HIGH WYCOMBE, England, February 8 /PRNewswire/ -- STELARA (ustekinumab) has today been accepted by the Scottish Medicines Consortium (SMC) for restricted use within NHS Scotland for the treatment of moderate to severe plaque psoriasis.(1) STELARA is the first in a novel class of biologics. The SMC guidance highlights that patients treated with STELARA achieved a significantly higher clinical response over a 12-week period compared to those treated with a different biologic treatment, etanercept (50mg twice-weekly).(1,2)

The SMC advice takes into account the benefits of an innovative Patient Access Scheme (PAS) proposed by Janssen-Cilag. After integrating the PAS into the health economic analysis, the breakdown indicated that STELARA would result in cost savings compared to continuous use of either etanercept 25mg or 50mg.(1)

The approval by the SMC for the use of STELARA in NHS Scotland provides both physicians and patients with a new treatment option, which is important because psoriasis can be a challenging disease to treat, says Dr. David Burden, Consultant Dermatologists at the Western Infirmary, Glasgow. One of the benefits my patients appreciate is that the injection is only every three months compared to every week for some alternative treatments.

Psoriasis is a chronic, painful autoimmune skin disease.(4) Up to 20-30% of people with psoriasis have the severe form of the disease, which can have both a physical and psychological impact on patients.(5,6) The impact on quality of life in people with psoriasis is comparable to other chronic illnesses such as heart disease, hypertension, diabetes and cancer.(7)

Around 125,000 people in Scotland suffer from psoriasis, a common condition which is not only painful and unsightly but has a huge impact on how you feel about yourself - it affects your confidence and can sometimes cause depression and anxiety. This is not helped by the fact that psoriasis has a low profile and as such is often misunderstood, comments Janice Johnson, Co-Founder and Trustee of the Psoriasis Scotland Arthritis Link Volunteers (PSALV). Some patients who have received STELARA have seen real benefits, so the SMC's advice for its use in NHS Scotland is a welcome decision.

In clinical studies, treatment with STELARA demonstrated a significant, visible improvement in patient's psoriasis with convenient 12 weekly maintenance dosing.(8,9) This has the potential to give patients with psoriasis greater freedom to live their lives with a significantly reduced burden of disease and without the inconvenience of frequent injections.

The SMC has accepted STELARA (ustekinumab) as a treatment option for moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and psoralen and UVA treatment (PUVA). The guidance states that treatment with STELARA should be discontinued in patients who do not achieve at least a 75% reduction in Psoriasis Area Severity Index (PASI 75) by week 16.(1)

About STELARA(R) Black Triangle Drug (ustekinumab)

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

STELARA is licensed for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (psoralen plus ultraviolet A light).(3)

Centocor Ortho Biotech Inc. developed STELARA and has exclusive marketing rights to the product in the United States. Janssen-Cilag has exclusive marketing rights in all countries outside of the United States. Centocor, Inc. and Janssen-Cilag are members of the Johnson Johnson family of companies.

SMC Advice(1)

Ustekinumab (Stelara) is accepted for restricted use within NHS Scotland for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and psoralen and UVA treatment (PUVA).

Significantly more patients treated with ustekinumab achieved at least 75% improvement in their Psoriasis Area and Severity Index (PASI 75) at week 12, compared with those treated with a tumour necrosis factor alpha antagonist.

Continued treatment should be restricted to patients who achieve a PASI 75 response within 16 weeks.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of ustekinumab. This SMC advice is dependent upon the continuing availability of the patient access scheme in NHS Scotland.

About Psoriasis Scotland Arthritis Link Volunteers (PSALV)

PSALV/Psoriasis Scotland is a peer led Scottish charity for people with skin psoriasis and/or psoriatic arthritis.

References:

1. Scottish Medicines Consortium. Ustekinumab, 45mg solutions for injection (STELARA). No. 572/09. 2010.

2. Griffiths C, Strober B, van de Kerkhof P et al. Comparison of Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis. N Engl J Med. 2010;362:118-28

3. Janssen-Cilag Ltd. STELARA 45mg solution for injection. Summary of Product Characteristics (SPC). 16 January 2009.

4. The Psoriasis Association. What is psoriasis? Accessed on 21 January 2010, from http://www.psoriasis-association.org.uk/what-is.html.

5. Smith CH, Anstey AV, Barker JN, et al. British Association of Dermatologists guidelines for use of biological interventions in psoriasis 2005. Br J Dermatol. 2005;153(3):486-497.

6. Kimball AB, Jacobson C, Weiss S, et al. The Psychosocial Burden of Psoriasis. Am J Clin Dermatol. 2005;6 (6):383-392.

7. Rapp SR, Feldman SR, Exum ML, et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999;41:401-7.

8. Leonardi CL, Kimball AB, Papp KA, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008;371:1665-74

9. Papp K, Langley RG, Lebwohl M, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008;371:1675-84.

SOURCE: Janssen-Cilag

CONTACT: For further information about PSALV please contact Janice Johnsonon +44-(0)131-556-4117 or janice.johnson5@btinternet.com. For furtherinformation, please contact: Alex Butler, Janssen-Cilag, Tel:+44-(0)1494-567-504, Email: AButler2@its.jnj.com. Liz Wyatt, ResoluteCommunications, Tel: +44-(0)20-7357-8187, Email:liz.wyatt@resolutecommunications.com