STELARA(R) Demonstrates Sustained High Level Efficacy in Japanese Psoriasis Patients Over 12 Months

SEOUL, South Korea, May 28, 2011 /PRNewswire/ --

- THIS MEDIA ALERT IS INTENDED FOR HONG KONG, NEW ZEALAND, THE PHILIPPINES, SINGAPORE AND THAILAND ONLY

- New Data Presented at World Congress of Dermatology

STELARA(R) has shown sustained efficacy in Japanese patients with moderate to severe psoriasis over 12 months according to new data presented today at the World Congress of Dermatology (WCD).[1]

Psoriasis, a chronic, immune-mediated disease that results from the overproduction of skin cells, affects 125 million people worldwide. The disease symptoms can range from mild, to moderate, to severe and disabling.

"We are delighted that these new data have shown that the initial positive results seen with STELARA were maintained over a 12 month period," said Dr Alexander Rodríguez Morales MD, Asia Pacific Medical Affairs Associate Director for Janssen.

"These results show a significant and sustained response in Japanese patients which adds to the growing body of evidence supporting the use of STELARA in various different ethnic populations."

The efficacy of treatment with STELARA was observed in a double-blind, placebo-controlled trial through 72 Weeks of follow-up. 158 patients were randomized to receive STELARA 45 mg (n=64) or 90 mg (n=62) at Weeks 0 and 4, then every 12 weeks, or placebo (n=32). At week 12, the placebo group crossed over to receive STELARA. Of these, 137 patients completed the study.

Efficacy was measured using Physician's Global Assessment (PGA), Psoriasis Area and Severity Index (PASI) and Nail Psoriasis Severity Index (NPSI).

Greater than 50% of patients randomized to STELARA achieved a PGA score of 0 or 1 at Week 12 and these response rates were maintained through Week 64. A similar trend was shown in the placebo-crossover patients.

At Week 12, after two doses of STELARA, a significantly greater proportion of patients achieved a PASI 50, PASI 75 and PASI 90 response, compared to patients receiving placebo.

Marked improvements in mean NAPSI scores were observed at Week 64 for patients maintained on STELARA therapy every 12 weeks.

Safety investigations showed, at Week 72, the proportion of patients reporting one or fewer adverse events was >96.9%. The rate of patients with one or fewer serious adverse events and one or fewer serious infections was <8.4%. No deaths or cases of tuberculosis or opportunistic infections were reported. An overall favourable risk-benefit was reported.

This analysis is one of a number of studies on the treatment of psoriasis with STELARA being announced at WCD.

More information on STELARA can be found at http://www.stelarainfo.com or http://www.janssen-cilag.com

Important Safety Information

STELARA is a prescription medicine that affects your immune system. STELARA can increase your chance of having serious side effects including:

Serious Infections

STELARA may lower your ability to fight infections and may increase your risk of infections. While taking STELARA, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

- Your doctor should check you for TB before starting STELARA and watch you closely for signs and symptoms of TB during treatment with STELARA.

- If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA.

You should not start taking STELARA if you have any kind of infection unless your doctor says it is okay.

Before starting STELARA, tell your doctor if you think you have an infection or have symptoms of an infection such as:

    
    - fever, sweats, or chills
    - muscle aches
    - cough
    - shortness of breath
    - blood in your phlegm
    - weight loss
    - warm, red, or painful skin or sores on your body
    - diarrhea or stomach pain
    - burning when you urinate or urinate more often than normal
    - feel very tired
    - are being treated for an infection
    - get a lot of infections or have infections that keep coming back
    - have TB, or have been in close contact with someone who has TB

After starting STELARA, call your doctor right away if you have any symptoms of an infection (see above).

STELARA can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. It is not known if people who take STELARA will get any of these infections because of the effects of STELARA on these proteins.

Cancer

STELARA may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer.

Reversible posterior leukoencephalopathy syndrome (RPLS)

RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.

Serious Allergic Reactions

Serious allergic reactions can occur. Get medical help right away if you have any symptoms such as: feeling faint, swelling of your face, eyelids, tongue, or throat, trouble breathing, throat or chest tightness, or skin rash.

Before receiving STELARA, tell your doctor if you:

- have any of the conditions or symptoms listed above for serious infections, cancer, or RPLS

- have recently received or are scheduled to receive an immunization (vaccine). People who take STELARA should not receive live vaccines. Tell your doctor if anyone in your house needs a vaccine. The viruses used in some types of vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before taking STELARA or one year after you stop taking STELARA. Non-live vaccinations received while taking STELARA may not fully protect you from disease.

- are receiving or have received allergy shots, especially for serious allergic reactions.

- ever had an allergic reaction to STELARA.

- receive phototherapy for your psoriasis.

- have any other medical conditions.

- are pregnant or plan to become pregnant. It is not known if STELARA will harm your unborn baby. You and your doctor should decide if you will take STELARA.

- are breast-feeding or plan to breast-feed. It is thought that STELARA passes into your breast milk. You should not breast-feed while taking STELARA without first talking to your doctor.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

- other medicines that affect your immune system

- certain medicines that can affect how your liver breaks down other medicines

Common side effects of STELARA include: upper respiratory infections, headache, and tiredness. These are not all of the side effects with STELARA. Tell your doctor about any side effect that bothers you or does not go away. Ask your doctor or pharmacist for more information.

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[1] Igarashi A, et al. Long Term Maintenance Therapy of Ustekinumab in Japanese Patients with Moderate-to-Severe Plaque Psoriasis. Proceedings of the 22nd World Congress of Dermatology; 2011 May 29-29; Seoul, Korea. P2505