New Four Year STELARA® Data Show Consistent Safety Profile Over Time in Patients With Moderate to Severe Plaque Psoriasis

SEOUL, Korea, May 25, 2011 /PRNewswire/ -- New findings presented from pooled analyses of the STELARA® (ustekinumab) psoriasis clinical development program showed that the safety profile of STELARA and rates of adverse events remained consistent and stable over time in adults with moderate to severe plaque psoriasis receiving up to four years of treatment.  Investigators also reported findings from an analysis of four placebo-controlled Phase 3 trials across patient populations on three continents and found that the efficacy and safety of STELARA in patients of Japanese and Korean-Taiwanese descent were consistent with findings previously reported in North American and European populations.  Both sets of data were presented at the 22nd World Congress of Dermatology in Seoul, Korea.

Psoriasis, a chronic, immune-mediated disease that results from the overproduction of skin cells, affects 125 million people worldwide. Plaque psoriasis often results in patches of thick, red or inflamed skin covered with silvery scales known as plaques. These plaques usually itch or feel sore, can crack and bleed, and can occur anywhere on the body.  The disease symptoms can range from mild, to moderate, to severe and disabling.  STELARA is currently approved in 57 countries for the treatment of moderate to severe plaque psoriasis.

"These findings are promising and support a favorable benefit-to-risk profile for STELARA with up to four years of treatment," said Kristian Reich, MD, Department of Dermatology of Dermatolgikum, Hamburg, Germany, and lead trial investigator for the PHOENIX 2 study. "Ongoing studies in psoriasis and psoriatic arthritis will continue to define the safety profile of STELARA in the psoriatic population."

Pooled safety data from a total of 3,117 patients who participated in a Phase 2 STELARA trial and the Phase 3 PHOENIX 1, PHOENIX 2 and ACCEPT studies showed rates of adverse events (AEs) to be generally stable over time through up to four years of treatment with STELARA, with the most commonly reported AEs [greater than 5 per 100 patient years (PY)] including nasopharyngitis, upper respiratory tract infection, arthralgia, sinusitis, headache and back pain and influenza.  Observed occurrences of AEs of interest, including serious infections (0.8 and 1.32 for 45 mg and 90 mg STELARA patient groups, respectively, per 100 PY), non-melanoma skin cancer (0.70; 0.53 per 100 PY, respectively), other malignancies (0.63; 0.61 per 100 PY, respectively) and major adverse cardiovascular events (MACE) (0.42; 0.36 per 100 PY, respectively) remained generally stable during the time periods evaluated.  The observed rate of malignancies (excluding non-melanoma skin cancers) was consistent with that expected in the general U.S. population, derived from the Surveillance, Epidemiology and End Results (SEER) Database.  Rate of non-fatal myocardial infarction (MI) or stroke was consistent with or lower than that expected in the general U.S. population and psoriasis populations, derived from the Framingham Database and General Practice Research Database (GPRD), respectively.

The four year safety analysis of the Phase 2, PHOENIX 1, PHOENIX 2 and ACCEPT trials evaluated the largest psoriasis-focused clinical trial safety database for a biologic reported to date, with more than 1,100 patients who have had at least three years of treatment with STELARA and more than 600 patients treated for four or more years for a total of nearly 6,800 PY.

Consistency of Responses across Different Ethnic Populations with Moderate to Severe Plaque Psoriasis: Results from the STELARA Psoriasis Clinical Development Program

Additional findings from a separate analysis found STELARA efficacy and safety across Asian populations with moderate to severe plaque psoriasis to be consistent with those observed in North American and European populations, according to data from PHOENIX 1 (n=766) and PHOENIX 2 (n=1230) compared with Japanese and Korean-Taiwanese populations evaluated in the JPN-02 (n=158) and PEARL (n=121) trials, respectively.

"Psoriasis is an autoimmune disease that affects millions of people worldwide from all ethnic backgrounds," said Reich.  "These data show the consistency of response with STELARA in the treatment of psoriasis across ethnic populations.  These findings are important considerations for the dermatology community."

In the four analyzed studies, patients received subcutaneous injections of STELARA 45 mg or 90 mg, or placebo at weeks 0 and 4, although only the STELARA 45 mg dose was evaluated in the PEARL trial. STELARA patients received a third dose at week 16, while placebo-treated patients crossed over to receive active treatment at weeks 12 and 16.  At week 12, the primary endpoint, a 75 percent improvement as measured by the Psoriasis Area Severity Index (PASI 75), was achieved by a significantly greater proportion of patients across all studies when compared with the placebo group (P > 0.001).  Among patients receiving STELARA 45 mg, 66.9 percent, 59.4 percent and 67.2 percent achieved PASI 75 in the North American/European, Japanese and Korean-Taiwanese patient populations, respectively.  In patients receiving 90 mg, 72.1 percent and 67.7 percent of patients achieved PASI 75 in the North American/European and Japanese populations.  Placebo rates of response were 3.5 percent, 6.5 percent and 5.0 percent in the PHOENIX 1 & 2, Japanese and PEARL trials, respectively.  These responses continued to improve through week 28 across groups, with similar responses seen in placebo-treated patients following cross over to treatment with STELARA.  

Rates of AEs and serious AEs through week 12 were comparable overall between STELARA and placebo groups in the North American/European, Japanese and Korean-Taiwanese trials.  Among patients receiving STELARA 45 mg (or 90 mg), 54.8 (49.7) percent, 65.6 (59.7) percent and 65.6 percent of patients across patient populations reported at least one AE, compared with 49.2 percent, 65.6 percent and 70.0 percent of placebo patients, respectively.  Similar safety results were seen through week 28 of each trial.  Please read the Important Safety Information for STELARA below.

About Psoriasis

Psoriasis is a chronic, immune-mediated disease that results from the overproduction of skin cells, which accumulate on the surface of the skin and cause red, scaly plaques that may crack and bleed.  It is estimated that nearly three percent of the world's population are living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.  

About the Phase 2 Study

The 36-week, double-blind, placebo-controlled trial, evaluated 320 patients with plaque psoriasis who were randomized to receive one of four dose regimens of STELARA (a single dose of 45 mg or 90 mg or four weekly doses of 45 mg or 90 mg) or placebo. Patients randomized to receive STELARA, whose PGA scores were less than excellent, received a single additional dose at week 16. Patients in the placebo group crossed over to receive 90 mg of STELARA at week 20. Safety data was collected through week 52 of the study.

About the PHOENIX 1 Trial

The Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis Followed by Long-term Extension (PHOENIX 1) evaluated the efficacy and safety of STELARA in the treatment of 766 patients with chronic plaque psoriasis. Patients were randomized to receive subcutaneously administered STELARA or placebo. Patients randomized to receive STELARA received 45 mg or 90 mg doses at weeks 0 and 4 followed by the same dose every 12 weeks. Patients in the placebo group crossed over to receive either 45 mg or 90 mg doses of STELARA at weeks 12 and 16 and every 12 weeks thereafter.  Some patients inadequately responding to STELARA at weeks 28 and 40 were eligible to switch to every 8 week dosing. The primary endpoint of the study was the proportion of patients achieving PASI 75 at week 12. Patients responding to STELARA through week 40 were randomized to continue treatment with STELARA or were switched to placebo with potential retreatment after loss of response.  The long-term extension of this trial is ongoing and is expected to be completed in June 2011; PHOENIX 1 will provide up to five years of safety and efficacy data.    

About the PHOENIX 2 Trial

The Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis Followed by Long-term Extension 2 (PHOENIX 2) evaluated the efficacy and safety of STELARA in 1,230 patients with moderate to severe plaque psoriasis. At baseline, patients were randomized to receive STELARA 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 STELARA 45 mg or 90 mg at weeks 12, 16 and every 12 weeks thereafter. The primary endpoint of the study was the proportion of patients achieving PASI 75 at week 12. Patients partially responding to STELARA at week 28 were randomized to continue treatment with STELARA every 12 weeks or were switched to every 8 week dosing.  Patients inadequately responding to STELARA at week 40 and during the long-term extension were eligible to switch to every 8 week dosing.   Patients inadequately responding to STELARA 45 mg every 8 weeks during the long-term extension were eligible to switch to 90 mg dosing.  For patients who underwent dose-escalation from STELARA 45 mg to 90 mg, pooled safety results were based on the dose received at the time an adverse event occurred.  The long-term extension of this trial is ongoing and is expected to be completed in November 2011; PHOENIX 2 will provide up to five years of safety and efficacy data.

About the ACCEPT Trial

The Phase 3, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Ustekinumab Compared to Etanercept (Enbrel®) in the Treatment of Subjects with Moderate to Severe Plaque Psoriasis (ACCEPT) included 903 patients with chronic plaque psoriasis (etanercept=347, STELARA 45 mg=209, STELARA 90 mg=347). Patients were randomized to receive subcutaneously administered STELARA or etanercept. Patients randomized to receive STELARA received 45 mg or 90 mg doses at weeks 0 and 4. Patients in the etanercept group received twice-weekly doses of 50 mg for 12 weeks. The primary endpoint of the study was the proportion of patients who achieved PASI 75 at week 12. At week 12, patients in the etanercept group who were classified as non-responders (i.e., had moderate, marked or severe psoriasis) received 90 mg of STELARA at weeks 16 and 20. STELARA non-responders received one additional dose of STELARA at week 16. Treatment was interrupted for all patients who had cleared, minimal or mild psoriasis at the end of week 12, and all patients were retreated with 45 or 90 mg STELARA when their disease worsened to moderate or worse.

About the PEARL Trial

PEARL was a Phase 3, multicenter, randomized study of subcutaneous injections of placebo and STELARA 45 mg for the treatment of moderate to severe plaque psoriasis in Korean and Taiwanese patients.  Those patients who were randomized to STELARA received 45 mg doses at weeks 0, 4 and 16, and a placebo injection at week 12 to maintain the blind.  Patients randomized to receive placebo at weeks 0 and 4 crossed over to receive STELARA 45 mg at weeks 12 and 16.  All patients were followed through week 36.  The primary endpoint of the study was the proportion of patients achieving PASI 75 at week 12.

About the Japanese (JPN02) Trial

JPN-02 was a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study to evaluate the efficacy and safety of STELARA in Japanese patients with moderate to severe plaque-type psoriasis.  STELARA was to be administered at either 45 mg or 90 mg subcutaneous at weeks 0 and 4 and then once every 12 weeks through week 52; or placebo at weeks 0 and 4 and cross over to receive either 45 mg or 90 mg STELARA at weeks 12 and 16 and then once every 12 weeks through week 52.  The primary endpoint of the study was the proportion of patients achieving PASI 75 at week 12.

About STELARA

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 companies have exclusive marketing rights 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.

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://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 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 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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