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| |  ACR: Enbrel (Etanercept) in TNF-Receptor Associated Periodic Fever Syndrome By Bruce Sylvester Special to DG News SAN FRANCISCO, CA. -- November 14, 2001 -- Enbrel (etanercept) therapy appears to safely decrease the severity, duration, and frequency of inflammatory symptoms in patients with tumour necrosis factor receptor associated fever syndrome (TRAPS). Researchers reported the findings yesterday (Nov. 13) at the American College of Rheumatology (ACR) annual meeting in San Francisco, California. "The [tumour necrosis factor] TNF receptor is one of the major mediators of inflammation in the human body. So we are not only learning more about treatment for the small number of TRAPS patients, but also more about the crucial TNF receptor pathway," said Keith Hull, MD, lead researcher and clinical fellow at the National Institutes of Arthritis Musculoskeletal and Skin Diseases in Bethesda, Maryland. "TRAPS is rare but it is one of the few diseases in which there is a mutation in the TNF receptor pathway. So our research will become a model for studying the TNF receptor pathway. Hopefully it will lead to a better understanding of inflammatory pathways in the body, so we cam aim research at a broader group of inflammatory diseases, like rheumatoid arthritis," Dr. Hull said. TRAPS is an autoinflammatory disorder resulting from mutations in TNFRSF1A, the gene that encodes the 55 kDa receptor for TNF. Clinically, patients present with recurring inflammatory attacks consisting of fever, rash, conjunctivitis, abdominal pain, and myalgia that are often severely disabling. Nonsteroidal anti-inflammatory drug (NSAID) therapy is largely ineffective in TRAPS patients, while glucocorticoids are somewhat more effective but have significant long-term toxicities. National Institutes of Health researchers undertook a six-month, open-labeled pilot study to determine the safety and efficacy of standard doses of Enbrel to alleviate symptoms of TRAPS. Fifteen symptomatic patients with known mutations in TNF RSF1A were enrolled into an Institutional Review Board-approved protocol consisting of four three-month phases: baseline observation; Enbrel, 25 mg for adults or 0.4 mg/kg for children, twice weekly; Enbrel, same dosing, three times per week; and finally withdrawal of Enbrel. Patients recorded symptoms and use of medications using a standardised diary throughout each phase of the study. Additionally, researchers took blood draws during each phase to assess C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and serum amyloid-A (SAA) levels from patients at baseline, between attacks and during attack episodes. Results from five patients who have completed the study reveal the ability of twice-weekly Enbrel to significantly decrease symptoms (derived using an attack score) by 74 percent from pretreatment levels, and by 87 percent when administered three times weekly. Patients returned to pretreatment symptom levels following the withdrawal of Enbrel. Enbrel dose-dependently decreased the baseline CRP (49 percent and 76 percent, respectively), ESR (23 percent and 47 percent, respectively), the amount of NSAIDs (61 percent and 87 percent, respectively) and glucocorticoids (80 percent and 85 percent, respectively) taken to relieve symptoms. The only reported adverse effect was that of minor local injection site irritation. "We were encouraged by its ability to decrease reported symptoms in 66 percent of patients, the first group of subjects to complete the protocol," Hull said.
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