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Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody (mAb) by Neutralizing TNF Using an In Vitro Bioanalytical Method
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Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody (mAb) by Neutralizing TNF Using an In Vitro Bioanalytical Method

Published on: September 16, 2017

Nontuberculous mycobacteria infections and anti-tumor necrosis factor-alpha therapy

Kevin L Winthrop1, Eric Chang, Shellie Yamashita

  • 1Departments of Infectious Diseases, Ophthalmology, and Public Health and Preventive Medicine, Oregon Health and Sciences University, Portland, Oregon 97239, USA. winthrop@ohsu.edu

Emerging Infectious Diseases
|October 29, 2009
PubMed

Insights

Patients on anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapy face increased risks of nontuberculous mycobacteria (NTM) infections. NTM disease, particularly from Mycobacterium avium, occurred in 44% of reported cases, with significant mortality and extrapulmonary spread.

Area of Science:

  • Immunology
  • Infectious Diseases
  • Pharmacovigilance

Background:

  • Anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapies are crucial for autoimmune diseases but are linked to increased tuberculosis risk.
  • The specific risk and characteristics of nontuberculous mycobacteria (NTM) infections in patients receiving anti-TNF-alpha therapy remain poorly understood.

Purpose of the Study:

  • To investigate the incidence and clinical features of nontuberculous mycobacteria (NTM) disease in patients undergoing anti-TNF-alpha therapy.
  • To identify common NTM species, associated anti-TNF-alpha agents, and patient demographics.

Main Methods:

  • A retrospective review of the US Food and Drug Administration MedWatch database was conducted.
  • Reports of NTM disease in patients receiving anti-TNF-alpha therapy were identified and analyzed.

Main Results:

  • Of 239 reports, 105 (44%) met NTM disease criteria. Mycobacterium avium was the most common pathogen (50%).
  • Infections were associated with infliximab, etanercept, and adalimumab, often with concurrent prednisone or methotrexate use.
  • A high rate of extrapulmonary involvement (44%) was observed, and 9% of patients died.

Conclusions:

  • Anti-TNF-alpha therapy is associated with a significant risk of NTM disease, including severe and disseminated forms.
  • Clinicians should maintain a high index of suspicion for NTM infections in patients treated with anti-TNF-alpha agents, especially those with Mycobacterium avium.
  • Early diagnosis and appropriate management are critical to improve outcomes in this vulnerable patient population.

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