Treat-to-Target Strategy With Etanercept for Ankylosing Spondylitis
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Observational

Summary: 
      Evaluate the disease activity guided tapering and discontinuation strategies of etanercept
      (ETN) in patients with ankylosing spondylitis (AS) in 48 weeks.
    

Detailed description: 
      Ankylosing spondylitis (AS), a subset of axial spondyloarthritis (axSpA), is a chronic
      inflammatory disorder characterized by inflammatory back pain and predominant involvement of
      sacroiliac joints and spine, leading to bony fusion of vertebrae and eventually disability in
      some patients. Nonsteroidal anti-inflammatory drugs (NSAIDs) are recognized as a first-line
      therapy for AS, but the overall response rates to NSAIDs are considerably unsatisfactory.
      With the advent of biologics, the outcomes of AS patients have been greatly improved.
      Biologics including tumor necrosis factor α (TNFα) inhibitors (TNFi) have been included in
      many recommendations for the treatment of AS. Etanercept, a recombinant human TNFα receptor,
      is capable of binding to TNFα and blocking its biological activities. It is effective in
      relieving symptoms, improving physical function, and reducing disease activity in patients
      with AS, and generally no severe adverse effects have been reported. However, the high
      expense of biologics restricts their long-term use, which urges a viable strategy to reduce
      the dosage of biologics while maintaining an optimal therapeutic efficacy. To investigate the
      stepwise tapering and discontinuation of TNFi based on disease activity in patients with AS,
      a 48-week, prospective, randomized, multicentric study was conducted. An etanercept
      biosimilar, rhTNFR:Fc (recombinant TNF receptor: Fc fusion protein, Yisaipu), which is one of
      the most widely used biosimilars in China, was used in this study.
    

Intervention name(s): tapering or discontinuation of etanercept
Intervention type(s): Drug
Intervention description(s): Active AS patients initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients who achieved inactive disease (ASDAS<1.3, group A) at week 12 were either assigned to sequential tapering group (A1) or discontinuation group (A2), and those who reached low disease activity (LDA) (1.3≤ASDAS<2.1, group B) were designated to sequential tapering group (B1), delayed tapering group (B2) or discontinuation group (B3).
Other intervention name(s): rhTNFR:Fc, Yisaipu
Intervention MeSH terms: Etanercept
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with AS were recruited in this study. Eligible patients were aged between 18 years
        old and 65 years old, and were diagnosed with AS according to 1984 revised New York
        classification criteria. Only patients meet both inclusion and exclusion criteria were
        included.