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Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks
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  1. J C Davis1,
  2. D M van der Heijde2,
  3. J Braun3,
  4. M Dougados4,
  5. J Cush5,
  6. D Clegg6,
  7. R D Inman7,
  8. A Kivitz8,
  9. L Zhou9,
  10. A Solinger9,
  11. W Tsuji9
  1. 1Division of Rheumatology, University of California, San Francisco, San Francisco, USA
  2. 2Department of Rheumatology, University Hospital Maastricht, Maastricht, The Netherlands
  3. 3Rheumazentrum, Ruhrgebiet, Landgrafenstr, Germany
  4. 4Rhumatologie B, Hopital Cochin, Paris, France
  5. 5Arthritis Consultation Center, Presbyterian Hospital of Dallas, Dallas, USA
  6. 6Division of Rheumatology, University of Utah Health Sciences Center, Salt Lake City, USA
  7. 7Toronto Western Hospital, Toronto, Ontario, Canada
  8. 8Clinical Research, Altoona Center for Clinical Research, Duncansville, USA
  9. 9Development, Amgen, Thousand Oaks, USA
  1. Correspondence to:
    Assistant Professor J C Davis
    University of California, San Francisco, 533 Parnassus Ave Rm U 383 Box 0633, San Francisco, California, USA; jdavismedicine.ucsf.edu

Abstract

Objective: To evaluate the continued safety and durability of clinical response in patients with ankylosing spondylitis receiving etanercept.

Methods: 277 patients who had participated in a previous randomised, double blind, placebo controlled 24 week trial were eligible to continue in this open label extension study. All patients who enrolled in the open label extension (n = 257) received subcutaneous etanercept 25 mg twice weekly for up to 72 weeks, for a combined 96 weeks of cumulative trial and open label experience. For the patients who had received etanercept for 24 weeks in the double blind trial, this represented almost 2 years of continuous etanercept treatment.

Results: Patients continuing etanercept treatment had a sustained response for almost 2 years, with 74% achieving an ASsessments in Ankylosing Spondylitis 20% (ASAS 20) response after 96 weeks of etanercept treatment. Patients who had received placebo in the preceding double blind trial had similar responses, with 70% of patients attaining an ASAS 20 response after 24 weeks of etanercept treatment and 78% achieving an ASAS 20 response after 72 weeks. Improved spinal mobility was seen in both groups. Etanercept was well tolerated in patients treated for up to 96 weeks.

Conclusion: The subcutaneous administration of twice weekly doses of etanercept provided sustained durability of response in the improvement of signs and symptoms of ankylosing spondylitis for nearly 2 years.

  • AS, ankylosing spondylitis
  • ASAS, ASsessment in Ankylosing Spondylitis
  • BASDAI, Bath Ankylosing Spondylitis Disease Activity Index
  • BASFI, Bath Ankylosing Spondylitis Function Index
  • CRP, C reactive protein
  • PPD, purified protein derivative
  • RCT, randomised clinical trial
  • SC, subcutaneous
  • ankylosing spondylitis
  • TNFR-Fc fusion protein
  • receptors
  • tumour necrosis factor
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Footnotes

  • Published Online First 26 May 2005

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