Janssen-Cilag’s STELARA(R) (Black Triangle Drug) (ustekinumab) Approved by NICE for the Treatment of Moderate to Severe Plaque Psoriasis

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STELARA (ustekinumab) has today been approved by the National Institute for Health and Clinical Excellence (NICE) as a treatment option for adults with moderate to severe plaque psoriasis,(1) a notoriously difficult-to-treat skin condition for which many patients report feeling dissatisfied and frustrated with existing treatment options.(2)

STELARA, the first in a new class of biologics for the treatment of psoriasis, works by targeting interleukin-12 (IL-12) and IL-23. It provides visible and significant improvements in psoriasis severity,(3,4) and has the added advantage of a convenient dosing regimen for patients - just five injections per year in comparison to a possible 104 injections with etanercept, a widely prescribed biologic therapy.(5,6)

Psoriasis, a chronic, non-contagious autoimmune disease resulting in the overproduction of skin cells, affects around 1.5 million people in the UK; up to 20-30% of whom suffer from the severe form of the disease.(7-9) Psoriasis can have both a significant physical and psychological impact on patients. Low self-confidence, depression, anxiety and sexual problems(10-12) are all common, and the impact on quality of life in people with psoriasis is comparable to other chronic illnesses such as heart disease, hypertension, diabetes and cancer.(13) In addition, researchers have shown that patients with psoriasis have an increased risk of developing other serious conditions such as cardiovascular disease, diabetes and obesity.(14-16)

“Psoriasis is an incurable chronic skin condition and many patients hate the way they look and are clinically depressed,” said Dr. Tony Downs, Consultant Dermatologist, Royal Devon and Exeter NHS Foundation Trust. “STELARA offers both physicians and patients an alternative treatment choice, which is important because psoriasis is not a straightforward disease. Its severity can wax and wane, it can become resistant to any treatment and patients can develop side effects to many of the current alternative treatment options. In clinical practice I have found STELARA to be effective in patients that have failed on other systemic therapies.”

In clinical studies, treatment with STELARA demonstrated a significant, visible improvement in patient’s psoriasis with convenient 12 weekly maintenance dosing.(3,4) 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.

“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 Professor Christopher Griffiths, Professor of Dermatology at the University of Manchester. “This is reflective of what I have seen in clinical practice, with patients experiencing considerable improvements in skin clearance with the added benefit of a convenient dosing regimen.”

Janssen-Cilag has worked together with NICE and the Department of Health to agree a specific UK access scheme under which people who weigh more than 100 kg and who are prescribed the 90 mg dose, as per the SPC, will receive both vials (2 x 45 mg) at the cost of a single vial.(1)

NICE has recommended STELARA (ustekinumab) as a treatment option for adults with plaque psoriasis for whom biologic therapy is being considered and when the following criteria are both met:(1)

- The disease is severe, as defined by a total Psoriasis Area Severity Index (PASI) score of 10 or more and a Dermatology Life Quality Index (DQLI) 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 has a contraindication to these treatments.

Primary Care Trusts have a statutory duty to implement NICE technology assessments within three months of publication.17 Further information on the NICE guidance can be found at www.nice.org.uk.

About STELARA(R)(Black Triangle Drug) (ustekinumab)

STELARA is a new, 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).(5)

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.

References:

1. National Institute for Health and Clinical Excellence. Ustekinumab for the treatment of adults with moderate to severe psoriasis. TA180. 2009.

2. Dubertret L, Mrowietz U, Ranki A, et al. European patient perspectives on the impact of psoriasis: the EUROPSO patient membership survey. Br J Dermatol. 2006;155(4):729-736.

3. 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

4. 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.

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

6. Wyeth Pharmaceuticals. ENBREL 25mg powder and solvent for solution for injection. Summary of Product Characteristics (SPC). 16 July 2009.

7. National Statistics Online. Population size. Accessed on 16 July 2009, from www.statistics.gov.uk/CCI/nugget.asp?ID=273 .

8. The Psoriasis Association. What is psoriasis? Accessed on 16 July 2009, from www.psoriasis-association.org.uk/what-is.html.

9. 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.

10. National Psoriasis Foundation. Spring 2007 Survey Panel Snapshot. Retrieved on 5th August 2009, from www.psoriasis.org/NetCommunity/Document.Doc?id=382

11. National Psoriasis Foundation. Fall 2006 Survey Panel Snapshot. Retrieved on 5th August 2009, from www.psoriasis.org/NetCommunity/Document.Doc?id=379

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

13. 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.

14. Henseler T, Christophers E. Disease concomitance in psoriasis. J Am Acad Dermatol. 1995;32(6):982-986.

15. Gelfand JM, Neimann AL, Shin DB, et al. Risk of myocardial infarction in patients with psoriasis. JAMA. 2006;296(14):1735-1741.

16. Herron MD, Hinckley M, Hoffman MS, et al. Impact of obesity and smoking on psoriasis presentation and management. Arch Dermatol. 2005; 141(12):1527-1534.

17. Criteria for the management of NICE clinical guidance. August 2005. Accessed on 16 September 2009, from www.nice.org.uk/media/sharedlearning/3_NICE%20Criteria%20v5.4x%2018-08-05.doc

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Source: Janssen-Cilag

For further information, please contact: Alex Butler, Janssen-Cilag, Tel: +44(0)1494-567-504, Email: AButler2 at its.jnj.com; Liz Wyatt, Resolute Communications, Tel: +44(0)20-7357-8187, Email: liz.wyatt at resolutecommunications.com