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Efficacy and safety of etanercept in patients from Latin America, Central Europe and Asia with early non‐radiographic axial spondyloarthritis
Author(s) -
Wei James ChengChung,
Tsai WenChan,
Citera Gustavo,
Kotak Sameer,
Llamado Lyndon
Publication year - 2018
Publication title -
international journal of rheumatic diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.795
H-Index - 41
eISSN - 1756-185X
pISSN - 1756-1841
DOI - 10.1111/1756-185x.12973
Subject(s) - medicine , etanercept , placebo , ankylosing spondylitis , clinical endpoint , erythrocyte sedimentation rate , adverse effect , quality of life (healthcare) , physical therapy , basdai , randomized controlled trial , arthritis , pathology , tumor necrosis factor alpha , psoriatic arthritis , nursing , alternative medicine
Aim 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 ( NCT 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 ( ASAS ) criteria. Secondary endpoints included other efficacy assessments, health‐related quality of life ( HRQ oL) 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 ASAS 40 ( P = 0.0413, at week 8), ASAS 5/6 ( 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 HRQ oL. Etanercept was well tolerated.