Spring House, PA (October 17, 2012) Findings from a Janssen Research & Development, LLC (Janssen)-sponsored Phase 2b trial evaluating the efficacy and safety of STELARA® (ustekinumab) in the treatment of moderate to severe Crohn’s disease appeared today in The New England Journal of Medicine. The results showed that among patients who had previously failed or were intolerant to at least one tumor necrosis factor (TNF) antagonist, a significantly greater proportion receiving intravenous (I.V.) STELARA 6 mg/kg achieved the primary endpoint of clinical response at week 6, defined as a 100-point reduction in the Crohn’s Disease Activity Index (CDAI), compared with patients receiving placebo (40 percent vs. 24 percent, respectively). Subsequent maintenance therapy with every eight-week subcutaneous (SC) STELARA among I.V. STELARA induction responders resulted in significantly higher rates of clinical remission at week 22 compared with placebo. STELARA targets interleukin (IL)-12 and IL-23, cytokines believed to play a role in immune-mediated inflammatory diseases including Crohn’s disease.
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.
“TNF inhibitors have significantly advanced the way we treat moderate to severe Crohn’s disease, yet it is essential to have alternative options for patients who may not respond or lose response to therapy,” said lead study investigator William Sandborn, MD, professor and chief of the Division of Gastroenterology at the University of California, San Diego (UCSD) School of Medicine and director of the UC San Diego Inflammatory Bowel Disease Center. “This study showed that treatment with STELARA induced response in adults who had failed or become intolerant to previous TNF inhibitors, and among those who responded, more patients achieved remission with continued maintenance therapy. This is promising data for the patient population with few remaining treatment options. Findings from the ongoing Phase 3 STELARA trials will provide further insight into the efficacy and safety of STELARA in this population, as well as in those who have not failed TNF inhibitors.”
In the induction phase of 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) study, patients received one of three I.V. doses of STELARA or placebo at week 0. At week 6, a significantly greater proportion of patients receiving 6 mg/kg I.V. STELARA (39.7 percent) achieved clinical response, the primary endpoint, compared with patients receiving placebo (23.5 percent). The proportions of patients receiving 1 mg/kg and 3 mg/kg were also greater (36.6 and 34.1 percent, respectively), though not significantly. The proportions of patients in clinical remission, defined as a CDAI score less than 150, at weeks 6 and 8 were not significant for any of the STELARA doses compared with placebo.
In the maintenance phase of the study, patients classified as responders to I.V. STELARA at week 6 were re-randomized to receive SC STELARA 90 mg or placebo at weeks 8 and 16. At week 22, a significantly greater proportion of patients who continued to receive SC STELARA were in clinical remission (41.7 percent) compared with patients re-randomized to receive SC placebo (27.4 percent). Among patients in remission at week 6, while not significant, 78.6 percent of STELARA-treated patients compared with 53.3 percent of placebo-treated patients maintained remission at week 22.
Rates of adverse events (AEs) and serious AEs for STELARA were similar overall to placebo groups, and both I.V. 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. However, through week 22, serious infections occurred in seven patients during the induction phase (one placebo, one STELARA 1 mg/kg, five STELARA 6 mg/kg) and 11 patients during the maintenance phase (seven in the SC placebo group, which received I.V. STELARA at week 0; four in the SC STELARA group). One basal cell carcinoma of the skin was reported in a patient who received STELARA 1 mg/kg followed by STELARA 90 mg. Infusion and injection site reactions occurred at similar rates in patients receiving either STELARA or placebo, and none were serious. No deaths, major adverse cardiovascular events (MACE) or incidents of tuberculosis (TB) were reported.
Two Phase 3 studies evaluating STELARA in the treatment of moderate to severe Crohn’s disease are currently enrolling: UNITI-1, which will evaluate STELARA in patients who have failed or who are intolerant to TNF inhibitors and UNITI-2, which will evaluate STELARA in patients who have failed steroids or immunomodulators, but who have not yet failed a TNF inhibitor.
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 I.V.-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 REMICADE® (infliximab), adalimumab or certolizumab pegol. The primary endpoint was clinical response (at least a 100-point reduction from baseline CDAI scores) at week 6. At week 8, responders and non-responders to I.V. STELARA induction were randomized separately to receive SC STELARA 90 mg or placebo at weeks 8 and 16. Patients who were responders to I.V. placebo at week 6 received SC placebo at weeks 8 and 16, while non-responders received SC STELARA 270 mg at week 8 followed by STELARA 90 mg at week 16.
About Crohn’s Disease
Crohn’s disease, a chronic inflammatory disease of the gastrointestinal tract, affects approximately 700,000 Americans.1 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 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.
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.
STELARA is currently in Phase 3 studies for the treatment of moderate to severe Crohn’s disease and active psoriatic arthritis.
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. For more information about STELARA, visit www.STELARAinfo.com.
Important Safety Information
STELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects including:
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
- 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.
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.
Please read the Medication Guide for STELARA® and discuss any questions you have 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.
The U.S. full prescribing information for STELARA® can be accessed at the following link: http://www.stelarainfo.com/pdf/PrescribingInformation.pdf
About Janssen Research & Development, LLC
At Janssen Research & Development, LLC, we are united and energized by one mission—to discover and develop innovative medicines that ease patients' suffering, and solve the most important unmet medical needs of our time. As one of the Janssen Pharmaceutical Companies of Johnson & Johnson, our strategy is to identify the biggest unmet medical needs and match them with the best science, internal or external, to find solutions for patients worldwide. We leverage our world-class discovery and development expertise, and operational excellence, to bring innovative, effective treatments in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. For more information on Janssen R&D, visit http://www.janssenrnd.com/.
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 Crohn’s & Colitis Foundation of America. What is Crohn’s disease? http://www.ccfa.org/what-are-crohns-and-colitis/what-is-crohns-disease/. Accessed October 17, 2012.
 Crohn’s & Colitis Foundation of America. Crohn’s Treatment Options. http://www.ccfa.org/what-are-crohns-and-colitis/what-is-crohns-disease/crohns-treatment-options.html. Accessed October 17, 2012.
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