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SAT0350 Quality of Life with Etanercept in Early Non-Radiographic Axial Spondyloarthritis: 24 and 48-Week Data from A Randomized, Double-Blind, Placebo-Controlled Trial
  1. J. Sieper1,
  2. E. Drescher2,
  3. J. Rosa3,
  4. R. Pedersen4,
  5. R. Bonin4,
  6. B. Vlahos4,
  7. J. Bukowski4,
  8. S. Kotak5
  1. 1Charité, Berlin, Germany
  2. 2Csolnoky Ferenc Hospital, Veszprem, Hungary
  3. 3Mediscan Group, Prague, Czech Republic
  4. 4Pfizer Inc, Collegeville, PA
  5. 5Pfizer Inc, New York, NY, United States

Abstract

Background Anti-TNF agents are recommended treatment for NSAID-resistant radiographic ankylosing spondylitis (AS). Long-term quality of life (QoL) data available in axial spondyloarthritis (axSpA), prior to radiographic detection of change (i.e., non-radiographic [nr-axSpA]) are limited.

Objectives To investigate long-term effects of etanercept (ETN) treatment on QoL in patients with nr-axSpA (who had an insufficient response to NSAID treatment) after 12 weeks of randomized treatment to ETN or placebo (PBO).

Methods Enrolled patients fulfilling ASAS axSpA criteria, not meeting the modified New York criteria for AS, who were symptomatic for 3 months–5 years, with BASDAI ≥4, and failed ≥2 NSAIDs, were randomized to ETN 50 mg weekly or PBO (double blind) for 12 weeks followed by open-label ETN 50 mg. QoLs were recorded over a total of 48 weeks. Patients were allowed stable NSAID therapy throughout the study. Analyses used an ANCOVA model with baseline scores, treatment, and MRI sacroiliitis positive/negative status as variables.

Results Of 208 participants who entered the open-label period (safety population; ETN=102; PBO=106) baseline mean age was 31.9 years; 60.6% were male, and mean disease duration was 2.5 years. By week 12, QoL improvements favoured ETN versus PBO in disease-specific, functional, and productivity domains such as BASDAI, BASFI, BAS-G, WPAI-AS, SF-36 physical component summary, and pain measures (P<0.05).1 During the open label phase, substantial improvements from baseline at weeks 24 and 48 were observed regardless of original 12-week treatment arm (table). Improvements with ETN treatment were sustained with little distinction between the groups receiving ETN for 12, 24 and 48 weeks.

Conclusions In patients with early, active nr-axSpA and an inadequate response to ≥2 NSAIDs, ETN demonstrated improvement in QoL measures for disease specific and functional domains compared to PBO during the first 12 weeks.1 Improvements in PROs were rapid and sustained after all patients were treated with etanercept (weeks 12-48) and similar between original 12-week treatment groups.

References

  1. Dougados M, et al. Arthritis Rheum. 2013;65(10):S656-657.

Acknowledgements The nr-axSpA trial (ClinicalTrials.gov, NCT01258738) was sponsored by Pfizer Inc. Medical writing support was provided by Stephanie Eide of Engage Scientific Solutions and was funded by Pfizer Inc.

Disclosure of Interest J. Sieper: None declared, E. Drescher: None declared, J. Rosa: None declared, R. Pedersen Employee of: Pfizer Inc., R. Bonin Employee of: Pfizer Inc., B. Vlahos Employee of: Pfizer Inc., J. Bukowski Employee of: Pfizer Inc., S. Kotak Shareholder of: Pfizer Inc., Employee of: Pfizer Inc.

DOI 10.1136/annrheumdis-2014-eular.2242

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