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


BACKGROUND
NCT01258738.
Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Walter P
WP
Maksymowych
Rheumatology Department, Paris Descartes University, Hôpital Cochin, Paris, France.
Maxime
M
Dougados
Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Désirée
http://orcid.org/0000-0002-5781-158X
D
van der Heijde
Department of Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Joachim
J
Sieper
Rheumazentrum Ruhrgebiet, Herne, Germany.
Jürgen
J
Braun
Department of Rheumatology, Instituto de Rehabilitación Psicofísica de Buenos Aires, Buenos Aires, Argentina.
Gustavo
G
Citera
Department of Rheumatology, University of Ghent, Ghent, Belgium.
Filip
F
Van den Bosch
Medical Affairs, Pfizer International Operations, Paris, France.
Isabelle
I
Logeart
Clinical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Joseph
J
Wajdula
Medical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Heather
H
Jones
Medical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Lisa
L
Marshall
Clinical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Randi
R
Bonin
Department of Biostatistics, Pfizer, Collegeville, Pennsylvania, USA.
Ron
R
Pedersen
Clinical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Bonnie
B
Vlahos
Global Health and Value, Pfizer, New York, New York, USA.
Sameer
S
Kotak
Clinical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Jack F
JF
Bukowski
D000328:Adult; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001368:Axis, Cervical Vertebra / Q000000981:diagnostic imaging / Q000473:pathology; D004311:Double-Blind Method; D000068800:Etanercept / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D012446:Sacroiliac Joint / Q000000981:diagnostic imaging / Q000473:pathology; D012720:Severity of Illness Index; D025241:Spondylarthritis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D013997:Time Factors; D016896:Treatment Outcome
D018501:Antirheumatic Agents; D000068800:Etanercept
Anti-TNF; Magnetic Resonance Imaging; Spondyloarthritis