Stelara Three-Year Efficacy and Safety Data Presented on Patients with Moderate to Severe Plaque Psoriasis
Chicago, IL, August 9, 2010 - New study findings showed that a majority of patients with moderate to severe plaque psoriasis who had a previous response to STELARA® (ustekinumab) sustained a clinical response for up to three years with continued treatment regardless of their body weight. Investigators also presented findings from an integrated safety analysis that included data from one Phase 2 and three Phase 3 trials in which treatment with STELARA demonstrated a favorable benefit-risk profile for up to three years of treatment, consistent with previous analyses. The data were presented at the Summer Academy Meeting of the American Academy of Dermatology in Chicago, and related findings were the subject of an article in the July issue of the Journal of the American Academy of Dermatology, entitled "Impact of weight on the efficacy and safety of ustekinumab in patients with moderate to severe psoriasis: Rationale for dosing recommendations."
In the PHOENIX 1 study, patients achieving at least a 75 percent improvement in their psoriasis as measured by the Psoriasis Area and Severity Index (PASI 75) at week 40 were randomized to continue treatment with every-12-week STELARA maintenance dosing based on body weight or to withdraw from treatment and only receive retreatment with loss of response. Patients under 100 kg (220 lbs) (n=246) received 45 mg doses of STELARA and patients over 100 kg (220 lbs) (n=133) received 90 mg doses of STELARA, which reflects the currently approved dosing regimen for STELARA. At week 148 of the study, 88 and 72 percent of participants receiving STELARA 45 mg and 90 mg every 12 weeks, respectively, sustained a PASI 75 response. Forty-eight and 44 percent of participants in the 45 mg and 90 mg treatment groups, respectively, achieved PASI 90 responses, a 90 percent improvement in their psoriasis. Rates of adverse events (AEs), AEs leading to discontinuation, and serious AEs were 89.2, 6.0 and 2.4 percent for patients receiving STELARA every 12 weeks, and 95.1, 7.4 and 9.9 percent, respectively, for those who withdrew from therapy and were potentially retreated.
"Bringing about and sustaining skin clearance is a top priority for patients living with psoriasis and for their dermatologists," said Alexa Kimball, MD, MPH, Associate Professor, Harvard Medical School; Department of Dermatology, Massachusetts General Hospital and lead study investigator. "These data provide the dermatology community with new insights into the long-term efficacy of STELARA and the treatment of this chronic autoimmune disorder."
Findings from a separate pooled safety analysis of data for STELARA evaluating more than 3,000 patients for periods up to three years, which totaled 4,782 patient-years (PY), were consistent with results from previous STELARA studies. The data, compiled from Phase 2 and Phase 3 clinical trials including the pivotal PHOENIX 1, PHOENIX 2 and ACCEPT studies, showed overall rates of AEs and serious AEs per 100 PY were comparable in the 45 mg and 90 mg STELARA patient groups. The most commonly reported AEs (>5%) included nasopharyngitis, upper respiratory tract infection, arthralgia, sinusitis, headache and back pain. Rates of serious infections (0.82 and 1.50 for 45 mg and 90 mg STELARA patient groups, respectively, per 100 PY), non-cutaneous malignancies (0.69; 0.46) and major cardiovascular events (0.41; 0.35) remained stable over time and were consistent with expected rates in both general or psoriasis populations.
"As with any medication, it is important for dermatologists to carefully monitor patients on biologic therapies to quickly and accurately identify and manage therapy-related safety concerns," said Craig Leonardi, MD, Clinical Professor of Dermatology, St. Louis University Medical School and study investigator. "It is encouraging to see that the favorable benefit-to-risk profile seen in STELARA clinical trials has been maintained in patients who've received the treatment for several years. Ongoing, five-year follow-up studies will allow us to continue to evaluate this treatment and the safety profile of STELARA."
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 bleed. It is estimated that approximately 7.5 million Americans and 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 PHOENIX 1 Trial (Phase 3 Study) PHOENIX 1 evaluated the efficacy and safety of ustekinumab 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. 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. Patients included in these analyses received 45 mg doses of STELARA for those under 100 kg or 90 mg doses of STELARA for those over 100 kg. PASI responses for those continuing every-12-week treatment with STELARA were reevaluated at week 148.
About the PHOENIX 2 Trial (Phase 3 Study) PHOENIX 2 is a randomized, double-blind, placebo-controlled, multicenter study evaluating 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 long-term extension of this trial is ongoing and is expected to be completed in October 2011; it will provide five years of safety and efficacy data.
About the ACCEPT Trial (Phase 3 Study) 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 the Phase 2 Study The 52-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.
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<http://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.
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®. Non-live vaccinations received while taking STELARA® may not fully protect you from disease. * 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.
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
Posted: August 2010