112 Analysis of long-term use of liposomal amikacin for inhalation (LAI) in patients with cystic fibrosis (CF) who have chronic infection from Pseudomonas aeruginosa

• Published in: Journal of cystic fibrosis Vol. 14; p. S85
• Main Authors: Bilton, D, Pressler, T, Fajac, I, Clancy, J.P, Minic, P, Cipolli, M, Galeva, I, Solé, A, Dupont, L.J, Mayer-Hamblett, N, Torchio, S, McGinnis, J.P, Eagle, G, Konstan, M
• Format: Journal Article
• Language: English
• Published: Elsevier B.V 01.06.2015
• Subjects: Pulmonary/Respiratory
• ISSN: 1569-1993; 1873-5010
• DOI: 10.1016/S1569-1993(15)30289-7

Objective Interim analysis to evaluate safety, tolerability, and efficacy of LAI, a novel amikacin formulation, in CF patients with chronic P aeruginosa infection previously treated with LAI or tobramycin inhalation solution (TIS). Methods In the CLEAR-108 trial, patients were randomized 1:1 to 3 treatment cycles (28 days on/28 days off) of LAI 590 mg QD or TIS 300 mg BID via nebulizer, and stratified by age and forced expiratory volume in 1 second (FEV1 ). Eligible patients completing the CLEAR-108 trial enrolled in CLEAR-110 for up to 12 treatment cycles of LAI 590 mg QD via nebulizer. Results Of 266 patients who completed CLEAR-108, 206 (92 LAI; 114 TIS) enrolled in CLEAR-110 and received at least 1 dose of LAI 590 mg QD. At this data cut, 149 patients had completed ≥1 year (6 cycles) of LAI treatment in CLEAR-110. At the end of the 6th off-treatment cycle, FEV1 continued to improve above baseline; relative mean change was 1.11% and 3.39% in patients on prior TIS and LAI, respectively. P aeruginosa sputum density reductions were similar regardless of prior treatment. 84.5% of patients on LAI had ≥1 TEAE (mild, 23.8%; moderate, 49.0%). As in CLEAR-108, most AEs were respiratory: the highest frequency occurred in Cycle 1 for patients in CLEAR-110 from the TIS arm (Cycles 1, 6: 21.1%, 8.6%). In the LAI arm, respiratory AEs were 7.6% and 8.9% for Cycles 1 and 6. A complete 2-year data set is expected in 2015. Conclusion LAI provides sustained pulmonary function improvement in CF patients infected with P aeruginosa. LAI has stable safety/tolerability with prolonged exposure. Data from ongoing analyses will deepen understanding of factors impacting patient response.