Etanercept in the longterm treatment of patients with ankylosing spondylitis
Dijkmans B et al. – In the two year study period, etanercept was clinically effective and well tolerated, with no unexpected safety findings, in pts with ankylosing spondylitis (AS). Methods- An evaluation of the 2-yr efficacy and safety of etanercept in pts with AS
- A 96-wk open-label extension study, which followed a 12-wk double-blind placebo-controlled trial
- Pts were treated with etanercept 25 mg x2/wk
- In all, 81 pts were enrolled (96% of the participants from the double-blind study)
- Key efficacy measures: improvement using-
- Assessment in Ankylosing Spondylitis 20% (ASAS20) criteria
- Bath Ankylosing Spondylitis Functional Index (BASFI), and
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
- Radiographic progression was evaluated using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) method
Results- Percentage of responders, by ASAS20 criteria, remained relatively constant in pts who received etanercept during the 12-wk double-blind study
- More pts from the placebo group became responders after being switched to etanercept
- A similar trend was also observed using the ASAS40 and ASAS5/6 criteria, the BASFI, and the BASDAI
- Most pts had no change from baseline in mSASSS values
- Etanercept was well tolerated:
- Most frequent AEs were injection site reactions, and headache
- Most frequent infections were upper respiratory tract infections and flu syndrome
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