Results Presented from the STELARA Clinical Development Program Also Demonstrate Consistency of Response across Multiple Ethnic Populations
SEOUL, Korea -- (BUSINESS WIRE) --
This release is intended for media in Hong Kong, New Zealand, The Philippines, Singapore and Thailand only.
New findings to be presented from pooled analyses of the STELARA® (ustekinumab) psoriasis clinical development program showed that the safety profile of STELARA and rates of adverse events remained consistent and stable over time in adults with moderate to severe plaque psoriasis receiving up to four years of treatment.1 Investigators also reported findings from an analysis of four placebo-controlled Phase 3 trials across patient populations on three continents and found that the efficacy and safety of STELARA in patients of Japanese, Korean and Taiwanese descent were consistent with findings previously reported in North American and European populations.2 Both sets of data were presented at the 22nd World Congress of Dermatology in Seoul, Korea.
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 usually itch or feel sore, can crack and bleed, and can occur anywhere on the body. The disease symptoms can range from mild, to moderate, to severe and disabling. STELARA is currently approved in 57 countries for the treatment of moderate to severe plaque psoriasis.
“These findings are promising and support a favorable benefit-to-risk profile for STELARA with up to four years of treatment,” said Kristian Reich, MD, Department of Dermatology of Dermatolgikum, Hamburg, Germany, and lead trial investigator for the PHOENIX 2 study. “Ongoing studies in psoriasis and psoriatic arthritis will continue to define the safety profile of STELARA in the psoriatic population.”
Pooled safety data from a total of 3,117 patients who participated in a Phase 2 STELARA trial and the Phase 3 PHOENIX 1, PHOENIX 2 and ACCEPT studies showed rates of adverse events (AEs) to be generally stable over time through up to four years of treatment with STELARA, with the most commonly reported AEs [greater than 5 per 100 patient years (PY)] including nasopharyngitis, upper respiratory tract infection, arthralgia, sinusitis, headache and back pain and influenza. Observed occurrences of AEs of interest, including serious infections (0.8 and 1.32 for 45 mg and 90 mg STELARA patient groups, respectively, per 100 PY), non-melanoma skin cancer (0.70; 0.53 per 100 PY, respectively), other malignancies (0.63; 0.61 per 100 PY, respectively) and major adverse cardiovascular events (MACE) (0.42; 0.36 per 100 PY, respectively) remained generally stable during the time periods evaluated. The observed rate of malignancies (excluding non-melanoma skin cancers) was consistent with that expected in the general U.S. population, derived from the Surveillance, Epidemiology and End Results (SEER) Database. Rate of non-fatal myocardial infarction (MI) or stroke was consistent with or lower than that expected in the general U.S. population and psoriasis populations, derived from the Framingham Database and General Practice Research Database (GPRD), respectively.1
The four year safety analysis of the Phase 2, PHOENIX 1, PHOENIX 2 and ACCEPT trials evaluated the largest psoriasis-focused clinical trial safety database for a biologic reported to date, with more than 1,100 patients who have had at least three years of treatment with STELARA and more than 600 patients treated for four or more years for a total of nearly 6,800 PY.1
Consistency of Responses across Different Ethnic Populations with Moderate-to-Severe Plaque Psoriasis: Results from the STELARA Psoriasis Clinical Development Program
Additional findings from a separate analysis found STELARA efficacy and safety across Asian populations with moderate to severe plaque psoriasis to be consistent with those observed in North American and European populations, according to data from PHOENIX 1 (n=766) and PHOENIX 2 (n=1230) compared with Japanese, Korean and Taiwanese populations evaluated in the JPN-02 (n=158) and PEARL (n=121) trials, respectively.2
“Psoriasis is an autoimmune disease that affects millions of people worldwide from all ethnic backgrounds,” said Dr Jai-Il Youn, Department of Dermatology, Seoul National University, Seoul, Korea and study investigator. “These data show the consistency of response with STELARA in the treatment of psoriasis across ethnic populations. These findings are important considerations for the dermatology community.”
In the four analyzed studies, patients received subcutaneous injections of STELARA 45 mg or 90 mg, or placebo at weeks 0 and 4, although only the STELARA 45 mg dose was evaluated in the PEARL trial. STELARA patients received a third dose at week 16, while placebo-treated patients crossed over to receive active treatment at weeks 12 and 16. At week 12, the primary endpoint, a 75 percent improvement as measured by the Psoriasis Area Severity Index (PASI 75), was achieved by a significantly greater proportion of patients across all studies when compared with the placebo group (P > 0.001). Among patients receiving STELARA 45 mg, 66.9 percent, 59.4 percent and 67.2 percent achieved PASI 75 in the North American/European, Japanese, Korean and Taiwanese patient populations, respectively. In patients receiving 90 mg, 72.1 percent and 67.7 percent of patients achieved PASI 75 in the North American/European and Japanese populations. Placebo rates of response were 3.5 percent, 6.5 percent and 5.0 percent in the PHOENIX 1 & 2, Japanese and PEARL trials, respectively. These responses continued to improve through week 28 across groups, with similar responses seen in placebo-treated patients following crossover to treatment with STELARA. STELARA-treated patients also demonstrated clinically meaningful improvements in quality of life, as measured by the Dermatology Life Quality Index (DLQI), at weeks 12 and 28 across the four trials.
Rates of AEs and serious AEs through week 12 were comparable overall between STELARA and placebo groups in the North American/European, Japanese, Korean and Taiwanese trials. Among patients receiving STELARA 45 mg (or 90 mg), 54.8 (49.7) percent, 65.6 (59.7) percent and 65.6 percent of patients across patient populations reported at least one AE, compared with 49.2 percent, 65.6 percent and 70.0 percent of placebo patients, respectively. Similar safety results were seen through week 28 of each trial. Please read the Important Safety Information for STELARA below.
About Psoriasis
Psoriasis is a chronic, immune-mediated disease that results from the overproduction of skin cells, which accumulate on the surface of the skin and cause red, scaly plaques that may crack and bleed. It is estimated that 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 STELARA
STELARA is currently approved in 57 countries, including Japan, Thailand, Hong Kong, Philippines, Singapore, Australia, New Zealand, Canada, Europe, the United States, Brazil and Mexico for the treatment of moderate to severe plaque psoriasis. 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.
About Janssen Asia Pacific
Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g. diabetes).
Employing more than 7,000 staff in 14 countries across Asia-Pacific, Janssen remains committed to addressing the varied and evolving healthcare requirements of the region.
Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. More information can be found at www.janssen-cilag.com
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1 Reich K, Leonardi C, Griffiths CEM, Szapary PO, Wasfi Y , Hsu MC, Gordon K. Update on the Cumulative Safety Experience of Ustekinumab: Result from the Ustekinumab Psoriasis Clinical Development Program with Up to 4 Years of Follow-up, Proceedings of the 22nd World Congress of Dermatology; 2011 May 29-29; Seoul, Korea. FC07-03
2 Youn J, Tsai TF, Reich K, Ho V, Yamauchi P, Song M, Kato T. Consistency of responses across different ethnic populations with moderate-to-severe psoriasis: Results from the ustekinumab psoriasis clinical development program. Proceedings of the 22nd World Congress of Dermatology; 2011 May 29-29; Seoul, Korea. P2504
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