Signal-to-noise ratio to assess magnitude, kinetics and impact on pharmacokinetics of the immune response to an adalimumab biosimilar
Background: The antidrug antibody (ADA) signal-to-noise (S/N) ratio was explored as a novel immunogenicity measure to evaluate the immune response of healthy subjects to a single dose of GP2017, an adalimumab biosimilar. Methodology/results: Bioanalytical methods used for the analysis of ADA S/N ratios and ADA titers were validated for sensitivity, precision and drug interference. ADA S/N ratios strongly correlated with ADA titers. Correlations between ADA area under the curve and ADAmax and pharmacokinetics (PK) were stronger for ADA S/N ratio than for ADA titers. Conclusion: ADA S/N ratio allowed for a more sensitive evaluation of the magnitude and kinetics of the immune response, was better correlated with adalimumab PK and was superior to ADA titers in assessing the impact of the immune response on PK.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 2023 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:16 |
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| Enthalten in: |
Bioanalysis - 16(2023), 1 vom: 14. Jan., Seite 33-48 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Guerrieri, Davide [VerfasserIn] |
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| Links: |
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| Themen: |
Adalimumab |
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| Anmerkungen: |
Date Completed 16.12.2023 Date Revised 16.12.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.4155/bio-2023-0152 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM365228796 |
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| 245 | 1 | 0 | |a Signal-to-noise ratio to assess magnitude, kinetics and impact on pharmacokinetics of the immune response to an adalimumab biosimilar |
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| 500 | |a Date Revised 16.12.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Background: The antidrug antibody (ADA) signal-to-noise (S/N) ratio was explored as a novel immunogenicity measure to evaluate the immune response of healthy subjects to a single dose of GP2017, an adalimumab biosimilar. Methodology/results: Bioanalytical methods used for the analysis of ADA S/N ratios and ADA titers were validated for sensitivity, precision and drug interference. ADA S/N ratios strongly correlated with ADA titers. Correlations between ADA area under the curve and ADAmax and pharmacokinetics (PK) were stronger for ADA S/N ratio than for ADA titers. Conclusion: ADA S/N ratio allowed for a more sensitive evaluation of the magnitude and kinetics of the immune response, was better correlated with adalimumab PK and was superior to ADA titers in assessing the impact of the immune response on PK | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a adalimumab | |
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| 650 | 4 | |a biosimilars | |
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| 650 | 4 | |a immunogenicity | |
| 650 | 4 | |a pharmacokinetics | |
| 650 | 4 | |a signal-to-noise ratio | |
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| 650 | 7 | |a Biosimilar Pharmaceuticals |2 NLM | |
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| 700 | 1 | |a Horvat, Matej |e verfasserin |4 aut | |
| 700 | 1 | |a Fan, Jamie |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Jessie |e verfasserin |4 aut | |
| 700 | 1 | |a Lemke, Lena |e verfasserin |4 aut | |
| 700 | 1 | |a Richter, Oliver von |e verfasserin |4 aut | |
| 700 | 1 | |a Poetzl, Johann |e verfasserin |4 aut | |
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