Sweden. Between 2000 and 2003, the Swedish Medical Products Agency (MPA) received 13 reports of tuberculosis (TB) in patients receiving tumour necrosis factor (TNF)- á antagonist treatment, with an additional two reports of atypical mycobacterial infection.
The ages of the patients in these cases ranged from 32 to 94 years, with infection developing within 12 months' treatment in six patients and after more than 12 months in five patients (duration unknown in two cases). Nine patients were receiving infliximab (Remicade), two were receiving etanercept (Enbrel) and one patient was receiving infliximab, etanercept, anakinra (Kineret) and adalimumab (Humira), with most patients receiving concomitant corticosteroids and a few also receiving methotrexate. In ten cases, the infection was deemed a possible reactivation of latent TB, in one case a primary infection and in two cases this could not be evaluated; two patients died from miliary TB or its complications. The MPA advises that "treatment of patients with latent tuberculosis or other evident risk factors must be considered only on very strong treatment indications".
Swedish Medical Products Agency document (Swedish), 28 May 2004. Available on the Internet at www.mpa.se