Psoriasis is a chronic, relapsing, inflammatory skin disorder with considerable clinical, psychosocial and economic burden. It affects a significant portion of the population. Psoriasis appears to be mediated by genetic factors and abnormal immune system functioning, including T lymphocyte and macrophage activation and the release of various cytokines such as: tumor necrosis factor alpha (TNF a) and interleukin 12 (IL-12) and 23 (IL-23). The introduction of new biological drugs: infliximab, etanercept, adalimumab and ustekinumab has brought a breakthrough in moderate-to-severe psoriasis treatment. This paper presents the results of pharmacokinetics studies and clinical trials on efficacy and safety of ustekinumab therapy. Ustekinumab (Stelara®), the newest biological agent, is a human monoclonal antibody that binds specifically to and neutralizes the effects of IL-12 and IL-23. The molecular, pharmacologic and clinical attributes of ustekinumab translate into rapid, substantial and sustained therapeutic benefit for patients with psoriasis. Ustekinumab’s less frequent dosing requirements (45 mg/90 mg at week 0 and 4, then every 12 weeks) set a new standard for convenience of psoriasis therapies. Its high degree of efficacy, tolerability and convenient dose regimen are anticipated to set the standard for future treatment compliance and satisfaction.

Ustekinumab is approved in the EU, US and Canada for use in patients with moderate to severe plaque psoriasis.