Volume 7, Issue 9 April 2014
There is an increased risk of tuberculosis, or reactivation of latent tuberculosis, during treatment with tumour necrosis factor alpha (TNF-alpha) inhibitors. Tuberculosis in patients receiving TNF-alpha inhibitors can be life-threatening, and deaths from tuberculosis have occurred in these patients. TNF-alpha inhibitors are therefore contraindicated in patients with active tuberculosis or other severe infections. Screen patients for active and latent tuberculosis before starting treatment with a TNF-alpha inhibitor. Monitor them closely for infectious diseases including tuberculosis before, during, and after treatment
TNF-alpha inhibitors are a class of biological medicines that block the proinflammatory cytokine TNF-alpha. The TNF-alpha inhibitors authorised in the UK are adalimumab, certolizumab, etanercept, golimumab, and infliximab. TNF-alpha inhibitors are authorised for the treatment of inflammatory and autoimmune conditions, such as rheumatoid arthritis, ankylosing spondylitits, Crohn’s disease, ulcerative colitis, psoriasis, and psoriatic arthritis.
Increased risk of tuberculosis
TNF-alpha plays an important role in inflammatory processes, and is involved in autoimmune diseases, and immune responses to infection. TNF-alpha inhibition increases susceptibility to infectious diseases, including tuberculosis, and increases the risk of reactivation of latent tuberculosis. An increased risk of tuberculosis in patients treated with TNF-alpha inhibitors has been confirmed in large observational studies. Reports of tuberculosis, including fatalities, in patients treated with TNF-alpha inhibitors continue to be received via the Yellow Card Scheme. In many cases extrapulmonary tuberculosis, presenting as either local or disseminated disease has been reported. In one recent case, a patient receiving a TNF-alpha inhibitor died from tuberculosis that had not been diagnosed.
Patient alert card
Companies are required to produce a patient alert card for TNF-alpha inhibitors which healthcare professionals should give to patients (see example below). The alert card warns patients of the risk of infectious diseases, particularly tuberculosis. The card describes possible signs and symptoms of tuberculosis, and advises patients to inform their doctor if they have signs of an infection.
Advice for healthcare professionals:
Diagnosis of tuberculosis
Advice to give to patients
BNF section 10.1.3 Drugs that suppress the rheumatic disease process: cytokine modulators
Product information for TNF-alpha inhibitors is available on the MHRA website