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Confirmation on the immunogenicity assay used in the SB4 phase III study: response to the comments by Meacci et al
  1. Paul Emery1,2,
  2. Jiří Vencovský3,
  3. Jung Won Kang4,
  4. Jeehoon Ghil4
  1. 1Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, UK
  2. 2NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK
  3. 3Institute of Rheumatology, Prague, Czech Republic
  4. 4Samsung Bioepis Co., Ltd. Incheon, Republic of Korea
  1. Correspondence to Professor Paul Emery, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK; p.emery{at}leeds.ac.uk

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We appreciate Meacci et al1 for the comments on the anti-drug antibody (ADA) detection methods.

As noted by Meacci et al, the Meso Scale Discovery (MSD) electrochemiluminescence (ECL) bridging assay (Maryland, USA) was used in the SB4 Phase III study to detect ADAs.2 The bridging assay format relies on the characteristics of ADA to crosslink two drug molecules conjugated to a capture and a detection label. Due to the methods employed in the ECL bridging technology, ECL is more sensitive and has higher drug tolerance compared with ELISA or surface plasmon resonance assay.3 ,4 Furthermore, in order to facilitate detection of ADA, the drug-ADA immune complexes in our study samples were dissociated through acid dissociation,4 leading to an improved drug tolerance.

According to the biosimilar guidelines5–7 the goal of the clinical immunogenicity assessment is to evaluate potential differences between the proposed product and the reference product in the incidence and severity of human immune responses. It is recommended that the sponsor should use assays that are sensitive and capable of detecting all antibodies induced against the product in all antibody-positive patients. For the reasons explained above, ECL was employed in our study as well as most of other biosimilar studies8–11 to detect any difference in immunogenicity between the biosimilar and reference product. Overall, as pointed out by Meacci et al, the use of ECL may have contributed to the higher incidence of ADA in our study compared with main literature data.12–14

We hope that the details and confirmation on the assay methods provide the readers of Annals of the Rheumatic Diseases additional reference for the immunogenicity data in our study.

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Footnotes

  • Competing interests None declared.

  • Provenance and peer review Commissioned; internally peer reviewed.

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