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Bilton D, Fajac I, Pressler T, et al. Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection. J Cyst Fibros. 2021;20(6):1010-1017doi: 10.1016/j.jcf.2021.05.013.
Bilton, D., Fajac, I., Pressler, T., Clancy, J. P., Sands, D., Minic, P., Cipolli, M., Galeva, I., Solé, A., Quittner, A. L., Jumadilova, Z., Ciesielska, M., Konstan, M. W. (2021). Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection. Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 20(6), 1010-1017. https://doi.org/10.1016/j.jcf.2021.05.013
Bilton, Diana, et al. "Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection." Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society vol. 20,6 (2021): 1010-1017. doi: https://doi.org/10.1016/j.jcf.2021.05.013
Bilton D, Fajac I, Pressler T, Clancy JP, Sands D, Minic P, Cipolli M, Galeva I, Solé A, Quittner AL, Jumadilova Z, Ciesielska M, Konstan MW. Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection. J Cyst Fibros. 2021 Nov;20(6):1010-1017. doi: 10.1016/j.jcf.2021.05.013. Epub 2021 Jun 16. PMID: 34144923.
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J Cyst Fibros. 2021 Nov;20(6):1010-1017. doi: 10.1016/j.jcf.2021.05.013. Epub 2021 Jun 16.

Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection.

Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society

Diana Bilton, Isabelle Fajac, Tacjana Pressler, John Paul Clancy, Dorota Sands, Predrag Minic, Marco Cipolli, Ivanka Galeva, Amparo Solé, Alexandra L Quittner, Zhanna Jumadilova, Monika Ciesielska, Michael W Konstan,

Affiliations

  1. Royal Brompton Hospital, Sydney Street, London SW3 6NP, United Kingdom.
  2. AP-HP, Centre-Université de Paris, 27, Rue du Faubourg Saint-Jacques, Paris 75014, France; European Reference Network ERN-LUNG, Cystic Fibrosis Core Network, Germany.
  3. Cystic Fibrosis Center, Rigshospitalet (Hospital), Blegdamsvej 9, Copenhagen 2100, Denmark.
  4. Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH 45229, USA.
  5. Cystic Fibrosis Department, Institute of Mother and Child, 17a Kasprzaka Str. 01-211, Warsaw, Poland.
  6. Institute for Mother and Child Health Care, Department of Pulmonology, Medical School University of Belgrade, 6-8, Radoja Dakica Str. New Belgrade 11070, Serbia.
  7. Cystic Fibrosis Center, Azienda Ospedaliera Universitaria Integrata, Piazzale Stefani, 1, Verona 37126, Italy.
  8. Pediatric Clinic, Infants Department, Alexandrovska University Hospital, 1 Georgi Sofiiski Blvd, Sofia 1431, Bulgaria.
  9. Lung Transplant and Cystic Fibrosis Unit, Hospital Universitari i Politecnic La Fe, Valencia 46026, Spain.
  10. Nicklaus Children's Research Institute, 3100 SW 62nd Ave, Miami, FL 33155, USA.
  11. Insmed Incorporated, 700 US Highway 202/206, Bridgewater, NJ 08807, USA.
  12. Case Western Reserve University and Rainbow Babies and Children's Hospital, 10900 Euclid Avenue, Cleveland, OH 44106, USA. Electronic address: [email protected].

PMID: 34144923 DOI: 10.1016/j.jcf.2021.05.013

Abstract

BACKGROUND: . In CLEAR-108-a phase 3, randomised, open-label study-once-daily amikacin liposome inhalation suspension (ALIS) was noninferior to twice-daily tobramycin inhalation solution (TIS) in improving lung function in patients with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa infection after 3 treatment cycles (28 days on/28 days off). The CLEAR-110 extension study (ClinicalTrials.gov: NCT01316276; EudraCT: 2011-000443-24) assessed long-term safety, tolerability, and efficacy of ALIS in eligible patients who completed CLEAR-108.

METHODS: . Patients received once-daily ALIS 590 mg for 12 treatment cycles (96 weeks). Patients were grouped by prior treatment: the "prior-ALIS" cohort received ALIS in CLEAR-108, and the "ALIS-naive" cohort received TIS in CLEAR-108.

RESULTS: . Overall, 206 patients (prior-ALIS, n=92; ALIS-naive, n=114) entered CLEAR-110 and received ≥1 dose of ALIS. Most patients (88.8%) experienced ≥1 treatment-emergent adverse event (TEAE) through day 672 (end of year 2). Most TEAEs (72.3%) were mild or moderate in severity. Severe TEAEs were reported in 31 patients (15.0%). Two life-threatening TEAEs (haemoptysis; intestinal obstruction) and 1 death (cardiac failure) were reported. Twenty-one patients (10.2%) discontinued treatment due to a TEAE (mostly infective pulmonary exacerbation of CF). Mean change from baseline in forced expiratory volume in 1 second percent predicted at day 672 was -3.1% (prior-ALIS, -4.0%; ALIS-naive, -2.3%). Mean change from baseline in sputum density of P. aeruginosa at day 672 was 0.02 (prior-ALIS, -0.16; ALIS-naive, 0.19) log CFU/g.

CONCLUSIONS: . Long-term treatment with ALIS was well tolerated with a favourable adverse event profile and demonstrated continued antibacterial activity in CF patients with chronic P. aeruginosa infection.

Copyright © 2021. Published by Elsevier B.V.

Keywords: ALIS; Amikacin; Cystic fibrosis; Liposomal; Pseudomonas aeruginosa

Conflict of interest statement

Declaration of Competing Interest D. Bilton: National Institute for Health Research funding support through the Imperial College, Royal Brompton Hospital, Specialist Respiratory Bio-Medical Research U

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