Continuous efficacy of etanercept in severe and advanced ankylosing spondylitis: results from a 12-week open-label extension of the SPINE study
Dougados M et al. – Despite the improvements in symptoms and inflammatory markers observed shortly after initiation of once–weekly etanercept, there was no notable plateauing effect on patient–reported outcomes. Indeed, signs and symptoms of severe and advanced active AS continued to improve after up to 24 weeks, treatment with etanercept.Methods
- Seventy–seven patients who completed the randomized, double–blind, placebo–controlled 12–week SPINE study enrolled in a 12–week open–label extension and received s.c. etanercept 50 mg once weekly.
- The etanercept/etanercept group received a total of 24 weeks treatment with etanercept (n = 38); the placebo/etanercept group received placebo during the double–blind study then 12 weeks’ etanercept treatment during the open–label extension (n = 39).
- At the end of the open–label extension, BASDAI scores in the etanercept/etanercept group had further decreased beyond reductions observed during the double–blind study [mean (s.d.) change from baseline –37.6 (22.4) at end of extension vs –27.4 (23.8) at end of double–blind study].
- Mean (s.d.) BASDAI scores also improved in the placebo/etanercept group once switched to etanercept [–28.6 (24.3) vs –15.0 (20.0)].
- Similar trends were observed in BASFI and BASMI scores. In the placebo/etanercept group, total back pain decreased to similar levels achieved in the etanercept group in the double–blind study.
- Pain levels continued to decrease with longer–term etanercept therapy in the etanercept/etanercept group.