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| |  Enbrel (Etanercept) Approved for First-Line Treatment of Moderately to Severely Active Rheumatoid Arthritis SEATTLE, WA -- June 7, 2000 -- A new use for Enbrel® (etanercept) was approved by the U.S. Food and Drug Administration (FDA). Enbrel is now indicated for reducing signs and symptoms and delaying structural damage in patients with moderately to severely active rheumatoid arthritis (RA). This new, expanded indication for Enbrel is based on data submitted in July 1999 in a supplemental biologics license application (sBLA) by Immunex Corp. and Wyeth-Ayerst, a division of American Home Products Corporation, co-marketers of Enbrel in North America. The sBLA included radiographic and clinical results of the Enbrel "ERA" trial -- a phase III randomized, double-blind, multi-center trial that included 632 adults who had early stage RA (less than three years and had never been treated previously with methotrexate). "Early diagnosis of rheumatoid arthritis is extremely important," said Dr. Roy Fleischmann, MD, Rheumatologist, Clinical Associate Professor of Medicine, University of Texas Health Science Center, Dallas, Texas, a key investigator in the Enbrel "ERA" study. "If the patient with moderately to severely active disease is not aggressively treated within those few months, certainly the first year of the disease, the chances of developing significant deformities which produce significant disability later in life may be very high." "My advice to somebody who feels they may have rheumatoid arthritis is to find a specialist they trust," said Jim Johnson, 37, of Aledo, Texas, a participant in the Enbrel "ERA" trial and a patient of Dr. Fleischmann. "I was pleased to learn that Enbrel has been shown to delay joint damage associated with active rheumatoid arthritis." The 632 participants in the Enbrel "ERA" study were randomized to receive either 25 mg or 10 mg of Enbrel, or up to 20 mg of methotrexate per week for 12 months. To ensure blinding of study treatments, patients received both injections and pills: Enbrel by injection twice weekly plus placebo pills weekly, or methotrexate pills weekly plus placebo injections twice weekly. Patients enrolled in this study had RA for a relatively short time (mean of one year), and had active disease (mean tender and swollen joint counts of 30 and 24, respectively, and reported four hours of morning stiffness). All patients had risk factors for rapidly progressive, erosive RA including the presence of rheumatoid factor and/or erosions on baseline x-rays of the hands, wrists and feet. The FDA approved Enbrel on November 2, 1998 to treat moderately to severely active rheumatoid arthritis in patients who have an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). In postmarketing use, serious infections and sepsis, including fatalities, have been reported. Many of these events occurred in patients predisposed to infections, such as those with advanced or poorly controlled diabetes. The most frequent adverse events in placebo-controlled trials in rheumatoid arthritis (n=349) were injection site reactions (ISR) (37 percent), infections (35 percent) and headache (17 percent). Only the rate of ISR was higher than placebo. The most frequent adverse events in the ERA trial (n=415) were infection (64 percent), ISR (34 percent) and headache (24 percent). Only the rate of ISR was higher than methotrexate. In all RA patients treated in clinical trials (n=1197), malignancies were rare (1 percent). In clinical trials, frequency of serious adverse events was 4 percent Enbrel compared to 5 percent placebo; and 6 percent Enbrel compared to 8 percent methotrexate. Enbrel acts by binding tumor necrosis factor (TNF). TNF is one of the dominant cytokines or proteins that play an important role in normal immune function and the cascade of reactions that cause the inflammatory process of RA. Enbrel competitively inhibits the binding of TNF molecules to the TNF receptor (TNFR) sites. The binding of Enbrel to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity. Related Links: Enbrel (etanercept), Immunex Corp., Wyeth-Ayerst and American Home Products Corporation.
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