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Correspondence response
Response to: ‘Lower anti-drug antibodies with etanercept biosimilar: Can Ctrough explain the differences’ by Shah
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  1. Paul Emery1,2,
  2. Jiří Vencovský3,
  3. Jeehoon Ghil4,
  4. Jung Won Kang4
  1. 1Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 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

https://doi.org/10.1136/annrheumdis-2016-210114

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    We appreciate Shah1 for the interest in and comments on the SB4 phase III study publication and subsequent correspondences regarding immunogenicity results.2–4

    The immunogenicity results in the SB4 phase III study2 (0.7% in SB4 and 13.1% in reference etanercept (ETN)) was concluded by the Committee for Medicinal Products for Human Use to be uncertain because of the low drug tolerance of the anti-drug antibody (ADA) assay that led to a low sensitivity …

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