HORSHAM, Pa., Oct. 31, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that it will be presenting results from 30 abstracts across the company's expanding rheumatology portfolio and pipeline products during the 2019 American College of Rheumatology (ACR)/Association for Rheumatology Health Professionals (ARHP) Annual Meeting taking place in Atlanta, Georgia from November 8-13.
Twenty-four week findings from the Phase 3 DISCOVER studies, which were designed to evaluate the efficacy and safety of investigational use of TREMFYA® (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA), will be presented at ACR, with DISCOVER-1 data included in the Plenary Session on Sunday, November 10, and DISCOVER-2 included as part of the late-breaking ePoster presentations on Tuesday, November 12.
Other presentations will share data covering many indications over a portfolio of five Janssen medications.
"The breadth of presentations at this year's meeting showcases results of our ongoing commitment to develop new treatment options to address the unmet needs of patients living with autoimmune disease," said Alyssa Johnsen, M.D., Ph.D., Vice President, Rheumatology Disease Area Leader, Janssen Research & Development, LLC. "We are particularly excited to share results from the DISCOVER-1 and -2 studies, which support our recent U.S. and European regulatory applications for the approval of TREMFYA as a treatment for psoriatic arthritis."
A complete listing of abstracts is provided in the table below. Notable data presentations at ACR include the following:
A plenary session and a late-breaking session featuring TREMFYA data from the DISCOVER program in psoriatic arthritis:
The two DISCOVER studies met their primary endpoints and are the foundation for Janssen's recent regulatory applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) seeking first-in-class approval for the treatment of adult patients with active PsA.
Oral presentations featuring clinical and mechanism of action data for the investigational use of STELARA® (ustekinumab) in systemic lupus erythematosus (SLE):
Based on results of the Phase 2 study, originally presented at ACR in 2017, Janssen announced the initiation of the Phase 3 LOTUS study, which will evaluate STELARA as a treatment for this chronic, inflammatory autoimmune disorder.
Poster presentations from the real-world evidence study AWARE (Comparative and Pragmatic Study of Golimumab IV Versus Infliximab in Rheumatoid Arthritis)
The AWARE study is part of Janssen's commitment to evaluating real-world evidence to better understand patient treatment experience in the clinical practice setting.
Abstract No. | Title | Date/Time |
TREMFYA (guselkumab) | ||
Abstract 807 (Plenary | Guselkumab, an Anti-interleukin-23p19 | Sunday, November 10 |
Abstract 1494 (Poster) | Guselkumab was More Effective than | Monday, November 11 |
Abstract L13 (Late-breaker | Guselkumab, an Anti-interleukin-23p19 | Tuesday, November 12 |
STELARA (ustekinumab) | ||
Abstract 2 (Poster) | Baseline Cytotoxic Gene Expression in the | Sunday, November 10 |
Abstract 244 (Poster) | Real-World Evidence Associated With the | Sunday, November 10 |
Abstract 676 (Poster) | Cluster Profiling of Patients in a Real-World | Sunday, November 10 |
Abstract 861 (Oral Presentation) | Cutaneous Lupus Erythematosus Disease | Sunday, November 10 |
Abstract 1124 (Poster) | The Direct and Indirect Costs of Illness | Monday, November 11 |
Abstract 1496 (Poster) | Comparative Effectiveness of Ustekinumab | Monday, November 11 |
Abstract 1537 (Poster) | Concomitant Treatment With Methotrexate | Monday, November 11 |
Abstract 1539 (Poster) | Ustekinumab and TNF Inhibitors Similarly | Monday, November 11 |
Abstract 1611 (Poster) | Systemic Lupus Erythematosus Registries: | Monday, November 11 |
Abstract 1767 (Oral Presentation) | Biomarker Profiling Reveals Novel | Monday, November 11 |
Abstract 2444 (Poster) | Real-world Treatment Patterns among | Tuesday, November 12 |
Abstract 2571 (Poster) | Early Improvement in SLEDAI-2K Responder | Tuesday, November 12 |
SIMPONI ARIA (golimumab) infusion | ||
Abstract 1204 (Poster) | Improvements in Health-Related Quality of | Monday, November 11 |
Abstract 1258 (Poster) | Effects of Intravenous Golimumab, an Anti- | Monday, November 11 |
Abstract 1417 (Poster) | Long-Term Effectiveness and Safety of | Monday, November 11 |
Abstract 1418 (Poster) | Predictors of Response, Adverse Events and | Monday, November 11 |
Abstract 1479 (Poster) | Multi-Symptom Impact on the EQ5D Index in | Monday, November 11 |
Abstract 1542 (Poster) | Long-Term Effectiveness and Safety of | Monday, November 11 |
Abstract 1543 (Poster) | Long-Term Effectiveness and Safety of | Monday, November 11 |
Abstract 1544 (Poster) | Predictors of Response, Adverse Events and | Monday, November 11 |
Abstract 1552 (Poster) | Clinically Meaningful Improvement in Skin | Monday, November 11 |
AWARE Study Analyses | ||
Abstract 1332 (Poster) | United States Rheumatology Practice-Based | Monday, November 11 |
Abstract 1365 (Poster) | Construct Validation of PROMIS Short Form | Monday, November 11 |
Others | ||
Abstract 1203 (Poster) | Psychometric Evaluation of the Patient- | Monday, November 11 |
Abstract 1403 (Poster) | CDAI Analysis of Dose Escalation in the | Monday, November 11 |
Abstract 2445 (Poster) | Enthesitis, Dactylitis, and Axial Disease in | Tuesday, November 12 |
Abstract 2489 (Poster) | Differences in Clinical Characteristics, Quality | Tuesday, November 12 |
Abstracts can be accessed on the ACR 2019 Annual Meeting website at: http://acrabstracts.org/.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic, systemic inflammatory condition that is often characterized by symptoms that include pain, stiffness and inflammation of the joints, which can lead to joint destruction and disability.1 An estimated 1.5 million Americans have the condition, which affects nearly three times as many women as men.2 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 numerous medications available to help alleviate symptoms and prevent joint destruction.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic, immune-mediated inflammatory disease characterized by peripheral joint inflammation, enthesitis, dactylitis, axial disease and the skin lesions associated with psoriasis.3,4 It is estimated that at least one million Americans are living with PsA, and up to 30 percent of patients living with psoriasis can develop PsA.5 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.3 Though the exact cause of PsA is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease.3
There are numerous medications available to help alleviate symptoms and prevent joint destruction.
About Ankylosing Spondylitis
Ankylosing spondylitis (AS) is a chronic, immune-mediated disease of the axial skeleton, affecting the sacroiliac joints and the spine. AS frequently also causes enthesitis, which is inflammation where ligaments and muscles attach to bones. It is the primary disease in a group of arthritis-related diseases known as spondyloarthritis.6 It is estimated that 700,000 people in the U.S. are living with AS.7 Peripheral joint involvement can occur. Other organs can also be involved, including the eyes (uveitis), heart and aorta and lungs. The disease typically affects men more often than women and manifests in early adulthood.8 In contrast to mechanical low back pain, inflammatory back pain and stiffness with AS worsen after a period of rest or upon waking up in the morning and improve after exercise, a hot bath or a shower. 8
About Systemic Lupus Erythematosus
Lupus is a chronic, inflammatory autoimmune disease that can affect many different body systems, including joints, skin, heart, lungs, kidneys and brain.9 SLE can range from mild to severe and is characterized by inflammation of any organ system and complex auto-antibody production (antibodies directed against normal human tissue).10 The disease most often affects women and disproportionately affects women of African American, Hispanic, Asian and Native American descent compared to Caucasian women.11 Incidence rates in the United States are estimated at 5.6 cases per 100,000. Lupus is estimated to affect at least 5 million people worldwide.12
About TREMFYA® (guselkumab)
TREMFYA® is a human monoclonal antibody developed by Janssen that selectively blocks the p19 subunit of interleukin (IL)-23 and is approved in the U.S., Canada, European Union, Japan and a number of other countries worldwide for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). Two Phase 3 programs evaluating TREMFYA® in the treatment of active psoriatic arthritis are ongoing.
TREMFYA is a trademark of Janssen Biotech, Inc.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TREMFYA®?
TREMFYA® may cause serious side effects, including infections. TREMFYA® is a prescription medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®.
Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of TREMFYA®?
TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?"
The most common side effects of TREMFYA® include: upper respiratory infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, and herpes simplex infections.
These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects.
Use TREMFYA® exactly as your healthcare provider tells you to use it.
Please read the full Prescribing Information, including Medication Guide for TREMFYA®, and discuss any questions that 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.
About STELARA® (ustekinumab)
STELARA® (ustekinumab), a human IL-12 and IL-23 antagonist, is approved in the United States for the treatment of: 1) adults and children 12 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; 2) adult patients (18 years or older) with active psoriatic arthritis, used alone or in combination with methotrexate (MTX); 3) adult patients (18 years and older) with moderately to severely active Crohn's disease; 4) adult patients (18 years and older) with moderately to severely active ulcerative colitis. STELARA is in Phase 3 development for the treatment of systemic lupus erythematosus, however, safety and efficacy in the treatment of patients with SLE has not been established and STELARA is not approved for this indication.
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.
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:
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. People who take STELARA® may also be more likely to get these infections.
Cancers
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 of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.
Lung Inflammation
Cases of lung inflammation have happened in some people who receive STELARA® and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn't go away during treatment with STELARA®.
Before receiving STELARA®, tell your doctor about all of your medical conditions, including 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: nasal congestion, sore throat, and runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, stomach pain, and diarrhea. 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.
Please read the full Prescribing Information and 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.
About SIMPONI ARIA® (golimumab)
SIMPONI ARIA® (golimumab), a tumor necrosis factor (TNF)-blocker, is approved in the U.S. for adults with moderate to severe rheumatoid arthritis, used in combination with methotrexate; active psoriatic arthritis and active ankylosing spondylitis.
More information about SIMPONI ARIA® is available at www.SimponiARIA.com.
Janssen Biotech, Inc. discovered and developed SIMPONI ARIA®.
IMPORTANT SAFETY INFORMATION
SERIOUS INFECTIONS
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:
Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with SIMPONI ARIA® and during treatment with SIMPONI ARIA®. Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are taking SIMPONI ARIA®. People who had a negative TB skin test before receiving SIMPONI ARIA® have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking SIMPONI ARIA®:
CANCER
Unusual cancers have been reported in children and teenage patients taking Tumor Necrosis Factor (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
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.
LIVER PROBLEMS
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.
BLOOD PROBLEMS
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
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, are breastfeeding, or plan to breastfeed, 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 6 months after birth.
COMMON SIDE EFFECTS
The most common side effects of SIMPONI ARIA® include: upper respiratory infection, abnormal liver tests, decreased blood cells that fight infection, viral infections, bronchitis, high blood pressure, and rash.
Please read the full Prescribing Information and Medication Guide for SIMPONI ARIA® 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.
About REMICADE® (infliximab)
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:
Crohn's Disease:
Pediatric Crohn's Disease:
Ulcerative Colitis:
Pediatric Ulcerative Colitis:
Rheumatoid Arthritis in combination with methotrexate:
Ankylosing Spondylitis:
Psoriatic Arthritis:
Plaque Psoriasis:
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
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:
Also tell your doctor if you:
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 most common side effects of REMICADE® include respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.
Please read the full Prescribing Information and Medication Guide for REMICADE® and discuss it 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.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the ongoing and planned development efforts involving SIMPONI ARIA®, TREMFYA® and STELARA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2018, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1 Centers for Disease Control and Prevention. "Rheumatoid Arthritis (RA)," Available at: http://www.cdc.gov/arthritis/basics/rheumatoid.htm. Accessed June 30, 2017.
2 Arthritis Foundation. "What is Rheumatoid Arthritis." Available at: http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php. Accessed August 2, 2017
3 National Center for Biotechnology Information, U.S. National Library of Medicine. Managing Patients with Psoriatic Disease: The Diagnosis and Pharmacologic Treatment of Psoriatic Arthritis in Patients with Psoriasis. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3958815/. Accessed October 2017.
4 Mayo Clinic. Psoriatic Arthritis. Available at: http://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/home/ovc-20233896. Accessed October 2017.
5 2017 Mease PJ, et al. J Am Acad Dermatol. 2013;69(5):729-735
6 Arthritis Foundation. Arthritis By The Numbers: Book of Trusted Fact and Figures. Available at: http://www.arthritis.org/Documents/Sections/About-Arthritis/arthritis-facts-stats-figures.pdf. Accessed October 2017.
7 National Center for Biotechnology Information, U.S. National Library of Medicine. Reveille. Epidemiology of Spondyloarthritis in North America. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3063892/. Accessed October 2017.
8 Mayo Clinic. Ankylosing Spondylitis. Available at: http://www.mayoclinic.org/diseases-conditions/ankylosing-spondylitis/basics/definition/con-20019766?p=1. Accessed October 2017.
9 Mayo Clinic. Lupus. Available at: http://www.mayoclinic.org/diseases-conditions/lupus/basics/definition/con-20019676. Accessed October 9, 2017.
10 Lupus Foundation of America. Different Types of Lupus. Available at https://resources.lupus.org/entry/types-of-lupus. Accessed October 9, 2017.
11 Lupus Research Alliance. About Lupus. Available at http://www.lupusresearch.org/understanding-lupus/what-is-lupus/about-lupus/. Accessed October 9, 2017.
12 Lim SS et al. Arthritis Rheumatol. 2014 Feb;66(2):357-68.
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