Theratyping cystic fibrosis patients to guide elexacaftor/tezacaftor/ivacaftor out-of-label prescription.


Journal

The European respiratory journal
ISSN: 1399-3003
Titre abrégé: Eur Respir J
Pays: England
ID NLM: 8803460

Informations de publication

Date de publication:
10 2023
Historique:
received: 18 01 2023
accepted: 16 08 2023
medline: 23 10 2023
pubmed: 12 9 2023
entrez: 11 9 2023
Statut: epublish

Résumé

Around 20% of people with cystic fibrosis (pwCF) do not have access to the triple combination elexacaftor/tezacaftor/ivacaftor (ETI) in Europe because they do not carry the F508del allele on the CF transmembrane conductance regulator ( CFTR activity correction was studied by short-circuit current in HNEC cultures at basal state (dimethyl sulfoxide (DMSO)) and after ETI incubation and expressed as percentage of normal (wild-type (WT)) CFTR activity after sequential addition of forskolin and Inh-172 (Δ 11 pwCF carried variants eligible for ETI according to the FDA label and 28 carried variants not listed by the FDA. ETI significantly increased CFTR activity of FDA-approved Primary nasal epithelial cells hold promise for expanding the prescription of CFTR modulators in pwCF carrying rare mutants. Additional variants should be discussed for ETI indication.

Sections du résumé

BACKGROUND
Around 20% of people with cystic fibrosis (pwCF) do not have access to the triple combination elexacaftor/tezacaftor/ivacaftor (ETI) in Europe because they do not carry the F508del allele on the CF transmembrane conductance regulator (
METHODS
CFTR activity correction was studied by short-circuit current in HNEC cultures at basal state (dimethyl sulfoxide (DMSO)) and after ETI incubation and expressed as percentage of normal (wild-type (WT)) CFTR activity after sequential addition of forskolin and Inh-172 (Δ
RESULTS
11 pwCF carried variants eligible for ETI according to the FDA label and 28 carried variants not listed by the FDA. ETI significantly increased CFTR activity of FDA-approved
CONCLUSIONS
Primary nasal epithelial cells hold promise for expanding the prescription of CFTR modulators in pwCF carrying rare mutants. Additional variants should be discussed for ETI indication.

Identifiants

pubmed: 37696564
pii: 13993003.00110-2023
doi: 10.1183/13993003.00110-2023
pii:
doi:

Substances chimiques

elexacaftor RRN67GMB0V
ivacaftor 1Y740ILL1Z
tezacaftor 0
Cystic Fibrosis Transmembrane Conductance Regulator 126880-72-6
Dimethyl Sulfoxide YOW8V9698H

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright ©The authors 2023. For reproduction rights and permissions contact permissions@ersnet.org.

Déclaration de conflit d'intérêts

Conflict of interest: P.R. Burgel reports grants from Vertex and GSK, outside the submitted work. N. Stremler reports advisory board participation with Vertex, outside the submitted work. B. Douvry reports grants and advisory board participation with Vertex, outside the submitted work. L. Le Clainche reports payment for expert testimony from Zambon, Novartis and Viatris, outside the submitted work. C. Marguet reports consulting fees from Vertex and Mylan, and payment for expert testimony from Vertex and Zambon, outside the submitted work. P. de Carli reports grants from Vaincre la Mucoviscidose, outside the submitted work. I. Sermet-Gaudelus reports support for the present manuscript from Vaincre la Mucoviscidose and Mucoviscidose ABCF2. I. Sermet-Gaudelus also reports, outside the submitted work, grants from Agence Nationale pour la Recherche, Assistance Publique–Hôpitaux de Paris and Vertex Innovation Award, and consulting fees and travel support from Vertex therapeutics. All other authors have nothing to disclose.

Auteurs

Elise Dreano (E)

INSERM, CNRS, Institut Necker Enfants Malades, Paris, France.
Université Paris-Cité, Paris, France.

Pierre Régis Burgel (PR)

Université Paris-Cité, Paris, France.
Respiratory Medicine and Cystic Fibrosis National Reference Center, Cochin Hospital, AP-HP, Paris, France.
INSERM U1016, Institut Cochin, Paris, France.
ERN-LUNG CF Network, Frankfurt, Germany.

Aurelie Hatton (A)

INSERM, CNRS, Institut Necker Enfants Malades, Paris, France.
Université Paris-Cité, Paris, France.

Naim Bouazza (N)

Université Paris-Cité, Paris, France.
Unité de Recherche Clinique, Hôpital Necker Enfants Malades, AP-HP, Paris, France.

Benoit Chevalier (B)

INSERM, CNRS, Institut Necker Enfants Malades, Paris, France.
Université Paris-Cité, Paris, France.

Julie Macey (J)

Centre de Ressources et de Compétence de la Mucoviscidose, CHU Pellegrin, Bordeaux, France.

Sylvie Leroy (S)

Centre de Ressources et de Compétence de la Mucoviscidose, CHU, Nice, France.

Isabelle Durieu (I)

Centre de Référence Adulte de la Mucoviscidose, Hospices Civils de Lyon, Université de Lyon, Équipe d'Accueil Health Services and Performance Research (HESPER) 7425, Lyon, France.

Laurence Weiss (L)

Centre de Ressources et de Compétence de la Mucoviscidose Pédiatrique, CHU, Strasbourg, France.

Dominique Grenet (D)

Centre de Ressources et de Compétence de la Mucoviscidose, Hôpital Foch, Suresnes, France.

Nathalie Stremler (N)

Centre de Ressources et de Compétence de la Mucoviscidose, Hôpital de la Timone, Marseille, France.

Camille Ohlmann (C)

Centre de Ressources et de Compétence de la Mucoviscidose Pédiatrique, Hospices Civils de Lyon, Bron, France.

Philippe Reix (P)

Centre de Ressources et de Compétence de la Mucoviscidose Pédiatrique, Hospices Civils de Lyon, Bron, France.

Michele Porzio (M)

Centre de Ressources et de Compétence de la Mucoviscidose Adulte, CHU, Strasbourg, France.

Pauline Roux Claude (P)

Centre de Ressources et de Compétence de la Mucoviscidose Adulte, CHU, Besancon, France.

Natacha Rémus (N)

Centre de Ressources et de Compétence de la Mucoviscidose Mixte, CHIC, Créteil, France.

Benoit Douvry (B)

Centre de Ressources et de Compétence de la Mucoviscidose Mixte, CHIC, Créteil, France.

Sylvie Montcouquiol (S)

Centre de Ressources et de Compétence de la Mucoviscidose Adulte, CHU, Clermont Ferrand, France.

Laure Cosson (L)

Centre de Ressources et de Compétence de la Mucoviscidose Pédiatrique, CHU, Tours, France.

Julie Mankikian (J)

Centre de Ressources et de Compétence de la Mucoviscidose Adulte, CHU, Tours, France.

Jeanne Languepin (J)

Centre de Ressources et de Compétence de la Mucoviscidose Mixte, CHU, Limoges, France.

Veronique Houdouin (V)

Centre de Ressources et de Compétence de la Mucoviscidose Pédiatrique, Hôpital Robert Debré, Paris, France.

Laurence Le Clainche (L)

Centre de Ressources et de Compétence de la Mucoviscidose Pédiatrique, Hôpital Robert Debré, Paris, France.

Anne Guillaumot (A)

Centre de Ressources et de Compétence de la Mucoviscidose Adulte, CHU, Nancy, France.

Delphine Pouradier (D)

Centre de Ressources et de Compétence de la Mucoviscidose Pédiatrique, Hôpital Mignot, Le Chesnay, France.

Adrien Tissot (A)

Centre de Ressources et de Compétence de la Mucoviscidose Adulte, CHU, Nantes, France.

Pascaline Priou (P)

Centre de Ressources et de Compétence de la Mucoviscidose Adulte, CHU, Angers, France.

Laurent Mély (L)

Centre de Ressources et de Compétence de la Mucoviscidose, Hôpital René Sabran, Hospices Civils de Lyon, Giens, France.

Frederique Chedevergne (F)

Cystic Fibrosis National Pediatric Reference Center, Pneumo-Allergologie Pédiatrique, Hôpital Necker Enfants Malades, AP-HP, Paris, France.

Muriel Lebourgeois (M)

Cystic Fibrosis National Pediatric Reference Center, Pneumo-Allergologie Pédiatrique, Hôpital Necker Enfants Malades, AP-HP, Paris, France.

Jean Lebihan (J)

Centre de Ressources et de Compétence de la Mucoviscidose Adulte, Centre de Perharidy, Roscoff, France.

Clémence Martin (C)

Université Paris-Cité, Paris, France.
Respiratory Medicine and Cystic Fibrosis National Reference Center, Cochin Hospital, AP-HP, Paris, France.

Flora Zavala (F)

INSERM, CNRS, Institut Necker Enfants Malades, Paris, France.
Université Paris-Cité, Paris, France.

Jennifer Da Silva (J)

Respiratory Medicine and Cystic Fibrosis National Reference Center, Cochin Hospital, AP-HP, Paris, France.

Lydie Lemonnier (L)

Vaincre La Mucoviscidose, Paris, France.

Mairead Kelly-Aubert (M)

INSERM, CNRS, Institut Necker Enfants Malades, Paris, France.
Université Paris-Cité, Paris, France.

Anita Golec (A)

INSERM, CNRS, Institut Necker Enfants Malades, Paris, France.
Université Paris-Cité, Paris, France.

Pierre Foucaud (P)

Vaincre La Mucoviscidose, Paris, France.

Christophe Marguet (C)

Centre de Ressources et de Compétence de la Mucoviscidose Pédiatrique, CHU, Rouen, France.

Aleksander Edelman (A)

INSERM, CNRS, Institut Necker Enfants Malades, Paris, France.
Université Paris-Cité, Paris, France.

Alexandre Hinzpeter (A)

INSERM, CNRS, Institut Necker Enfants Malades, Paris, France.
Université Paris-Cité, Paris, France.

Paola de Carli (P)

Vaincre La Mucoviscidose, Paris, France.

Emmanuelle Girodon (E)

INSERM, CNRS, Institut Necker Enfants Malades, Paris, France.
Université Paris-Cité, Paris, France.
Service de Médecine Génomique des Maladies de Système et d'Organe, Hôpital Cochin, Paris, France.
These three authors contributed equally to this work as co-last authors.

Isabelle Sermet-Gaudelus (I)

INSERM, CNRS, Institut Necker Enfants Malades, Paris, France isabelle.sermet@aphp.fr.
Université Paris-Cité, Paris, France.
ERN-LUNG CF Network, Frankfurt, Germany.
Centre de Ressources et de Compétence de la Mucoviscidose Pédiatrique, Hôpital Mignot, Le Chesnay, France.
These three authors contributed equally to this work as co-last authors.

Iwona Pranke (I)

INSERM, CNRS, Institut Necker Enfants Malades, Paris, France.
Université Paris-Cité, Paris, France.
These three authors contributed equally to this work as co-last authors.

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