Just as any powerful immunosuppressive agent raises concerns regarding infectious complications, similarly there are concerns that it may diminish immunosur-veillance of abnormal cells and thus raise the risk of malignancy. However, the available data for all anti-TNF agents is reassuring and suggests that the observed occurrence of solid tumours in patients that have been exposed to TNF inhibitors is no different to that expected on the basis of frequencies reported in age-, sex-, and race-matched subjects from the surveillance, epidemiology, and end results database (SEER database of the National Cancer Institute of the USA).
Lymphomas of both Hodgkin's and non-Hodgkin's type have been reported as occurring in patients after exposure to all of the available TNF inhibitors, but it is difficult to ascribe an unequivocal causal link to the therapy. This is because rheumatoid arthritis itself is a risk factor for lymphoma, with a risk that correlates with the activity and severity of disease (Baecklund et al. 1998). In one study, the odds ratio for development of lymphoma was 25.8 for rheumatoid patients with high inflammatory activity, compared with low inflammatory activity. The standardized incidence rates observed for lymphomas occurring with the use of TNF inhibitors in the context of clinical trials are within the range expected based on other publications for standardized incidence rates in rheumatoid arthritis itself. The contributions of other anti-rheumatic drugs to this risk, including azathioprine and methotrexate, are not clear. The majority of lymphomas observed with the use of TNF inhibitors are of non-Hodgkin's type, with a mean time to onset of between 10 and 21 months.
In conclusion, there is a higher rate of lymphoma occurrence in rheumatoid patients than there is in healthy age- and sex-matched controls. Lymphomas have been reported in patients treated with anti-TNF therapies, but it remains unclear whether the medication is a contributory factor or causal or simply indicative of a patient population that is likely to have had more severe inflammatory disease activity prior to exposure to an anti-TNF drug (Keystone 2003).
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