Kalden JR, Schulze-Koops H. Immunogenicity and loss of response to TNF inhibitors: implications for rheumatoid arthritis treatment. Nat Rev Rheumatol. 2017;13(12):707–18.
Article CAS PubMed Google Scholar
Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, et al. Lipid-reduction variability and antidrug-antibody formation with bococizumab. N Engl J Med. 2017;376(16):1517–26.
Article CAS PubMed Google Scholar
Bennett CL, Luminari S, Nissenson AR, Tallman MS, Klinge SA, McWilliams N, et al. Pure red-cell aplasia and epoetin therapy. N Engl J Med. 2004;351(14):1403–8.
Article CAS PubMed Google Scholar
Jullien D, Prinz JC, Nestle FO. Immunogenicity of biotherapy used in psoriasis: the science behind the scenes. J Invest Dermatol. 2015;135(1):31–8.
Jiang Z, Kamerud J, Zhang M, Ruiz CC, Guadiz C, Fichtner A, et al. Strategies to develop highly drug-tolerant cell-based neutralizing antibody assay: neutralizing antidrug antibodies extraction and drug depletion. Bioanalysis. 2020;12(18):1279–93.
Article CAS PubMed Google Scholar
Jolicoeur P, Tacey RL. Development and validation of cell-based assays for the detection of neutralizing antibodies to drug products: a practical approach. Bioanalysis. 2012;4(24):2959–70.
Article CAS PubMed Google Scholar
Wu B, Chung S, Jiang XR, McNally J, Pedras-Vasconcelos J, Pillutla R, et al. Strategies to determine assay format for the assessment of neutralizing antibody responses to biotherapeutics. AAPS J. 2016;18(6):1335–50.
Article CAS PubMed Google Scholar
Gouty D, Cai CC, Cai XY, Kasinath A, Kumar V, Alvandkouhi S, et al. Recommendations for the development and validation of neutralizing antibody assays in support of biosimilar assessment. AAPS J. 2017;20(1):25.
Article CAS PubMed Google Scholar
Xu W, Maas B, Roadcap B, Swarup A, Steinmetz T, Luo L, et al. Neutralization activity of anti-drug antibodies against a biotherapeutic can be predicted from a comprehensive pharmacokinetics, pharmacodynamics, and anti-drug antibody data analysis. AAPS J. 2022;24(6):102.
Article CAS PubMed Google Scholar
Hu J, Wala I, Han H, Nagatani J, Barger T, Civoli F, et al. Comparison of cell-based and non-cell-based assay platforms for the detection of clinically relevant anti-drug neutralizing antibodies for immunogenicity assessment of therapeutic proteins. J Immunol Methods. 2015;419:1–8.
Article CAS PubMed Google Scholar
Finco D, Baltrukonis D, Clements-Egan A, Delaria K, Gunn GR 3rd, Lowe J, et al. Comparison of competitive ligand-binding assay and bioassay formats for the measurement of neutralizing antibodies to protein therapeutics. J Pharm Biomed Anal. 2011;54(2):351–8.
Article CAS PubMed Google Scholar
Holst JJ. From the incretin concept and the discovery of GLP-1 to today’s diabetes therapy. Front Endocrinol (Lausanne). 2019;10:260.
Nauck MA, Quast DR, Wefers J, Pfeiffer AFH. The evolving story of incretins (GIP and GLP-1) in metabolic and cardiovascular disease: a pathophysiological update. Diabetes Obes Metab. 2021;23(Suppl 3):5–29.
Article CAS PubMed Google Scholar
Kusminski CM, Perez-Tilve D, Muller TD, DiMarchi RD, Tschop MH, Scherer PE. Transforming obesity: the advancement of multi-receptor drugs. Cell. 2024;187(15):3829–53.
Article CAS PubMed PubMed Central Google Scholar
Ansari S, Khoo B, Tan T. Targeting the incretin system in obesity and type 2 diabetes mellitus. Nat Rev Endocrinol. 2024;20(8):447–59.
Article CAS PubMed Google Scholar
Coskun T, Sloop KW, Loghin C, Alsina-Fernandez J, Urva S, Bokvist KB, et al. LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: from discovery to clinical proof of concept. Mol Metab. 2018;18:3–14.
Article CAS PubMed PubMed Central Google Scholar
Mack JK, Bivi N. Upfront acid treatment with low final pH: the development and testing of a novel method to improve drug tolerance in antidrug antibody assays. Bioanalysis. 2023;15(19):1179–91.
Article CAS PubMed Google Scholar
Chen YQ, Pottanat TG, Carter QL, Troutt JS, Konrad RJ, Sloan JH. Affinity capture elution bridging assay: a novel immunoassay format for detection of anti-therapeutic protein antibodies. J Immunol Methods. 2016;431:45–51.
Article CAS PubMed Google Scholar
Bourdage JS, Cook CA, Farrington DL, Chain JS, Konrad RJ. An affinity capture elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug. J Immunol Methods. 2007;327(1):10–7.
Article CAS PubMed Google Scholar
Ballman KK, Peek VL, Sloan JH, Li J, Konrad RJ, Wen Y. Cross-reactive polyclonal antibodies raised against galnac-conjugated siRNA recognize mostly the GalNAc moiety. AAPS J. 2024;26(3):41.
Article CAS PubMed Google Scholar
Peek VL, Lemen DM, Konrad RJ, Wen Y. A competitive ligand binding assay for detection of neutralizing antibodies against an insulin analog. J Immunol Methods. 2023;523:113575.
Article CAS PubMed Google Scholar
Simmons E, Wen Y, Li J, Qian YW, Wong LC, Konrad RJ, et al. A sensitive and drug tolerant assay for detecting anti-AAV9 antibodies using affinity capture elution. J Immunol Methods. 2023;512:113397.
Article CAS PubMed Google Scholar
Coskun T, Urva S, Roell WC, Qu H, Loghin C, Moyers JS, et al. LY3437943, a novel triple glucagon, GIP, and GLP-1 receptor agonist for glycemic control and weight loss: From discovery to clinical proof of concept. Cell Metab. 2022;34(9):1234-47 e9.
Article CAS PubMed Google Scholar
Mullins GR, Hodsdon ME, Li YG, Anglin G, Urva S, Schneck K, et al. Tirzepatide immunogenicity on pharmacokinetics, efficacy, and safety: analysis of data from phase 3 studies. J Clin Endocrinol Metab. 2024;109(2):361–9.
Comments (0)