Abstract
A number of published case reports suggest an association of tumor necrosis factor (TNF) alpha antagonist use and manifest leishmaniasis. Despite increasing popularity of antagonising TNF alpha for the treatment of autoimmune disorders, systematic research on the risk of opportunistic leishmaniasis in patients receiving these drugs is lacking. This perspective identifies areas of uncertainty regarding the safety profile of TNF alpha antagonist drugs and their clinical use in patients at risk of leishmaniasis. Then, we reflect on how current pharmacovigilance activities in Europe could be enhanced to help reduce these uncertainties. Our aim is to stimulate a debate about this important drug safety issue with potential consequences for patients receiving TNF alpha antagonists living in or travelling to areas endemic for leishmaniasis.
Highlights
Since their introduction about a decade ago, tumour necrosis factor (TNF) alpha antagonist drugs have greatly improved the clinical management of autoimmune disorders and are widely used in rheumatology
This was surprising, since prescription data from the countries where the cases occurred showed that each of the three drugs was prescribed about often. These findings suggest that opportunistic leishmaniasis is more likely to occur in patients receiving TNF alpha monoclonal antibodies than in patients treated with etanercept
Crucial for improved case detection and reduced underreporting will be a closer link between existing national drug registers and institutions specialised in the diagnosis and therapy of leishmaniasis, e.g. tropical medicine institutes, dermatology departments, etc
Summary
Since their introduction about a decade ago, tumour necrosis factor (TNF) alpha antagonist drugs have greatly improved the clinical management of autoimmune disorders and are widely used in rheumatology. The flipside of the coin is an increase in infectious disease risk in patients treated with these drugs Both reactivation of latent infections and increased susceptibility to new infections have been observed in patients receiving TNF alpha antagonist therapy. Depending on their mode of action, the TNF alpha antagonist drugs most widely used can be distinguished in two major groups: monoclonal antibodies, such as infliximab and adalimumab, and the receptor construct etanercept [1]. Based on a brief summary of published information on opportunistic leishmaniasis and use of TNF alpha antagonists, this perspective identifies areas of uncertainty regarding their safety profile and their clinical use in patients at risk of leishmaniasis. The reported time period from initiation of treatment to onset of leishmaniasis ranged from 0.5 to 48 months, consistent with both reactivation of latent infection and increased susceptibility to new infection
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