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

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Clinical and epidemiological research
Extended report
Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study
  1. Walter P Maksymowych1,
  2. Maxime Dougados2,
  3. Désirée van der Heijde3,
  4. Joachim Sieper4,
  5. Jürgen Braun5,
  6. Gustavo Citera6,
  7. Filip Van den Bosch7,
  8. Isabelle Logeart8,
  9. Joseph Wajdula9,
  10. Heather Jones10,
  11. Lisa Marshall10,
  12. Randi Bonin9,
  13. Ron Pedersen11,
  14. Bonnie Vlahos9,
  15. Sameer Kotak12,
  16. Jack F Bukowski9
  1. 1Department of Medicine, University of Alberta, Edmonton, Alberta, Canada
  2. 2Rheumatology Department, Paris Descartes University, Hôpital Cochin, Paris, France
  3. 3Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
  4. 4Department of Medicine, Charité—Universitätsmedizin Berlin, Berlin, Germany
  5. 5Rheumazentrum Ruhrgebiet, Herne, Germany
  6. 6Department of Rheumatology, Instituto de Rehabilitación Psicofísica de Buenos Aires, Buenos Aires, Argentina
  7. 7Department of Rheumatology, University of Ghent, Ghent, Belgium
  8. 8Medical Affairs, Pfizer International Operations, Paris, France
  9. 9Clinical Affairs, Pfizer, Collegeville, Pennsylvania, USA
  10. 10Medical Affairs, Pfizer, Collegeville, Pennsylvania, USA
  11. 11Department of Biostatistics, Pfizer, Collegeville, Pennsylvania, USA
  12. 12Global Health and Value, Pfizer, New York, New York, USA
  1. Correspondence to Dr Walter P Maksymowych, Department of Medicine, University of Alberta, 562 Heritage Medical Research Building, Edmonton, Alberta, Canada T6G 2S2; walter.maksymowych{at}ualberta.ca

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.

  • Magnetic Resonance Imaging
  • Spondyloarthritis
  • Anti-TNF

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/annrheumdis-2015-207596

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