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Ann Rheum Dis. 2016 Jul;75(7):1328-35. doi: 10.1136/annrheumdis-2015-207596. Epub 2015 Aug 12.

Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study.

Author information

1
Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
2
Rheumatology Department, Paris Descartes University, Hôpital Cochin, Paris, France.
3
Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
4
Department of Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.
5
Rheumazentrum Ruhrgebiet, Herne, Germany.
6
Department of Rheumatology, Instituto de Rehabilitación Psicofísica de Buenos Aires, Buenos Aires, Argentina.
7
Department of Rheumatology, University of Ghent, Ghent, Belgium.
8
Medical Affairs, Pfizer International Operations, Paris, France.
9
Clinical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
10
Medical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
11
Department of Biostatistics, Pfizer, Collegeville, Pennsylvania, USA.
12
Global Health and Value, Pfizer, New York, New York, USA.

Abstract

OBJECTIVE:

To evaluate the efficacy and safety of etanercept (ETN) after 48 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 50 mg/week or placebo (PBO) for 12 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 48 weeks.

TRIAL REGISTRATION NUMBER:

NCT01258738.

KEYWORDS:

Anti-TNF; Magnetic Resonance Imaging; Spondyloarthritis

PMID:
26269397
PMCID:
PMC4941178
DOI:
10.1136/annrheumdis-2015-207596
[Indexed for MEDLINE]
Free PMC Article

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