title: Efficacy and safety of etanercept in patients from Latin America, Central Europe and Asia with early non-radiographic axial spondyloarthritis.
abstract: OBJECTIVE
  To evaluate etanercept in patients from Latin America, Central/Eastern Europe, and Asia with non-radiographic axial spondyloarthritis (nr-axSpA).
  
  
  METHODS
  A subset analysis was performed on nr-axSpA patients from Argentina, Colombia, the Czech Republic, Hungary, Russia and Taiwan who were enrolled in EMBARK (NCT01258738). 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 (ASAS) criteria. Secondary endpoints included other efficacy assessments, health-related quality of life (HRQoL) and safety.
  
  
  RESULTS
  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 ASAS40 (P = 0.0413, at week 8), ASAS5/6 (P = 0.0126), Ankylosing Spondylitis Disease Activity Score - C-reactive protein (CRP) inactive disease (P = 0.0093), Spondyloarthritis Research Consortium of Canada magnetic resonance imaging of sacroiliac joint scores (P = 0.0014), high-sensitivity CRP (P=0.032), and erythrocyte sedimentation rate (P = 0.0082). Statistically significant improvements in the etanercept-treated group compared with placebo group were observed for nocturnal back pain (P = 0.040), total back pain (P = 0.025), physician global assessment of disease (P = 0.023), and Work Productivity and Activity Impairment Questionnaire percent impairment while working (P = 0.047). Adverse events were similar between the two treatment groups.
  
  
  CONCLUSIONS
  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 HRQoL. Etanercept was well tolerated.
authors.affiliation: Division of Allergy, Immunology and Rheumatology, Chung Shan Medical University Hospital, Taichung, Taiwan.|Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan.|Institute of Integrated Medicine, China Medical University, Taichung, Taiwan.
authors.forename: James Cheng-Chung
authors.initials: JC
authors.lastname: Wei
authors.affiliation: Division of Rheumatology, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
authors.forename: Wen-Chan
authors.initials: WC
authors.lastname: Tsai
authors.affiliation: Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina.
authors.forename: Gustavo
authors.initials: G
authors.lastname: Citera
authors.affiliation: Pfizer, New York, New York, USA.
authors.forename: Sameer
authors.initials: S
authors.lastname: Kotak
authors.affiliation: Pfizer, Makati, Philippines.
authors.forename: Lyndon
authors.initials: L
authors.lastname: Llamado
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001118:Argentina; D003105:Colombia; D004311:Double-Blind Method; D000068800:Etanercept / Q000009:adverse effects / Q000627:therapeutic use*; D005060:Europe; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D011788:Quality of Life; D012074:Remission Induction; D012720:Severity of Illness Index; D025241:Spondylarthritis / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D013624:Taiwan; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D000068800:Etanercept
keywords: ankylosing spondylitis; etanercept; spondyloarthritis; tumor necrosis factor