About ENBREL
ENBREL has more than 16 years of collective clinical experience1 and 1.6 million patient-years of experience worldwide, across indications.1*
ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). ENBREL is also approved for treating the signs and symptoms of moderate to severe polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis, ankylosing spondylitis (AS), and moderate to severe plaque psoriasis.
Learn more about ENBREL and how it works.
Discover some of the attributes of ENBREL, like its half-life.
Find out about flexible administration options.
Understand some of the important adverse events reported with ENBREL.
*Based on estimated number of patient-years from 1998 through January 2008. Estimated number of patient-years is calculated by region based on the number of ENBREL units distributed and an estimated average dose.
What is ENBREL?
ENBREL is the only fully human soluble tumor necrosis factor (TNF) receptor. ENBREL 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 IgG1.3
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How does ENBREL work?
Although the exact cause of RA is unknown, elevated levels of TNF are found in the involved tissues and fluids of patients with RA. Elevated levels of TNF are also found in the tissues and fluids of patients with psoriatic arthritis, AS, and plaque psoriasis.3
ENBREL was designed to bind specifically to TNF and block its interaction with cell surface TNF receptors, thereby modulating the biological responses induced or regulated by TNF. These are the inflammatory responses that play an important part in RA, JIA, psoriatic arthritis, AS, and plaque psoriasis.
ENBREL binds to TNF limiting the amount of active TNF.3
What are the attributes of ENBREL?
- ENBREL has a mean half-life of 4.3 days. After administration of 25 mg of ENBREL to 25 patients with rheumatoid arthritis, a mean ± standard duration half-life of 102 ± 30 hours was observed with clearance of 160 ± 80 mL per hour.3
- ENBREL has not been shown to induce neutralizing antibodies.* Non-neutralizing antibodies were detected in approximately 6% of adult patients on ENBREL. There was no apparent correlation of antibody development to clinical response or adverse events.3
*The observed incidence of any antibody positivity is highly dependent on several factors. Therefore, comparison of the incidence of antibodies to ENBREL with the incidence of antibodies to other products may be misleading.
- ENBREL does not lyse cells in vitro in the presence or absence of complement. The clinical significance of this is unknown.
- ENBREL binds reversibly with TNF.4,5
Does ENBREL offer flexible administration options?
ENBREL offers 4 convenient administration options, including:
- ENBREL® SureClick™ autoinjectors, which are available for single use only in 50 mg/mL
- ENBREL prefilled syringes, which are available in 25 mg/0.5 ml and 50 mg/mL dosage strengths for single use only
- ENBREL multiple-use vials, which contain 25 mg of ENBREL for multiple doses
- ENBREL 25 mg vial adapters, which are used to assist with mixing the powder with the liquid and withdrawing ENBREL
What are the important adverse events reported with ENBREL?
All medicines are associated with adverse events, including ENBREL. The most common adverse events for ENBREL was injection site reactions, occurring in approximately 37% of patients. Injection site reactions were described as mild to moderate reddening of the skin, and/or itching, pain, or swelling that lasted approximately 3 to 5 days. Most reactions resolved and tended to occur in the first month, then decreased in frequency. This generally did not cause people to stop using ENBREL.3
The most common adverse events in adult clinical trials were injection site reactions, infections, and headache.3
Infections, including serious infections, some fatal, have been observed in patients treated with ENBREL. Tuberculosis (TB) has been observed in patients receiving tumor necrosis factor (TNF)-blocking agents, including ENBREL. In clinical trials of all TNF inhibitors, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may be up to several-fold higher in RA and psoriasis patients, particularly those patients with highly active disease. The role of TNF inhibitors in the development of lymphoma is unknown.3
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How can I learn more about ENBREL?
To find out more about ENBREL, call 1-888-4ENBREL (1-888-436-2735)
or visit www.enbrel.com/hcp/index.jsp.
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