Clinical efficacy and safety of etanercept versus sulfasalazine in patients with
ankylosing spondylitis: a randomized, double-blind trial.
Author(s): Braun J, van der Horst-Bruinsma IE, Huang F, Burgos-Vargas R, Vlahos B, Koenig
AS, Freundlich B.
Affiliation(s): Rheumatology Medical Center, Ruhr District, Herne, Germany.
Publication date & source: 2011, Arthritis Rheum. , 63(6):1543-51
OBJECTIVE: Etanercept, a fully human tumor necrosis factor (TNF) receptor, is an
effective treatment in patients with ankylosing spondylitis (AS). Sulfasalazine
is frequently used for the treatment of both axial symptoms and peripheral
symptoms of AS, and it has been the recommended therapy before the use of an
anti-TNF agent when peripheral arthritis is present. Until now, no clinical trial
has compared the efficacy and safety of a TNF blocker with that of sulfasalazine.
This study was undertaken to compare the efficacy and safety of etanercept with
that of sulfasalazine after 16 weeks of treatment in patients with axial and
peripheral manifestations of AS.
METHODS: In this randomized, double-blind study, patients received etanercept 50
mg once weekly (n=379) or sulfasalazine titrated to a maximum of 3 gm/day (n=187)
for 16 weeks. The primary end point was the proportion of patients who achieved
the Assessment of SpondyloArthritis international Society criteria for 20%
improvement (ASAS20) at 16 weeks. Last observation carried forward was predefined
for imputation of missing values.
RESULTS: The mean age of the patients was 41 years, 74% were male, and the mean
disease duration was 7.6 years. The proportion of ASAS20 responders at week 16
was greater among patients treated with etanercept compared with those treated
with sulfasalazine (75.9% versus 52.9%; P<0.0001). As early as week 2 of
treatment, etanercept was found to be more effective than sulfasalazine
(P<0.0001) in ameliorating both the axial symptoms and peripheral manifestations.
Serious adverse events rarely occurred, and the rate of serious adverse events
did not differ between groups.
CONCLUSION: In this population of patients with AS, etanercept was significantly
more effective than sulfasalazine in improving the signs and symptoms of AS in
the axial skeleton and peripheral joints.