Six‐month results of a double‐blind, placebo‐controlled trial of etanercept treatment in patients with active ankylosing spondylitis

摘要: Objective There is increasing evidence that tumor necrosis factor α (TNFα) centrally involved in the pathogenesis of ankylosing spondylitis (AS) and other spondylarthritides. This study was designed to investigate efficacy anti-TNFα therapy with etanercept, a 75-kd receptor fusion protein, active AS. Methods This multicenter trial had 2 phases: an initial placebo-controlled period 6 weeks' duration observational phase lasting 24 weeks. Thirty patients AS were included. They randomized into groups, which received either etanercept (25 mg twice weekly) (n = 14) or placebo 16) for Then both groups treated etanercept. Nonsteroidal antiinflammatory drug (NSAID) treatment could be continued, but disease-modifying antirheumatic drugs (DMARDs) steroids withdrawn prior study. All total 12 weeks followed up at least The Bath Disease Activity Index (BASDAI), Functional Index, Metrology pain level on numeric rating scale, quality life by Short Form 36, C-reactive protein (CRP) assessed. primary outcome parameter ≥50% improvement BASDAI. Results Treatment resulted 50% regression disease activity 57% these week 6, versus 6% placebo-treated (P 0.004). After switched 56% improved. mean ± SD BASDAI improved from 6.5 1.2 baseline 3.5 1.9 group, no group 0.003 between groups). Similarly, pain, function, mobility, not < 0.05). Mean CRP levels decreased significantly 0.001). There ongoing all parameters until 18, respectively (i.e., throughout treatment). relapses occurred 6.2 3.0 after cessation No severe adverse events, including major infections, observed during trial. Conclusion This shows short-term basis (3 months), clearly efficacious who are receiving NSAID DMARDs steroids. therapy, almost experienced relapse within few Thus, it seems probable must administered continuously most achieve permanent inhibition inflammatory process.