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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: rowe sm. 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 …
Lessons from other fields of medicine, Part 2: Cystic fibrosis.
Vijaykumar K, Rowe SM. Vijaykumar K, et al. Among authors: rowe sm. Handb Clin Neurol. 2023;192:119-130. doi: 10.1016/B978-0-323-85538-9.00006-7. Handb Clin Neurol. 2023. PMID: 36796937 Review.
Since then, CF care has transformed beyond just symptomatic treatment to include a variety of small-molecule therapies that address the basic electrophysiologic defect and cause profound improvements in physiology, clinical manifestations, and long-term outcomes, designed …
Since then, CF care has transformed beyond just symptomatic treatment to include a variety of small-molecule therapies that address the basi …
PROMISE: Working with the CF community to understand emerging clinical and research needs for those treated with highly effective CFTR modulator therapy.
Nichols DP, Donaldson SH, Frederick CA, Freedman SD, Gelfond D, Hoffman LR, Kelly A, Narkewicz MR, Pittman JE, Ratjen F, Sagel SD, Rosenfeld M, Schwarzenberg SJ, Singh PK, Solomon GM, Stalvey MS, Kirby S, VanDalfsen JM, Clancy JP, Rowe SM. Nichols DP, et al. Among authors: rowe sm. J Cyst Fibros. 2021 Mar;20(2):205-212. doi: 10.1016/j.jcf.2021.02.003. Epub 2021 Feb 19. J Cyst Fibros. 2021. PMID: 33619012 Free PMC article. Review.
Multiple observational research studies are now being conducted to better understand the impacts of this important therapeutic milestone on long-term outcomes, patient care needs, and future research priorities. ...
Multiple observational research studies are now being conducted to better understand the impacts of this important therapeutic milestone on …
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 …
Long term clinical effectiveness of ivacaftor in people with the G551D CFTR mutation.
Guimbellot JS, Baines A, Paynter A, Heltshe SL, VanDalfsen J, Jain M, Rowe SM, Sagel SD; GOAL-e2 Investigators. Guimbellot JS, et al. Among authors: rowe sm. J Cyst Fibros. 2021 Mar;20(2):213-219. doi: 10.1016/j.jcf.2020.11.008. Epub 2020 Nov 25. J Cyst Fibros. 2021. PMID: 33249004 Free PMC article.
BACKGROUND: The cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, ivacaftor, was first approved for people with CF and the G551D CFTR mutation. This study describes the long-term clinical effectiveness of ivacaftor in this population. METHODS: We cond …
BACKGROUND: The cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, ivacaftor, was first approved for people with CF and …
Gaming Console Home-Based Exercise for Adults with Cystic Fibrosis: Study Protocol.
Lowman JD, Solomon GM, Rowe SM, Yuen HK. Lowman JD, et al. Among authors: rowe sm. Int J Caring Sci. 2020 Spring/Summer;13(2):1530-1540. Int J Caring Sci. 2020. PMID: 33163109 Free PMC article.
METHODS: A single group pretest-posttest design will be used to examine the immediate (12-weeks) and long-term effect (24-weeks) of a home-based exergame program on improving pulmonary-related function (physical fitness and respiratory function) in sedentary adults with CF …
METHODS: A single group pretest-posttest design will be used to examine the immediate (12-weeks) and long-term effect (24-weeks) of a …
Haemophilus influenzae persists in biofilm communities in a smoke-exposed ferret model of COPD.
Hunt BC, Stanford D, Xu X, Li J, Gaggar A, Rowe SM, Raju SV, Swords WE. Hunt BC, et al. Among authors: rowe sm. ERJ Open Res. 2020 Aug 11;6(3):00200-2020. doi: 10.1183/23120541.00200-2020. eCollection 2020 Jul. ERJ Open Res. 2020. PMID: 32802827 Free PMC article.
METHODS: In this study, we used a recently described ferret model for COPD, in which animals undergo chronic long-term exposure to cigarette smoke, to define host-pathogen interactions during COPD-related NTHi infections. ...
METHODS: In this study, we used a recently described ferret model for COPD, in which animals undergo chronic long-term exposure to ci …
Effect of equine chorionic gonadotropin on reproductive performance in a dairy herd in Northern Queensland, Australia.
Rowe SM, Pryor L, Tranter WP, Hosie J, Cavalieri J. Rowe SM, et al. Theriogenology. 2019 Feb;125:30-36. doi: 10.1016/j.theriogenology.2018.10.016. Epub 2018 Oct 18. Theriogenology. 2019. PMID: 30388468
In this herd, a single treatment of eCG at the first synchronized estrus after PSM improved reproductive performance in the short term, but not at subsequent inseminations....
In this herd, a single treatment of eCG at the first synchronized estrus after PSM improved reproductive performance in the short term …
A revised airway epithelial hierarchy includes CFTR-expressing ionocytes.
Montoro DT, Haber AL, Biton M, Vinarsky V, Lin B, Birket SE, Yuan F, Chen S, Leung HM, Villoria J, Rogel N, Burgin G, Tsankov AM, Waghray A, Slyper M, Waldman J, Nguyen L, Dionne D, Rozenblatt-Rosen O, Tata PR, Mou H, Shivaraju M, Bihler H, Mense M, Tearney GJ, Rowe SM, Engelhardt JF, Regev A, Rajagopal J. Montoro DT, et al. Among authors: rowe sm. Nature. 2018 Aug;560(7718):319-324. doi: 10.1038/s41586-018-0393-7. Epub 2018 Aug 1. Nature. 2018. PMID: 30069044 Free PMC article.
We identify a rare cell type, the Foxi1(+) pulmonary ionocyte; functional variations in club cells based on their location; a distinct cell type in high turnover squamous epithelial structures that we term 'hillocks'; and disease-relevant subsets of tuft and goblet cells. …
We identify a rare cell type, the Foxi1(+) pulmonary ionocyte; functional variations in club cells based on their location; a distinct cell …
Sensitivity of ivacaftor to drug-drug interactions with rifampin, a cytochrome P450 3A4 inducer.
Guimbellot JS, Acosta EP, Rowe SM. Guimbellot JS, et al. Among authors: rowe sm. Pediatr Pulmonol. 2018 May;53(5):E6-E8. doi: 10.1002/ppul.23971. Epub 2018 Feb 28. Pediatr Pulmonol. 2018. PMID: 29488691 Free PMC article.
While the interaction of rifampin and ivacaftor has been examined in vitro, severe adverse events resulting from this interaction have not been reported in the literature. In this report, we describe the termination of steady, long-term improvement in a patient taking ivac …
While the interaction of rifampin and ivacaftor has been examined in vitro, severe adverse events resulting from this interaction have not b …
16 results