Ex vivo model predicted in vivo efficacy of CFTR modulator therapy in a child with rare genotype.


Journal

Molecular genetics & genomic medicine
ISSN: 2324-9269
Titre abrégé: Mol Genet Genomic Med
Pays: United States
ID NLM: 101603758

Informations de publication

Date de publication:
04 2021
Historique:
revised: 15 01 2021
received: 17 11 2020
accepted: 19 02 2021
pubmed: 14 3 2021
medline: 15 12 2021
entrez: 13 3 2021
Statut: ppublish

Résumé

New drugs that target the basic defect in cystic fibrosis (CF) patients may now be used in a large number of patients carrying responsive mutations. Nevertheless, further research is needed to extend the benefit of these treatments to patients with rare mutations that are still uncharacterized in vitro and that are not included in clinical trials. For this purpose, ex vivo models are necessary to preliminary assessing the effect of CFTR modulators in these cases. We report the clinical effectiveness of lumacaftor/ivacaftor therapy prescribed to a CF child with a rare genetic profile (p.Phe508del/p.Gly970Asp) after testing the drug on nasal epithelial cells. We observed a significant drop of the sweat chloride value, as of the lung clearance index. A longer follow-up period is needed to define the effects of therapy on pancreatic status, although an increase of the fecal elastase values was found. Drug response obtained on nasal epithelial cells correlates with changes in vivo therapeutic endpoints and can be a predictor of clinical efficacy of novel drugs especially in pediatric patients.

Sections du résumé

BACKGROUND
New drugs that target the basic defect in cystic fibrosis (CF) patients may now be used in a large number of patients carrying responsive mutations. Nevertheless, further research is needed to extend the benefit of these treatments to patients with rare mutations that are still uncharacterized in vitro and that are not included in clinical trials. For this purpose, ex vivo models are necessary to preliminary assessing the effect of CFTR modulators in these cases.
METHOD
We report the clinical effectiveness of lumacaftor/ivacaftor therapy prescribed to a CF child with a rare genetic profile (p.Phe508del/p.Gly970Asp) after testing the drug on nasal epithelial cells. We observed a significant drop of the sweat chloride value, as of the lung clearance index. A longer follow-up period is needed to define the effects of therapy on pancreatic status, although an increase of the fecal elastase values was found.
CONCLUSION
Drug response obtained on nasal epithelial cells correlates with changes in vivo therapeutic endpoints and can be a predictor of clinical efficacy of novel drugs especially in pediatric patients.

Identifiants

pubmed: 33713579
doi: 10.1002/mgg3.1656
pmc: PMC8123755
doi:

Substances chimiques

Aminophenols 0
Aminopyridines 0
Benzodioxoles 0
CFTR protein, human 0
Chloride Channel Agonists 0
Chlorides 0
Quinolones 0
Cystic Fibrosis Transmembrane Conductance Regulator 126880-72-6
ivacaftor 1Y740ILL1Z
Pancreatic Elastase EC 3.4.21.36
lumacaftor EGP8L81APK

Types de publication

Case Reports Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e1656

Informations de copyright

© 2021 The Authors. Molecular Genetics & Genomic Medicine published by Wiley Periodicals LLC.

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Auteurs

Vito Terlizzi (V)

Cystic Fibrosis Regional Reference Center,, Department of Paediatric Medicine, Anna Meyer Children's University, Florence, Italy.

Felice Amato (F)

Department of Molecular Medicine and Medical Biotechnology, University of Naples Federico II.
CEINGE - Advanced Biotechnologies, Naples, Italy.

Chiara Castellani (C)

Cystic Fibrosis Regional Reference Center,, Department of Paediatric Medicine, Anna Meyer Children's University, Florence, Italy.

Beatrice Ferrari (B)

Cystic Fibrosis Regional Reference Center,, Department of Paediatric Medicine, Anna Meyer Children's University, Florence, Italy.

Luis J V Galietta (LJV)

Telethon Institute of Genetics and Medicine (TIGEM, Pozzuoli, Italy).
Department of Translational Medical Sciences, University of Naples Federico II, Napoli, Italy.

Giuseppe Castaldo (G)

Department of Molecular Medicine and Medical Biotechnology, University of Naples Federico II.
CEINGE - Advanced Biotechnologies, Naples, Italy.

Giovanni Taccetti (G)

Cystic Fibrosis Regional Reference Center,, Department of Paediatric Medicine, Anna Meyer Children's University, Florence, Italy.

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Classifications MeSH