HORSHAM, P.A., Nov. 3, 2016 -- Janssen Biotech, Inc. announced today that 28 abstracts will be presented at the 2016 American College of Rheumatology (ACR) Annual Meeting taking place in Washington, D.C. from November 11-16, 2016. Data from the extensive rheumatology portfolio including new Phase 3 study results evaluating SIMPONI ARIA® (golimumab) infusion in adults with active ankylosing spondylitis (AS); a pooled safety analysis of STELARA® (ustekinumab) in psoriatic arthritis (PsA), Crohn's disease, and psoriasis; and real world data of patients with rheumatoid arthritis (RA) on REMICADE® (infliximab) will be presented. Pipeline presentations of note include results from a Phase 2a study evaluating guselkumab, a novel anti-interleukin (IL)-23 monoclonal antibody (mAb) in the treatment of adults with active PsA and results from a Phase 3 study evaluating sirukumab*, an IL-6 mAb, in the treatment of moderately to severely active RA. Several posters highlighting research in systemic lupus erythematosus (SLE) will also be presented.
"At Janssen, we are committed to addressing the unmet needs of patients living with rheumatic diseases today, and in the future through our continued efforts in research and development of therapies with novel mechanisms of action and different delivery systems," said Andrew Greenspan, M.D., Vice President, Janssen Scientific Affairs, LLC. "We're proud to present the latest data at the American College of Rheumatology meeting from our portfolio and pipeline, including new data for SIMPONI ARIA® in the treatment of patients with ankylosing spondylitis."
JANSSEN ABSTRACTS TO BE PRESENTED DURING ACR INCLUDE:
Abstracts can be accessed on the ACR 2016 Annual Meeting website at: http://acrabstracts.org/.
SIMPONI ARIA® (golimumab) infusion
- Safety and Efficacy of Intravenous Golimumab in Adult Patients with Active Ankylosing Spondylitis: Results through Week 28 (Presentation 56212)
- Oral Presentation: Sunday, November 13, 4:30 pm – 6:00 pm
Guselkumab (Anti-IL23 mAb)
Sirukumab* (Anti-IL6 mAb)
SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
HEALTH ECONOMICS AND OUTCOMES RESEARCH DATA
Rheumatoid arthritis (RA) is a chronic, systemic inflammatory condition that is often characterized by symptoms that include pain, stiffness and inflammation of the joints, and in some cases, joint destruction and disability. An estimated 1.5 million Americans1 have the condition, which affects nearly three times as many women as men. While the cause of RA is unknown, many cases are believed to result from genetic and environmental factors. There is no medical cure for RA, but there are several medications available to help alleviate symptoms.
Psoriatic arthritis (PsA) is a chronic immune-mediated inflammatory disease characterized by both joint inflammation and the skin lesions associated with psoriasis which effects 125 million people worldwide.6 An estimated 600,000 Americans—and more than 12 million people worldwide—have PsA.5 While estimates of the prevalence of psoriatic arthritis among people living with psoriasis vary, up to 30 percent may develop inflammatory arthritis.1 The disease causes pain, stiffness and swelling in and around the joints and commonly appears between the ages of 30 and 50, but can develop at any time.2 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
Ankylosing spondylitis is a chronic, immune-mediated disease that causes enthesitis, or inflammation where ligaments and muscles attach to bones, most commonly those within the spine. It is the primary disease in a group of arthritis-related diseases known as spondylitis, spondyloarthropathy or spondyloarthritis.3 The disease affects men more often than women and typically manifests in early adulthood.4 In contrast to mechanical low back pain, low back pain and stiffness with ankylosing spondylitis worsen after a period of rest or upon waking up in the morning and improve after exercise, a hot bath or a shower.3
Systemic lupus erythematosus (SLE) also known as lupus is a chronic, complex and prevalent autoimmune disease that affects more than 1.5 million Americans7 and 5 million people worldwide.8 In lupus, the immune system, which is designed to protect against infection, creates antibodies that attack the body's own tissues and organs — the kidneys, brain, heart, lungs, blood, skin, and joints. Lupus is difficult to diagnose because symptoms come and go, mimic those of other diseases, and there is no single laboratory test that can definitively diagnose it. More than 90 percent of those with lupus are women, mostly between the ages of 15 to 44 and women of color are two to three times more at risk for lupus than Caucasians.7
Guselkumab is an investigational human monoclonal antibody with a novel mechanism of action that targets the protein interleukin (IL)-23 and is in Phase 3 development as a subcutaneously administered therapy for the treatment of moderate to severe plaque psoriasis. A Phase 2 study evaluating guselkumab in the treatment of moderately to severely active psoriatic arthritis is also ongoing.
Sirukumab is an investigational human monoclonal IgG1 kappa antibody in Phase 3 development for the treatment of adult patients with moderately to severely active RA. Sirukumab targets the cytokine IL-6, a naturally occurring protein that is believed to play a role in autoimmune conditions like RA. In December 2011, Janssen and GSK entered into a licensing and co-development collaboration agreement, initially for RA. Under the terms, Janssen has exclusive rights to commercialize sirukumab in Asia Pacific, Europe, the Middle East and Africa, while GSK retains commercialization rights in North, Central and South America.* Prior to the agreement, Janssen had been developing sirukumab for RA. U.S. and European Union regulatory filings for RA were announced in September 2016 and in Japan in October 2016.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us on Twitter at https://twitter.com/JanssenGlobal.
SIMPONI ARIA® is a tumor necrosis factor (TNF) blocker indicated in the U.S. for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate.
More information about SIMPONI ARIA® is available at www.SimponiARIA.com.
Janssen Biotech, Inc. discovered and developed SIMPONI ARIA®.
IMPORTANT SAFETY INFORMATION
SIMPONI ARIA® (golimumab) can lower your ability to fight infections. Serious and sometimes fatal events may occur. There have been reports of serious infections including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that have spread throughout the body. Other possible serious side effects may include lymphoma, a rare and fatal cancer called hepatosplenic T-cell lymphoma, skin cancer, other cancers, hepatitis B, heart failure, nervous system problems, lupus-like symptoms, or allergic reactions. To learn more about these and other risks, please read the Important Safety Information, and the Medication Guide, and talk with your doctor.
SIMPONI ARIA® (golimumab) is a prescription medicine. SIMPONI ARIA® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI ARIA® and will closely monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
You should not receive SIMPONI ARIA® if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults receiving TNF blockers, including SIMPONI ARIA®, the chances for getting lymphoma or other cancers may increase. Hepatosplenic T-cell lymphoma, a rare and fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking a TNF blocker with azathioprine or 6-mercaptopurine. You should tell your doctor if you have had or develop lymphoma or other cancers.
Some people treated with SIMPONI ARIA® developed skin cancer. Tell your doctor if any changes in the appearance of your skin or growths on your skin occur during or after your treatment with SIMPONI ARIA®. Your doctor should periodically examine your skin, especially if you have a history of skin cancer.
USE WITH OTHER DRUGS
Tell your doctor about all the medications you take including ORENCIA (abatacept), KINERET (anakinra), ACTEMRA (tocilizumab), RITUXAN (rituximab), or another TNF blocker, or if you are scheduled to or recently received a vaccine. People receiving SIMPONI ARIA® should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer).
HEPATITIS B INFECTION
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are receiving TNF-blocker medicines, such as SIMPONI ARIA®. Some of these cases have been fatal. Your doctor should do blood tests before and after you start treatment with SIMPONI ARIA®. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:
Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI ARIA®. If you develop new or worsening heart failure with SIMPONI ARIA®, you may need treatment in a hospital, and it may result in death. Your doctor will closely monitor you if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath, swelling of your lower legs or feet, or sudden weight gain.
NERVOUS SYSTEM PROBLEMS
Rarely, people using TNF blockers, including SIMPONI ARIA®, can have nervous system problems such as multiple sclerosis or Guillain-Barré syndrome. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.
IMMUNE SYSTEM PROBLEMS
Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, swelling of the feet, ankles or legs.
Serious liver problems can happen in people using TNF blockers, including SIMPONI ARIA®. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.
Low blood counts have been seen with people using TNF blockers, including SIMPONI ARIA®. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.
Allergic reactions can happen in people who use TNF-blocker medicines, including SIMPONI ARIA®. Tell your doctor if you have any symptoms of an allergic reaction while receiving SIMPONI ARIA® such as hives, swollen face, breathing trouble, or chest pain. Some reactions can be serious and life-threatening.
OTHER CONSIDERATIONS TO TELL YOUR DOCTOR
Tell your doctor if you have psoriasis.
Tell your doctor if you are pregnant, planning to become pregnant or are breastfeeding or have a baby and received SIMPONI ARIA® during pregnancy. Tell your baby's doctor before your baby receives any vaccine because of an increased risk of infection for up to six months after birth.
COMMON SIDE EFFECTS
The most common side effects of SIMPONI ARIA® include: upper respiratory infection, viral infections, bronchitis, high blood pressure, and rash.
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.
STELARA® is a human interleukin-12 and -23 antagonist indicated in the U.S. for the treatment of adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy, active psoriatic arthritis (PsA), alone or in combination with methotrexate, moderately to severely active Crohn's disease (CD) who have failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed a tumor necrosis factor (TNF) blocker or failed or were in intolerant to treatment with one or more TNF.
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.
Before starting STELARA®, tell your doctor if you:
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. People who take STELARA® may also be more likely to get these infections.
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. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA®. Tell your doctor if you have any new skin growths.
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. Stop using STELARA® and get medical help right away if you have any symptoms such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.
Before receiving STELARA®, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
When prescribed STELARA®:
Common side effects of STELARA® include: upper respiratory infections, headache, tiredness, joint pain, nausea, itching, vomiting, vaginal yeast infections, urinary tract infections, and redness at the injection site. These are not all of the possible side effects with STELARA®. Tell your doctor about any side effect that you experience. 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.
REMICADE® was the first anti-tumor necrosis factor (TNF)-alpha treatment approved in the United States in August 1998 and the first TNF inhibitor to be approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology. REMICADE® has demonstrated broad clinical utility with indications in Crohn's disease, rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, ulcerative colitis (UC), pediatric Crohn's disease and psoriasis. The safety and efficacy of REMICADE® have been well established in clinical trials over the past 17 years and through commercial experience with more than 2.7 million patients treated worldwide.
In the U.S., REMICADE® is approved for the following indications:
- Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active disease.
Janssen Biotech, Inc. discovered and developed REMICADE® and markets the product in the United States. The Janssen Pharmaceutical Companies market REMICADE® in Canada, Central and South America, the Middle East, Africa and Asia Pacific.
In Japan, Indonesia, and Taiwan, Janssen Biotech, Inc. licenses distribution rights to REMICADE® to Mitsubishi Tanabe Pharma Corporation. In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to REMICADE® to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co, Inc.
Important Safety Information (U.S.)
Only your doctor can recommend a course of treatment after checking your health condition. REMICADE® (infliximab) can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE®.
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking REMICADE® and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including REMICADE®, the chances of getting lymphoma or other cancers may increase.
You should discuss any concerns about your health and medical care with your doctor.
What should I tell my doctor before I take REMICADE®?
You should let your doctor know if you have or ever had any of the following:
What should I watch for and talk to my doctor about before or while taking REMICADE®?
The following serious (sometimes fatal) side effects have been reported in people taking REMICADE®.
You should tell your doctor right away if you have any of the signs listed below:
The more common side effects with REMICADE® are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.
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.
1. World Health Organization. The Global Burden of Disease: 2004 Update. p32. Available at: http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf. Accessed October 2016.
2. National Psoriasis Foundation. About Psoriatic Arthritis. Available at: http://www.psoriasis.org/psoriatic-arthritis. Accessed October 2016.
3. Arthritis Foundation. Ankylosing Spondylitis. Available at http://www.arthritis.org/about-arthritis/types/ankylosing-spondylitis. Accessed October 2016.
4. Mayo Clinic. Ankylosing Spondylitis. Available at http://www.mayoclinic.org/diseases-conditions/ankylosing-spondylitis/basics/definition/con-20019766?p=1. Accessed October 2016.
5. Spondylitis Association of America. Living with Psoriatic Arthritis (PsA): An Overview Of PsA: Available at http://www.spondylitis.org/About-Spondylitis/Psoriatic-Arthritis
6. World Psoriasis Day. Available at: http://www.worldpsoriasisday.com/web/page.aspx?sid=8538. Accessed October 2016.
7. Lupus Research Institute. Lupus Fact Sheet. Available at http://www.lupusresearchinstitute.org/lupus-facts/lupus-fact-sheet. Accessed on September 6, 2016.
8. Lupus Foundation of America. About Us, Statistics on Lupus. Available at http://www.lupus.org/about/statistics-on-lupus. Accessed October 2016.
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