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Understanding and addressing the needs of people with cystic fibrosis in the era of CFTR modulator therapy.
Hisert KB, Birket SE, Clancy JP, Downey DG, Engelhardt JF, Fajac I, Gray RD, Lachowicz-Scroggins ME, Mayer-Hamblett N, Thibodeau P, Tuggle KL, Wainwright CE, De Boeck K. Hisert KB, et al. Among authors: downey dg. Lancet Respir Med. 2023 Oct;11(10):916-931. doi: 10.1016/S2213-2600(23)00324-7. Epub 2023 Sep 9. Lancet Respir Med. 2023. PMID: 37699420 Review.
VX-659-Tezacaftor-Ivacaftor in Patients with Cystic Fibrosis and One or Two Phe508del Alleles.
Davies JC, Moskowitz SM, Brown C, Horsley A, Mall MA, McKone EF, Plant BJ, Prais D, Ramsey BW, Taylor-Cousar JL, Tullis E, Uluer A, McKee CM, Robertson S, Shilling RA, Simard C, Van Goor F, Waltz D, Xuan F, Young T, Rowe SM; VX16-659-101 Study Group. Davies JC, et al. N Engl J Med. 2018 Oct 25;379(17):1599-1611. doi: 10.1056/NEJMoa1807119. Epub 2018 Oct 18. N Engl J Med. 2018. PMID: 30334693 Free PMC article. Clinical Trial.
Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial.
Heijerman HGM, McKone EF, Downey DG, Van Braeckel E, Rowe SM, Tullis E, Mall MA, Welter JJ, Ramsey BW, McKee CM, Marigowda G, Moskowitz SM, Waltz D, Sosnay PR, Simard C, Ahluwalia N, Xuan F, Zhang Y, Taylor-Cousar JL, McCoy KS; VX17-445-103 Trial Group. Heijerman HGM, et al. Among authors: downey dg. Lancet. 2019 Nov 23;394(10212):1940-1948. doi: 10.1016/S0140-6736(19)32597-8. Epub 2019 Oct 31. Lancet. 2019. PMID: 31679946 Free PMC article. Clinical Trial.
Building global development strategies for cf therapeutics during a transitional cftr modulator era.
Mayer-Hamblett N, van Koningsbruggen-Rietschel S, Nichols DP, VanDevanter DR, Davies JC, Lee T, Durmowicz AG, Ratjen F, Konstan MW, Pearson K, Bell SC, Clancy JP, Taylor-Cousar JL, De Boeck K, Donaldson SH, Downey DG, Flume PA, Drevinek P, Goss CH, Fajac I, Magaret AS, Quon BS, Singleton SM, VanDalfsen JM, Retsch-Bogart GZ. Mayer-Hamblett N, et al. Among authors: downey dg. J Cyst Fibros. 2020 Sep;19(5):677-687. doi: 10.1016/j.jcf.2020.05.011. Epub 2020 Jun 7. J Cyst Fibros. 2020. PMID: 32522463 Free PMC article. Review.
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. Among authors: downey dg. 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
Riociguat for the treatment of Phe508del homozygous adults with cystic fibrosis.
Derichs N, Taylor-Cousar JL, Davies JC, Fajac I, Tullis E, Nazareth D, Downey DG, Rosenbluth D, Malfroot A, Saunders C, Jensen R, Solomon GM, Vermeulen F, Kaiser A, Willmann S, Saleh S, Droebner K, Sandner P, Bear CE, Hoffmann A, Ratjen F, Rowe SM; Rio-CF Study Group. Derichs N, et al. Among authors: downey dg. J Cyst Fibros. 2021 Nov;20(6):1018-1025. doi: 10.1016/j.jcf.2021.07.015. Epub 2021 Aug 19. J Cyst Fibros. 2021. PMID: 34419414 Free article. Clinical Trial.
Empire-CF study: A phase 2 clinical trial of leukotriene A4 hydrolase inhibitor acebilustat in adult subjects with cystic fibrosis.
Elborn JS, Konstan MW, Taylor-Cousar JL, Fajac I, Horsley A, Sutharsan S, Aaron SD, Daines CL, Uluer A, Downey DG, Lucidi VV, Ahuja S, Springman E, Mershon J, Grosswald R, Rowe SM; EMPIRE-CF study group. Elborn JS, et al. Among authors: downey dg. J Cyst Fibros. 2021 Nov;20(6):1026-1034. doi: 10.1016/j.jcf.2021.08.007. Epub 2021 Sep 17. J Cyst Fibros. 2021. PMID: 34538755 Free PMC article. Clinical Trial.
Efficacy and safety of elexacaftor plus tezacaftor plus ivacaftor versus tezacaftor plus ivacaftor in people with cystic fibrosis homozygous for F508del-CFTR: a 24-week, multicentre, randomised, double-blind, active-controlled, phase 3b trial.
Sutharsan S, McKone EF, Downey DG, Duckers J, MacGregor G, Tullis E, Van Braeckel E, Wainwright CE, Watson D, Ahluwalia N, Bruinsma BG, Harris C, Lam AP, Lou Y, Moskowitz SM, Tian S, Yuan J, Waltz D, Mall MA; VX18-445-109 study group. Sutharsan S, et al. Among authors: downey dg. Lancet Respir Med. 2022 Mar;10(3):267-277. doi: 10.1016/S2213-2600(21)00454-9. Epub 2021 Dec 20. Lancet Respir Med. 2022. PMID: 34942085 Clinical Trial.
Factors for severe outcomes following SARS-CoV-2 infection in people with cystic fibrosis in Europe.
Jung A, Orenti A, Dunlevy F, Aleksejeva E, Bakkeheim E, Bobrovnichy V, Carr SB, Colombo C, Corvol H, Cosgriff R, Daneau G, Dogru D, Drevinek P, Vukic AD, Fajac I, Fox A, Fustik S, Gulmans V, Harutyunyan S, Hatziagorou E, Kasmi I, Kayserová H, Kondratyeva E, Krivec U, Makukh H, Malakauskas K, McKone EF, Mei-Zahav M, de Monestrol I, Olesen HV, Padoan R, Parulava T, Pastor-Vivero MD, Pereira L, Petrova G, Pfleger A, Pop L, van Rens JG, Rodic M, Schlesser M, Storms V, Turcu O, Woz Niacki L, Yiallouros P, Zolin A, Downey DG, Naehrlich L. Jung A, et al. Among authors: downey dg. ERJ Open Res. 2021 Dec 27;7(4):00411-2021. doi: 10.1183/23120541.00411-2021. eCollection 2021 Oct. ERJ Open Res. 2021. PMID: 34984210 Free PMC article.
92 results