TY - JOUR T1 - Amikacin Liposome Inhalation Suspension Clinical Benefit-Risk Assessment for Refractory MAC Lung Disease JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00623-2021 SP - 00623-2021 AU - Theodore K. Marras AU - Mariam Hassan AU - Kevin C. Mange AU - Monika Ciesielska AU - Shilpa Dhar Murthy AU - Zhanna Jumadilova AU - Anjan Chatterjee Y1 - 2022/01/01 UR - http://openres.ersjournals.com/content/early/2022/03/02/23120541.00623-2021.abstract N2 - Mycobacterium avium complex (MAC) is the leading cause of nontuberculous mycobacterial lung disease, which can be associated with progressive lung damage and increased mortality [1]. Patients with MAC lung disease have substantial disease burden and limited treatment options [1]. Up to 40% of patients experience failure with lengthy multidrug treatments, relapse, or reinfection [2]. For patients with treatment-refractory MAC lung disease (persistent MAC-positive sputum despite ≥6 months of guideline-based therapy [GBT]), international guidelines recommend the addition of amikacin liposome inhalation suspension (ALIS) to GBT regimens [3]. In clinical trials, patients with treatment-refractory MAC lung disease had improved culture conversion with ALIS+GBT versus GBT [4, 5].FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.Conflict of interest: Dr. Marras reports support for the present manuscript received from Insmed Inc. Disclosures made outside the submitted work: Grants or contracts received from Insmed Inc., and Oregon Health & Science University. Consulting fees received from Insmed, RedHill and Spero. Honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events received from France Foundation, Astra Zeneca, and Novartis. Support for attending meetings and/or travel from NTM Info and Research. Participation on a Data Safety Monitoring Board or Advisory Board for Clofazimine trial. Leadership or fiduciary role in other board, society, committee or advocacy group, unpaid for Toronto NTM patient group.Conflict of interest: Dr. Hassan reports support for the present manuscript received from Insmed Inc. The author is a current employee of Insmed Pharmaceuticals, and as an employee owns stock and stock options for Insmed Pharmaceuticals.Conflict of interest: Dr. Ciesielska reports support for the present manuscript received from Insmed Inc. The author is a current employee of Insmed Pharmaceuticals, and as an employee owns stock and stock options for Insmed Pharmaceuticals.Conflict of interest: Dr. Mange reports support for the present manuscript received from Insmed Inc. The author is a current employee of Insmed Pharmaceuticals, and as an employee owns stock and stock options for Insmed Pharmaceuticals.Conflict of interest: Dr. Chatterjee reports support for the present manuscript received from Insmed Inc. The author is a current employee of Insmed Pharmaceuticals, and as an employee owns stock and stock options for Insmed Pharmaceuticals.Conflict of interest: Dr. Murthy reports support for the present manuscript received from Insmed Inc. The author is a current employee of Insmed Pharmaceuticals, and as an employee owns stock and stock options for Insmed Pharmaceuticals.Conflict of interest: Dr. Jumadilova reports support for the present manuscript received from Insmed Inc. The author is a current employee of Insmed Pharmaceuticals, and as an employee owns stock and stock options for Insmed Pharmaceuticals. ER -