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Amikacin Liposome Inhalation Suspension in Refractory Mycobacterium avium Complex Lung Disease: A Profile of Its Use
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.
Abstract:
Amikacin liposome inhalation suspension (ALIS) [Arikayce® Liposomal (EU); Arikayce® (USA)], a liposomal suspension of the aminoglycoside amikacin (590 mg) for nebulization via the Lamira® Nebulizer System, is available as add-on therapy for treatment-refractory Mycobacterium avium complex (MAC) lung disease in adults who have little or no alternative treatment options. Its addition to guideline-based therapy (GBT) significantly improved the likelihood of achieving sputum culture conversion (defined as three consecutive monthly MAC-negative sputum cultures) by month 6 relative to GBT alone in adults with treatment-refractory MAC lung disease, with the conversion response maintained over up to 12 months' therapy and at 3 months' post treatment in significantly higher proportions of ALIS plus GBT than GBT alone recipients. ALIS as an add-on therapy to GBT was associated with an increased risk of respiratory adverse reactions compared with GBT alone, but treatment-emergent adverse events associated with systemic amikacin exposure were uncommon.
Insights
Amikacin liposome inhalation suspension (ALIS) significantly improves treatment outcomes for refractory Mycobacterium avium complex lung disease. This add-on therapy enhances sputum culture conversion rates compared to guideline-based therapy alone.
Area of Science:
- Pulmonology
- Infectious Diseases
- Pharmacology
Background:
- Treatment-refractory Mycobacterium avium complex (MAC) lung disease presents a significant unmet need.
- Limited alternative treatment options exist for patients with advanced MAC lung disease.
Purpose of the Study:
- To evaluate the efficacy and safety of amikacin liposome inhalation suspension (ALIS) as an add-on therapy for treatment-refractory MAC lung disease.
- To assess the impact of ALIS on sputum culture conversion rates and treatment outcomes.
Main Methods:
- A study involving adults with treatment-refractory MAC lung disease receiving ALIS as add-on therapy to guideline-based therapy (GBT).
- Sputum culture conversion (three consecutive monthly MAC-negative cultures) was a primary endpoint.
- Assessment of conversion rates at 6 and 12 months, and 3 months post-treatment.
Main Results:
- ALIS addition to GBT significantly improved the likelihood of sputum culture conversion by month 6 compared to GBT alone.
- The observed conversion response was maintained over up to 12 months of therapy and 3 months post-treatment.
- Increased respiratory adverse reactions were noted with ALIS, but systemic amikacin adverse events were infrequent.
Conclusions:
- ALIS is an effective add-on therapy for improving sputum culture conversion in adults with treatment-refractory MAC lung disease.
- While respiratory side effects are a consideration, ALIS offers a valuable therapeutic option for patients with limited alternatives.
- The sustained conversion response highlights the potential long-term benefits of ALIS in managing MAC lung disease.
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