Amikacin liposome inhalation suspension for Mycobacterium avium complex pulmonary disease : A subgroup analysis of Japanese patients in the randomized, phase 3, CONVERT study
Copyright © 2024 [The Author/The Authors]. Published by Elsevier B.V. All rights reserved..
BACKGROUND: CONVERT, a randomized, active-controlled, global, Phase 3 trial demonstrated that patients with treatment-refractory Mycobacterium avium complex (MAC) pulmonary disease were more likely to achieve culture conversion with amikacin liposome inhalation suspension (ALIS) plus guideline-based therapy (GBT) versus those continuing on GBT alone. This subgroup analysis reports the efficacy and safety of ALIS in Japanese patients enrolled in CONVERT.
METHODS: Japanese patients aged ≥20 years with treatment-refractory MAC pulmonary disease from Japanese sites were included. Patients were randomized to receive once-daily 590 mg ALIS + GBT or GBT alone; patients converting by Month 6 remained in the study to complete 12-month treatment followed by a 12-month off-treatment period. Nonconverters exited the study at Month 8. The primary endpoint was the proportion of patients achieving culture conversion by Month 6.
RESULTS: Of the 59 Japanese patients screened, 48 were randomized to receive ALIS + GBT (n = 34) or GBT alone (n = 14), and 41/48 (85.4 %) were women. The mean (standard deviation) age of patients was 64.5 (8.6) years, and 83.3 % of patients had bronchiectasis at baseline. By Month 6, sputum culture conversion was cumulatively achieved in 9/34 (26.5 %) patients receiving ALIS + GBT versus none receiving GBT alone. Treatment-emergent adverse events were reported in 94.1 % and 100.0 % of patients receiving ALIS + GBT and GBT alone, respectively. No deaths were reported.
CONCLUSIONS: The efficacy observed in the Japanese subpopulation was largely consistent with that in the overall CONVERT study population, with more patients achieving culture conversion with ALIS + GBT versus GBT alone. Safety profiles were similar between the overall population and the Japanese subpopulation.
CLINICAL TRIAL REGISTRATION: NCT02344004.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:62 |
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| Enthalten in: |
Respiratory investigation - 62(2024), 2 vom: 15. März, Seite 284-290 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Morimoto, Kozo [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 26.02.2024 Date Revised 19.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT02344004 Citation Status MEDLINE |
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| doi: |
10.1016/j.resinv.2023.12.012 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM36768280X |
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| 245 | 1 | 0 | |a Amikacin liposome inhalation suspension for Mycobacterium avium complex pulmonary disease |b A subgroup analysis of Japanese patients in the randomized, phase 3, CONVERT study |
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| 500 | |a Date Revised 19.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02344004 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2024 [The Author/The Authors]. Published by Elsevier B.V. All rights reserved. | ||
| 520 | |a BACKGROUND: CONVERT, a randomized, active-controlled, global, Phase 3 trial demonstrated that patients with treatment-refractory Mycobacterium avium complex (MAC) pulmonary disease were more likely to achieve culture conversion with amikacin liposome inhalation suspension (ALIS) plus guideline-based therapy (GBT) versus those continuing on GBT alone. This subgroup analysis reports the efficacy and safety of ALIS in Japanese patients enrolled in CONVERT | ||
| 520 | |a METHODS: Japanese patients aged ≥20 years with treatment-refractory MAC pulmonary disease from Japanese sites were included. Patients were randomized to receive once-daily 590 mg ALIS + GBT or GBT alone; patients converting by Month 6 remained in the study to complete 12-month treatment followed by a 12-month off-treatment period. Nonconverters exited the study at Month 8. The primary endpoint was the proportion of patients achieving culture conversion by Month 6 | ||
| 520 | |a RESULTS: Of the 59 Japanese patients screened, 48 were randomized to receive ALIS + GBT (n = 34) or GBT alone (n = 14), and 41/48 (85.4 %) were women. The mean (standard deviation) age of patients was 64.5 (8.6) years, and 83.3 % of patients had bronchiectasis at baseline. By Month 6, sputum culture conversion was cumulatively achieved in 9/34 (26.5 %) patients receiving ALIS + GBT versus none receiving GBT alone. Treatment-emergent adverse events were reported in 94.1 % and 100.0 % of patients receiving ALIS + GBT and GBT alone, respectively. No deaths were reported | ||
| 520 | |a CONCLUSIONS: The efficacy observed in the Japanese subpopulation was largely consistent with that in the overall CONVERT study population, with more patients achieving culture conversion with ALIS + GBT versus GBT alone. Safety profiles were similar between the overall population and the Japanese subpopulation | ||
| 520 | |a CLINICAL TRIAL REGISTRATION: NCT02344004 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a CONVERT | |
| 650 | 4 | |a Japan | |
| 650 | 4 | |a Mycobacterium avium complex | |
| 650 | 4 | |a Nontuberculous mycobacteria | |
| 650 | 4 | |a Subgroup analysis | |
| 650 | 7 | |a Amikacin |2 NLM | |
| 650 | 7 | |a 84319SGC3C |2 NLM | |
| 650 | 7 | |a Anti-Bacterial Agents |2 NLM | |
| 650 | 7 | |a Liposomes |2 NLM | |
| 700 | 1 | |a Nonaka, Mizu |e verfasserin |4 aut | |
| 700 | 1 | |a Yamazaki, Yoshitaka |e verfasserin |4 aut | |
| 700 | 1 | |a Nakagawa, Taku |e verfasserin |4 aut | |
| 700 | 1 | |a Takasaki, Jin |e verfasserin |4 aut | |
| 700 | 1 | |a Tsuyuguchi, Kazunari |e verfasserin |4 aut | |
| 700 | 1 | |a Kitada, Seigo |e verfasserin |4 aut | |
| 700 | 1 | |a Jumadilova, Zhanna |e verfasserin |4 aut | |
| 700 | 1 | |a Yuen, Dayton W |e verfasserin |4 aut | |
| 700 | 1 | |a Ciesielska, Monika |e verfasserin |4 aut | |
| 700 | 1 | |a Hasegawa, Naoki |e verfasserin |4 aut | |
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