Back to Search
Start Over
Efficacy and safety of etanercept in patients from Latin America, Central Europe and Asia with early non-radiographic axial spondyloarthritis.
- Source :
-
International journal of rheumatic diseases [Int J Rheum Dis] 2018 Jul; Vol. 21 (7), pp. 1443-1451. Date of Electronic Publication: 2016 Nov 11. - Publication Year :
- 2018
-
Abstract
- Aim: To evaluate etanercept in patients from Latin America, Central/Eastern Europe, and Asia with non-radiographic axial spondyloarthritis (nr-axSpA).<br />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.<br />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.<br />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.<br /> (© 2016 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.)
- Subjects :
- Adult
Antirheumatic Agents adverse effects
Argentina
Colombia
Double-Blind Method
Etanercept adverse effects
Europe
Female
Health Status
Humans
Male
Quality of Life
Remission Induction
Severity of Illness Index
Spondylarthritis diagnosis
Spondylarthritis physiopathology
Spondylarthritis psychology
Taiwan
Time Factors
Treatment Outcome
Antirheumatic Agents therapeutic use
Etanercept therapeutic use
Spondylarthritis drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1756-185X
- Volume :
- 21
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- International journal of rheumatic diseases
- Publication Type :
- Academic Journal
- Accession number :
- 27863065
- Full Text :
- https://doi.org/10.1111/1756-185X.12973