| Sumario: | Skin diseases like psoriasis, pyoderma gangrenosum and Behcets disease are often chronic with the need for continuous treatment and follow-up. Traditional treatment like phototherapy or systemic therapy with ciclosporin, metotrexate and retinoids are not always effective or cause long-term side effects. New biological agents, which target pathologic T cell activity, have been developed. This report deals with the biological agents tumour necrosis factor alpha (TNF-alpha) inhibitors (infliximab (Remicade(r))), adalimumab (Humira(r)), etanercept (Enbrel(r)) and efalizumab (Raptiva(r)) which is a T cell modulator. Methods The systematic review was performed according to procedures described in the Norwegian Knowledge Centre for the Health Servicesf handbook. The work was carried out together with a review team of external professionals. The literature was identified by a systematic search in electronic databases. The pharmaceutical companies were also invited to dispatch documentation. A health economic consideration based on available literature was written. Results 26 publications were included in the report. 24 of the publications were on psoriasis, one on pyoderma gangrenosum and one on Behcets disease. Sixteen of the studies are RCTs and ten are follow-up studies or separate publications of the included RCTs. The results show that both the TNF-alpha inhibitors and efalizumab are significantly more effective than placebo for the treatment of moderate to severe psoriasis at week 10-12. The quality of life was also improved compared to placebo treatment. There is lack of RCTs concerning other skin diseases than psoriasis. Long term data for evaluation of adverse events were not identified, and conclusions regarding long-term safety cannot be drawn. Conclusions There is good evidence that TNF-alpha inhibitors and efalizumab are efficacious in the treatment of moderate to severe psoriasis. We did not find studies comparing TNF-alpha inhibitors and efalizumab with traditional treatment. Limited data is available concerning safety in long-term use. One study on health economics performed in England indicates that etanercept and efalizumab are cost-effective for patients with severe psoriasis and low quality of life that responds well to the treatment.
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