Reporting of potential immunogenicity with biologic drugs: Clarity and accuracy required

Annals of the Rheumatic Diseases

Volumn 75, Issue 5, 2016, Pages e24-

  Moots, Robert J ^a   Balsa, Alejandro ^a   Wolbink, Gertjan ^a  

^a UNIVERSITY OF LIVERPOOL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; BIOSIMILAR AGENT; DRUG ANTIBODY; ETANERCEPT; SB 4; UNCLASSIFIED DRUG; ANTIRHEUMATIC AGENT; NEUTRALIZING ANTIBODY;

ANTIBODY DETECTION; DRUG EFFICACY; DRUG SAFETY; HUMAN; IMMUNOGENICITY; LETTER; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; BLOOD; IMMUNOLOGY; METHODOLOGY;

ANTIBODIES, NEUTRALIZING; ANTIRHEUMATIC AGENTS; BIOLOGICAL PRODUCTS; BIOSIMILAR PHARMACEUTICALS; ETANERCEPT; HUMANS; RESEARCH DESIGN;

EID: 84958073489     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2016-209178     Document Type: Letter

References (3)

1. Emery P, Vencovsky J, Sylwestrzak A, et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis 2015; Published Online First 6 July 2015. http://dx.doi.org/10.1136/annrheumdis-2015-207588
2. Felis-Giemza A, Moots RJ. Measurement of anti-drug antibodies to biologic drugs. Rheumatology (Oxford) 2015;54:1941-3.
3. Van Schouwenburg PA, Rispens T, Wolbink GJ. Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis. Nat Rev Rheumatol 2013;9:164-72.