tuberculosis (TNF-alpha antibody, and Crohn's disease)

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  • infliximab is an anti-TNFalpha monoclonal antibody that is authorised for the treatment of severe, fistulising or active Crohn's disease. Also this treatment is authorised for use in reducing the signs and symptoms of active rheumatoid arthritis in patients whose response to conventional therapies has been in adequate

  • TNF-alpha - this is a polypeptide cytokine that modulates cellular immune responses and mediates inflammation; treatment with infliximab may, via inhibition of TNF-alpha, affect normal immune responses and may result in the predisposition of patients to opportunistic infections

  • in February 2001, the Committee on Safety of Medicines reported that there had been 28 spontaneous reports of the onset or re-activation of tuberculosis suspected to be a reaction to infliximab therapy. Some reports have been of unusual extrapulmonary tuberculosis and some have been of miliary tuberculosis. In the majority of these reported cases, there has been a prior history of treatment with immunosuppressants including corticosteroids

  • there is an increased risk of tuberculosis in patients with infliximab
    • the increased rate of tuberculosis has been attributed in some reports to be due to inadequate screening for latent tuberculosis before initiation of treatment (2) while other reports found a consistent increase in new cases despite adequate preventive measures (3)

Reference:

  • (1) Committee on Safety of Medicines (2001), Current Problems in Pharmacovigilance, 27, 1-8.
  • (2) Gomez-Reino JJ, Carmona L, Angel Descalzo M. Risk of tuberculosis in patients treated with tumor necrosis factor antagonists due to incomplete prevention of reactivation of latent infection. Arthritis Rheum. 2007;57(5):756-761
  • (3) Jauregui-Amezaga A, Turon F, Ordas I, et al. Risk of developing tuberculosis under anti-TNF treatment despite latent infection screening. J Crohns Colitis. 2013;7(3):208-212

Last reviewed 01/2018

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