Washington, DC, November 12, 2012 – Janssen Research & Development, LLC (Janssen) announced today new findings from PSUMMIT II, a Phase 3 investigational study that showed patients with active psoriatic arthritis, including those previously treated with one to five tumor necrosis factor (TNF) inhibitors, receiving the interleukin (IL)-12/23 inhibitor STELARA® (ustekinumab) demonstrated significant improvements in signs and symptoms of the disease. Significantly more patients receiving either STELARA 45 mg or 90 mg achieved at least a 20 percent improvement in signs and symptoms according to American College of Rheumatology criteria (ACR 20) at week 24, the primary endpoint, than did patients receiving placebo regardless of background methotrexate use. During a late-breaker session of PSUMMIT 1, the initial Phase 3 study, investigators will present 52-week data that showed improvement in efficacy of STELARA over time in treating signs and symptoms of the disease. These data are being presented at the 2012 Annual Meeting of the American College of Rheumatology.
In the Phase 3 Multicenter, Randomized, Double-blind, Placebo‑controlled trial of Ustekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis Including Those Previously Treated with Biologic Anti-TNF-alpha Agent(s) (PSUMMIT II) study, patients with active psoriatic arthritis despite treatment with disease-modifying antirheumatic drugs (DMARDs), nonsteroidal anti-inflammatory drugs (NSAIDs) and/or anti-TNF-alpha therapy (not intended as a superiority or comparative claim versus TNF inhibitors) were randomized to receive subcutaneous STELARA 45 mg or 90 mg or placebo at weeks 0, 4 and then every 12 weeks. At week 24, the primary endpoint was met as statistically significantly greater proportions of patients achieving ACR 20 responses (a standard measure of improvement in disease activity) were observed in patients receiving STELARA 45 mg (43.7 percent of patients) or STELARA 90 mg (43.8 percent of patients) compared with 20.2 percent of patients receiving placebo (P < 0.001 for both comparisons). Among patients previously treated with TNF inhibitors, 36.7 percent of patients and 34.5 percent of patients receiving STELARA 45 mg or 90 mg, respectively, achieved ACR 20 at week 24 compared with 14.5 percent of patients receiving placebo (P = 0.006 for STELARA 45 mg, P = 0.011 for STELARA 90 mg).
"TNF inhibitors are the only approved biologic treatment option for psoriatic arthritis, but not all patients benefit from these currently available treatments," said Christopher Ritchlin, M.D., M.P.H., Professor of Medicine and Director of the Rheumatology Fellowship Program and the Clinical Immunology Research Center at the University of Rochester Medical Center, and lead study investigator. "A biologic therapy with a different mechanism of action, like ustekinumab, which has shown benefit in the treatment of psoriatic arthritis in two Phase 3 studies, is exciting for the rheumatology community."
In PSUMMIT II, significantly greater proportions of patients receiving STELARA 45 or 90 mg achieved ACR 50 at week 24 compared with placebo (17.5 and 22.9 percent vs. 6.7 percent, P = 0.018 for STELARA 45 mg, P = 0.001 for STELARA 90 mg). ACR 70 responses for both STELARA groups were greater, though not significantly, than for the placebo group at week 24. Of patients with at least three percent body surface involvement of psoriasis at the start of PSUMMIT II, 51.3 percent and 55.6 percent of patients receiving STELARA 45 mg and 90 mg achieved at least a 75 percent improvement in psoriasis, respectively, as measured by the Psoriasis Area Severity Index (PASI 75), compared with five percent of patients receiving placebo (P < 0.001 for both comparisons). Significant improvements from baseline to week 24 were also observed in physical function, as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI), in the STELARA 45 mg and 90 mg treatment groups compared with placebo-treated patients (P = 0.001 for STELARA 45 mg, P < 0.001 for STELARA 90 mg).
Similar proportions of patients experienced at least one adverse event (AE) through week 16, the placebo-controlled period, among those receiving STELARA 45 mg (63.1 percent), STELARA 90 mg (60.6 percent) and placebo (54.8 percent) with infections being the most common AE. Serious AEs reported among the groups were: STELARA 45 mg (zero percent), STELARA 90 mg (1.0 percent) and placebo (4.8 percent). No cases of tuberculosis (TB), opportunistic infections, major adverse cardiovascular events (MACE) or deaths occurred. Through week 24, one serious infection due to complications of pre-existent interstitial lung disease was reported in the placebo group and one skin malignancy (squamous cell carcinoma in situ) occurred in the STELARA 90 mg group.
Improvement of Signs and Symptoms by STELARA in Patients with Active Psoriatic Arthritis: Week 52 Results of the Phase 3, Multicenter, Double-blind, Placebo-controlled PSUMMIT I Study
Findings from the Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled trial of Ustekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis (PSUMMIT I) study are the focus of a late breaker oral presentation. PSUMMIT I is evaluating the efficacy and safety of STELARA in patients with active psoriatic arthritis despite treatment with conventional therapy (anti-TNF-alpha naïve) through 108 weeks. Patients were randomized to receive subcutaneous STELARA 45 mg or 90 mg or placebo at weeks 0, 4 and then every 12 weeks. At week 24, 42.4 percent and 49.5 percent of patients receiving STELARA 45 mg and 90 mg, respectively, achieved ACR 20, the primary endpoint, compared with 22.8 percent of patients receiving placebo (P < 0.001 for both comparisons). Patients who qualified for early escape at week 16 were considered non-responders for the primary and major secondary analyses at week 24. Following week 24 assessment, patients receiving STELARA 45 mg and 90 mg continued to receive every-12-week maintenance therapy, and placebo patients were crossed over to receive STELARA 45 mg induction (at weeks 24 and 28) and maintenance therapy every 12 weeks thereafter. Observed data showed that signs and symptoms continued to increase between weeks 24 and week 52, with 55.7 percent, 60.3 percent and 65.2 percent of patients in the STELARA 45 mg, STELARA 90 mg and placebo crossover groups, respectively, demonstrating ACR 20 response.
"Long-term management of the signs and symptoms of disease is essential in the treatment of psoriatic arthritis, a systemic inflammatory disease that can be marked by chronic pain and dysfunction," said Arthur Kavanaugh, M.D., Professor of Medicine, and Director of the Center for Innovative Therapy at the University of California, San Diego, and co-principal investigator. "These results build on previously reported 24-week data from the PSUMMIT I trial of ustekinumab and demonstrate efficacy and improvements in disease activity at one year for patients living with psoriatic arthritis."
ACR 50 and ACR 70 response rates increased from week 24 through week 52 among patients receiving STELARA maintenance therapy. At week 24, among patients receiving STELARA 45 mg, 24.9 percent achieved ACR 50 compared with 8.7 percent in the placebo group (P < 0.001), which increased to 31.4 percent at week 52, and 12.2 percent achieved ACR 70 compared with 2.3 percent in the placebo group (P < 0.001) at week 24, which increased to 18 percent at week 52. Similar changes were observed in the STELARA 90 mg group at week 24 as 27.9 percent achieved ACR 50 compared with 8.7 percent in the placebo group (P < 0.001), which increased to 37 percent at week 52, and 14.2 percent achieved ACR 70 compared with 2.3 percent in the placebo group (P < 0.001) at week 24, which increased to 21.2 percent at week 52. Investigators also reported continued improvements in physical function and skin symptoms through the end of the study, with nearly half of patients demonstrating clinically meaningful change from baseline in HAQ-DI scores, and more than two-thirds of patients achieving PASI 75 at week 52.
Among study participants affected with enthesitis (inflammation of the entheses, the sites where tendons or ligaments attach to bone, n=425) or dactylitis (inflammation of the finger or toe, n=286) at baseline, patients receiving STELARA achieved clinically relevant improvements in both measures at week 24 and week 52. At week 24, median percent changes in enthesitis scores (-42.9 for STELARA 45 mg and -50.0 for STELARA 90 mg) and dactylitis scores (-75.0 for STELARA 45 mg and -70.8 for STELARA 90 mg) were significantly higher than those seen for patients receiving placebo (P < 0.001 for all comparisons). Improvements in enthesitis scores (-83.3, -74.2 and -87.5) and dactylitis scores (-100 in all patients) in the STELARA 45 mg, 90 mg and crossover groups, respectively, continued through week 52.
A similar proportion of patients experienced at least one AE or serious AE through week 16, the placebo-controlled period of PSUMMIT I. Safety through week 52 was consistent with that observed during the placebo-controlled period between STELARA 45 mg and 90 mg groups in the incidence of AEs (66.8 percent and 64.7 percent, respectively) and serious AEs (5.9 percent and 3.4 percent, respectively). No malignancies, cases of TB, opportunistic infections or deaths occurred through week 52. Investigators reported three MACE in STELARA-treated patients in patients with multiple pre-existing cardiovascular risk factors.
About PSUMMIT II
The PSUMMIT II trial is a Phase 3, multicenter, randomized, double-blind, placebo‑controlled study including 312 adults with psoriatic arthritis designed to evaluate the efficacy and safety of STELARA in adults with psoriatic arthritis. The trial included patients diagnosed with active psoriatic arthritis who had at least five tender and five swollen joints and C-reactive protein (CRP) levels of at least 0.3 mg/dL despite treatment with DMARDs and/or NSAIDs and/or prior exposure to anti-TNF treatment, including 8 to 14 weeks of exposure to currently available anti-TNF-alpha treatments and/or documented evidence of anti-TNF-alpha intolerance/toxicity with 8 to 14 weeks exposure. Concurrent methotrexate use was permitted but not mandated. Within the trial, 180 patients had prior exposure to anti-TNF-alpha treatments and 132 patients were anti-TNF-alpha naïve.
Patients were randomized to three groups: STELARA 45 mg or STELARA 90 mg at weeks 0, 4, and then every 12 weeks or placebo. At week 16, patients with less than a five percent improvement in tender and swollen joint counts were entered into blinded early escape to receive STELARA 45 mg (patients receiving placebo) or STELARA 90 mg (patients receiving STELARA 45 mg). The primary endpoint was ACR 20 response at week 24. Secondary endpoints at week 24 included ACR 50 and ACR 70 response, Disease Activity Score (DAS) 28 using CRP (DAS28-CRP) response, PASI 75 in patients with at least three percent body surface area involvement at baseline, improvements in enthesitis and dactylitis scores and improvements in HAQ-DI scores.
About PSUMMIT I
The PSUMMIT I trial is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study including 615 adults with psoriatic arthritis designed to evaluate the efficacy and safety of STELARA in adults with psoriatic arthritis. The trial included patients diagnosed with active psoriatic arthritis who had at least five tender and five swollen joints and CRP levels of at least 0.3 mg/dL despite treatment with DMARDs and/or NSAIDs. Patients were naïve to treatment with anti-TNF-alpha therapies and/or IL-12/23 inhibitors.
Patients were randomized to three groups: STELARA 45 mg or STELARA 90 mg at weeks 0, 4 and then every 12 weeks or placebo. At week 16, patients with less than a five percent improvement in tender and swollen joint counts were entered into blinded early escape to receive STELARA 45 mg (patients receiving placebo) or STELARA 90 mg (patients receiving STELARA 45 mg). The primary endpoint was ACR 20 response at week 24. Secondary endpoints at week 24 included ACR 50 and ACR 70 response, DAS28-CRP response, PASI 75 in patients with at least three percent body surface area involvement at baseline, improvements in enthesitis and dactylitis scores and improvements in HAQ-DI scores. Safety and efficacy results were reported through week 52 in the trial. Initial week 24 results were presented earlier this year at the 2012 EULAR Annual Congress.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic immune-mediated inflammatory disease characterized by both joint inflammation and the skin lesions associated with psoriasis that affects up to 37 million people worldwide. While estimates of the prevalence of psoriatic arthritis among people living with psoriasis vary, up to 30 percent may develop inflammatory arthritis. Though the exact cause of psoriatic arthritis is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease.2
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 under investigation in Phase 3 development programs for the treatment of active psoriatic arthritis and moderate to severe Crohn's disease.
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 69 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.
1. Your doctor should check you for TB before starting STELARA® and watch you closely for signs and symptoms of TB during treatment with STELARA®.
2. 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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 About Psoriasis: Statistics. National Psoriasis Foundation. http://www.psoriasis.org/learn_statistics. Accessed November 1, 2012.
 About Psoriatic Arthritis. National Psoriasis Foundation. http://psoriasis.org/psoriatic-arthritis. Accessed November 1, 2012.
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