{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,2]],"date-time":"2026-11-02T23:51:21Z","timestamp":1793663481459,"version":"4.5.1"},"reference-count":34,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2026,1,23]],"date-time":"2026-01-23T00:00:00Z","timestamp":1769126400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,4,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Rationale<\/jats:title>\n                    <jats:p>Guidelines recommend amikacin liposome inhalation suspension (ALIS) for refractory Mycobacterium avium complex lung disease (MACLD) treatment, alongside other antibiotics. Efficacy of ALIS on microbiological endpoints and patient-reported outcomes (PROs) in the newly diagnosed MACLD population is unknown.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>ARISE aimed to validate Quality of Life\u2013Bronchiectasis Respiratory Domain (QOL-B RD) and Patient-Reported Outcomes Measurement Information System Short Form v1.0-Fatigue 7a (PROMIS F SF-7a) in patients treated for new\/recurrent MACLD. We present treatment outcome results, including microbiological endpoints, PROs, and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Adults with noncavitary MACLD were randomized 1:1 to ALIS (590\u2009mg) or empty liposome control (comparator), plus azithromycin (250\u2009mg) and ethambutol (15\u2009mg\/kg) once daily for 6\u2009months, then 1 month off treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 99 patients, most had Mycobacterium intracellulare (43.4%) and\/or M avium (32.3%) infections. Culture conversion with ALIS was achieved by 80.6% by month 6 (comparator, 63.9%) and 78.8% by month 7 (comparator, 47.1%; nominal P\u2009=\u2009.0010). Among patients achieving culture conversion by month 6, first negative culture defining conversion occurred at month 1 for 74.3% with ALIS (comparator, 46.7%). Mean QOL-B RD score through month 7 improved with ALIS versus plateauing with comparator after month 3; both arms showed improved PROMIS F SF-7a without between-arm difference. Positive correlations between culture conversion and improved QOL-B RD score were observed with ALIS. No ALIS-related serious adverse events or deaths were reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>More patients with newly diagnosed MACLD receiving 6 months of ALIS alongside a macrolide-based regimen achieved culture conversion by month 6 and month 7 numerically more rapidly versus comparator. No new safety signals were identified.<\/jats:p>\n                    <jats:p>Clinical trial registered with www.clinicaltrials.gov (NCT04677543).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/annalsats\/aaoaf064","type":"journal-article","created":{"date-parts":[[2026,1,23]],"date-time":"2026-01-23T09:02:33Z","timestamp":1769158953000},"page":"536-547","source":"Crossref","is-referenced-by-count":6,"title":["Amikacin liposome inhalation suspension in newly diagnosed\n                    <i>Mycobacterium avium<\/i>\n                    complex lung disease (ARISE): a 6-month double-blind, active comparator trial"],"prefix":"10.1093","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3324-926X","authenticated-orcid":false,"given":"Charles L","family":"Daley","sequence":"first","affiliation":[{"name":"Division of Mycobacterial and Respiratory Diseases, National Jewish Health and the University of Colorado School of Medicine , Denver, CO,","place":["United 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Medical University of South Carolina , Charleston, SC,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David E","family":"Griffith","sequence":"additional","affiliation":[{"name":"Division of Mycobacterial and Respiratory Diseases, National Jewish Health and the University of Colorado School of Medicine , Denver, CO,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0717-7450","authenticated-orcid":false,"given":"Naoki","family":"Hasegawa","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Keio University School of Medicine , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8239-9275","authenticated-orcid":false,"given":"Kozo","family":"Morimoto","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Fukuj\u016bji Hospital, Japan 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Kaohsiung,","place":["Taiwan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9483-7412","authenticated-orcid":false,"given":"Korkut","family":"Avsar","sequence":"additional","affiliation":[{"name":"Lungenaerzte am Rundfunkplatz , Munich,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3860-0063","authenticated-orcid":false,"given":"Dario","family":"Andrisani","sequence":"additional","affiliation":[{"name":"Respiratory Disease Unit, Azienda Policlinico di Modena, University of Modena and Reggio Emilia , Modena,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6825-2050","authenticated-orcid":false,"given":"Luigi Ruffo","family":"Codecasa","sequence":"additional","affiliation":[{"name":"TB Reference Centre and Lab, Villa Marelli Institute, Niguarda Hospital , 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