Semi‐Mechanistic Population Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling of Dupilumab on Pre‐Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) in Uncontrolled Moderate‐To‐Severe Asthma
ABSTRACT In this study, we investigated the pharmacokinetic/pharmacodynamic (PK/PD) relationship of dupilumab as an add‐on therapy in the intent‐to‐treat (ITT) uncontrolled moderate‐to‐severe asthma population and identified the factors significantly contributing to variability in forced expiratory...
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| Vydáno v: | CPT: pharmacometrics and systems pharmacology Ročník 14; číslo 8; s. 1370 - 1380 |
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| Hlavní autoři: | , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
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United States
John Wiley & Sons, Inc
01.08.2025
John Wiley and Sons Inc Wiley |
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| ISSN: | 2163-8306, 2163-8306 |
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| Abstract | ABSTRACT
In this study, we investigated the pharmacokinetic/pharmacodynamic (PK/PD) relationship of dupilumab as an add‐on therapy in the intent‐to‐treat (ITT) uncontrolled moderate‐to‐severe asthma population and identified the factors significantly contributing to variability in forced expiratory volume in 1 second; (FEV1). A semi‐mechanistic population PK/PD model was developed using data from two placebo‐controlled pivotal studies in 2654 adult and adolescent patients (n = 794 treated with placebo; n = 1860 treated with dupilumab 200 mg [400‐mg loading dose] or 300 mg [600‐mg loading dose] administered subcutaneously every 2 [Q2W] or 4 weeks [Q4W]). Treatment effect was described using a dupilumab concentration‐dependent direct‐response Emax model, and placebo effect was described using an empirical time‐dependent function. Demographic variables, baseline disease characteristics, type‐2 inflammation biomarkers, and immunogenicity were tested as covariates using the stepwise forward selection and backward elimination method. Baseline type‐2 inflammation biomarkers (fractional exhaled nitric oxide [FeNO] level and blood eosinophil [EOS] count) were found to be significant covariates for FEV1, with greater efficacy in patients with elevated biomarker levels. None of the other tested covariates, including age (12–87 years), had a significant impact on FEV1. The PK/PD model predicted near‐maximum FEV1 response (0.1 L) over a dose of dupilumab. 200–300 mg Q2W in patients with moderate‐to‐severe asthma. |
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| AbstractList | In this study, we investigated the pharmacokinetic/pharmacodynamic (PK/PD) relationship of dupilumab as an add-on therapy in the intent-to-treat (ITT) uncontrolled moderate-to-severe asthma population and identified the factors significantly contributing to variability in forced expiratory volume in 1 second; (FEV
). A semi-mechanistic population PK/PD model was developed using data from two placebo-controlled pivotal studies in 2654 adult and adolescent patients (n = 794 treated with placebo; n = 1860 treated with dupilumab 200 mg [400-mg loading dose] or 300 mg [600-mg loading dose] administered subcutaneously every 2 [Q2W] or 4 weeks [Q4W]). Treatment effect was described using a dupilumab concentration-dependent direct-response E
model, and placebo effect was described using an empirical time-dependent function. Demographic variables, baseline disease characteristics, type-2 inflammation biomarkers, and immunogenicity were tested as covariates using the stepwise forward selection and backward elimination method. Baseline type-2 inflammation biomarkers (fractional exhaled nitric oxide [FeNO] level and blood eosinophil [EOS] count) were found to be significant covariates for FEV
, with greater efficacy in patients with elevated biomarker levels. None of the other tested covariates, including age (12-87 years), had a significant impact on FEV
. The PK/PD model predicted near-maximum FEV
response (0.1 L) over a dose of dupilumab. 200-300 mg Q2W in patients with moderate-to-severe asthma. ABSTRACT In this study, we investigated the pharmacokinetic/pharmacodynamic (PK/PD) relationship of dupilumab as an add‐on therapy in the intent‐to‐treat (ITT) uncontrolled moderate‐to‐severe asthma population and identified the factors significantly contributing to variability in forced expiratory volume in 1 second; (FEV1). A semi‐mechanistic population PK/PD model was developed using data from two placebo‐controlled pivotal studies in 2654 adult and adolescent patients (n = 794 treated with placebo; n = 1860 treated with dupilumab 200 mg [400‐mg loading dose] or 300 mg [600‐mg loading dose] administered subcutaneously every 2 [Q2W] or 4 weeks [Q4W]). Treatment effect was described using a dupilumab concentration‐dependent direct‐response Emax model, and placebo effect was described using an empirical time‐dependent function. Demographic variables, baseline disease characteristics, type‐2 inflammation biomarkers, and immunogenicity were tested as covariates using the stepwise forward selection and backward elimination method. Baseline type‐2 inflammation biomarkers (fractional exhaled nitric oxide [FeNO] level and blood eosinophil [EOS] count) were found to be significant covariates for FEV1, with greater efficacy in patients with elevated biomarker levels. None of the other tested covariates, including age (12–87 years), had a significant impact on FEV1. The PK/PD model predicted near‐maximum FEV1 response (0.1 L) over a dose of dupilumab. 200–300 mg Q2W in patients with moderate‐to‐severe asthma. In this study, we investigated the pharmacokinetic/pharmacodynamic (PK/PD) relationship of dupilumab as an add-on therapy in the intent-to-treat (ITT) uncontrolled moderate-to-severe asthma population and identified the factors significantly contributing to variability in forced expiratory volume in 1 second; (FEV1). A semi-mechanistic population PK/PD model was developed using data from two placebo-controlled pivotal studies in 2654 adult and adolescent patients (n = 794 treated with placebo; n = 1860 treated with dupilumab 200 mg [400-mg loading dose] or 300 mg [600-mg loading dose] administered subcutaneously every 2 [Q2W] or 4 weeks [Q4W]). Treatment effect was described using a dupilumab concentration-dependent direct-response Emax model, and placebo effect was described using an empirical time-dependent function. Demographic variables, baseline disease characteristics, type-2 inflammation biomarkers, and immunogenicity were tested as covariates using the stepwise forward selection and backward elimination method. Baseline type-2 inflammation biomarkers (fractional exhaled nitric oxide [FeNO] level and blood eosinophil [EOS] count) were found to be significant covariates for FEV1, with greater efficacy in patients with elevated biomarker levels. None of the other tested covariates, including age (12-87 years), had a significant impact on FEV1. The PK/PD model predicted near-maximum FEV1 response (0.1 L) over a dose of dupilumab. 200-300 mg Q2W in patients with moderate-to-severe asthma.In this study, we investigated the pharmacokinetic/pharmacodynamic (PK/PD) relationship of dupilumab as an add-on therapy in the intent-to-treat (ITT) uncontrolled moderate-to-severe asthma population and identified the factors significantly contributing to variability in forced expiratory volume in 1 second; (FEV1). A semi-mechanistic population PK/PD model was developed using data from two placebo-controlled pivotal studies in 2654 adult and adolescent patients (n = 794 treated with placebo; n = 1860 treated with dupilumab 200 mg [400-mg loading dose] or 300 mg [600-mg loading dose] administered subcutaneously every 2 [Q2W] or 4 weeks [Q4W]). Treatment effect was described using a dupilumab concentration-dependent direct-response Emax model, and placebo effect was described using an empirical time-dependent function. Demographic variables, baseline disease characteristics, type-2 inflammation biomarkers, and immunogenicity were tested as covariates using the stepwise forward selection and backward elimination method. Baseline type-2 inflammation biomarkers (fractional exhaled nitric oxide [FeNO] level and blood eosinophil [EOS] count) were found to be significant covariates for FEV1, with greater efficacy in patients with elevated biomarker levels. None of the other tested covariates, including age (12-87 years), had a significant impact on FEV1. The PK/PD model predicted near-maximum FEV1 response (0.1 L) over a dose of dupilumab. 200-300 mg Q2W in patients with moderate-to-severe asthma. In this study, we investigated the pharmacokinetic/pharmacodynamic (PK/PD) relationship of dupilumab as an add‐on therapy in the intent‐to‐treat (ITT) uncontrolled moderate‐to‐severe asthma population and identified the factors significantly contributing to variability in forced expiratory volume in 1 second; (FEV 1 ). A semi‐mechanistic population PK/PD model was developed using data from two placebo‐controlled pivotal studies in 2654 adult and adolescent patients ( n = 794 treated with placebo; n = 1860 treated with dupilumab 200 mg [400‐mg loading dose] or 300 mg [600‐mg loading dose] administered subcutaneously every 2 [Q2W] or 4 weeks [Q4W]). Treatment effect was described using a dupilumab concentration‐dependent direct‐response E max model, and placebo effect was described using an empirical time‐dependent function. Demographic variables, baseline disease characteristics, type‐2 inflammation biomarkers, and immunogenicity were tested as covariates using the stepwise forward selection and backward elimination method. Baseline type‐2 inflammation biomarkers (fractional exhaled nitric oxide [FeNO] level and blood eosinophil [EOS] count) were found to be significant covariates for FEV 1 , with greater efficacy in patients with elevated biomarker levels. None of the other tested covariates, including age (12–87 years), had a significant impact on FEV 1 . The PK/PD model predicted near‐maximum FEV 1 response (0.1 L) over a dose of dupilumab. 200–300 mg Q2W in patients with moderate‐to‐severe asthma. In this study, we investigated the pharmacokinetic/pharmacodynamic (PK/PD) relationship of dupilumab as an add‐on therapy in the intent‐to‐treat (ITT) uncontrolled moderate‐to‐severe asthma population and identified the factors significantly contributing to variability in forced expiratory volume in 1 second; (FEV1). A semi‐mechanistic population PK/PD model was developed using data from two placebo‐controlled pivotal studies in 2654 adult and adolescent patients (n = 794 treated with placebo; n = 1860 treated with dupilumab 200 mg [400‐mg loading dose] or 300 mg [600‐mg loading dose] administered subcutaneously every 2 [Q2W] or 4 weeks [Q4W]). Treatment effect was described using a dupilumab concentration‐dependent direct‐response E max model, and placebo effect was described using an empirical time‐dependent function. Demographic variables, baseline disease characteristics, type‐2 inflammation biomarkers, and immunogenicity were tested as covariates using the stepwise forward selection and backward elimination method. Baseline type‐2 inflammation biomarkers (fractional exhaled nitric oxide [FeNO] level and blood eosinophil [EOS] count) were found to be significant covariates for FEV1, with greater efficacy in patients with elevated biomarker levels. None of the other tested covariates, including age (12–87 years), had a significant impact on FEV1. The PK/PD model predicted near‐maximum FEV1 response (0.1 L) over a dose of dupilumab. 200–300 mg Q2W in patients with moderate‐to‐severe asthma. ABSTRACT In this study, we investigated the pharmacokinetic/pharmacodynamic (PK/PD) relationship of dupilumab as an add‐on therapy in the intent‐to‐treat (ITT) uncontrolled moderate‐to‐severe asthma population and identified the factors significantly contributing to variability in forced expiratory volume in 1 second; (FEV1). A semi‐mechanistic population PK/PD model was developed using data from two placebo‐controlled pivotal studies in 2654 adult and adolescent patients (n = 794 treated with placebo; n = 1860 treated with dupilumab 200 mg [400‐mg loading dose] or 300 mg [600‐mg loading dose] administered subcutaneously every 2 [Q2W] or 4 weeks [Q4W]). Treatment effect was described using a dupilumab concentration‐dependent direct‐response Emax model, and placebo effect was described using an empirical time‐dependent function. Demographic variables, baseline disease characteristics, type‐2 inflammation biomarkers, and immunogenicity were tested as covariates using the stepwise forward selection and backward elimination method. Baseline type‐2 inflammation biomarkers (fractional exhaled nitric oxide [FeNO] level and blood eosinophil [EOS] count) were found to be significant covariates for FEV1, with greater efficacy in patients with elevated biomarker levels. None of the other tested covariates, including age (12–87 years), had a significant impact on FEV1. The PK/PD model predicted near‐maximum FEV1 response (0.1 L) over a dose of dupilumab. 200–300 mg Q2W in patients with moderate‐to‐severe asthma. |
| Author | Davis, John D. Kanamaluru, Vanaja Xu, Christine Zhang, Li |
| AuthorAffiliation | 1 Sanofi, Bridgewater New Jersey USA 2 Regeneron Pharmaceuticals, Inc. Tarrytown New York USA |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/40536285$$D View this record in MEDLINE/PubMed |
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| Copyright | 2025 The Author(s). published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. 2025 The Author(s). CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. 2025. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the "License"). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
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| Keywords | asthma forced expiratory volume in 1 s population pharmacokinetic/pharmacodynamic dupilumab monoclonal antibodies |
| Language | English |
| License | Attribution-NonCommercial-NoDerivs 2025 The Author(s). CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
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| Notes | Li Zhang —Former employee (employed at Sanofi at the time of the study). Funding Research was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 ObjectType-Undefined-3 Funding: Research was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. |
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In this study, we investigated the pharmacokinetic/pharmacodynamic (PK/PD) relationship of dupilumab as an add‐on therapy in the intent‐to‐treat (ITT)... In this study, we investigated the pharmacokinetic/pharmacodynamic (PK/PD) relationship of dupilumab as an add‐on therapy in the intent‐to‐treat (ITT)... In this study, we investigated the pharmacokinetic/pharmacodynamic (PK/PD) relationship of dupilumab as an add-on therapy in the intent-to-treat (ITT)... ABSTRACT In this study, we investigated the pharmacokinetic/pharmacodynamic (PK/PD) relationship of dupilumab as an add‐on therapy in the intent‐to‐treat (ITT)... |
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| SubjectTerms | Adolescent Adult Aged Airway management Anti-Asthmatic Agents - administration & dosage Anti-Asthmatic Agents - pharmacokinetics Anti-Asthmatic Agents - pharmacology Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - pharmacokinetics Antibodies, Monoclonal, Humanized - pharmacology Asthma Asthma - drug therapy Asthma - physiopathology Biomarkers Bronchodilators Dose-Response Relationship, Drug Double-Blind Method Drug dosages dupilumab Female Forced Expiratory Volume - drug effects forced expiratory volume in 1 s Humans Inflammation Male Middle Aged Missing data Models, Biological Monoclonal antibodies Patients Pediatrics Pharmacodynamics Pharmacokinetics Placebo effect Population population pharmacokinetic/pharmacodynamic Severity of Illness Index Software Spirometry Steroids Young Adult |
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| Title | Semi‐Mechanistic Population Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling of Dupilumab on Pre‐Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) in Uncontrolled Moderate‐To‐Severe Asthma |
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