Phase 2b Data Show Treatment With STELARA® Induced and Maintained Clinical Response in Patients With Moderate to Severe Crohn's Disease

CHICAGO, May 9, 2011 /PRNewswire/ -- New study findings showed that treatment with STELARA® (ustekinumab) induced and maintained clinical response in patients with moderate to severe Crohn's disease who had previously failed or were intolerant to at least one tumor necrosis factor (TNF) antagonist.  Investigators presented findings from a Phase 2b study at Digestive Disease Week, which showed nearly 40 percent of patients receiving STELARA 6 mg/kg achieved clinical response, defined as a 100 point reduction in the Crohn's Disease Activity Index (CDAI), at week 6, the primary endpoint of the study.  Additionally, a significantly greater proportion of week 6 responders to STELARA continuing treatment with STELARA through week 22 were in clinical response and in clinical remission compared with the group treated with placebo.  

Crohn's disease, a chronic autoimmune disorder of the gastrointestinal tract, affects an estimated 700,000 Americans, and up to three quarters of people living with Crohn's disease may require surgery when medications can no longer control the symptoms of the disease.(1)

"Nearly half the patients participating in the study had a previous inadequate response to at least two TNF antagonists," said William Sandborn, M.D., University of California at San Diego, and lead study investigator.  "While TNF blockers have advanced the treatment of Crohn's disease, for patients who do not respond or lose response, treatment options are limited.  These results suggest the potential of STELARA as a treatment option for Crohn's disease, which is promising considering many patients still struggle with the debilitating effects of this immunological disease as a result of lack of response or loss of response to previous biologic treatment."

In the study, patients received one of three intravenous (IV) doses of STELARA or placebo at week 0.  At week 6, 36.6 percent, 34.1 percent and 39.7 percent of patients receiving STELARA 1 mg/kg, 3 mg/kg or 6 mg/kg, respectively, achieved clinical response, compared with 23.5 percent of patients receiving placebo (P = 0.021 for STELARA 1 mg/kg vs. placebo; P = 0.057 for STELARA 3 mg/kg vs. placebo; P = 0.005 for STELARA 6 mg/kg vs. placebo).  The difference in clinical remission was not statistically significant at week 6, a secondary endpoint, with any of the doses tested compared with placebo.  In the maintenance phase of the study, individuals classified as responders to STELARA at week 6 were re-randomized to receive subcutaneous (SC) STELARA 90 mg or placebo at weeks 8 and 16.  At week 22, 69.4 percent of patients maintained clinical response with continued STELARA treatment compared with 42.5 percent of patients receiving placebo (P < 0.001).  Clinical remission was seen in 41.7 percent of initial STELARA responders who continued with therapy compared with 27.4 percent of responders re-randomized to receive placebo (P = 0.029).  

"Based on these positive results, we look forward to studying STELARA in a Phase 3 program for the treatment of moderate to severe Crohn's disease, both in patients who have failed conventional treatment and in those who have failed anti-TNF therapy," said Jerome A. Boscia, M.D., Head of Immunology Development, Centocor Research & Development, Inc. "We believe STELARA holds great promise as a 'pipeline in a product' for the treatment of multiple inflammatory conditions, including Crohn's disease, and we look forward to the continued clinical development of this biologic therapy."

About the CERTIFI Trial

The Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist Therapy (CERTIFI) trial included 526 patients with moderately to severely active Crohn's disease who were randomized to receive IV-administered STELARA 1 mg/kg, 3 mg/kg, 6mg/kg or placebo.  All participating patients had previously failed or proved to be intolerant to a range of TNF antagonists including infliximab (REMICADE®), adalimumab (Humira®) or certolizumab pegol (Cimzia®).  The primary endpoint was clinical response (at least a 100 point reduction from baseline CDAI scores) at week 6.  At week 8, patients who were classified as responders or non-responders to IV STELARA at week 6 were re-randomized to receive SC STELARA 90 mg or placebo at weeks 8 and 16. Patients who responded to IV placebo by week 6 received SC placebo at weeks 8 and 16, while non-responders received SC STELARA 270 mg at week 8 followed by STELARA 90mg at week 16.

Rates of adverse events (AEs) and serious AEs were similar overall for STELARA and placebo groups, and both IV and SC STELARA were well-tolerated by study participants.  There were similar proportions of overall AEs, serious AEs and infections in the STELARA- and placebo-treated groups during both the induction and maintenance phases.  Through week 22, there were no deaths, serious opportunistic infections or cases of tuberculosis, malignancies or major adverse cardiovascular events.  Infusion and injection site reactions were uncommon in patients receiving STELARA or placebo and none were serious.  

About Crohn's Disease

Crohn's disease, a chronic inflammatory disease of the gastrointestinal tract, affects approximately 700,000 Americans. The cause of Crohn's disease is not known, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition or diet and other environmental factors. Symptoms of Crohn's disease can vary but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss and fever. There is currently no cure for Crohn's disease.

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 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.  Centocor Ortho Biotech Inc. 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 the expectations and projections of Centocor Ortho Biotech Inc. and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, 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; trends toward health care cost containment; and increased scrutiny of the healthcare industry by government agencies.  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 January 2, 2011.  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.)

About Digestive Disease Week (DDW)

DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 7 - 10, 2011, at McCormick Place, Chicago, IL. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

Humira is a registered trademark of Abbott Laboratories.

Cimzia is a registered trademark of the UCB Group of Companies.

References:

1. Crohn's and Colitis Foundation of America. About Crohn's Disease. Available at: http://ccfa.org/info/about/crohns. Accessed March 21, 2011.

SOURCE Centocor Ortho Biotech Inc.

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