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  • Immunogenicity, drug trough levels and therapeutic response in patients with rheumatoid arthritis or ankylosing spondylitis after 24-week golimumab treatment

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Immunogenicity, drug trough levels and therapeutic response in patients with rheumatoid arthritis or ankylosing spondylitis after 24-week golimumab treatment
  1. Der-Yuan Chen1,2,3,4,
  2. Yi-Ming Chen1,2,3,
  3. Wei-Ting Hung1,2,
  4. Hsin-Hua Chen1,2,
  5. Chia-Wei Hsieh1,2,
  6. Yi-Hsing Chen1,2,
  7. Wen-Nan Huang1,
  8. Tsu-Yi Hsieh1
  1. 1 Division of Allergy, Immunology and Rheumatology, Taichung Veterans General Hospital, Taichung, Taiwan
  2. 2 Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan
  3. 3 Institute of Biomedical Science and Rong Hsing Research Center for Translational Medicine, National Chung Hsing University, Taichung, Taiwan
  4. 4 Institute of Microbiology and Immunology, Chung Shan Medical University, Taichung, Taiwan
  1. Correspondence to Dr Der-Yuan Chen, Division of Allergy, Immunology and Rheumatology, Taichung Veterans General Hospital, Taichung, Taiwan. No. 1650, Sec. 4, Taiwan Boulevard, Taichung 40705, Taiwan; dychen{at}vghtc.gov.tw

https://doi.org/10.1136/annrheumdis-2015-207978

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    Golimumab, a fully humanised antitumour necrosis factor (anti-TNF)-α monoclonal antibody, has been proven effective in the treatment of both rheumatoid arthritis (RA)1 and ankylosing spondylitis (AS).2 As with other anti-TNF-α inhibitors, golimumab may elicit antidrug antibodies (ADAb), leading to pharmacokinetic changes.3 ,4 With the limited data regarding the immunogenicity of golimumab,1 ,2 ,5 we aim to evaluate the relations among ADAb, serum drug trough levels, therapeutic response and methotrexate (MTX) dosage in golimumab-treated patients.

    We initially enrolled 78 biologic-naïve patients who started golimumab therapy at a dosage of 50 mg given subcutaneously once a month. Two patients with AS were lost to follow-up due to skin reactions at the 2nd and 3rd month, respectively. Hence, the remaining 76 patients (33 RA and 43 AS) completed the 24-week treatment course, and were eligible for this study. Serum ADAb levels and drug trough levels were determined at week 24 of golimumab therapy by bridging ELISA and capture ELISA (Progenika Biopharma SA, Derio, Spain), respectively, a modified version of the method used in our previous study.6 A positive ADAb result was defined as a titre >30 arbitrary unit/mL in combination with a golimumab level <5.0 μg/mL. Because all of the enrolled patients were …

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    Footnotes

    • Y-MC, W-TH and H-HC contributed equally.

    • Contributors All authors made substantive intellectual contributions to the present study and approved the final manuscript. D-YC conceived of the study, generated the original hypothesis, designed the study, acquired clinical data, analysed data, drafted and revised the manuscript. Y-MC, W-TH and H-HC contributed equally to this work, conceived the study, acquired clinical data, analysed data and drafted the manuscript. C-WH, Y-HC, W-NH and T-YH performed clinical assessments and data acquisition, statistical analysis and drafted the manuscript.

    • Funding This work was supported by a grant (TCVGH 1037305C) from Taichung Veterans General Hospital.

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval Institutional Review Board of Taichung Veterans General Hospital.

    • Provenance and peer review Not commissioned; externally peer reviewed.