Efficacy and safety of infliximab in patients with ankylosing spondylitis over a two-year period.
OBJECTIVE
To assess safety and efficacy of infliximab in patients with ankylosing spondylitis (AS) through 102 weeks.


METHODS
Patients (n = 279) with active AS were randomized to either group 1 (n = 78; placebo through week 24 and then infliximab 5 mg/kg from weeks 24 through 96) or group 2 (n = 201; infliximab 5 mg/kg through week 96). The primary efficacy end point at week 24 (>or=20% improvement in the ASsessment in Ankylosing Spondylitis International Working Group criteria [ASAS20]) was assessed with an intent-to-treat analysis of observed data.


RESULTS
More patients in group 2 than group 1 achieved the ASAS20 response at week 24 (61.2% versus 19.2%; P < 0.001). By week 102, groups 1 and 2 were similar with regard to ASAS20 response (72.1% versus 73.9%); ASAS40 responses at week 102 were 45.9% versus 59.4%. No new safety issues were discerned.


CONCLUSIONS
Infliximab demonstrated sustained efficacy and safety over 2 years in this large cohort of patients with active AS.
Braun
Jürgen
J
Rheumazentrum Ruhrgebiet, Herne, Germany. j.braun@rheumazentrum-ruhrgebiet.de
Deodhar
Atul
A
Dijkmans
Ben
B
Geusens
Piet
P
Sieper
Joachim
J
Williamson
Paul
P
Xu
Weichun
W
Visvanathan
Sudha
S
Baker
Daniel
D
Goldstein
Neil
N
van der Heijde
Désirée
D