One of the biggest questions when it comes to anti-tumor necrosis ± therapy (anti-TNF) is what is the overall risk/benefit ratio. There is no question that this group of drugs induces positive clinical responses in most patients.  However, there remains concern about toxicity, including potentially problems such as infection and malignancy.

One method of assessing the risk/benefit ratio would be overall mortality or rate of death. On the one hand, by effectively controlling systemic inflammation, treatment with TNF ± blockers could potentially improve mortality.   It has been established that patients with the most severe RA have increased mortality. On the other hand, if serious adverse effects due to these drugs were common, this could have a negative effect on overall mortality.

Most studies so far appear to show that treatment with TNF ± blockers has a beneficial effect on mortality.

Data from one study analyzed 22,545 RA patients from across the United States over 85,691 patient-years of follow-up (Michaud K, Wolfe F. Reduced mortality among RA patients treated with anti-TNF therapy and methotrexate. Program and abstracts of the American College of Rheumatology 2005 Annual Scientific Meeting; November 13-17, 2005; San Diego, California. Abstract 296).

The 1713 deaths in this population group were analyzed to determine causes and other factors that might have contributed to death.

Compared with patients not receiving TNF ± blockers or methotrexate (MTX), the use of TNF ± blockers, the use of MTX, and the use of TNF ± blockers plus MTX were all associated with statistically significantly lower risks for death.

Also, a large Swedish study examined 1534 patients, 949 of whom were on TNF ± blockers.  This population group was scrutinized for factors associated with mortality. Overall, patients on TNF ± blockers had a slightly lower mortality rate that was not statistically significant compared with those not on TNF ± blockers. However, when adjusted for disease severity, using the Health Assessment Questionnaire score, TNF-± blocker treated patients had a significantly lower mortality (Jacobsson LTH, Turesson C, Nilsson L, et al. Treatment with TNF-blockers is associated with reduced premature mortality in patients with rheumatoid arthritis. Program and abstracts of EULAR 2006: 7th Annual European Congress of Rheumatology; June 21-24, 2006; Amsterdam, The Netherlands. Abstract).

This encouraging data should not induce a cavalier response by rheumatologists about this group of medicines.  Anti-TNF drugs are a wonderful development; however, close observation of patients on these drugs is mandatory.

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