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New Biologic STELARA(TM) Receives Approval in Europe for Treatment of Moderate to Severe Plaque Psoriasis

Beerse, Belgium (ots/PRNewswire)

- First and Only Biologic Approved With Infrequent, Every
Twelve-Week Maintenance Dosing
BEERSE, Belgium, January 22 /PRNewswire/ --
Janssen-Cilag announced today that STELARA(TM) (ustekinumab), the
first in a new class of biologics, has been approved by the European
Commission for use across Europe. The approved indication of
ustekinumab is 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 PUVA (psoralen plus
ultraviolet A light). With the approval by the European Commission,
ustekinumab is approved in 27 countries in the EU. Psoriasis, a
chronic skin disease that affects between two and three percent of
the European population,[1] is associated with substantial physical
and emotional burdens and potentially serious co-morbidities.[2,3]
In clinical studies, treatment with ustekinumab demonstrated
significant improvements in patients' psoriasis, and quality of life,
which were sustained with as few as four injections a year (every
twelve weeks) following two starter doses at weeks 0 and 4. The
approval of ustekinumab offers adults living with moderate-to-severe
plaque psoriasis a new therapy which has the potential to make a
considerable impact on their daily lives.
The approval is based on data from two large, pivotal Phase III,
multi-centre, randomised, double-blind, placebo controlled trials
(PHOENIX 1 & 2) involving nearly 2,000 patients in whom the efficacy
and safety of ustekinumab in the treatment of moderate-to-severe
plaque psoriasis were evaluated.[4,5] Two-thirds or more of patients
achieved the primary endpoint  of each trial, at least 75%
improvement in psoriasis using the Psoriasis Area and Severity Index
(PASI 75) at week 12, after receiving just two doses of ustekinumab
45 mg or 90 mg, respectively, at weeks 0 and 4. At week 12, 66
percent to 76 percent of patients receiving ustekinumab 45 mg or 90
mg doses, respectively, achieved PASI 75 compared with 3 to 4 per
cent of patients receiving placebo (p<0.001). The majority of
responders receiving injections every 12 weeks maintained PASI 75
response through up to 18 months.
Rates of serious adverse events, including serious infections,
malignancies and cardiovascular events, were low and consistent with
the expected background rates. The most common adverse reactions in
Phase III clinical trials were arthralgia, cough, headache, injection
site erythema, nasopharyngitis and upper respiratory tract infection.
Most were considered to be mild and did not necessitate
discontinuation of therapy.
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 between
two and three percent of the European population have psoriasis.[1]
Twenty to thirty percent of people  with psoriasis have cases that
are considered severe.[6]
About STELARA (ustekinumab)
Ustekinumab is a new, 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.
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.
Important Safety Information
STELARA 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 STELARA in clinical trials. Do not start STELARA during an
active infection. If a serious infection develops, monitor patients
carefully and stop STELARA until the infection resolves. Patients
should be evaluated for tuberculosis (TB) infection prior to
initiating treatment with STELARA.
STELARA is a selective immunosuppressant. Immunosuppressive
agents have the potential to increase the risk of malignancy.
Malignancies have been observed in patients receiving STELARA in
clinical trials. Caution should be exercised when considering the use
of STELARA in patients with a history of malignancy or when
considering continuing treatment in patients who develop a
malignancy.
    References
    1. Schäfer T. Epidemiology of Psoriasis; Review and the German
       Perspective. Dermatology. 2006;212:327-337.
    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. Henseler T, Christophers E. Disease concomitance in psoriasis. J Am
       Acad Dermatol. 1995;32(6):982-986.
    4. 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). The Lancet.
       2008;371:1665-74.
    5. 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). The Lancet.
       2008;371:1675-84.
    6. 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.

Contact:

For further information, please contact: Jennifer Tear, Janssen
Cilag, Turnhoutsweg 30, Beerse 2340, Belgium. Tel: +32-14-60-26-38,
Mobile +32-473-55-94-60, Email JTear1@its.jnj.com . Media Investors:
Tina Pinto, Johnson & Johnson, Phone: +1-732-524-2034.

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