TY - JOUR T1 - Etanercept in the Longterm Treatment of Patients With Ankylosing Spondylitis JF - The Journal of Rheumatology JO - J Rheumatol DO - 10.3899/jrheum.081033 SP - jrheum.081033 AU - Ben Dijkmans AU - Paul Emery AU - Markku Hakala AU - Marjatta Leirisalo-Repo AU - Emilio Martin Mola AU - Laurence Paolozzi AU - Carlo Salvarani AU - Raimon Sanmarti AU - Jean Sibilia AU - Joachim Sieper AU - Filip Van Den Bosch AU - Désirée van der Heijde AU - Sjef van der Linden AU - Joseph Wajdula Y1 - 2009/05/01 UR - http://www.jrheum.org/content/early/2009/04/28/jrheum.081033.abstract N2 - Objective To evaluate the 2-year efficacy and safety of etanercept in patients with ankylosing spondylitis (AS). Methods A 96-week open-label extension study, which followed a 12-week double-blind placebo- controlled trial, was designed to provide longterm efficacy and safety data, including radiographic outcomes, for patients treated with etanercept 25 mg twice weekly (NCT00421980). In all, 81 patients were enrolled (96% of the participants from the double-blind study). Key efficacy measures included improvement using theAssessment inAnkylosing Spondylitis 20% (ASAS20) criteria, the Bath Ankylosing Spondylitis Functional Index (BASFI), and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Radiographic progression was evaluated using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) method. Paired t tests were used to test within- group changes from baseline. Results The percentage of responders, by ASAS20 criteria, remained relatively constant in patients who received etanercept during the 12-week double-blind study (60% at Week 0 and 83% at Week 96 of the open-label extension); more patients from the placebo group became responders after being switched to etanercept (23% and 74%, respectively). A similar trend was also observed using the ASAS40 and ASAS5/6 criteria, the BASFI, and the BASDAI. Most patients had no change from baseline in mSASSS values. Etanercept was well tolerated; the most frequent adverse events were injection site reactions (n = 30; 37.0%) and headache (n = 18; 22.2%), and the most frequent infections were upper respiratory tract infections (n = 43; 53.1%) and flu syndrome (n = 22; 27.2%). Conclusion For 2 years, etanercept was clinically effective and well tolerated, with no unexpected safety findings. ER -