Enbrel, (Etanercept), About Arthritis:"Enbrel is a new type of arthritis medication, developed by Immunex, and classified as a biologic response modifier. Can Enbrel Help Early, Active RA? Immunex Corporation has applied to the FDA for consideration that Enbrel be indicated for early active rheumatoid arthritis based on phase III trial results, from your About guide to Arthritis, Carol Eustice. Enbrel: Approved By Canada As Demand Soars. Enbrel, Canada's first biologic therapy for RA, has been approved. Since the drug first became available in the U.S. in 1998, demand has soared, necessitating the construction of new manufacturing plants and an enrollment program for users, from About guide to Arthritis, Carol Eustice.Enbrel Trial For Psoriatic Arthritis. A clinical trial of Enbrel for the treatment of severe psoriatic arthritis revealed promising results, from your About guide to Arthritis, Carol Eustice."
http://f.about.com/z/js/spr04.htm

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Enbrel, (Etanercept), U.S. Federal Drug Administration:"Product Approval Information - Licensing Action. Proper name: Etanercept. Tradename: Enbrel. Manufacturer: Immunex Corp, Seattle, WA, License #1132. Indication: Reducing signs and symptoms of active arthritis in patients with psoriatic arthritis. Approval Date: 1/15/2002. Type of submission: Biologics license supplement."
http://www.fda.gov/cber/products/etanimm011502.htm

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Enbrel, (Etanercept), Johns Hopkins Arthritis:"Unchanged for over a decade, the standard of care for ankylosing spondylitis has been a combination of physical therapy and nonsteroidal anti–inflammatory drugs (NSAIDs) and unproven agents such as sulfasalazine and methotrexate. However, recent studies have demonstrated the efficacy of infliximab in the treatment of ankylosing spondylitis (see article). Adding to these findings, Gorman et al (NEJM 346:1349–56, 2002) found that a four month course of etanercept resulted in significant and sustained improvement in patients with ankylosing spondylitis. Methods: Forty patients with active ankylosing spondylitis were entered into a randomized, double-blind, placebo-controlled trial. Patients received either a twice-weekly 25 mg dose of etanercept or placebo for four months. Patients were allowed to take NSAIDs, oral corticosteroids (10 mg/day) and disease–modifying antirheumatic drugs (DMARDs) at stable doses during the trial."
http://www.hopkins-arthritis.som.jhmi.edu/news-archive/2002/etanercept_spondylitis.html

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Enbrel:"Enbrel is indicated for reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis. ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients 4 years of age and older who have had an inadequate response to one or more DMARDs. ENBREL is indicated for reducing signs and symptoms of active arthritis in patients with psoriatic arthritis. The most frequent adverse events in placebo-controlled RA clinical trials involving 349 adults were injection site reactions (ISR) (37%), infections (35%), and headache (17%). Only the rate of ISR was higher than that of placebo. The most frequent adverse events in a methotrexate-controlled clinical trial of 415 adults with early-stage RA were infections (64%), ISR (34%), and headache (24%). Of these, only the rate of ISR was higher than that of methotrexate. In all 1,197 RA patients studied, malignan cies were rare (1%). Adverse events in the psoriatic arthritis trial were similar to those reported in RA clinical trials."
http://www.enbrel.com/home.jsp?fvar=0

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Enbrel, (Etanercept), American College of Rheumatology (ACR):"Classification Criteria for Establishing the Diagnosis of Rheumatoid Arthritis. Diagnosis of rheumatoid arthritis requires the presence of at least 4 of 7 criteria below: 1. Morning stiffness in and around joints lasting more than 1 hour. 2. Arthritis in at least 1 area in a wrist, metacarpophalangeal (MCP), or proximal interphalangeal (PIP) joint (hands or fingers) for greater than or equal to 6 weeks. 3. Simultaneous swelling or fluid accumulation in 3 or more joints for greater than or equal to 6 weeks. 4. Symmetric (bilateral joint) involvement for greater than or equal to 6 weeks. 5. Presence of rheumatoid nodules. 6. Positive serum rheumatoid factor. 7. Radiographic changes typical of RA (erosion or unequivocal bony decalcification in or adjacent to the involved joint) on hand and wrist present."
http://www.regence.com/trgmedpol/drugs/dru35.html

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Enbrel, (Etanercept), RxList:"Enbrel, (etanercept) is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. ENBREL is supplied as a sterile, white, preservative-free, lyophilized powder for parenteral administration after reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol). Following reconstitution, the solution of ENBREL is clear and colorless, with a pH of 7.4 ± 0.3. Each single-use vial of ENBREL contains 25 mg etanercept, 40 mg mannitol, 10 mg sucrose, and 1.2 mg tromethamine."
http://www.rxlist.com/cgi/generic/etanercept.htm

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Enbrel, (Etanercept), American College Of Rheumatology:"In May 1999, Immunex and Wyeth-Ayerst announced changes in product labeling for etanercept, based on serious infectious events observed in etanercept-treated rheumatoid arthritis (RA) patients. Etanercept, a fusion protein composed of dimeric soluble p75 tumor necrosis factor (TNF) receptor and a human IgG Fc fragment, received FDA approval on November 2, 1998, for the treatment of moderate to severe, active RA patients who have not responded to one or more disease-modifying anti-rheumatic drugs (DMARDs). Etanercept was also approved by the FDA on May 28, 1999, for the treatment of JRA. As TNF plays a crucial role in the inflammatory response, and because the inflammatory response helps provide protection from infectious organisms, investigators and clinicians remain alert to the consideration that inhibition of TNF (e.g., with etanercept) may place patients at a greater risk of infection. Such concerns may further be amplified in RA, where there may be a six- to nine-fold increase of infection-related deaths. This risk is increased further with increasing disease severity. Clinical Trials Experience1. In the package insert, etanercept-treated patients in clinical trials were reported to have a greater frequency of upper respiratory tract infections (16% placebo, 29% etanercept). Yet, etanercept patients did not manifest a greater number of "serious" infectious events (1.3% placebo, 0.9% etanercept) in these short term, placebo-controlled clinical trials. Analysis of all etanercept-exposed patients (from both open-label and placebo-controlled trials) shows that 22 of 745 patients (3%) developed serious infections. Only one infection-related death (one of 745 patients or 0.13%) was observed in these clinical trials."
http://www.rheumatology.org/research/hotline/0799adverse.html

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Etanercept, Enbrel, Drug Guide 2002:"Etanercept, Enbrel: 25 mg twice per week, given by subcutaneous (beneath the skin) injection Drug must be refrigerated prior to use. Mix prior to injection. Do not shake. May be injected into the thigh, abdomen or upper arm. Pain or burning in throat; redness, itching, pain and/or swelling at the site of the injection; runny or stuff nose. For etanercept and infliximab: Let your doctor know if you have one of the following: active infection, exposure to tuberculosis or if you have a central nervous system disorder, including demyelinating disorders such as multiple sclerosis, myelitis or optic neuritis. Administration of these agents should be discontinued if you develop a serious infection. Live vaccines should not be given concurrently with these drugs. For etanercept (Enbrel): Because supplies of Enbrel may be limited until mid-2002 (when a new manufacturing plant will open) people taking Enbrel or wanting to take Enbrel should call and register with the manufacturer to help ensure access."
http://www.arthritis.org/conditions/DrugGuide/brms.asp

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Etanercept, Arthritis Insight:"How does it work? Designed specifically to treat inflammatory arthritis, it works by binding to the tumor necrosis factor, which is a key player in the inflammation inflammatory arthritis. Like a sponge soaking up excess water, Etanercept soaks up excess tumour necrosis factor resulting in less inflammation. Dosage: Etanercept is available in 25mg vials for injection. The injections are given twice weekly and may be self injected after proper instruction is given. How should I take it? Mix and inject the medication following the enclosed instructions. The injection is given under the skin. Injection sites should be rotated to avoid irritation. Contraindications: This medication should not be used in persons with an infection or a history of systemic infections."
http://jraworld.arthritisinsight.com/medical/meds/enbrel.html

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