Etanercept

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[edit] BRAND NAMES

[edit] MECHANISM OF ACTION

Etanercept is a fusion protein produced by recombinant DNA that has been designed to block the activity of a chemical messenger in the body called tumour necrosis factor (TNF).

Tumour necrosis factor (TNF) is a dominant cytokine that is involved in normal inflammatory and immune responses. It plays an important role in the inflammatory processes of Rheumatoid Arthritis, polyarticular Juvenile Idiopathic Arthritis, psoriatic plaques, psoriatic arthritis and ankylosing spondylitis. Elevated levels of TNF are found in involved tissues and fluids of patients suffering from these diseases.

Etanercept acts as a competitive inhibitor of TNF binding to its cell surface receptors, and thereby inhibits the biological activity of TNF. Biological activities attributed to TNF include induction of proinflammatory cytokines (such as interleukins IL-1 and IL-6), enhancement of leukocyte movement or migration from the blood vessels into the tissues, and increasing the release of cell adhesion molecules (CAMs).

[edit] INDICATIONS

  • Rheumatoid Arthritis: Treatment of moderate to severe, active rheumatoid arthritis in adult patients. Etanercept can be initiated in combination with methotrexate (MTX) or used alone.
  • Juvenile Idiopathic Arthritis (JIA): Etanercept is indicated for reducing signs and symptoms of moderately to severely active polyarticular JIA in pediatric patients 2 years of age and older.
  • Psoriatic Arthritis (PsA): Adult patients with active PsA, Etanercept can be used in combination with methotrexate (MTX) in patients who do not respond adequately to MTX alone
  • Ankylosing Spondylitis (AS): Etanercept is indicated for reducing signs and symptoms in adult patients with active AS.
  • Plaque Psoriasis (Ps): Treatment of adult patients (18 years or older) with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

[edit] DOSAGE

Etanercept is administered by subcutaneous injection.

  • Adult Rheumatoid arthritis, Psoriatic arthritis and ankylosing spondylitis: 25 mg twice weekly or 50 mg once weekly, with or without methotrexate (MTX)
  • Adult Plaque Psoriasis: 50 mg twice weekly for 3 months, followed by 50 mg once weekly
  • Juvenile Idiopathic Arthritis: 0.8 mg/kg weekly, with a maximum of 50 mg per week

[edit] CONTRAINDICATIONS

  • Hypersensitivity to Etanercept
  • Sepsis or risk of sepsis
  • Treatment with Etanercept should not be initiated in patients with active infections, including chronic or localised infections.

[edit] WARNINGS AND PRECAUTIONS

  • Invasive fungal infections: Consider empiric anti-fungal therapy for patients at risk for invasive fungal infections who develop a severe systemic illness on Enbrel (those who reside or travel to regions where mycoses are endemic)
  • Demyelinating disease: Etanercept has been associated in rare instances with exacerbation or new onset, of demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.
  • Cases of lymphoma have been observed in patients receiving TNF blocking agents.
  • Heart failure: Worsening or new onset, may occur
  • Haematologic reactions (aplastic anemia, pancytopenia): Advise patients to seek immediate medical attention if symptoms develop, and consider stopping Etanercept
  • Hepatitis B virus reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop Etanercept and begin anti-viral therapy
  • Anaphylaxis or serious allergic reactions may occur
  • Stop Etanercept if lupus-like syndrome or autoimmune hepatitis develops.

[edit] INTERACTIONS

  • Abatacept: Increased risk of serious infection
  • Anakinra: Increased risk of serious infection
  • Live vaccines: Avoid use with Etanercept
  • Cyclophosphamide: use with Etanercept is not recommended

[edit] PREGNANCY AND LACTATION

  • Pregnancy Category B (US). Developmental toxicity studies have been performed in rats and rabbits at doses ranging from 60- to 100-fold higher than the human dose and have revealed no evidence of harm to the fetus due to Etanercept. There are, however, no studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Etanercept should be used during pregnancy only if clearly needed.
  • Because of the potential for serious adverse reactions in nursing infants from Etanercept, a decision should be made whether to discontinue nursing or to discontinue the drug

[edit] SIDE EFFECTS

The most common side effects with Etanercept are injection site reactions (including bleeding, bruising, redness, itching, pain and swelling) and infections (including colds, and lung, bladder and skin infections).

[edit] RELATED LINKS

Novel Treatments for Rheumatoid Arthritis

[edit] BIBLIOGRAPHY

[edit] REFERENCES