Long-term Safety and Tolerability of Omadacycline for the Treatment of Mycobacterium abscessus Infections.

Autor: Mingora CM; Medical University of South Carolina, Charleston, South Carolina, USA., Bullington W; Medical University of South Carolina, Charleston, South Carolina, USA., Faasuamalie PE; Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA., Levin A; National Jewish Health and University of Colorado School of Medicine,Denver, Colorado, USA., Porter G; New York University Grossman School of Medicine, New York, New York, USA., Stadnick R; Oregon Health & Science University, Portland, Oregon, USA., Varley CD; Oregon Health & Science University, Portland, Oregon, USA., Addrizzo-Harris D; New York University Grossman School of Medicine, New York, New York, USA., Daley CL; National Jewish Health and University of Colorado School of Medicine,Denver, Colorado, USA., Olivier KN; Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA., Winthrop KL; Oregon Health & Science University, Portland, Oregon, USA., Dorman SE; Medical University of South Carolina, Charleston, South Carolina, USA., Flume PA; Medical University of South Carolina, Charleston, South Carolina, USA.
Jazyk: angličtina
Zdroj: Open forum infectious diseases [Open Forum Infect Dis] 2023 Jul 03; Vol. 10 (7), pp. ofad335. Date of Electronic Publication: 2023 Jul 03 (Print Publication: 2023).
DOI: 10.1093/ofid/ofad335
Abstrakt: Background: Mycobacterium abscessus is a virulent human pathogen. Treatment is complex and often poorly tolerated with suboptimal rates of eradication, highlighting the need for improved therapeutics. This study reports clinical experience with omadacycline for treatment of M abscessus infections at five large nontuberculous mycobacterial (NTM) disease clinics across the United States to better understand long-term safety and tolerability.
Methods: We conducted a multicenter retrospective chart review of adults with M abscessus infections. All patients treated with omadacycline as part of a multidrug therapeutic regimen through December 2021 were included. Clinical data from time of omadacycline initiation and up to 12 months of follow-up were collected. Descriptive statistics were performed.
Results: Analysis included 117 patients. Among patients with M abscessus isolate subspeciation, 58 of 71 (81.7%) were M abscessus spp abscessus . In isolates with reported drug susceptibility testing, 15 of 70 (21.4%) had confirmed susceptibility to macrolides. The most common site of infection was lungs. Median duration omadacycline treatment was 8 months (range, 0.25-33 months; interquartile range, 4-15 months). Omadacycline was discontinued in 60 patients (51.3%); 20 completed planned treatment course, 23 experienced intolerance or adverse event leading to drug cessation, and 17 stopped due to cost, death (unrelated to NTM infection or therapy), or another reason. In those with pulmonary disease, 44 of 95 (46%) had 1 or more negative cultures at time of final microbiological assessment, with 17 of 95 (18%) achieving culture conversion.
Conclusions: This study reports data supporting long-term safety and tolerability of omadacycline along with signal of effectiveness in treatment of M abscessus infections.
Competing Interests: Potential conflicts of interest. C. M. M. receives grant support from the Cystic Fibrosis Foundation. C. D. V. receives research grant support from NTMir and the Medical Research Foundation of Oregon. D. A.-H. receives grant support from AN2 Therapeutics, Insmed, Boehringer Ingelheim, Hill-Rom, and Zambone. C. L. D. conducts contracted research with AN2 Therapeutics, Bugworks, Insmed, and Paratek Pharma; serves as a consultant for Genentech, Pfizer, and Cepheid; serves as an advisory board member for AN2 Therapeutics, AstraZeneca, Hyfe, Insmed, Juvabis, Mannkind Corporation, Matinas BioPharma Holdings, Paratek Pharma, Spero Therapeutics, and Zambone; and is part of data monitoring committees for Ostuka Pharmaceutical, Eli Lilly and Company, and the Bill & Melinda Gates Foundation. K. N. O. receives grant support for Beyond Air and serves as an advisory board member for Pfizer, Mannkind Corporation, Spero Therapeutics, Paratek Pharma, and AN2 Therapeutics. K. L. W. receives research support from Insmed, Paratek Pharma, Red Hill Biopharma, AN2 Therapeutics, Renovion, and Spero Therapeutics and serves as a consultant for Insmed, Paratek Pharma, Red Hill Biopharma, AN2 Therapeutics, Renovion, and Spero Therapeutics. P. A. F. receives grant support from AbbVie, Aceragen, AN2 Therapeutics, Armata, AstraZeneca, Cystic Fibrosis Foundation Therapeutics, Insmed, Janssen, NIH, Novavax, RedHill, Sound Pharmaceuticals, Spero, and Vertex Pharmaceuticals and serves as a consultant for Aceragen, AN2, Arrevus, Chiesi, Eloxx Pharmaceuticals, Insmed, Ionis Pharmaceuticals, Janssen Research and Development, McKesson, Siona, Spero Therapeutics, and Vertex Pharmaceuticals. All other authors report no potential conflicts.
(© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
Databáze: MEDLINE
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