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Gorovits B; Clements-Egan A; Birchler M; Liang M; Myler H; Peng K; Purushothama S; Rajadhyaksha M; Salazar-Fontana L; Sung C; Xue L
AAPS J 2016[Mar]; 18 (2): 311-20 PMID26821802show ga
Pre-existing antibodies to biotherapeutic drugs have been detected in drug-naive subjects for a variety of biotherapeutic modalities. Pre-existing antibodies are immunoglobulins that are either specific or cross-reacting with a protein or glycan epitopes on a biotherapeutic compound. Although the exact cause for pre-existing antibodies is often unknown, environmental exposures to non-human proteins, glycans, and structurally similar products are frequently proposed as factors. Clinical consequences of the pre-existing antibodies vary from an adverse effect on patient safety to no impact at all and remain highly dependent on the biotherapeutic drug modality and therapeutic indication. As such, pre-existing antibodies are viewed as an immunogenicity risk factor requiring a careful evaluation. Herein, the relationships between biotherapeutic modalities to the nature, prevalence, and clinical consequences of pre-existing antibodies are reviewed. Initial evidence for pre-existing antibody is often identified during anti-drug antibody (ADA) assay development. Other interfering factors known to cause false ADA positive signal, including circulating multimeric drug target, rheumatoid factors, and heterophilic antibodies, are discussed.
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AAPS+J 2016 ; 18 (2): 311-20
