Effective serum level of etanercept biosimilar and effect of antidrug antibodies on drug levels and clinical efficacy in Chinese patients with ankylosing spondylitis
To investigate the effective serum level of etanercept biosimilar in Chinese patients with ankylosing spondylitis (AS) who achieve AS Disease Activity Score-C-reactive protein (ASDAS-CRP) < 2.1, and the effect of antidrug antibodies on drug levels and clinical efficacy.
Our study enrolled 60 patients with AS who were treated with etanercept biosimilar. Serum and clinical data were collected at baseline and treatment weeks 4, 12, and 24. Drug levels and antidrug antibody levels were measured using an enzyme-linked immunosorbent assay while tumour necrosis factor (TNF)-α levels were measured using cytometric bead array. A receiver operating characteristic (ROC) curve was used to analyse effective serum level of etanercept biosimilar.
Patients with ASDAS-CRP ≥ 2.1 exhibited significantly lower drug levels than those with ASDAS-CRP < 2.1 did. The cut-off values of effective serum level of patients with AS who achieved ASDAS-CRP < 2.1 at weeks 4, 12, and 24 were 2.32, 2.12, and 2.36 μg/mL, respectively. Patients with drug levels above the cut-off value had lower Bath AS Disease Activity Index (BASDAI) and TNF-α levels. Antidrug antibodies had no effect on the Assessment of Spondylosis Arthritis International Society (ASAS) remission rates, but patients with antidrug antibodies had lower drug levels and higher TNF-α levels.
Detecting serum drug levels and antidrug antibody levels might facilitate estimation of the clinical efficacy and adjustment of medication regimen during etanercept biosimilar therapy in Chinese patients with AS.
KeywordsAnkylosing spondylitis Biological therapy Drug monitoring Etanercept Pharmacokinetics
The authors are grateful to the patients who were involved in this study, as well as the nurses and medical doctors for performing clinical assessments.
Yidian Dong contributed to the acquisition, analysis or interpretation of data, and drafting the manuscript. Ping Li contributed to the study conception and design. Tingshuang Xu contributed to the preservation of serum and supervision of the study. Liqi Bi contributed to the study conception and design and final approval of the version published.
The authors also thank the support from national key research and development program of China (No. 2017YFC0909002).
Compliance with ethical standards
This study was conducted in accordance with the ethical standards of the Helsinki Declaration and approved by the Ethical Committee of the China-Japan Union Hospital of Jilin University (approval number, 2015-wjw008). Each patient was selected following a rigorous process and provided written informed consent.
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