NICE guidance - etanercept and efalizumab for the treatment of adults with psoriasis

Etanercept:

• etanercept is a recombinant human tumour necrosis factor (TNF) receptor fusion protein that inhibits the activity of TNF
  • TNF is a cytokine that is released from T lymphocytes; it mediates inflammation and modulates the cellular immune response
  • etanercept is licensed for the 'treatment of adults with moderate to severe plaque psoriasis who have failed to respond to, or who have a contraindication to, or who are intolerant to other systemic therapies including ciclosporin, methotrexate or PUVA'
    • also licensed for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate
• etanercept, within its licensed indications, administered at a dose not exceeding 25 mg twice weekly is recommended for the treatment of adults with plaque psoriasis only when the following criteria are met.
  • the disease is severe as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10
  • the psoriasis has failed to respond to standard systemic therapies including ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet radiation); or the person is intolerant to, or has a contraindication to, these treatments
• etanercept treatment should be discontinued in patients whose psoriasis has not responded adequately at 12 weeks. Further treatment cycles are not recommended in these patients. An adequate response is defined as either:
  • a 75% reduction in the PASI score from when treatment started (PASI 75) or
  • a 50% reduction in the PASI score (PASI 50) and a five-point reduction in DLQI from when treatment started

Efalizumab:

• efalizumab is a T-cell modulator that blocks T-cell activation or migration. It is licensed for the 'treatment of adults with moderate to severe plaque psoriasis who have failed to respond to, or who have a contraindication to, or who are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA'
  • the UK marketing authorisation for efalizumab also specifies that the psoriasis should be chronic, and it is contraindicated in patients with specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as the sole or predominant form
• efalizumab, within its licensed indications, is recommended for the treatment of adults with plaque psoriasis under the circumstances detailed in above only if their psoriasis has failed to respond to etanercept or they are shown to be intolerant of, or have contraindications to, treatment with etanercept.
• further treatment with efalizumab is not recommended in patients unless their psoriasis has responded adequately at 12 weeks as defined above for etanercept

Notes:

• recommended that the use of etanercept and efalizumab for psoriasis should be initiated and supervised only by specialist physicians experienced in the diagnosis and treatment of psoriasis
• if a person has both psoriasis and psoriatic arthritis their treatment should be managed by collaboration between a rheumatologist and a dermatologist

Reference:

1. NICE (July 2006). Etanercept and Efalizumab for the treatment of adults with psoriasis