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Biopharmaceuticals Dermatology

 News Release - October 6, 2010

New Data Demonstrate Treatment With STELARA(R) (Black Triangle Drug) (ustekinumab) Results in Sustained Improvements in Psoriasis Severity and Quality of Life up to Three Years

HIGH WYCOMBE, England, October 6, 2010 -- (Healthcare Sales & Marketing Network) -- New data presented today at the European Academy of Dermatology and Venereology (EADV) Congress indicate the significant improvement in patients' psoriasis and quality of life, demonstrated with STELARA(R) (Black Triangle Drug) (ustekinumab) at week 12, is sustained in the majority of patients up to three years.(1,2)

Psoriasis is a chronic, non-contagious, autoimmune disease which results in the over production of skin cells. It affects approximately 1.5 million(3,4) people in the UK and can have a significant physical and psychological impact on people affected. In addition, many people living with moderate to severe psoriasis report feeling dissatisfied with conventional treatment options, which can be time consuming to use.(5)

An analysis of 766 patients in the PHOENIX 1 registration trial showed for the first time the long-term efficacy of maintenance therapy with ustekinumab - a first in class biologic therapy for moderate to severe plaque psoriasis - up to three years.(1) Treatment with 12-weekly maintenance dosing, following two starter doses at weeks 0 and 4, of ustekinumab resulted in rapid improvement in skin symptoms, and peaked at week 24 when 76% and 85% of patients receiving 45mg and 90mg ustekinumab, respectively, achieved a 75% improvement in their psoriasis, as measured by the Psoriasis Area and Severity Index (PASI 75). This result was sustained through to week 148 (although some patients required dose interval adjustment to 8 weekly) when 64% and 76% of the 45mg and 90mg groups, respectively, achieved PASI 75.(1) For 45mg and 90mg patients who adjusted dosing (n=120[32%], n=79[23%], respectively), PASI 75 response rates were 51% and 57% at week 148.(1)

It has been reported that people living with psoriasis may experience low self-confidence, depression, anxiety and sexual problems(6-8), and for some the impact on quality of life is comparable to other chronic illnesses such as heart disease, hypertension, diabetes and cancer.(9) Further long-term results presented at the EADV Congress showed meaningful quality of life improvements in patients receiving regular maintenance therapy with ustekinumab, up to a period of three years.(2) Over 70% of patients in the PHOENIX 1 trial experienced significant improvements in skin disease specific quality of life with a clinically meaningful score of greater than or equal to 5 improvement in Disease Life Quality Index (DLQI) at year 3.(2)

"During registration trials, ustekinumab showed great promise delivering significant improvements in skin symptoms and quality of life at week 12. The three year data presented today gives a better understanding of the role of ustekinumab in the long-term management of psoriasis," comments Dr Pierre-Dominique Ghislain*, Consultant Dermatologist, St-Luc University Hospital, UCL, Brussels and study investigator. "Bringing about and sustaining relief from the physical and psychological impact of psoriasis is of great importance to patients and their dermatologists. This data provides the clinical evidence to support the valuable role that ustekinumab may play in helping to achieve this in clinical practice."

In addition, separate findings from a pooled safety analysis of data for ustekinumab evaluating 3,117 patients for periods up to three years, were consistent with results from previous studies.(10) The data, compiled from the pivotal Phase 3 PHOENIX 1 and 2 trials, and the ACCEPT trial, which compared the efficacy and safety of ustekinumab with etanercept, showed that overall rates of adverse events and serious adverse events per 100 patient years were stable and consistent over time.(10)

"Psoriasis is a chronic condition that can have a considerable impact on self-esteem, confidence and overall quality of life. New research on treatments for psoriasis is extremely valuable in order to offer the best care for people with the condition" comments Helen McAteer, Chief Executive of The Psoriasis Association. "Having data that demonstrates the long-term efficacy, safety and improvements in quality of life with ustekinumab means that people with moderate to severe psoriasis have another treatment option they can turn to."

*Dr Ghislain has on occasion acted as a paid advisor for Janssen.

About Psoriasis

Psoriasis is a chronic, immune-mediated inflammatory disease, which results from the over-production of skin cells resulting in their accumulation on the surface of the skin, which causes red, scaly plaques that may itch and bleed. It is estimated that 1.5 million people in the UK have psoriasis.(3,4) Twenty to thirty percent of those with psoriasis have severe disease.(11)

The Dermatology Life Quality Index (DLQI)

The DLQI is a skin disease-specific, patient-reported, 10-item questionnaire assessing six different aspects of patients' quality of life - symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI scores range from 0 to 30, with higher scores indicating poorer quality of life. A DLQI score of 0 or 1 indicates no negative effect on a patient's life, while DLQI scores >10 represent a very large impact of disease on quality of life.(12)

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

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

The recommended dosing regimen for ustekinumab is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter. For patients with a body weight of greater than 100 kg the dose is 90 mg administered subcutaneously, followed by a 90 mg dose 4 weeks later, then every 12 weeks thereafter.

In patients weighing greater than 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these patients.

Centocor Ortho Biotech Inc. discovered and developed ustekinumab and has exclusive marketing rights to the product in the United States. Janssen have exclusive marketing rights in all countries outside of the United States.

Important Safety Information

Ustekinumab is a selective immunosuppressant and may have the potential to increase the risk of infections and reactivate latent infections. Serious infections have been observed in patients receiving ustekinumab in clinical trials. Do not start ustekinumab during an active infection. If a serious infection develops, monitor patients carefully and stop ustekinumab until the infection resolves. Patients should be evaluated for tuberculosis (TB) infection prior to initiating, and during, treatment with ustekinumab.

Ustekinumab is a selective immunosuppressant. Immunosuppressive agents have the potential to increase the risk of malignancy. Malignancies have been observed in patients receiving ustekinumab in clinical trials. Caution should be exercised when considering the use of ustekinumab in patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy.

Serious allergic reactions have been reported in the post-marketing setting, in some cases several days after treatment. Anaphylaxis and angioedema have occurred. If an anaphylactic or other serious allergic reaction occurs, administration of ustekinumab should be discontinued immediately and appropriate therapy instituted.

About Janssen

Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g. diabetes).

Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. More information can be found at http://www.janssen-cilag.co.uk/.

References:

1. Ghislain et al.Maintenance of long-term efficacy of ustekinumab through year 3 for patients with moderate-to-severe psoriasis. Poster presented at:19th Congress of the European Academy of Dermatology and Venereology; 2010 October 06-10;Gothenburg, Sweden. Poster P589.

2. Leonardi et al. Sustained improvement in skin disease-specific quality of life in patients with moderate to severe psoriasis receiving ustekinumab maintenance therapy: Long term results from PHOENIX 1. Poster presented at:19th Congress of the European Academy of Dermatology and Venereology; 2010 October 06-10;Gothenburg, Sweden. Poster P653.

3. National Statistics Online. Population size. Available at: http://www.statistics.gov.uk/CCI/nugget.asp?ID=273. Accessed on September 14, 2010.

4. The Psoriasis Association. What is psoriasis? Available at: http://www.psoriasis-association.org.uk/what-is.html. Accessed September 14, 2010.

5. 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.

6. National Psoriasis Foundation. Spring 2007 Survey Panel Snapshot. Available at: http://www.psoriasis.org/NetCommunity/Document.Doc?id=382 Last Accessed on 19 August 2010

7. National Psoriasis Foundation. Fall 2006 Survey Panel Snapshot. Available at: http://www.psoriasis.org/NetCommunity/Document.Doc?id=379 Last Accessed on 19 August 2010.

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

9. 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.

10. Reich et al. Ustekinumab Safety Update: Cummulative safety experience from longer-term follow-up of patients treated in the ustekinumab psoriasis clinical development program. Poster presented at:19th Congress of the European Academy of Dermatology and Venereology; 2010 October 06-10;Gothenburg, Sweden. Poster P560.

11. 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.

12. Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol 2008; 159: 997-1035.


Source: Janssen Pharmaceutical

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