RT Journal Article
SR Electronic
T1 Etanercept in the Longterm Treatment of Patients With Ankylosing Spondylitis
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 1256
OP 1264
DO 10.3899/jrheum.081033
VO 36
IS 6
A1 BEN DIJKMANS
A1 PAUL EMERY
A1 MARKKU HAKALA
A1 MARJATTA LEIRISALO-REPO
A1 EMILIO MARTIN MOLA
A1 LAURENCE PAOLOZZI
A1 CARLO SALVARANI
A1 RAIMON SANMARTI
A1 JEAN SIBILIA
A1 JOACHIM SIEPER
A1 FILIP Van Den BOSCH
A1 DÉSIRÉE van der HEIJDE
A1 SJEF van der LINDEN
A1 JOSEPH WAJDULA
YR 2009
UL http://www.jrheum.org/content/36/6/1256.abstract
AB 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 the Assessment in Ankylosing 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.