STELARA(TM) Shows Greater Efficacy Than Etanercept for Treatment of Moderate to Severe Plaque Psoriasis: Phase 3 Comparator Study Published in The New England Journal of Medicine

HORSHAM, Pa., Jan. 14 /PRNewswire/ -- Findings from an international, Phase 3 clinical study comparing the efficacy and safety of STELARA™ (ustekinumab) with etanercept (Enbrel®) in the treatment of moderate to severe plaque psoriasis appear today in The New England Journal of Medicine.  The results showed a significantly higher clinical response with both doses of STELARA than with etanercept over a 12-week period.  The first-of-its-kind head-to-head study comparing two biologic agents for plaque psoriasis also shows the efficacy of STELARA among patients in the study who failed to respond to etanercept.

Psoriasis is an inflammatory disorder characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain.  It is estimated that approximately 7.5 million Americans and nearly 3 percent of the world's population are living with psoriasis, which can present in various forms, ranging from mild to severe and disabling. 

"This study provides important comparative efficacy information about the treatment of moderate to severe plaque psoriasis with two biologic agents," said professor Christopher Griffiths, MD, FRCP, University of Manchester, Manchester, UK, and lead trial investigator.  "We observed a substantial proportion of patients achieving high levels of skin clearance with ustekinumab, both through the study's primary endpoint at week 12 and following crossover from etanercept, including in those patients who showed a lack of response to etanercept during the study."

In the comparator study, 68 and 74 percent of patients receiving subcutaneous injections of STELARA (45 mg or 90 mg) at weeks 0 and 4 achieved at least a 75 percent reduction in psoriasis as measured by the Psoriasis Area and Severity Index (PASI 75) at week 12, the primary endpoint, compared with 57 percent of patients receiving subcutaneous injections of 50 mg etanercept twice per week for 12 weeks (P = 0.01 for STELARA 45 mg; P < 0.001 for STELARA 90 mg, each compared with etanercept).  Onset of clinical response appeared more rapidly among STELARA-treated patients, with higher numbers of patients achieving PASI 75 by week 8 compared with patients receiving etanercept.  

Investigators also reported that a greater proportion of patients receiving STELARA achieved a marked improvement in psoriasis as assessed by PASI 90 response, or nearly complete clearance of psoriasis.  At week 12, 36 percent of patients receiving STELARA 45 mg and 45 percent of patients receiving STELARA 90 mg achieved PASI 90 compared with 23 percent of patients receiving etanercept (P < 0.001 for each comparison versus etanercept).  Moreover, a greater proportion of patients in both the STELARA 45 mg and 90 mg treatment groups achieved a Physician Global Assessment (PGA) score of "cleared" or "minimal" (65 percent and 71 percent, respectively) compared with patients in the etanercept treatment group (49 percent) (P < 0.001 for each comparison versus etanercept).

Patients who had an inadequate response to etanercept, as measured by PGA score (classified as moderate, marked or severe psoriasis at week 12), received one injection of STELARA 90 mg at weeks 16 and 20.  At week 28, investigators reported that 49 and 23 percent of patients who failed to respond to etanercept and who crossed over to STELARA achieved PASI 75 and PASI 90, respectively.

In addition, patients classified as responders (having a PGA score of cleared, minimal or mild) at week 12 discontinued therapy until recurrence of psoriasis (PGA of moderate or greater).  In these patients, the median length of time to disease recurrence was longer for STELARA patients (14.4 and 18.1 weeks for 45 and 90mg, respectively) than for etanercept patients (7.3 weeks).  Response was regained in 84 percent of patients following retreatment with two STELARA (45 mg or 90 mg) injections.

Through week 12 of the study, the percentages of study participants experiencing at least one adverse event (AE) were comparable between the STELARA 45 mg group (66 percent), the STELARA 90 mg group (69 percent) and the etanercept 50 mg group (70 percent).  Those patients experiencing at least one serious AE through week 12 were reported as follows: 1.9 percent and 1.2 percent of patients receiving STELARA 45 mg or 90 mg, respectively, compared with 1.2 percent of patients receiving etanercept.  Rates of specific AEs were generally comparable between treatment groups with the exception of injection site reactions, which were reported in 25 percent of patients treated with etanercept versus 4.3 percent and 3.7 percent with STELARA 45 mg and 90 mg, respectively, though this disparity may have been influenced by the greater number of etanercept injections administered (at least 24 in the 12-week portion of the study) compared with two STELARA injections.  

Through week 64, AEs were generally comparable between patients in the 45 mg (87 percent) and 90 mg (89 percent) STELARA groups.  In patients who crossed over from etanercept to STELARA, generally similar proportions experienced AEs (79 percent versus 65 percent) and serious AEs (3.5 percent versus 3.4 percent) before versus after transitioning to STELARA.

About the ACCEPT Trial

The Phase 3, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Ustekinumab Compared to Etanercept 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 Psoriasis

Psoriasis is a chronic, immune-mediated disease that results from the overproduction of skin cells, resulting in their accumulation on the surface of the skin, which causes red, scaly plaques that may itch and bleed.  It is estimated that approximately 7.5 million people in the United States are living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.

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.  STELARA is approved in 44 countries around the world including Canada, Europe and the United States for the treatment of moderate-to-severe plaque psoriasis.

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 Centocor Ortho Biotech Inc.

Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology and oncology.  The company was formed when Centocor, Inc. and Ortho Biotech Inc. were consolidated in late 2008, and was renamed Centocor Ortho Biotech Inc.  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.  Centocor Ortho Biotech is a wholly-owned subsidiary of Johnson & Johnson.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995.  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 Centocor Ortho Biotech Inc. and/or Johnson & Johnson's expectations and projections.  Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment.  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 28, 2008.  Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson.  Neither Centocor Ortho Biotech Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

Enbrel is a registered trademark of Amgen and Wyeth Pharmaceuticals.

SOURCE Centocor Ortho Biotech Inc.

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