Indications

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In adult patients with rheumatoid arthritis, the European Medicines Agency (2005) has approved etanercept 25 mg twice weekly (alternatively, 50 mg once weekly, as two 25-mg injections or a single 50-mg injection, has been shown to be safe and effective) as monotherapy or in combination with methotrexate in those who have had an inadequate response to previous treatment with other disease-modifying antirheumatic drugs (DMARDs), including methotrexate. It is also approved for patients with severe, active, and progressive rheumatoid arthritis in those not previously treated with methotrexate. The drug has been shown to reduce the signs and symptoms of rheumatoid arthritis (at a dose of 25 mg twice weekly or 50 mg weekly), inhibit the progression of structural damage, and improve physical function in patients with rheumatoid arthritis.

Etanercept 0.4 mg/kg (up to 25 mg per dose maximum) twice weekly is also indicated for the treatment of active polyarticular-course juvenile chronic arthritis in children aged 4-17 years with an inadequate response or intolerability to methotrexate.

Etanercept 50 mg once weekly (or 25 mg twice weekly) is indicated for the treatment of severe active anky-losing spondylitis in patients with an inadequate response to conventional therapy and for the treatment of active and progressive psoriatic arthritis in patients with an inadequate response to previous DMARD therapy. Etanercept has been shown to improve the clinical signs and symptoms of ankylosing spondylitis in affected patients. In patients with psoriatic arthritis, etanercept (50 mg once weekly or 25 mg twice weekly) can reduce the signs and symptoms of the disease, inhibit progression of structural damage of active arthritis, and improve physical function.

Etanercept is also indicated for the treatment of moderate to severe plaque psoriasis in those who have failed to respond to, or who have a contraindication to, or are intolerant of, other systemic therapy including methotrexate, cyclosporine, or psoralen plus ultraviolet A phototherapy. The recommended dose in plaque psoriasis patients is 25 mg twice weekly until remission is achieved, for up to 24 weeks. Alternatively, 50 mg twice weekly may be used for up to 12 weeks, and if needed, followed by a dose of 25 mg twice weekly until remission is achieved, for up to 24 weeks. In patients with psoriasis, etanercept has been shown to reduce the signs and symptoms of the disease, including the proportion of body surface area affected and measures of plaque severity (induration, erythema, and scaling).

A summary of adverse events associated with eta-nercept treatment based on clinical trial and postmarketing experience is presented in Table 4.4. The most

Table 4.4. Frequency of adverse events associated with etanercept based on clinical trials and postmarketing experience

Frequency"

Adverse event

Very common (> 1/10)

Injection site reactions

Infections

Common (> 1/100, <1/10)

Fever

Pruritus

Allergic reactions

Autoantibody formation

Common (> 1/1,000, < 1/100)

Serious infections

Rash

Angioedema

Urticaria

Thrombocytopenia

a Number of adult patients expected to experience the reaction a Number of adult patients expected to experience the reaction common adverse events associated with etanercept therapy are injection site reactions, including bleeding, bruising, erythema, itching, pain, and swelling. Serious adverse events have been reported in patients receiving etanercept, some fatal, including infections, lymphoma (observed rates and incidence are similar to those expected for the population studied), as well as neurologic and hematologic disorders.

Etanercept is contraindicated in patients with sepsis or risk of sepsis and should not be initiated in patients with active infections, including chronic or localized infections. Clinicians should refer to the product label for a comprehensive list of patient warnings and precautions.

Outside of Europe, some countries may follow the US Food and Drug Administration indications. In the United States, etanercept is approved for moderate to severe active rheumatoid arthritis (as monotherapy or as combination therapy with methotrexate, DMARD failure not required), moderate to severe active polyar-ticular juvenile arthritis in those with an inadequate response to at least one DMARD, active ankylosing spondylitis, active psoriatic arthritis, and chronic moderate to severe plaque psoriasis (in candidates for systemic therapy or phototherapy). The recommended dose for etanercept in the United States is 50 mg once weekly in adults with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. In psoriasis patients, the dose is 50 mg twice weekly for 3 months followed by 50 mg once weekly. The recommended dose for pediatric patients with rheumatoid arthritis is 0.8 mg/kg per week (maximum 50 mg/week).

Etanercept is available in Europe as single-use 25-mg and 50-mg vials and a 25-mg multiple-dose vial of lyophilized powder for reconstitution. It is also available as a prefilled syringe containing 50-mg etanercept for single use or 25-mg etanercept for single use. In the United States, etanercept is available as 25-mg multiple-dose vials of lyophilized powder for reconstitution, as well as a 1-ml prefilled syringe containing 50-mg eta-nercept for single use, and an autoinjector containing 50-mg etanercept for single use.

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