Confirmation on the immunogenicity assay used in the SB4 phase III study: response to the comments by Meacci et al

Paul Emery¹, Jiří Vencovský², Jung Won Kang³, Jeehoon Ghil³

Affiliations

¹ Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, UK NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
² Institute of Rheumatology, Prague, Czech Republic.
³ Samsung Bioepis Co., Ltd. Incheon, Republic of Korea.

PMID: 27190097
DOI: 10.1136/annrheumdis-2016-209696

Free article

Comment

Confirmation on the immunogenicity assay used in the SB4 phase III study: response to the comments by Meacci et al

Paul Emery et al. Ann Rheum Dis. 2016 Jul.

Free article

. 2016 Jul;75(7):e40.

doi: 10.1136/annrheumdis-2016-209696. Epub 2016 May 17.

Authors

Paul Emery¹, Jiří Vencovský², Jung Won Kang³, Jeehoon Ghil³

Affiliations

¹ Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, UK NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
² Institute of Rheumatology, Prague, Czech Republic.
³ Samsung Bioepis Co., Ltd. Incheon, Republic of Korea.

PMID: 27190097
DOI: 10.1136/annrheumdis-2016-209696

No abstract available

Keywords: Disease Activity; Inflammation; Treatment.

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A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy.
Emery P, Vencovský J, Sylwestrzak A, Leszczyński P, Porawska W, Baranauskaite A, Tseluyko V, Zhdan VM, Stasiuk B, Milasiene R, Barrera Rodriguez AA, Cheong SY, Ghil J. Emery P, et al. Ann Rheum Dis. 2017 Jan;76(1):51-57. doi: 10.1136/annrheumdis-2015-207588. Epub 2015 Jul 6. Ann Rheum Dis. 2017. PMID: 26150601 Free PMC article. Clinical Trial.
Anti Etanercept and anti SB4 antibodies detection: impact of the assay method.
Meacci F, Manfredi M, Infantino M, Grossi V, Benucci M. Meacci F, et al. Ann Rheum Dis. 2016 Jul;75(7):e39. doi: 10.1136/annrheumdis-2016-209665. Epub 2016 Apr 29. Ann Rheum Dis. 2016. PMID: 27130906 No abstract available.

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Confirmation on the immunogenicity assay used in the SB4 phase III study: response to the comments by Meacci et al

Affiliations

Confirmation on the immunogenicity assay used in the SB4 phase III study: response to the comments by Meacci et al

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Affiliations

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Medical