Research Consortium of Canada magnetic resonance imaging of sacroiliac joint scores (<jats:italic>P</jats:italic> = 0.0014), high‐sensitivity <jats:styled-content style="fixed-case">CRP</jats:styled-content> (<jats:italic>P</jats:italic>=0.032), and erythrocyte sedimentation rate (<jats:italic>P</jats:italic> = 0.0082). Statistically significant improvements in the etanercept‐treated group compared with placebo group were observed for nocturnal back pain (<jats:italic>P</jats:italic> = 0.040), total back pain (<jats:italic>P</jats:italic> = 0.025), physician global assessment of disease (<jats:italic>P</jats:italic> = 0.023), and Work Productivity and Activity Impairment Questionnaire percent impairment while working (<jats:italic>P</jats:italic> = 0.047). Adverse events were similar between the two treatment groups.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>In this subset of patients with nr‐axSpA from Latin America, Central/Eastern Europe, and Asia, treatment with etanercept, compared with placebo, resulted in improved disease symptoms and patient <jats:styled-content style="fixed-case">HRQ</jats:styled-content>oL. Etanercept was well tolerated.</jats:p></jats:sec>