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| |  Malignancies in Etanercept-Treated Patients Uncommon: Presented at EULAR By Jill Stein PARIS -- June 14, 2008 -- Rates of malignancies in patients receiving etanercept appear to be similar to that of the general population, say researchers, following review of double-blind portions of several clinical trials involving etanercept for all indications. The findings were reported in a poster presentation on June 13 at EULAR 2008, the Annual Congress of the European League Against Rheumatism. Etanercept is a fully human soluble anti-tumour necrosis factor receptor approved for rheumatoid arthritis (RA), juvenile RA, ankylosing spondylitis, psoriatic arthritis, and psoriasis (PsO). Alice B. Gottlieb, MD, Tufts-New England Medical Center, Boston, Massachusetts, and colleagues examined malignancy events in patients receiving etanercept for approved indications. The study included all events that occurred while the patient was on the study drug or within 30 days after the last dose. A total of 44 trials were analysed. The double-blind portions included data from up to 2,284 patients who took placebo or disease-modifying antirheumatic drugs with 1,242 patient-years and up to 4,593 patients who took etanercept, with 2,965 patient-years of etanercept exposure. Malignancies were identified using the Surveillance Epidemiology and End Results (SEER) guidelines for counting malignancies. Standardised incidence ratios (SIR) were calculated taking sex and age distribution into consideration. The SIR for malignancies in all clinical trials was 1.00. Fifteen cases of lymphoma were reported across all indications (SIR = 2.93; 95% CI = 1.64, 4.83), mostly in RA studies (SIR = 3.45; 95% CI = 1.83, 5.89). The higher than anticipated lymphoma rates in patients with RA may be evidence of an increased risk present in RA populations as has been previously suggested, the authors said. The SIR for melanoma for all clinical trials including all indications was 2.07 (95% CI = 0.95, 3.93). All 3 of the patients with PsO who reported melanomas had undergone earlier psoralen and ultra violet A light therapy. The SIRs (95% CI) for squamous-cell carcinoma (SCC) in patients with PsO were 2.09 (1.27, 3.22) and 4.96 (3.03, 7.66), respectively, when compared to general population data with high- or low-sun exposure. Nearly three-fourths of patients with PsO who reported SCCs received phototherapy at some point in time. The investigators found a low incidence of basal-cell carcinoma for patients with PsO (SIR = 0.60; 95% CI = 0.38, 0.89) and for all indications including PsO combined (SIR = 0.25; 95% CI = 0.19, 0.33). The SCC rate was higher in the PsO population, and it has not been established whether this is due to previous phototherapy with or without etanercept treatment. Dr. Gottlieb and her colleagues emphasised that additional experience is needed to better understand the risk of rare events such as lymphoma and SCC. Funding for the study was provided by Immunex Corp. and by Wyeth Pharmaceuticals. [Presentation title: Malignancies From Patients Receiving Etanercept Across Approved Indications. Abstract FRI0113]
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