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Logo of annrheumdAnnals of the Rheumatic DiseasesCurrent TOCInstructions for authors
Ann Rheum Dis. Nov 2005; 64(11): 1557–1562.
Published online Apr 20, 2005. doi:  10.1136/ard.2004.035105
PMCID: PMC1755272

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

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.

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.
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Figures and Tables

Figure 1
 Patient disposition in an open label trial examining sustained durability and tolerability of etanercept in patients with AS. BIW, twice weekly.
Figure 2
 (A) ASAS 20, ASAS 50, and ASAS 70 responses in patients who received placebo in the preceding RCT and enrolled in the open label extension study, by length of treatment. (B) Durability of response, indicated by ASAS 20, ASAS 50, and ASAS 70 ...
Figure 3
 (A) Percentage of patients who attained the modified ASAS 5/6 (20% improvement in five of six criteria—patient's global assessment, pain, physical function, inflammation, a measure of spinal mobility, and an acute phase reactant—with ...

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