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SMC ISSUES A POSITIVE RECOMMENDATION FOR STELARA® (USTEKINUMAB) IN THE TREATMENT OF PSORIATIC ARTHRITIS


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© Business Wire 2014
2014-03-10 18:15:04 -

FOR MEDICAL TRADE MEDIA ONLY

Janssen UK announced today that the Scottish Medicines Consortium (SMC) has recommended the use of Stelara ® (ustekinumab) for the treatment of active psoriatic arthritis in adult patients in NHS Scotland. Ustekinumab is the first in a class of biologics with a novel mode of action that targets interleukin-12 (IL-12) and interleukin-23 (IL-23), which are naturally occurring proteins that are important in regulating immune responses.

“We are delighted that the SMC has approved the use of ustekinumab in Scotland for people with psoriatic arthritis,” said Peter Barnes, Medical Director at Janssen. “Psoriatic arthritis can have a significant impact on quality of life, and the availability of ustekinumab means that patients will have access to a valuable new treatment

option for this debilitating condition.”


Janssen has completed a robust clinical trial programme to establish the efficacy and long-term tolerability profile of ustekinumab in psoriatic arthritis, with the biggest biologic trial to date in this indication, involving over 900 patients. Ustekinumab already has an established heritage in plaque psoriasis with efficacy and tolerability data from five years of clinical experience and an estimated exposure of over 200,000 patient years world-wide. 1

Psoriatic arthritis occurs when the body's immune system begins to attack healthy cells and tissue. This abnormal immune response causes inflammation in the joints as well as the overproduction of skin cells. 2 Before today, patients with psoriatic arthritis only had access to licensed biologic therapies with one mode of action, anti-TNFα (anti-tumour necrosis factor alpha). Ustekinumab will provide psoriatic arthritis patients with an alternative therapy, which offers a convenient dosing schedule with treatment once every 12 weeks.*

The European Commission approved, in September 2013, the use of ustekinumab, alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Ustekinumab was previously approved by the European Commission for 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 (MTX) or PUVA (psoralen and ultraviolet A) in January 2009.

*The first dose is initially followed by a second dose four weeks later and then every 12 weeks thereafter


*ENDS*

Notes to editor


About Psoriatic Arthritis

Psoriatic arthritis is a chronic immune-mediated inflammatory disease characterised by both joint inflammation and the skin lesions associated with psoriasis. Psoriasis affects an estimated 1.8 million people in the UK, approximately two–three percent of the population. 3 Over time, approximately 10 to 30 percent of patients with psoriasis will develop psoriatic arthritis and display arthritic symptoms. 4 Though the exact cause of psoriatic arthritis is unknown, genetic susceptibility, changes in the immune system and environmental factors are all believed to play a role in the onset of the disease. 5,6


About 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. Ustekinumab is indicated 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 or PUVA. It is also indicated alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. 7

In the treatment of psoriatic arthritis, the recommended dosing regimen for adults and the elderly (≥ 65 years) is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter. Alternatively, 90 mg may be used in patients with a body weight > 100 kg. 7


The safety data described below reflect exposure to ustekinumab in 7 controlled phase 2 and 3 studies of 4,031 patients with psoriasis and/or psoriatic arthritis, including 3,106 exposed for at least 6 months, 1,482 exposed for at least 4 years, and 838 exposed for at least five years. 7


The most common adverse reactions (> 5%) in controlled periods of the psoriasis and psoriatic arthritis clinical studies with ustekinumab were nasopharyngitis, headache and upper respiratory tract infection. Most were considered to be mild and did not necessitate discontinuation of study treatment. The most serious adverse reaction that has been reported for ustekinumab is serious hypersensitivity reactions including anaphylaxis. 7


For further information on adverse events click here. : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww ..

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

The Summary of Product Characteristics for ustekinumab, which includes safety information, can be found on the eMC website here.

: cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. Janssen provides information on ustekinumab for healthcare professionals here. : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww ..



About Janssen

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in immunology, oncology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world.

The legal entity for Janssen in the UK and Ireland is Janssen-Cilag Ltd.
Please visit www.janssen.co.uk : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. for more information.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2012.
Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. , www.jnj.com : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

References


1. Janssen PSUR data on file. December 2013.

2. Mayo Clinic. About psoriatic arthritis. Available at: www.mayoclinic.org/diseases-conditions/psoriatic- arthritis/basics/causes/con-20015006. : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. Last accessed March 2014.

3. The Psoriasis Association. Facts about psoriasis. Available at: www.psoriasis- association.org.uk/pages/view/about- psoriasis. Last accessed March 2014. : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww ..

4. National Psoriasis Foundation. About Psoriasis: Statistics. Available at: www.psoriasis.org/learn_statistics. : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww ..

Last accessed March 2014


5. FitzGerald O, Winchester R. Psoriatic arthritis: from pathogenesis to therapy. Arthritis Res Ther


2009; 11(1):214.

6. Chandran V, Raychaudhuri SP. Geoepidemiology and environmental factors of psoriasis and psoriatic arthritis. J Autoimmun 2010; 34(3):J314-321.

7. Stelara Summary of Product Characteristics. Last updated 26 February 2014.

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Janssen UKJayant ChavdaPhone: +44 1494 567898Email:

jchavda8@ITS.JNJ.com : mailto:jchavda8@ITS.JNJ.com orPublicis

Life Brands ResoluteLisa BashorumPhone: +44 (0) 20 7397

7495Email: lisa.bashorum@publicislifebrandsresolute.com : mailto:lisa.bashorum@publicislifebrandsresolute.com


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