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Long-term safety and efficacy of elexacaftor/tezacaftor/ivacaftor in people with cystic fibrosis and at least one F508del allele: 144-week interim results from a 192-week open-label extension study.
Daines CL, Tullis E, Costa S, Linnemann RW, Mall MA, McKone EF, Polineni D, Quon BS, Ringshausen FC, Rowe SM, Selvadurai H, Taylor-Cousar JL, Withers NJ, Ahluwalia N, Moskowitz SM, Prieto-Centurion V, Tan YV, Tian S, Weinstock T, Xuan F, Zhang Y, Ramsey B, Griese M; VX17-445-105 Study Group. Daines CL, et al. Among authors: mckone ef. Eur Respir J. 2023 Dec 7;62(6):2202029. doi: 10.1183/13993003.02029-2022. Print 2023 Dec. Eur Respir J. 2023. PMID: 37945033 Free PMC article. Clinical Trial.
BACKGROUND: In two pivotal phase 3 trials, up to 24 weeks of treatment with elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) was efficacious and safe in patients with cystic fibrosis (CF) 12 years of age who have at least one F508del allele. The aim of this study is to assess long- …
BACKGROUND: In two pivotal phase 3 trials, up to 24 weeks of treatment with elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) was efficacious a …
A population-level strain genotyping method to study pathogen strain dynamics in human infections.
Morgan SJ, Durfey SL, Ravishankar S, Jorth P, Ni W, Skerrett DT, Aitken ML, McKone EF, Salipante SJ, Radey MC, Singh PK. Morgan SJ, et al. Among authors: mckone ef. JCI Insight. 2021 Dec 22;6(24):e152472. doi: 10.1172/jci.insight.152472. JCI Insight. 2021. PMID: 34935640 Free PMC article.
A hallmark of chronic bacterial infections is the long-term persistence of 1 or more pathogen species at the compromised site. ...
A hallmark of chronic bacterial infections is the long-term persistence of 1 or more pathogen species at the compromised site. ...
Long-term safety and efficacy of tezacaftor-ivacaftor in individuals with cystic fibrosis aged 12 years or older who are homozygous or heterozygous for Phe508del CFTR (EXTEND): an open-label extension study.
Flume PA, Biner RF, Downey DG, Brown C, Jain M, Fischer R, De Boeck K, Sawicki GS, Chang P, Paz-Diaz H, Rubin JL, Yang Y, Hu X, Pasta DJ, Millar SJ, Campbell D, Wang X, Ahluwalia N, Owen CA, Wainwright CE; VX14-661-110 study group. Flume PA, et al. Lancet Respir Med. 2021 Jul;9(7):733-746. doi: 10.1016/S2213-2600(20)30510-5. Epub 2021 Feb 10. Lancet Respir Med. 2021. PMID: 33581080
Here, we present results of study 661-110 (EXTEND), a 96-week open-label extension study that assessed long-term safety, tolerability, and efficacy of tezacaftor-ivacaftor in participants aged 12 years or older with cystic fibrosis who were homozygous or heterozygous for t …
Here, we present results of study 661-110 (EXTEND), a 96-week open-label extension study that assessed long-term safety, tolerability …
Pathway analysis of a genome-wide gene by air pollution interaction study in asthmatic children.
Ierodiakonou D, Coull BA, Zanobetti A, Postma DS, Boezen HM, Vonk JM, McKone EF, Schildcrout JS, Koppelman GH, Croteau-Chonka DC, Lumley T, Koutrakis P, Schwartz J, Gold DR, Weiss ST. Ierodiakonou D, et al. Among authors: mckone ef. J Expo Sci Environ Epidemiol. 2019 Jun;29(4):539-547. doi: 10.1038/s41370-019-0136-3. Epub 2019 Apr 26. J Expo Sci Environ Epidemiol. 2019. PMID: 31028280 Free PMC article.
For NO(2)-related FEV(1) responses, we identified pathways involved in cellular adhesion, oxidative stress, inflammation, and metabolic responses. CONCLUSION: The host lung function response to long-term exposure to pollution is linked to genes involved in cellular adhesio …
For NO(2)-related FEV(1) responses, we identified pathways involved in cellular adhesion, oxidative stress, inflammation, and metabolic resp …
Assessment of safety and efficacy of long-term treatment with combination lumacaftor and ivacaftor therapy in patients with cystic fibrosis homozygous for the F508del-CFTR mutation (PROGRESS): a phase 3, extension study.
Konstan MW, McKone EF, Moss RB, Marigowda G, Tian S, Waltz D, Huang X, Lubarsky B, Rubin J, Millar SJ, Pasta DJ, Mayer-Hamblett N, Goss CH, Morgan W, Sawicki GS. Konstan MW, et al. Among authors: mckone ef. Lancet Respir Med. 2017 Feb;5(2):107-118. doi: 10.1016/S2213-2600(16)30427-1. Epub 2016 Dec 21. Lancet Respir Med. 2017. PMID: 28011037 Clinical Trial.
BACKGROUND: The 24-week safety and efficacy of lumacaftor/ivacaftor combination therapy was shown in two randomised controlled trials (RCTs)-TRAFFIC and TRANSPORT-in patients with cystic fibrosis who were aged 12 years or older and homozygous for the F508del-CFTR mutation. We aim …
BACKGROUND: The 24-week safety and efficacy of lumacaftor/ivacaftor combination therapy was shown in two randomised controlled trials (RCTs) …
Ambient air pollution, lung function, and airway responsiveness in asthmatic children.
Ierodiakonou D, Zanobetti A, Coull BA, Melly S, Postma DS, Boezen HM, Vonk JM, Williams PV, Shapiro GG, McKone EF, Hallstrand TS, Koenig JQ, Schildcrout JS, Lumley T, Fuhlbrigge AN, Koutrakis P, Schwartz J, Weiss ST, Gold DR; Childhood Asthma Management Program Research Group. Ierodiakonou D, et al. Among authors: mckone ef. J Allergy Clin Immunol. 2016 Feb;137(2):390-9. doi: 10.1016/j.jaci.2015.05.028. Epub 2015 Jul 14. J Allergy Clin Immunol. 2016. PMID: 26187234 Free PMC article.
Increased 4-month average nitrogen dioxide concentrations were associated with reduced postbronchodilator FEV1 and FVC percent predicted. Long-term exposures to sulfur dioxide were associated with reduced PC20 (percent change per interquartile range, -6% [95% CI, -11% to - …
Increased 4-month average nitrogen dioxide concentrations were associated with reduced postbronchodilator FEV1 and FVC percent predicted. Lo …
Sustained Benefit from ivacaftor demonstrated by combining clinical trial and cystic fibrosis patient registry data.
Sawicki GS, McKone EF, Pasta DJ, Millar SJ, Wagener JS, Johnson CA, Konstan MW. Sawicki GS, et al. Among authors: mckone ef. Am J Respir Crit Care Med. 2015 Oct 1;192(7):836-42. doi: 10.1164/rccm.201503-0578OC. Am J Respir Crit Care Med. 2015. PMID: 26132840
However, whether these improvements reflect a change in disease trajectory cannot be determined without longer-term analyses with an appropriate comparator population. OBJECTIVES: To examine, over a 3-year period, whether ivacaftor therapy affects pulmonary function and nu …
However, whether these improvements reflect a change in disease trajectory cannot be determined without longer-term analyses with an …
Long-term safety and efficacy of ivacaftor in patients with cystic fibrosis who have the Gly551Asp-CFTR mutation: a phase 3, open-label extension study (PERSIST).
McKone EF, Borowitz D, Drevinek P, Griese M, Konstan MW, Wainwright C, Ratjen F, Sermet-Gaudelus I, Plant B, Munck A, Jiang Y, Gilmartin G, Davies JC; VX08-770-105 (PERSIST) Study Group. McKone EF, et al. Lancet Respir Med. 2014 Nov;2(11):902-910. doi: 10.1016/S2213-2600(14)70218-8. Epub 2014 Oct 9. Lancet Respir Med. 2014. PMID: 25311995 Clinical Trial.
Patients were eligible if they had a Gly551Asp-CFTR mutation on at least one allele. The primary objective was to assess the long-term safety profile of ivacaftor as assessed by adverse events, clinical laboratory assessments, electrocardiograms, vital signs, and physical …
Patients were eligible if they had a Gly551Asp-CFTR mutation on at least one allele. The primary objective was to assess the long-term …
Pulmonary blastoma: a case report and review of the literature.
Smyth RJ, Fabre A, Dodd JD, Bartosik W, Gallagher CG, McKone EF. Smyth RJ, et al. Among authors: mckone ef. BMC Res Notes. 2014 May 13;7:294. doi: 10.1186/1756-0500-7-294. BMC Res Notes. 2014. PMID: 24885892 Free PMC article. Review.
They display a biphasic histology with mesenchymal and epithelial components. Historically, the term pulmonary blastoma had included both pure fetal adenocarcinomas, pleuropulmonary blastomas as well as the classic biphasic blastomas. ...
They display a biphasic histology with mesenchymal and epithelial components. Historically, the term pulmonary blastoma had included …