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Study: TNF inhibitors raise skin cancer risk

Sunday September 11, 2011
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Biological agents used to treat rheumatoid arthritis seem to be associated with an increased risk of skin cancer, according to a systematic review of published research.

Inflammatory arthritis has been linked to an increased risk of some cancers, such as lymphoma and lung cancer, but a lower risk of others, such as bowel and breast cancers. But it has been unclear to what extent tumor necrosis factor inhibitors affect risk. TNF inhibitors include the monoclonal antibodies infliximab and adalimumab and the protein etanercept.

Reporting for the Annals of the Rheumatic Diseases, the researchers based their findings on 21 studies and eight conference abstracts that met their strict inclusion criteria of reporting data on cancer associated with TNF inhibitors. In all, this set provided information on more than 40,000 patients and almost 150,000 cumulative years of exposure to these drugs.

The studies were drawn from an extensive search of clinical research databases and findings presented to the American College of Rheumatology, the European League against Rheumatism and the British Society for Rheumatology between 1998 and 2010.

The pooled risk from seven studies for the development of any cancer showed negligible or no increased risk overall. Two studies indicated no evidence that patients taking TNF inhibitors over the long term were at increased risk of cancer either. And although patients who previously had cancer before were more likely to be diagnosed with the disease again, this pattern was not affected by the use of TNF inhibitors.

But four studies showed that patients treated with these drugs were 45% more likely to develop skin cancer other than melanoma, with two studies indicating that patients taking TNF inhibitors were 79% more likely to develop a melanoma than patients not taking these drugs.

"This systematic review and meta analysis provides reassurance to physicians and patients that the treatment of [rheumatoid arthritis] with TNF inhibitors does not increase the risk of malignancy, particularly lymphoma," the authors wrote. "However, it does appear to increase the risk of skin cancer, including melanoma."

To view the study data, visit http://bit.ly/qQrxOD.

FDA Warning

In other news regarding TNF inhibitors, the U.S. Food and Drug Administration has informed healthcare professionals that the boxed warning for the entire class of TNF-alpha blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria.

In addition, the boxed warning and warnings and precautions sections of the labels for all TNFa blockers have been revised to include consistent information about the risk for serious infections and the associated disease-causing pathogens.

Serious, including fatal, infections are a known risk of TNFa blockers, according to the FDA. These infections can involve various organ systems and sites due to bacterial, mycobacterial (tuberculosis), fungal (histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, blastomycosis, pneumocystosis), viral (hepatitis B) and other organisms that usually do not cause disease in healthy people, but can cause serious illness when a person's immune system has weakened.

The FDA recently reviewed cases of infection in patients treated with TNFa blockers. It said the addition of Legionella and Listeria to the drug tables of TNFa blockers will provide healthcare professionals with more information about opportunistic pathogens that can cause serious infections in patients treated with TNFa blockers.

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