Efficacy and safety of etanercept in patients from Latin America, Central Europe and Asia with early non-radiographic axial spondyloarthritis
| Autor: | Wen-Chan Tsai, James Cheng-Chung Wei, Sameer Kotak, Gustavo Citera, Lyndon John Q Llamado |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Adult
Male Subset Analysis medicine.medical_specialty Time Factors Health Status Argentina Taiwan Colombia Placebo Severity of Illness Index Etanercept 03 medical and health sciences 0302 clinical medicine Double-Blind Method Rheumatology Quality of life Internal medicine Spondylarthritis medicine Clinical endpoint Back pain Humans 030212 general & internal medicine 030203 arthritis & rheumatology Ankylosing spondylitis medicine.diagnostic_test business.industry Remission Induction medicine.disease Europe Treatment Outcome Antirheumatic Agents Erythrocyte sedimentation rate Quality of Life Physical therapy Female medicine.symptom business medicine.drug |
| Zdroj: | International Journal of Rheumatic Diseases. 21:1443-1451 |
| ISSN: | 1756-1841 |
| Popis: | 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 (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. |
| Databáze: | OpenAIRE |
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