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SAT0372 Clinical and Imaging Efficacy of Etanercept in Early Non-Radiographic Axial Spondyloarthritis: 48-Week Treatment Data
  1. W.P. Maksymowych1,
  2. D. van der Heijde2,
  3. M. Dougados3,
  4. J. Sieper4,
  5. J. Braun5,
  6. G. Citera6,
  7. C. Miceli-Richard7,
  8. J. C.-C. Wei8,
  9. R. Pedersen9,
  10. R. Bonin9,
  11. I. Logeart10,
  12. J. Wajdula9,
  13. M.U. Rahman9,
  14. B. Vlahos9,
  15. J. Bukowski9
  1. 1University of Alberta, Edmonton, Canada
  2. 2Leiden University Medical Center, Leiden, Netherlands
  3. 3Paris-Descartes University, Paris, France
  4. 4Charité-Universitätsmedizin Berlin, Berlin
  5. 5Rheumazentrum Ruhrgebiet, Herne, Germany
  6. 6Consultorios Reumatolόgicos Pampa, Buenos Aires, Argentina
  7. 7Hôpital de Bicêtre, Paris-Sud University, Paris, France
  8. 8Chung Shan Medical University Hospital, Taichung, Taiwan, Province of China
  9. 9Pfizer Inc, Collegeville, PA, United States
  10. 10Pfizer France, Paris, France

Abstract

Background Our previous data show that Etanercept (ETN) has superior clinical and anti-inflammatory efficacy to placebo (PBO) in patients with non-radiographic axial spondyloarthritis (nr-axSpA) and inadequate response to NSAIDs in a 12 week double-blind PBO controlled trial.

Objectives To examine clinical and anti-inflammatory efficacy of ETN at wk 48 (12 wk double blind followed by 36 wk open-label treatment phase).

Methods Patients with symptom duration >3 mths–<5 yrs, fulfilling ASAS axSpA criteria without meeting radiographic criteria for ankylosing spondylitis, having BASDAI ≥4, and failure with ≥2 NSAIDs were enrolled and randomized to ETN 50 mg QW or PBO. Both groups continued stable NSAID therapy. After 12 wks all patients received ETN 50 mg open-label. Clinical assessments (ASAS, ASDAS, BASDAI, BASFI) and MRI of sacroiliac (SI) joint and spine were performed (SPARCC and ASspiMRI scoring methods). Analyses used an ANCOVA model with baseline scores, treatment, MRI sacroiliitis +/-, as variables.

Results Of 215 initially randomized patients (mITT population), 205 entered the open label phase (ETN=100; PBO=105). The proportion of patients achieving ASAS40 by 12 wks (primary endpoint) was 33.3% of those treated with ETN and 14.7% of PBO treated patients, improving to 52.7% of patients in the combined groups by wk 48. MRI-SI joint inflammation was reduced from baseline to wk12 in ETN and PBO treatment groups by 56.7% and 16.4%, respectively, and 65.2% (combined treatment groups) by wk 48. SAE caused 1 discontinuation (pyrexia) between wks 12–48 and infections (the most frequent AE) occurred in 43/208 patients.

Table 1.

Effects of ETN vs PBO in patients with nr-axSpA at wk 48

Conclusions In patients with early, active nr-axSpA and an inadequate response to ≥2 NSAIDs, clinical and imaging outcomes improved from baseline to a greater extent with etanercept therapy than with PBO, during the first 12 weeks. In the ensuing 36 week open label period, these outcomes continued to improve. There were no new safety signals.

Acknowledgements The study NCT01258738 was funded by Pfizer Inc. Medical writing support was provided by Rachael Profit of Engage Scientific, Envision Pharma Group, and was funded by Pfizer Inc.

Disclosure of Interest W. Maksymowych Grant/research support: AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Janssen, Merck, Pfizer, Synarc, and UCB, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Janssen, Merck, Pfizer, Synarc, and UCB, Employee of: CaRE Arthritis Ltd, D. van der Heijde Grant/research support: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Centocor, Chugai, Daiichi, Eli Lilly, GlaxoSmithKline, Janssen Biologics, Merck, Novartis, Novo Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, and Vertex, Consultant for: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Centocor, Chugai, Daiichi, Eli Lilly, GlaxoSmithKline, Janssen Biologics, Merck, Novartis, Novo Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, and Vertex, Employee of: Imaging Rheumatology bv, M. Dougados Grant/research support: AbbVie, Celgene, Eli Lilly, Novartis, Pfizer, Roche, and Sanofi-Aventis, J. Sieper Consultant for: Abbott, Eli-Lilly, Janssen, Merck, Novartis, Pfizer, and UCB, Speakers bureau: Abbott, Eli-Lilly, Janssen, Merck, Novartis, Pfizer, and UCB, J. Braun Grant/research support: Abbott, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, and UCB, G. Citera Grant/research support: Pfizer, Consultant for: Bristol-Myers Squibb, Pfizer, and Abbott., C. Miceli-Richard Grant/research support: AbbVie, Bristol-Myers Squibb, Janssen, and Pfizer, Consultant for: AbbVie, Bristol-Myers Squibb, Janssen, and Pfizer, J. Wei Grant/research support: Abbott, AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Eli Lilly, GlaxoSmithKline, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB, Consultant for: Abbott, AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Eli Lilly, GlaxoSmithKline, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB, R. Pedersen Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, R. Bonin Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, I. Logeart Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, J. Wajdula Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, M. Rahman Employee of: Pfizer Inc at the time of the study, B. Vlahos Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, J. Bukowski Shareholder of: Pfizer Inc, Employee of: Pfizer Inc

DOI 10.1136/annrheumdis-2014-eular.1138

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