Progression from tuberculosis infection to TB disease is a recognized risk of TNF inhibitor use. TNF inhibitors are among the most widely used drugs in the U.S. These include and are not limited to: infliximab (REMICADE), adalimumab (HUMIRA) (AMJEVITA), etanercept (ENBREL) (ELERZI), golimumab (SIMPONI), certolizumab (CIMZIA), adatacept (ORENCIA), rituximab (RITUXAN HYCELA), tocilizumab (ACTEMRA), ustekinumab (STELARA), guselkumab (TREMFYA), and infliximab (INFLECTRA).
The Food and Drug Administration (FDA) has determined that tuberculosis (TB) disease is a potential adverse reaction from treatment with the tumor necrosis factor-alpha (TNF-α) antagonists the products are labeled accordingly. These products work by blocking TNF-α, an inflammatory cytokine, and are approved for treating rheumatoid arthritis and other selected autoimmune diseases. TNF-α is associated with the immunology and pathophysiology of certain infectious diseases, notably TB; blocking TNF-α can allow TB disease to emerge from Mycobacterium tuberculosis infection.
Practitioners who prescribe TNF-α antagonists should educate their patients about the symptoms of TB disease, with added emphasis on extrapulmonary symptoms, which can include fever, malaise, or development of a mass. A patient with symptoms should undergo diagnostic testing for TB. In addition to following local reporting requirements, health-care providers should report TB cases associated with TNF-α antagonists to FDA's Medwatch system.
Healthcare providers should evaluate patients for TB infection prior to initiating treatment with a TNF inhibitor . Initiate treatment of TB prior to administering a TNF inhibitor. Monitor patients for signs and symptoms of TB disease during and after TNF inhibitor treatment. Do not administer TNF inhibitors to patients with TB disease.