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Stelara gets NICE approval

Janssen-Cilag gets NICE approval for biologic psoriasis treatment

The National Institute for Health and Clinical Excellence (NICE) has approved Janssen-Cilag's Stelara (ustekinumab) for the treatment of moderate to severe plaque psoriasis in adults.

Stelara, a first in class biologic for the treatment of psoriasis – a notoriously difficult-to-treat skin condition – works by targeting interleukin-12 (IL-12) and IL-23. It provides visible and significant improvements in psoriasis severity; in addition, it has the advantage of a convenient dosing regimen for patients – just five injections per year compared to a possible 104 injections with etanercept, a widely prescribed biologic therapy.

In clinical trials, Stelara demonstrated a significant, visible improvement in patient's psoriasis with convenient 12 weekly maintenance dosing. "Two-thirds of patients taking Stelara in placebo-controlled trials saw a significant, visible improvement in their psoriasis in as little as 12 weeks," said Christopher Griffths, Professor of Dermatology at the University of Manchester.

NICE has recommended Stelara as a treatment option for adults with plaque psoriasis for whom biologic therapy is being considered and when the following criteria are both met:

  • The disease is severe, as defined by a total Psoriasis Area Severity Index score of 10 or more and a Dermatology Life Quality Index score of more than 10
  • The psoriasis has not responded to standard systemic therapies, including ciclosporin, methotrexate and PUVA (psoralen and long-wave ultra-violet radiation), or the person is intolerant of or had a contraindication to these treatments.

    Stelara is a new, fully human monoclonal antibody with a novel mechanism of action that targets the p40 subunit of the cytokines IL-12 and IL-23, which are naturally occurring proteins important in regulating immune responses and are thought to be associated with some immune-mediated inflammatory disorders, including plaque psoriasis.

  • 23rd September 2009

    From: Healthcare

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