Tuesday, September 4, 2012 (Last Updated: 09/05/2012)TUESDAY, Sept. 4 (HealthDay News) -- For patients with rheumatoid arthritis (RA), the use of biologic response modifiers (BRMs) for at least six months is not associated with an increased risk of malignancy compared with placebo or other disease-modifying antirheumatic drugs (DMARDs), according to a study published in the Sept. 5 issue of the Journal of the American Medical Association.
Maria A. Lopez-Olivo, M.D., Ph.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues examined the risk of malignancy in 29,423 patients with RA enrolled in 63 randomized controlled trials that compared the safety of any BRM with placebo and/or any traditional DMARD, with a minimum follow-up of 24 weeks.
The researchers found that there was no statistically significant increased risk of developing malignancy. Two hundred eleven patients developed malignancy during the trial, mainly solid tumors (118) and skin cancers (48). A very low incidence rate for any malignancy during the first year of therapy was noted for BRM plus methotrexate (0.77 percent); BRM monotherapy (0.64 percent); and controls (0.66 percent). The odds were lower for anakinra plus methotrexate versus methotrexate alone (Peto odds ratio, 0.11). There was no significant risk for specific cancer sites, although for patients receiving tumor necrosis factor inhibitors versus controls, the Peto odds ratio for lymphoma was 2.1 (95 percent confidence interval, 0.55 to 8.4).
"Overall, our findings do not support an increased risk of malignancy for patients with RA receiving BRMs in randomized controlled trials of at least 24 weeks' duration," the authors write.
Hematology & Oncology
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