Technology Appraisal Guidance No. 103
Source: National Institute for Health and Care Excellence
1.1 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.
- 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.
1.4 NICE has withdrawn its guidance on the use of efalizumab for the treatment of adults with psoriasis because the EMEA's Committee for Medicinal Products for Human Use has reviewed possible links between the drug and a rare but deadly brain infection and said the benefits of efalizumab no longer outweigh its risks, because of safety concerns, notably the occurrence of progressive multifocal leukoencephalopathy.
1.5 It is recommended that the use of etanercept 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.
1.6 NICE has withdrawn its guidance on the use of efalizumab for the treatment of adults with psoriasis because the EMEA's Committee for Medicinal Products for Human Use has reviewed possible links between the drug and a rare but deadly brain infection and said the benefits of efalizumab no longer outweigh its risks, because of safety concerns, notably the occurrence of progressive multifocal leukoencephalopathy.
The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at http://www.nice.org.uk/guidance/ta103
Copies of the document can also be obtained by contacting 0845 003 7783 or emailing email@example.com and quoting reference number N1090.
This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
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Etanercept and Efalizumab for the Treatment of Adults with Psoriasis.
Issue Date: July 2006
Review Date: July 2008