Evidence map›Paper›PMID 36831163›Full record

ArticleBiomedicines2023

Simultaneous Quantification of Ivacaftor, Tezacaftor, and Elexacaftor in Cystic Fibrosis Patients' Plasma by a Novel LC-MS/MS Method.

Federica Pigliasco, Alessia Cafaro, Manuela Stella, Giammarco Baiardi, Sebastiano Barco, Nicoletta Pedemonte, Claudia D'Orsi, Federico Cresta, Rosaria Casciaro, Carlo Castellani and 3 more

Open access · goldAbstract read
In one paragraph

Article in Biomedicines, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
8.3field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

  1. Medication adherence to CFTR modulators in patients with cystic fibrosis: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2024
    Pooled it
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  4. Observational
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  7. Remote analysis and management of sweat biomarkers using a wearable microfluidic sticker in adult cystic fibrosis patients.Proceedings of the National Academy of Sciences of the United States of America · 2025
    Article
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  14. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 1 country.

Federica PigliascoDepartment of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, 16132 Genoa, Italy.
Alessia CafaroChromatography and Mass Spectrometry Section, Central Laboratory of Analysis, IRCCS Istituto Giannina Gaslini, 16147 Genoa, Italy.ORCID 0000-0003-1132-1267
Manuela StellaPharmacology & Toxicology Unit, Department of Internal Medicine, University of Genoa, Viale Benedetto XV 2, 16132 Genoa, Italy.ORCID 0000-0002-2897-2245
Giammarco BaiardiPharmacology & Toxicology Unit, Department of Internal Medicine, University of Genoa, Viale Benedetto XV 2, 16132 Genoa, Italy.ORCID 0000-0001-7809-077X
Sebastiano BarcoChromatography and Mass Spectrometry Section, Central Laboratory of Analysis, IRCCS Istituto Giannina Gaslini, 16147 Genoa, Italy.ORCID 0000-0002-1148-427X
Nicoletta PedemonteUOC Genetica Medica, IRCCS Istituto Giannina Gaslini, 16147 Genoa, Italy.ORCID 0000-0002-5161-1720
Claudia D'OrsiDepartment of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, 16132 Genoa, Italy.
Federico CrestaCystic Fibrosis Center, IRCCS Istituto Giannina Gaslini, 16147 Genoa, Italy.ORCID 0000-0002-2483-5374
Rosaria CasciaroCystic Fibrosis Center, IRCCS Istituto Giannina Gaslini, 16147 Genoa, Italy.
Carlo CastellaniCystic Fibrosis Center, IRCCS Istituto Giannina Gaslini, 16147 Genoa, Italy.ORCID 0000-0003-1916-0963
Maria Grazia CalevoEpidemiology and Biostatistics Unit, Scientific Directorate, IRCCS Istituto Giannina Gaslini, 16147 Genova, Italy.
Francesca MattioliPharmacology & Toxicology Unit, Department of Internal Medicine, University of Genoa, Viale Benedetto XV 2, 16132 Genoa, Italy.ORCID 0000-0001-8460-0262
Giuliana CangemiChromatography and Mass Spectrometry Section, Central Laboratory of Analysis, IRCCS Istituto Giannina Gaslini, 16147 Genoa, Italy.
Istituto Giannina Gaslini · ITEnte Ospedaliero Ospedali Galliera · ITUniversity of Genoa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The new breakthrough cystic fibrosis (CF) drug combination of ivacaftor (IVA), tezacaftor (TEZ), and elexacaftor (ELX), namely "caftor" drugs, directly modulates the activity and trafficking of the defective CF transmembrane conductance regulator protein (CFTR) underlying the CF disease. The role of therapeutic drug monitoring (TDM) of caftor drugs in clinical settings has recently been established. The availability of reliable and robust analytical methods for the quantification of IVA, TEZ, and ELX is essential to support dose-concentration-effect studies. We have developed and validated a new liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the rapid and simultaneous quantification of IVA, TEZ, and ELX from the plasma of CF patients. The method was based on a rapid extraction protocol from 50 μL human plasma and separation on a reversed-phase C-18 HPLC column after the addition of deuterated internal standards. Accurate analyte quantification using multiple reaction monitoring (MRM) detection was then obtained using a Thermofisher Quantiva triple-quadrupole MS coupled to an Ultimate 3000 UHPLC. The method has been validated following international (EMA) guidelines for bioanalytical method validation and has been tested on plasma samples from 62 CF patients treated with the three-drug combination IVA/TEZ/ELX, marketed as Kaftrio

Indexed as

CFTRelexacaftorivacaftorLC–MS/MStezacaftortherapeutic drug monitoring

Identifiers

PMID36831163
PMCPMC9953078
OpenAlexW4321378234

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.