Safety and Outcomes of Amikacin Liposome Inhalation Suspension for Mycobacterium abscessus Pulmonary Disease

Zweijpfenning, Sanne M.H.; Chiron, R.; Essink, Sharon; Schildkraut, Jodie A.; Akkerman, Onno W.; Aliberti, Stefano; Altenburg, Josje; Arets, B.; Braeckel, Eva Van; Delaere, Bénédicte; Gohy, Sophie; Haarman, Eric G.; Lorent, Natalie; McKew, Genevieve; Morgan, Lucy; Wagner, Dirk; Ingen, Jakko van; Hoefsloot, Wouter

doi:10.1016/j.chest.2022.01.015

Cited by 14 publications

(5 citation statements)

References 11 publications

(11 reference statements)

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“…The indication for ALIS may expand to other diseases in the future, because there are reports of its efficacy in cystic fibrosis patients with chronic Pseudomonas aeruginosa infection; 29 clinical trials have been proposed for the treatment of Mycobacterium abscessus infections using ALIS. 30 In this context, this report summarising events that occur early in treatment is valuable.…”

Section: Discussionmentioning

confidence: 99%

Early-Phase Adverse Effects and Management of Liposomal Amikacin Inhalation for Refractory Mycobacterium avium Complex Lung Disease in Real-World Settings

Morita¹,

Namkoong²,

Yagi³

et al. 2022

IDR

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Amikacin liposome inhalation suspension (ALIS), which efficiently allows amikacin to reach the pulmonary periphery for effect while minimising systemic adverse effects, was recently approved for treating Mycobacterium avium complex (MAC) infections. The international Phase 3 open-label clinical trials showed promising results, contributing to sputum culture conversion, but few studies have examined the efficacy and adverse effects of ALIS using real-world data. We identified the clinical outcome and adverse effects of ALIS in the early phase of treatment, for more effective and safe use in clinical practice. Patients and Methods:The study population consisted of patients with MAC lung disease (MAC-LD), introduced to ALIS therapy after July 2021 at Keio University Hospital due to poor response to multidrug therapy. The sputum smear/culture results, symptoms, adverse effects, and the serum amikacin concentrations of the early phase of ALIS inhalation therapy were examined. Results: A total of 11 patients (9 women; median age 64.6 years) were included in this study. The median disease duration of MAC-LD was 13.7 years, and all patients exhibited a positive culture at the beginning of ALIS inhalation. Three of the six patients (50.0%) who were initially sputum-smear-positive were confirmed to have become sputum-smear-negative within one month, including one culture conversion. ALIS inhalation therapy caused some adverse effects in nine patients (81.8%); however, no serious systemic adverse effects were observed. The most common adverse effect was hoarseness (72.7%), which mostly occurred around 1 week after initiation. The medians of peak serum amikacin concentrations were 1.4 and 2.3 μg/mL for the first and third inhalations, respectively. Trough serum concentrations just before the third inhalation were <1.2 μg/mL in all patients. Conclusion: ALIS therapy might be a treatment option for patients with refractory MAC infection with long disease duration and a poor response to guideline-based therapy.

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Section: Discussionmentioning

confidence: 99%

Early-Phase Adverse Effects and Management of Liposomal Amikacin Inhalation for Refractory Mycobacterium avium Complex Lung Disease in Real-World Settings

Morita¹,

Namkoong²,

Yagi³

et al. 2022

IDR

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“…Treatment of M. abscessus with inhaled amikacin has also been investigated but with no clear benefit. However, it is suggested as a continuation treatment after induction phase 14. The rationale behind using antibiotic inhalation therapy is to maximise the local therapeutic effect while minimising the often severe side effects.…”

Section: Discussionmentioning

confidence: 99%

PulmonaryMycobacterium abscessusinfection treated in combination with inhaled tigecycline

Pedersen,

Fløe,

Løkke

et al. 2023

BMJ Case Rep

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Pulmonary disease caused byMycobacterium abscessusis difficult to treat, as there is currently no reliable evidence-based treatment. Treatment is long, complex and has many side effects. In this case, we report a patient with treatment-refractory pulmonaryM.abscessusdisease, treated with inhaled tigecycline. Treatment with inhaled tigecycline lasted 15 months with comparably limited side effects. There were no positive mycobacterial cultures in the follow-up period of 2 years. Inhaled tigecycline is an option in the treatment of pulmonaryM. abscessuswhen first-line treatment fails. Additional research should investigate this further.

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“…The combination of standard treatment and nebulized amikacin may be also effective for Mycobacterium abscessus infection, although conversion does not reach 50% [56]. Conversion rates will be slightly lower in CF patients.…”

Section: Mycobacterial Infectionsmentioning

confidence: 99%

Advances in inhaled antibiotics for management of respiratory tract infections

Riveiro

Casal

Abelleira

et al. 2023

Current Opinion in Pulmonary Medicine

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Purpose of reviewThe incidence of bacterial respiratory tract infections is growing. In a context of increasing antibiotic resistance and lack of new classes of antibiotics, inhaled antibiotics emerge as a promising therapeutic strategy. Although they are generally used for cystic fibrosis, their use in other conditions is becoming more frequent, including no-cystic fibrosis bronchiectasis, pneumonia and mycobacterial infections.Recent findingsInhaled antibiotics exert beneficial microbiological effects in bronchiectasis and chronic bronchial infection. In nosocomial and ventilator-associated pneumonia, aerosolized antibiotics improve cure rates and bacterial eradication. In refractory Mycobacterium avium complex infections, amikacin liposome inhalation suspension is more effective in achieving long-lasting sputum conversion. In relation to biological inhaled antibiotics (antimicrobial peptides, interfering RNA and bacteriophages), currently in development, there is no still enough evidence that support their use in clinical practice.SummaryThe effective antimicrobiological activity of inhaled antibiotics, added to their potential to overcoming resistances to systemic antibiotics, make inhaled antibiotics a plausible alternative.

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Safety and Outcomes of Amikacin Liposome Inhalation Suspension for Mycobacterium abscessus Pulmonary Disease

Cited by 14 publications

References 11 publications

Early-Phase Adverse Effects and Management of Liposomal Amikacin Inhalation for Refractory Mycobacterium avium Complex Lung Disease in Real-World Settings

Early-Phase Adverse Effects and Management of Liposomal Amikacin Inhalation for Refractory Mycobacterium avium Complex Lung Disease in Real-World Settings

PulmonaryMycobacterium abscessusinfection treated in combination with inhaled tigecycline

Advances in inhaled antibiotics for management of respiratory tract infections

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