Newer Therapy Recommended For Treatment-Refractory Mac Pulmonary Inefection
AT A GLANCE
ARLINGTON, Va. – A newer therapy that acts like a Trojan horse to attack bacteria should be reserved for patients with certain treatment-refractory lung infections, according to updated nontuberculous mycobacterial (NTM) pulmonary disease guidelines released by the Infectious Diseases Society of America (IDSA), the American Thoracic Society (ATS), the European Respiratory Society (ERS) and the European Society of Clinical Microbiology and Infectious Disease (ESCMID). It is being published in Clinical Infectious Diseases and the European Respiratory Journal.
The therapy, amikacin liposome inhalation suspension (Arikayce®), was approved by the Food and Drug Administration (FDA) in September 2018 to treat people with treatment-refractory Mycobacterium avium complex (MAC), a common cause of NTM pulmonary disease. The antibiotic amikacin is encased in fat globules called liposomes and inhaled into the lungs, where it is released into cells to attack the bacteria. The new IDSA guidelines are in alignment with the FDA that the treatment should only be given to MAC patients who haven’t improved after at least six months of standard therapy.
“Infectious diseases and pulmonary specialists have the expertise to treat these complex NTM pulmonary disease patients, who often require 12-18 months of therapy, sometimes including intravenous treatment,” said Charles L. Daley, MD, lead author of the guidelines and chief of the division of mycobacterial and respiratory infections at National Jewish Health, Denver. “It is likely many patients are being undertreated and others overtreated. The new guidelines should help provide clarity for diagnosis and treatment.”
The new guidelines update the 2007 guidelines, for the first time employing the methodical Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, which specifies the quality and weight of the evidence for diagnosis and treatment. The previous guidelines covered a large amount of material making them complex and difficult to follow. The new guidelines are more focused and provide easier guidance to ensure more patients are treated appropriately, he said.
The guidelines recommend three sputum specimens be obtained at least a week apart and at least two be positive to confirm the person has NTM pulmonary disease. About half of people with the disease do not require antibiotics, at least initially, said Dr. Daley. When it is necessary, treatment typically involves a combination of antibiotics.
MAC is one of more than 190 species and subspecies of mycobacteria, many of which can cause NTM pulmonary disease in humans and can become chronic. While NTM are found in the environment and can be inhaled, few people develop the disease. However, NTM pulmonary disease has increased from 7 per 100,000 people in 2008 to 12 per 100,00 people in 2015, according to one study. The majority of those with NTM pulmonary disease are women, most of whom are 65 and older and have underlying lung disease.
“Many patients can be cured of the infection, but their underlying lung disease remains incurable,” said Richard J. Wallace Jr., MD, FIDSA, co-author of the guidelines and chairman of the department of microbiology and director of the microbacterial clinical and research laboratory, University of Texas Health Science Center, Tyler. “Other patients can’t be cured of their NTM infection, but can be stabilized with treatment.”
The guidelines were developed by experts from the United States, Canada, Germany, Italy, Netherlands, France, Spain and Switzerland. In addition to Drs. Daley and Wallace, the guidelines panel was co-chaired by Emmanuelle Cambau, M.D. PhD, and Christoph Lange MD, PhD. Other members of the panel include Jonathan M. Iaccarino, M.D. M.S, Claire Andrejak, M.D. MPH PhD, Erik C. Bottger, M.D., Jan Brozek, M.D. PhD, David E. Griffith M.D., Lorenzo Guglielmetti, M.D.PhD, Gwen A. Huitt, M.D., Shandra L. Knight, MS, Philip Leitman, MBA, Theodore K. Marras, M.D., Kenneth N. Olivier, M.D. MPH, Miguel Santin, M.D. PhD, Jason E. Stout, M.D., Enrico Tortoli ScD, Jakko van Ingen, M.D. PhD, Dirk Wagner, M.D., and Kevin L. Winthrop, M.D.
IDSA has published more than 50 treatment guidelines on various conditions and infections, ranging from HIV/AIDS to skin and soft tissue infections. As with other IDSA guidelines, the NTM pulmonary disease guidelines will be available in a smartphone format and a pocket-sized quick-reference edition.
Note: For a copy of the NTM pulmonary disease guidelines released July 6, 2020, please contact firstname.lastname@example.org.
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The Infectious Diseases Society of America (IDSA), based in Arlington, Va., is a professional society representing more than 12,000 physicians and scientists who specialize in infectious diseases. For more information, visit www.idsociety.org. Follow IDSA on Facebook and Twitter.
Clinical Infectious Diseases is a leading journal in the field of infectious diseases with a broad international readership. The journal publishes articles on a variety of subjects of interest to practitioners and researchers. Topics range from clinical descriptions of infections, public health, microbiology, and immunology to the prevention of infection, the evaluation of current and novel treatments, and the promotion of optimal practices for diagnosis and treatment. The journal publishes original research, editorial commentaries, review articles, and practice guidelines and is among the most highly cited journals in the field of infectious diseases. Clinical Infectious Diseases is an official publication of the Infectious Diseases Society of America (IDSA).
The European Respiratory Journal (ERJ) is the official scientific journal of the European Respiratory Society (ERS) and the most highly regarded peer-reviewed respiratory journal in Europe, with a current impact factor of 11.807. The ERJ features cutting-edge clinical and experimental work in the field of respiratory medicine as well as task force reports and guidelines, reviews and editorials.
About the American Thoracic Society
Founded in 1905, the American Thoracic Society (ATS) is the world's leading medical association dedicated to advancing pulmonary, critical care and sleep medicine. The Society’s more than 16,000 members prevent and fight respiratory disease around the globe through research, education, patient care and advocacy. The ATS publishes four journals, the American Journal of Respiratory and Critical Care Medicine, the American Journal of Respiratory Cell and Molecular Biology, the Annals of the American Thoracic Society and ATS Scholar.
The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) (https://www.escmid.org/ ) is the largest European society active in the field of infection with 67 ESCMID-affiliated societies, reaching more than 33,000 clinical/medical microbiologists and infectious diseases specialists in Europe and around the world. ESCMID organizes scientific meetings, educational events, exchange visits between specialists, research and professional matters, issues guidelines, and supported the journal “Clinical Microbiology and Infection” (www.clinicalmicrobiologyandinfection.com).