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Multicenter Study
. 2023 Oct 18;67(10):e0082423.
doi: 10.1128/aac.00824-23. Epub 2023 Sep 28.

Long-term evaluation of clinical success and safety of omadacycline in nontuberculous mycobacteria infections: a retrospective, multicenter cohort of real-world health outcomes

Amer El Ghali  1 , Taylor Morrisette  2   3 , Sara Alosaimy  1 , Kristen Lucas  1 , Maria G Tupayachi-Ortiz  4 , Raaga Vemula  5 , Carly Wadle  5 , Julie V Philley  5 , Carlos Mejia-Chew  6 , Yasir Hamad  6 , Ryan W Stevens  7 , John D Zeuli  7 , Andrew J Webb  7 , Christina T Fiske  8 , Anahit Simonyan  9 , Christo L Cimino  9 , Mehriban Mammadova  10 , Virginia E Umana  10 , Rodrigo Hasbun  10 , Saira Butt  11 , Kyle C Molina  12 , Michael Thomas  12 , Emily A Kaip  13 , Jeannette Bouchard  14 , Tristan W Gore  14 , Catessa Howard  15 , M Gabriela Cabanilla  16 , Dana J Holger  17 , Jeremy J Frens  18 , Melissa Barger  19 , Aaron Ong  20 , Keira A Cohen  20 , Michael J Rybak  1   21   22
Affiliations
Multicenter Study

Long-term evaluation of clinical success and safety of omadacycline in nontuberculous mycobacteria infections: a retrospective, multicenter cohort of real-world health outcomes

Amer El Ghali et al. Antimicrob Agents Chemother. .

Abstract

Infections due to nontuberculous mycobacteria (NTM) continue to increase in prevalence, leading to problematic clinical outcomes. Omadacycline (OMC) is an aminomethylcycline antibiotic with FDA orphan drug and fast-track designations for pulmonary NTM infections, including Mycobacteroides abscessus (MAB). This multicenter retrospective study across 16 U.S. medical institutions from January 2020 to March 2023 examined the long-term clinical success, safety, and tolerability of OMC for NTM infections. The cohort included patients aged ≥18 yr, who were clinically evaluable, and` had been treated with OMC for ≥3 mo without a previous diagnosis of cystic fibrosis. The primary outcome was 3 mo clinical success, with secondary outcomes including clinical improvement and mortality at 6- and 12 mo, persistence or reemergence of infection, adverse effects, and reasons for OMC utilization. Seventy-five patients were included in this analysis. Most patients were female (48/75, 64.0%) or Caucasian (58/75, 77.3%), with a median (IQR) age of 59 yr (49-67). Most had NTM pulmonary disease (33/75, 44.0%), skin and soft tissue disease (19/75, 25.3%), or osteomyelitis (10/75, 13.3%), and Mycobacterium abscessus (60/75, 80%) was the most commonly isolated NTM pathogen. The median (IQR) treatment duration was 6 mo (4 - 14), and the most commonly co-administered antibiotic was azithromycin (33/70, 47.1%). Three-month clinical success was observed in 80.0% (60/75) of patients, and AEs attributable to OMC occurred in 32.0% (24/75) of patients, leading to drug discontinuation in 9.3% (7/75).

Keywords: Mycobacterium abscessus; culture conversion; nontuberculous mycobacteria; omadacycline.

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Conflict of interest statement

A.E., T.M., K.L., M.G.T-O., R.V., C.W., Y.H., R.W.S., J.D.Z, A.J.W., A.S., C.L.C, M.M., V.E.U, S.B., K.C.M., M.T., E.A.K., J.B., T.W.G., C.H., M.G.C., D.J.H., J.J.F., M.B., A.O., J.S. have no conflicts of interest to disclose. S.A. is currently an employee of Aimmune Therapeutics, a Nestle Company. J.V.P. has been on advisory boards for Insmed, A2N, Paratek Pharmaceuticals, and Cipla Technologies, and has spoken for Insmed. M.P.V. received research funding from Paratek Pharmaceuticals, Cumberland Pharmaceuticals, Insmed, AN2, Spero, Hillrom, and Electromed. C.M-C. has consulted for HIVE Medical Inc, and has received grant funding from the CDC (CDC# 1U54CK000617-01-00). C.T.F. has spoken for Insmed. R.H. has consulted for and received research funding from Biofire Diagnostics. K.A.C. is currently employed by Janssen pharmaceutical companies of Johnson & Johnson and has received consulting fees from Insmed, Hillrom, Merck, and Microbion, and AN2, unrelated to the current investigation, and was supported by National Heart, Lung, and Blood Institute K08 HL1139994 and the Burroughs Welcome Fund Career Award for Medical Scientists. M.J.R. has received funds for research and consulting or participated in speaking bureaus for Abbvie, Baselia, Ferring, Melinta, Merck, Paratek Pharmaceuticals, Shionogi, Tetraphase, and T2 Biosystems and is partially supported by National Institute of Allergy and Infectious Diseases R21 AI163726. Conflicts that the editors considered relevant to the content of the manuscript have been disclosed.

Figures

Fig 1
Fig 1
Mycobacterium species characteristics. (A) n = 75, Breakdown of all mycobacteria isolated from cultures; NTM, nontuberculous mycobacterium (B) n = 35, Characterization of subspeciation results of patients where data were available; Subsp., subspecies.
Fig 2
Fig 2
Outcomes of concomitantly administered antibiotics with omadacycline. (A) Frequency and clinical outcomes associated with combined antibiotics with omadacycline in patients with nontuberculous Mycobacterium-pulmonary disease (NTM-PD) represents outcomes for any regimen containing the individual antibiotic; IV, intravenous; INH, inhaled (B) Frequency and clinical outcomes of the most utilized drug regimens combined with OMC in NTM-PD patients (n = 33); INH, inhaled; IV, intravenous; * Did not meet clinical success endpoint.
See this image and copyright information in PMC

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