Healthcare Industry News: Black Triangle Drug
News Release - May 19, 2010
STELARA(TM) Significantly Improves Symptoms of Depression, Anxiety and Health-Related Quality of Life in Patients With Moderate to Severe PsoriasisHIGH WYCOMBE, England, May 19, 2010 -- (Healthcare Sales & Marketing Network) -- New research published online in the Journal of the American Academy of Dermatology (JAAD) shows that treatment with STELARA(TM)(Black Triangle Drug) (ustekinumab) significantly improves symptoms of depression, anxiety and health-related quality of life in patients with moderate to severe psoriasis compared to placebo. These results are from an analysis of prespecified quality of life measures from one of the large, pivotal phase III trials for STELARA, PHOENIX 2.
Psoriasis affects approximately 1.5 million people in the UK,[1,2] with 20-30% of those considered to have severe disease. It is a chronic skin condition that can be painful and potentially debilitating, and is associated with much higher rates of clinically significant psychiatric symptoms, including depression and anxiety, compared with the general population (25-43% vs 1.6-10%).[4-7]
Data from the 1,230 patients included in the PHOENIX 2 study show comparable levels of depression and anxiety to previous studies in psoriasis patients, as analysed using the Hospital Anxiety and Depression Scale (HADS). At baseline, over a quarter of patients reported symptoms of depression (27%; HADS-D greater than or equal to 8, mild to severe symptoms) and more than a third reported symptoms of anxiety (40%; HADS-A greater than or equal to 8). The mean baseline scores of depression and anxiety reported by patients (HADS-D, 5.1; HADS-A, 6.9) are comparable to, or worse than patients diagnosed with breast cancer (2.8; 6.8) and chronic obstructive pulmonary disease (7.6; 7.0), further demonstrating the overall impact of psoriasis on patients' health-related quality of life (HRQoL).[9,10]
At week 12, 63.5% of patients (141 out of 222 patients) treated with STELARA reported improvements in symptoms of depression, defined as a change in HADS-D score from greater than or equal to 8, at baseline (mild to severe depression) to a HADS-D score of < 8 (normal). This was compared with 29.9% of patients receiving placebo (29 out of 97 patients, P < 0.001). Similarly, 47.9% of STELARA-treated patients (152 out of 317 patients) with symptoms of anxiety reported improvements at week 12, defined as a change in HADS-A score of greater than or equal to 8 at baseline (mild to severe anxiety) to < 8 (normal) compared to 22.2% of placebo-treated patients (37 out of 167 patients, P < 0.001). This response was maintained up to week 24 in the STELARA-treated group.
HRQoL was also assessed in the study using the Dermatology Life Quality Index (DLQI), a clinically recognised measure of the impact of skin disease on quality of life. Improvements in HRQoL were observed at week 12 of treatment, with 55.9% of STELARA-treated patients achieving a normal DLQI score (0 or 1) compared with only 3.2% of patients receiving placebo (P < 0.001). Improvements in HRQoL were maintained through to week 24 for those patients receiving treatment with STELARA.
About the PHOENIX 2 trial
PHOENIX 2 is a randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of ustekinumab in 1230 patients with moderate-to-severe plaque psoriasis. At baseline, patients were randomized to receive ustekinumab 45 mg or 90 mg at weeks 0, 4, and every 12 weeks thereafter, or placebo at weeks 0 and 4. Patients initially randomized to placebo at baseline were assigned to cross over to either ustekinumab 45 mg or 90 mg at weeks 12, 16, and every 12 weeks thereafter. The long-term extension of this trial is ongoing and is expected to be completed in October 2011; it will provide 5 years of safety and efficacy data.
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.[1,2] Twenty to thirty percent of those with psoriasis have severe disease.
About STELARA(TM)(Black Triangle Drug) (ustekinumab)
Ustekinumab is a human monoclonal antibody with a novel mechanism of action that targets the p40 sub-unit of 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 some immune-mediated inflammatory disorders, including plaque psoriasis.
The recommended dosing regimen for ustekinumab is an initial dose of 45 mg administered subcutaneously at week 0, followed by a 45 mg dose at week 4, and then every 12 weeks thereafter. For patients with a body weight of greater than 100 kg the dose is 90 mg administered subcutaneously at week 0, followed by a 90 mg dose at week 4, 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 STELARA and has exclusive marketing rights to the product in the United States. Janssen-Cilag companies have exclusive marketing rights in all countries outside of the United States. Centocor Ortho Biotech Inc and Janssen-Cilag are part of the Johnson & Johnson family of companies.
The Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is used to assess anxiety and depression. It has two subscales, one measuring anxiety (HADS-A) and the other measuring depression (HADS-D). Each subscale consists of 7 questions and is measured separately on a scale of 0 to 21. A lower score indicates less severity. Cases of anxiety or depression are each defined by subscale scores of greater than or equal to 8, and categorized as mild (score of 8 to 10), moderate (score of 11 to 14), and severe (score of 15 to 21). Scores of 0 to 7 are considered normal.
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.
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 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.
 National Statistics Online. Population size. Available at: http://www.statistics.gov.uk/CCI/nugget.asp?ID=273. Accessed on January 07, 2010.
 The Psoriasis Association. What is psoriasis? Available at:http://www.psoriasis-association.org.uk/what-is.html. Accessed January 07, 2010.
 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.
 Cohen AD, Ofek-Shlomai A, Vardy DA et al. Depression in dermatological patients identified by the Mini International Neuropsychiatric Interview questionnaire. J Am Acad Dermatol. 2006:54:94-9.
 Wittchen HU, Zhao S, Kessler RC et al. DSM-III-R generalised anxiety disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1994;51:355-64.
 Olfson M, Marcus SC, Druss B et al. National trends in the outpatient treatment of depression. JAMA. 2002;287:203-9.
 Hong J, Koo B, Koo J. The psychosocial and occupational impact of chronic skin disease. Dermatologic Therapy. 2008;21:54-9.
 Langley R, Feldman S, Han C et al. Ustekinumab significantly improves symptoms of anxiety, depression and skin-related quality of life in patients with moderate-to-severe psoriasis. J Acad Am Derm. Published online May 10, 2010. doi:10.1016/j.jaad.2009.09.014.
 Puhan MA, Frey M, Büchi S et al. The minimal important difference of the hospital anxiety and depression scale in patients with chronic obstructive pulmonary disease. Health Qual Life Outcomes. 2008;6:46.
 Browall M, Ahlberg K, Karlsson P et al. Health-related quality of life during adjuvant treatment for breast cancer among postmenopausal women. Eur J Oncol Nurs. 2008;12:180-9.
 Janssen-Cilag Ltd. STELARA Summary of Product Characteristics (SPC). Published on EMEA website on 25th January 2010.
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