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Research Article

Factors Contributing to the Nonlinear Pharmacokinetics of Astegolimab: A Close Examination of Potential Causes

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Pages 1305-1314 | Received 05 Jun 2023, Accepted 11 Sep 2023, Published online: 04 Oct 2023

References

  • Bagnasco D , TestinoE, NicolaSet al. Specific therapy for T2 asthma. J. Pers. Med.12(4), 593 (2022).
  • Kelsen SG , AgacheIO, SoongWet al. Astegolimab (anti-ST2) efficacy and safety in adults with severe asthma: a randomized clinical trial. J. Allergy Clin. Immunol.148(3), 790–798 (2021).
  • Caselli C . Inflammation in cardiac disease: focus on Interleukin-33/ST2 pathway. Inflammat. Cell Signal.1(1), e149 (2014).
  • Ovacik M , LinK. Tutorial on monoclonal antibody pharmacokinetics and its considerations in early development. Clin. Translat. Sci.11(6), 540–552 (2018).
  • Tang MT , KeirME, EricksonRet al. Review article: nonclinical and clinical pharmacology, pharmacokinetics and pharmacodynamics of etrolizumab, an anti-β7 integrin therapy for inflammatory bowel disease. Aliment Pharmacol. Ther.47(11), 1440–1452 (2018).
  • Deng R , JinF, PrabhuS, IyerS. Monoclonal antibodies: what are the pharmacokinetic and pharmacodynamic considerations for drug development?Expert Opin. Drug Metab. Toxicol.8(2), 141–160 (2012).
  • Wang J , IyerS, FielderPJ, DavisJD, DengR. Projecting human pharmacokinetics of monoclonal antibodies from nonclinical data: comparative evaluation of prediction approaches in early drug development. Biopharm. Drug Dispos.37(2), 51–65 (2016).
  • Bartelds GM , WijbrandtsCA, NurmohamedMTet al. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann. Rheum. Dis.66(7), 921–926 (2007).
  • Lecluse LL , DriessenRJ, SpulsPIet al. Extent and clinical consequences of antibody formation against adalimumab in patients with plaque psoriasis. Arch. Dermatol.146(2), 127–132 (2010).
  • Levy G . Pharmacologic target-mediated drug disposition. Clin. Pharmacol. Ther.56(3), 248–252 (1994).
  • Fischer SK . Factors that impact pharmacokinetic measurements of antibody therapeutics: what is your PK assay telling you?Bioanalysis9, 1531–1533 (2017).
  • Peng K , XuK, LiuLet al. Critical role of bioanalytical strategies in investigation of clinical PK observations, a phase I case study. MAbs6(6), 1500–1508 (2014).
  • Fischer SK . Factors that impact pharmacokinetic measurements of antibody therapeutics: what is your PK assay telling you?Bioanalysis9(20), 1531–1533 (2017).
  • Samineni D , GirishS, LiC. Impact of shed/soluble targets on the PK/PD of approved therapeutic monoclonal antibodies. Expert Rev. Clin. Pharmacol.9(12), 1557–1569 (2016).
  • Tang C , PrueksaritanontT. Theoretical analysis of interplay of therapeutic protein drug and circulating soluble target: temporal profiles of ‘free’ and ‘total’ drug and target. Pharm. Res.28(10), 2447–2457 (2011).
  • Fischer SK , YangJ, AnandBet al. The assay design used for measurement of therapeutic antibody concentrations can affect pharmacokinetic parameters: case studies. MAbs4(5), 623–631 (2012).

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