STELARA(TM) and REMICADE(R) Data in Treatment of Plaque Psoriasis to be Presented at American Academy of Dermatology (AAD) Meeting

MIAMI, March 4 /PRNewswire/ -- Data evaluating the efficacy and safety of STELARA™ (ustekinumab) and REMICADE® (infliximab) in patients with plaque psoriasis who had an inadequate response to Enbrel® (etanercept) will be presented at the 68th Annual Meeting of the American Academy of Dermatology (AAD) in Miami, Fla., from March 5-9, 2010.  Cumulative safety data for STELARA™ (up to 18 months) based on pooled analyses of one Phase 2 and two Phase 3 clinical trials will also be presented.

"These data underscore our commitment to advancing the understanding and treatment of moderate to severe plaque psoriasis," said Dr. Thomas F. Schaible, Vice President, Medical Affairs, Centocor Ortho Biotech Inc. "We are pleased to be in a position to share these findings with the medical community at this year's AAD annual meeting, as the only company to offer two biologic options for the management of this chronic disease."

Data being presented as electronic posters include:

• The ustekinumab safety experience in patients with moderate-to-severe psoriasis: Results from pooled analyses of Phase 2 and Phase 3 clinical trial data (Abstract P3336)

Authors: K. Gordon, North Shore University Health Systems, Skokie, IL; C. Leonardi, Center Dermatology, St. Louis, MO; K. Reich, Dermatologikum Hamburg, Hamburg, Germany; N. Yeilding, Centocor Research & Development, Malvern, PA

• Ustekinumab treatment in patients with moderate-to-severe psoriasis who are non-responders to etanercept: Results from a Phase 3 clinical trial (Abstract P3357)

Authors: C. E. M. Griffiths, University of Manchester, United Kingdom; A. Menter, Baylor University Medical Center, Dallas, TX; B. Strober, New York University School of Medicine, New York, NY; N. Yeilding, Centocor Research & Development, Malvern, PA

• Efficacy and safety of infliximab therapy in plaque psoriasis patients previously treated with etanercept: Analysis of PSUNRISE (Abstract P3341)

Authors: A.B. Gottlieb, Tufts Medical Center, Boston, MA; J. Wang, Johnson & Johnson Pharmaceutical Research & Development, Horsham, PA; M. Chevrier, Centocor Ortho Biotech Services, Horsham, PA; R. Kalb, SUNY at Buffalo School of Medicine, Buffalo, NY

Electronic poster exhibit viewing stations will be open during the course of the meeting at the Miami Beach Convention Center in Hall D.  

About STELARA™ (ustekinumab)

STELARA™, a human interleukin (IL)-12 and IL-23 antagonist, is approved for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.  IL-12 and IL-23 are naturally occurring proteins that are believed to play a role in psoriasis.  For more information about STELARA™, visit www.STELARAinfo.com.

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 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.

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™
• receive phototherapy for your psoriasis
• have any other medical conditions
• are pregnant or plan to become pregnant, or are breast-feeding or plan to breast-feed

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the Medication Guide for STELARA™ and discuss any questions you have with your doctor.

About REMICADE

REMICADE was the first anti-TNF-alpha treatment to be approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology.  REMICADE has demonstrated broad clinical utility with indications in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), ulcerative colitis (UC), pediatric Crohn's disease (PCD) and plaque psoriasis (PsO).  The safety and efficacy of REMICADE have been well established in clinical trials over the past 17 years and through commercial experience with more than one million patients treated worldwide.

In the U.S., REMICADE is approved for the following indications:

• Reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active RA, when administered in combination with methotrexate.  
• Reducing signs and symptoms in patients with active AS
• Reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatric patients with moderately to severely active CD who have had an inadequate response to conventional therapy.  
• Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD.  
• Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active UC who have had an inadequate response to conventional therapy.
• Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with PsA.  
• Treatment of adult patients with chronic severe plaque PsO who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.  

REMICADE is unique among available anti-TNF biologic therapies.  Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting.  REMICADE is a two-hour infusion administered every 6 or 8 weeks (indication-dependent), following a standard induction regimen that requires treatment at weeks 0, 2 and 6.  As a result, REMICADE patients may require as few as six treatments each year.

Important Safety Information

IMPORTANT SAFETY INFORMATION

Only your doctor can recommend a course of treatment after checking your health condition. REMICADE® (infliximab) can cause serious side effects such as lowering your ability to fight infections. There are reports of serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE®.

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. A rare form of fatal lymphoma has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking REMICADE® and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including REMICADE®, the chances of getting lymphoma or other cancers may increase.

You should discuss any concerns about your health and medical care with your doctor.

What should I tell my doctor before I take REMICADE®?

You should let your doctor know if you have or ever had any of the following:

• Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start REMICADE®.
• Lived in a region where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
• Infections that keep coming back, have diabetes or an immune system problem.
• Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
• Heart failure or any heart condition. Many people with heart failure should not take REMICADE®.
• Hepatitis B virus (HBV) infection or think you may be a carrier of HBV.
• Nervous system disorders (like multiple sclerosis or Guillain-Barre syndrome).

Also tell your doctor about any medications you are taking, including vaccines or Kineret (anakinra), and if you are pregnant, plan to become pregnant or are nursing. Adults and children should not receive a live vaccine while taking REMICADE®.

What should I watch for and talk to my doctor about before or while taking REMICADE®?

The following serious (sometimes fatal) side effects have been reported in people taking REMICADE®.

You should tell your doctor right away if you have any of the signs listed below:

• Infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. REMICADE® can make you more likely to get an infection or make any infection that you have worse.
• Lymphoma, or any other cancers in adults and children.  
• Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
• Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
• Liver injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
• Blood disorders—fever that doesn't go away, bruising, bleeding or severe paleness.
• Nervous system disorders—numbness, weakness, tingling, changes in your vision or seizures.
• Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
• Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun. The more common side effects with REMICADE® are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.
• Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.  

Please read the Medication Guide for REMICADE® at www.remicade.com and discuss it with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

About Centocor Ortho Biotech Inc.

Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology and oncology.  Built upon a pioneering history, Centocor Ortho Biotech Inc. harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options.  Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care.  For more information about Centocor Ortho Biotech, visit: www.centocororthobiotech.com.  

SOURCE Centocor Ortho Biotech Inc.

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