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Cancer Risks to Remicade® and Humira® Explained Papers from coast to coast have picked up a study from this week's Journal of the American Medical Association citing an increased rate of several types of cancer and of serious infection. It has been known for years that these treatments increase the risk of certain types of cancer or infection (such as lymphoma and tuberculosis). While even rarer than these previously-known (but uncommon) problems, there appears to be a slightly increased risk for a broader set of cancers and infections in patients undergoing anti-TNF treatment.
The study examined Remicade® (infliximab), which to date is the only anti-TNF therapy that the FDA has approved for the treatment of IBD. The study also examined Humira® (adalimumab), a treatment that is currently undergoing clinical trials for the treatment of Crohn's disease.
The study, led by investigators at Mayo Clinic, used "meta-analysis" to combine and assess the results from a large set of clinical studies already in the literature. With the large number of patients and years of treatment represented by these combined studies, less common events associated with treatment can be detected. Overall, the study suggests that the increased risk of cancer (lymphoma, skin, gastrointestinal, breast and lung) or serious infection may be three-fold and two-fold, respectively. The risk appears to be mainly in patients receiving high dose treatment (more than 6 mg/kg every 8 weeks; or adalimumab, 40 mg every other week). Curiously, the increased risk of cancer occurred early, and there was not a further increase of cancer with longer times.
What Does This Mean for Patients?What might this study mean for patients considering or undergoing anti-TNF treatment? First, it is important to emphasize that while the risk of these adverse events is increased, it is still extremely low compared to the high rate of clinical improvement for IBD. Considering the serious health consequences of active IBD, this study doesn't fundamentally change the balance of efficacy and safety for anti-TNF treatment. Second, it is encouraging that the risk of these adverse events does not appear to increase with prolonged treatment. In fact, this finding is biologically curious, and suggests (according to the authors), that anti-TNF treatment may simply accelerate the detection of preexisting cancer, rather than induce more cancer over the long run. Third, the study suggests that lower doses of anti-TNF treatment may reduce or avoid these adverse events.
Compared to the clinical trials analyzed for this study, the present recommended dosing for anti-TNF is at lower levels. So, at currently recommended anti-TNF levels, most patients may not be placed at the increased risk for cancer and infection described in the Mayo study. Accordingly, the study supports currently recommended lower doses of anti-TNF, when such doses permit adequate IBD control to be achieved.
Date Posted: May 19, 2006 |
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