EXTENDED REPORT

Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks

J C Davis¹, D M van der Heijde², J Braun³, M Dougados⁴, J Cush⁵, D Clegg⁶, R D Inman⁷, A Kivitz⁸, L Zhou⁹, A Solinger⁹, W Tsuji⁹

¹ Division of Rheumatology, University of California, San Francisco, San Francisco, USA
² Department of Rheumatology, University Hospital Maastricht, Maastricht, The Netherlands
³ Rheumazentrum, Ruhrgebiet, Landgrafenstr, Germany
⁴ Rhumatologie B, Hopital Cochin, Paris, France
⁵ Arthritis Consultation Center, Presbyterian Hospital of Dallas, Dallas, USA
⁶ Division of Rheumatology, University of Utah Health Sciences Center, Salt Lake City, USA
⁷ Toronto Western Hospital, Toronto, Ontario, Canada
⁸ Clinical Research, Altoona Center for Clinical Research, Duncansville, USA
⁹ Development, Amgen, Thousand Oaks, USA

Correspondence to:
Assistant Professor J C Davis
University of California, San Francisco, 533 Parnassus Ave Rm U 383 Box 0633, San Francisco, California, USA; jdavis{at}medicine.ucsf.edu

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.

Abbreviations: 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

Keywords: ankylosing spondylitis; TNFR-Fc fusion protein; receptors; tumour necrosis factor

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