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

The aim of the study was to evaluate the continued safety and durability of clinical response in patients with ankylosing spondylitis receiving etanercept.

Patients (N = 277) who participated in a previous randomized, 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 patients who received etanercept for 24 weeks in the double-blind trial, this could represent almost 2 years of continuous etanercept treatment. Researchers found that patients continuing etanercept treatment experienced a sustained response for approaching 2 years, with 74% achieving an ASsessments in Ankylosing Spondylitis 20% (ASAS 20) response after 96 weeks of etanercept treatment. Patients who received placebo in the preceding double-blind trial demonstrated similar responses, with 70% of patients attaining an ASAS 20 response after 24 weeks of etanercept therapy and 78% achieving an ASAS 20 response after 72 weeks. Patients in both groups demonstrated improved spinal mobility. Etanercept was well tolerated in patients treated for up to 96 weeks. Researchers concluded that the subcutaneous administration of 2 weekly doses of etanercept provided sustained durability of response in the improvement of signs and symptoms of ankylosing spondylitis for nearly 2 years.(Source: PMID: 15843448 [PubMed – as supplied by publisher]: Ann Rheum Dis. 2005 Apr 20; [Epub ahead of print]: May 2005.)