STELARA(TM) Significantly Improves Symptoms of Depression, Anxiety and Health-Related Quality of Life in Patients With Moderate to Severe Psoriasis

HIGH WYCOMBE, England, May 19, 2010 - 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.[3] 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).[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.[8]

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.[8]

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.

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.[1,2] Twenty to thirty percent of those with psoriasis have severe
disease.[3]

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.[11]

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.

References:

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[1] National Statistics Online. Population size. Available at:
www.statistics.gov.uk/CCI/nugget.asp?ID=273. Accessed on January 07,
2010.

[2] The Psoriasis Association. What is psoriasis? Available
at:www.psoriasis-association.org.uk/what-is.html. Accessed January 07,
2010.

[3] 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.

[4] 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.

[5] 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.

[6] Olfson M, Marcus SC, Druss B et al. National trends in the
outpatient treatment of depression. JAMA. 2002;287:203-9.

[7] Hong J, Koo B, Koo J. The psychosocial and occupational
impact of chronic skin disease. Dermatologic Therapy. 2008;21:54-9.

[8] 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.

[9] 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.

[10] 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.

[11] Janssen-Cilag Ltd. STELARA Summary of Product
Characteristics (SPC). Published on EMEA website on 25th January 2010.

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