دورية أكاديمية

Evaluating drug interaction potential from cytokine release syndrome using a physiologically based pharmacokinetic model: A case study of teclistamab.

التفاصيل البيبلوغرافية
العنوان: Evaluating drug interaction potential from cytokine release syndrome using a physiologically based pharmacokinetic model: A case study of teclistamab.
المؤلفون: Willemin ME; Janssen Research & Development, Beerse, Belgium., Wang Lin SX; Janssen Research & Development, Spring House, Pennsylvania, USA., De Zwart L; Janssen Research & Development, Beerse, Belgium., Wu LS; Janssen Research & Development, South San Francisco, California, USA., Miao X; Janssen Research & Development, Spring House, Pennsylvania, USA., Verona R; Janssen Research & Development, Spring House, Pennsylvania, USA., Banerjee A; Janssen Research & Development, Spring House, Pennsylvania, USA., Liu B; Janssen Research & Development, Raritan, New Jersey, USA., Kobos R; Janssen Research & Development, Raritan, New Jersey, USA., Qi M; Janssen Research & Development, Raritan, New Jersey, USA., Ouellet D; Janssen Research & Development, Spring House, Pennsylvania, USA., Goldberg JD; Janssen Research & Development, Raritan, New Jersey, USA., Girgis S; Janssen Research & Development, Spring House, Pennsylvania, USA.
المصدر: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2024 Jul; Vol. 13 (7), pp. 1117-1129. Date of Electronic Publication: 2024 Jun 03.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Wiley Country of Publication: United States NLM ID: 101580011 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2163-8306 (Electronic) Linking ISSN: 21638306 NLM ISO Abbreviation: CPT Pharmacometrics Syst Pharmacol Subsets: MEDLINE
أسماء مطبوعة: Publication: 2015- : Hoboken, NJ : Wiley
Original Publication: New York, NY : Nature Pub. Group
مواضيع طبية MeSH: Drug Interactions* , Interleukin-6*/blood , Cytokine Release Syndrome*/drug therapy , Models, Biological*, Humans ; Cytochrome P-450 Enzyme System/metabolism ; Area Under Curve ; Cyclosporine/pharmacokinetics ; Cyclosporine/administration & dosage ; Midazolam/pharmacokinetics ; Midazolam/administration & dosage ; Omeprazole/pharmacokinetics ; Omeprazole/administration & dosage ; Simvastatin/pharmacokinetics ; Simvastatin/administration & dosage
مستخلص: Cytokine release syndrome (CRS) was associated with teclistamab treatment in the phase I/II MajesTEC-1 study. Cytokines, especially interleukin (IL)-6, are known suppressors of cytochrome P450 (CYP) enzymes' activity. A physiologically based pharmacokinetic model evaluated the impact of IL-6 serum levels on exposure of substrates of various CYP enzymes (1A2, 2C9, 2C19, 3A4, 3A5). Two IL-6 kinetics profiles were assessed, the mean IL-6 profile with a maximum concentration (C max ) of IL-6 (21 pg/mL) and the IL-6 profile of the patient presenting the highest IL-6 C max (288 pg/mL) among patients receiving the recommended phase II dose of teclistamab in MajesTEC-1. For the mean IL-6 kinetics profile, teclistamab was predicted to result in a limited change in exposure of CYP substrates (area under the curve [AUC] mean ratio 0.87-1.20). For the maximum IL-6 kinetics profile, the impact on omeprazole, simvastatin, midazolam, and cyclosporine exposure was weak to moderate (mean AUC ratios 1.90-2.23), and minimal for caffeine and s-warfarin (mean AUC ratios 0.82-1.25). Maximum change in exposure for these substrates occurred 3-4 days after step-up dosing in cycle 1. These results suggest that after cycle 1, drug interaction from IL-6 effect has no meaningful impact on CYP activities, with minimal or moderate impact on CYP substrates. The highest risk of drug interaction is expected to occur during step-up dosing up to 7 days after the first treatment dose (1.5 mg/kg subcutaneously) and during and after CRS.
(© 2024 The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)
References: Clin Pharmacokinet. 2010 May;49(5):295-310. (PMID: 20384392)
Clin Pharmacol Ther. 2009 Jul;86(1):54-61. (PMID: 19369937)
Drug Metab Dispos. 2022 Oct;50(10):1322-1331. (PMID: 36100353)
Clin Pharmacol Ther. 2022 Mar;111(3):579-584. (PMID: 34496043)
Eur J Clin Pharmacol. 2004 May;60(3):165-71. (PMID: 15045499)
Blood. 2011 May 5;117(18):4691-5. (PMID: 21292775)
Am J Hematol. 2020 May;95(5):548-567. (PMID: 32212178)
J Card Fail. 2002 Oct;8(5):315-9. (PMID: 12411982)
Biosensors (Basel). 2022 Sep 14;12(9):. (PMID: 36140141)
Curr Drug Metab. 2012 Sep 1;13(7):923-9. (PMID: 22475265)
CPT Pharmacometrics Syst Pharmacol. 2022 Jul;11(7):822-832. (PMID: 35445542)
Clin Pharmacol Ther. 2011 May;89(5):735-40. (PMID: 21430660)
Blood. 2014 Jul 10;124(2):188-95. (PMID: 24876563)
CPT Pharmacometrics Syst Pharmacol. 2024 Mar;13(3):396-409. (PMID: 38044486)
CPT Pharmacometrics Syst Pharmacol. 2024 Feb;13(2):234-246. (PMID: 38050329)
Drug Metab Dispos. 2011 Feb;39(2):170-3. (PMID: 21036951)
CPT Pharmacometrics Syst Pharmacol. 2024 Jul;13(7):1117-1129. (PMID: 38831634)
N Engl J Med. 2022 Aug 11;387(6):495-505. (PMID: 35661166)
Clin Pharmacol Ther. 2013 Aug;94(2):260-8. (PMID: 23588308)
Blood Adv. 2020 Sep 22;4(18):4538-4549. (PMID: 32956453)
Clin Pharmacol Ther. 2023 Jun;113(6):1185-1198. (PMID: 36477720)
CPT Pharmacometrics Syst Pharmacol. 2022 Jan;11(1):30-43. (PMID: 34791831)
Clin Transl Sci. 2023 Jun;16(6):922-936. (PMID: 36890677)
J Clin Pharmacol. 2015 Dec;55(12):1386-94. (PMID: 26054042)
Biochem Pharmacol. 1999 Apr 15;57(8):951-4. (PMID: 10086330)
Lancet. 2021 Aug 21;398(10301):665-674. (PMID: 34388396)
Drug Metab Dispos. 2013 Sep;41(9):1598-609. (PMID: 23792813)
Drug Metab Dispos. 2011 Aug;39(8):1415-22. (PMID: 21555507)
J Pharmacol Exp Ther. 1994 Jan;268(1):515-21. (PMID: 8301593)
Pharmaceuticals (Basel). 2022 Apr 22;15(5):. (PMID: 35631335)
AAPS J. 2016 May;18(3):767-76. (PMID: 26961818)
Br J Clin Pharmacol. 2016 Jul;82(1):160-7. (PMID: 26991517)
Clin Pharmacol Ther. 2015 Mar;97(3):247-62. (PMID: 25670209)
Clin Transl Sci. 2022 Feb;15(2):464-476. (PMID: 34581012)
Pharmacogenetics. 2002 Mar;12(2):101-9. (PMID: 11875364)
Drug Metab Pharmacokinet. 2010;25(4):367-78. (PMID: 20814158)
AAPS J. 2019 Mar 18;21(3):42. (PMID: 30887238)
CPT Pharmacometrics Syst Pharmacol. 2015 Sep;4(9):507-15. (PMID: 26451330)
معلومات مُعتمدة: Janssen Research & Development, LLC
المشرفين على المادة: 0 (Interleukin-6)
9035-51-2 (Cytochrome P-450 Enzyme System)
83HN0GTJ6D (Cyclosporine)
R60L0SM5BC (Midazolam)
KG60484QX9 (Omeprazole)
AGG2FN16EV (Simvastatin)
تواريخ الأحداث: Date Created: 20240604 Date Completed: 20240715 Latest Revision: 20240717
رمز التحديث: 20240717
مُعرف محوري في PubMed: PMC11247108
DOI: 10.1002/psp4.13144
PMID: 38831634
قاعدة البيانات: MEDLINE
الوصف
تدمد:2163-8306
DOI:10.1002/psp4.13144