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Janssen Biotech Inc. Release: New STELARA® Five-Year Data Show Consistent Efficacy and Safety Profile in Treatment of Moderate to Severe Plaque Psoriasis


6/6/2012 12:13:30 PM

VERONA, Italy, June 6, 2012 /PRNewswire/ -- New efficacy and safety data from the Phase 3 PHOENIX 1 study, one of two pivotal registration trials, showed that maintenance treatment with STELARA® (ustekinumab) for up to five years resulted in consistent, significant clinical response in adults with moderate to severe plaque psoriasis. Among responders receiving STELARA 45 mg or 90 mg and randomized to continue maintenance therapy through five years, 79 and 81 percent of patients, respectively, experienced at least a 75 percent improvement in psoriasis as measured by the Psoriasis Area and Severity Index (PASI 75) at the end of the treatment period. Investigators also reported a consistent benefit-to-risk profile for STELARA through five years and observed treatment with the biologic therapy to be generally well-tolerated with rates of adverse events (AEs), including infections, malignancies and cardiovascular events, remaining stable over time. The data were presented today at the 9th Annual European Academy of Dermatology and Venereology Spring Symposium in Verona, Italy.

"These data are important to the professional dermatology community as we now have five-year datathe longest continuous study evaluating a biologic in the treatment of psoriasisthat reinforce our understanding of STELARA efficacy and safety as a therapeutic option," said Alexa Kimball, MD, MPH, Associate Professor, Harvard Medical School, Department of Dermatology, Massachusetts General Hospital and lead study investigator. "STELARA continues to be an important option for dermatologists in the treatment of moderate to severe plaque psoriasis, and these findings are reassuring for physicians and their patients living with this chronic disease who might be candidates for biologic therapy."

In the PHOENIX 1 study, patients were randomized to receive placebo or STELARA 45 mg or 90 mg at weeks 0 and 4. Following assessment of PASI 75 at week 12, the primary endpoint, STELARA-treated patients continued to receive treatment every 12 weeks. At week 40, PASI 75 responders were re-randomized to receive maintenance therapy with STELARA or to withdraw from treatment and only receive retreatment with loss of response. More than two-thirds (n=517) of all STELARA-treated patients (n=753) in PHOENIX 1 continued to receive STELARA through the last scheduled five-year dose. Among the responders who continued treatment from week 40 through the end of the study, 48 and 59 percent had PASI 90 in the STELARA 45 mg and 90 mg groups, respectively, with up to five years of treatment. Efficacy was similarly maintained in an overall analysis of the study population, with 63 and 72 percent of all PHOENIX 1 participants achieving PASI 75, and 40 and 49 percent achieving PASI 90, of those individuals receiving STELARA 45 mg or 90 mg, respectively.

Adverse events were evaluated in more than 753 ustekinumab-treated patients with a total 3,104 patient-years (PY) of follow-up. Rates of AEs (221 and 209 per 100 PY), serious AEs (5.3 and 5.4 per 100 PY) and infections (84 and 82 per 100 PY) in the STELARA 45 mg and 90 mg treatment groups, respectively, remained stable over time. Rates of serious infection (1.03 per 100 PY), non-melanoma skin cancer (0.45 per 100 PY), malignancy other than non-melanoma skin cancer (0.48 per 100 PY), and major adverse cardiovascular events (0.35 per 100 PY) in combined STELARA groups were similarly consistent over the five-year period. No new safety signals were reported with the increased duration of exposure.

As part of a post-marketing commitment with the United States Food and Drug Administration (FDA) for safety surveillance of STELARA, Janssen Biotech, Inc. is conducting the PSOriasis Longitudinal Assessment Registry (PSOLAR). PSOLAR is an international, multicenter, prospective, observational study evaluating long-term safety and clinical outcomes for patients receiving (or eligible to receive) treatment for psoriasis with biologics and/or conventional systemic agents in academic and community-based settings. Patients completing PHOENIX 1 are being transitioned into PSOLAR when possible to continue collection of long-term safety data.

About Psoriasis
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 can crack and bleed, and may occur anywhere on the body. The disease symptoms can range from mild, to moderate, to severe and disabling. It is estimated that nearly three percent of the world's population is living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.

About PHOENIX 1
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 for up to five years. 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 maintenance treatment with their original dose of STELARA through the end of the study or to withdraw from treatment and only receive retreatment upon loss of response. After week 76, subjects continued on treatment in a long-term extension for up to 5 years.

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.

In its 2012 Consensus Guidelines for the Management of chronic Plaque Psoriasis, the National Psoriasis Foundation supports the choice of STELARA as a first-line systemic therapy for moderate to severe plaque psoriasis. For more information about STELARA, visit www.STELARAinfo.com.

Janssen Biotech, Inc. discovered STELARA and has exclusive marketing rights to the product in the United States. The Janssen pharmaceutical companies maintain exclusive worldwide marketing rights to STELARA, which is currently approved for the treatment of moderate to severe plaque psoriasis in 65 countries.

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 youthink 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 awayif 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 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 Janssen Biotech, Inc.
Janssen Biotech, Inc. redefines the standard of care in immunology, oncology, urology and nephrology. Built upon a rich legacy of innovative firsts, Janssen Biotech has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease. Beyond its innovative medicines, Janssen Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and health care professionals have access to the latest treatment information, support services and quality care. For more information on Janssen Biotech, Inc. or its products, visit www.janssenbiotech.com.

Janssen Biotech is one of the Janssen Pharmaceutical Companies of Johnson & Johnson which are dedicated to addressing and solving some of the most important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to people throughout the world. Follow us on Twitter at www.twitter.com/JanssenUS.

SOURCE Janssen Biotech



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