Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study.
Ann Rheum Dis
; 75(7): 1328-35, 2016 Jul.
Article
en En
| MEDLINE
| ID: mdl-26269397
ABSTRACT
OBJECTIVE:
To evaluate the efficacy and safety of etanercept (ETN) after 48â weeks in patients with early active non-radiographic axial spondyloarthritis (nr-axSpA).METHODS:
Patients meeting Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA, but not modified New York radiographic criteria, received double-blind ETN 50â mg/week or placebo (PBO) for 12â weeks, then open-label ETN (ETN/ETN or PBO/ETN). Clinical, health, productivity, MRI and safety outcomes were assessed and the 48-week data are presented here.RESULTS:
208/225 patients (92%) entered the open-label phase at week 12 (ETN, n=102; PBO, n=106). The percentage of patients achieving ASAS40 increased from 33% to 52% between weeks 12 and 48 for ETN/ETN and from 15% to 53% for PBO/ETN (within-group p value <0.001 for both). For ETN/ETN and PBO/ETN, the EuroQol 5 Dimensions utility score improved by 0.14 and 0.08, respectively, between baseline and week 12 and by 0.23 and 0.22 between baseline and week 48. Between weeks 12 and 48, MRI Spondyloarthritis Research Consortium of Canada sacroiliac joint (SIJ) scores decreased by -1.1 for ETN/ETN and by -3.0 for PBO/ETN, p<0.001 for both. Decreases in MRI SIJ inflammation and C-reactive protein correlated with several clinical outcomes at weeks 12 and 48.CONCLUSIONS:
Patients with early active nr-axSpA demonstrated improvement from week 12 in clinical, health, productivity and MRI outcomes that was sustained to 48â weeks. TRIAL REGISTRATION NUMBER NCT01258738.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Imagen por Resonancia Magnética
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Antirreumáticos
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Espondiloartritis
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Etanercept
Tipo de estudio:
Clinical_trials
Límite:
Adult
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Female
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Humans
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Male
Idioma:
En
Revista:
Ann Rheum Dis
Año:
2016
Tipo del documento:
Article
País de afiliación:
Canadá