HORSHAM, Pa., Nov. 4, 2015 /PRNewswire/ -- Janssen Biotech, Inc. announced today that more than 35 abstracts from the Janssen Pharmaceutical Companies will be presented at the 2015 American College of Rheumatology (ACR) annual meeting. Data from the rheumatology portfolio of both injection and infusion biologic treatment options will include efficacy and safety data from Phase 3 studies for STELARA® (ustekinumab), Phase 3 health-related quality of life data for SIMPONI ARIA® (golimumab for infusion), long-term outcomes data for SIMPONI® (golimumab), an ethnographic study investigating shared decision-making between rheumatologists and rheumatoid arthritis (RA) patients, and a patient-reported outcomes assessment of intravenous (IV) treatment for RA patients, which includes REMICADE® (infliximab).
"At Janssen, we have delivered on the promise of new treatments for individuals with autoimmune diseases for nearly two decades," said Andrew Greenspan, M.D., Vice President, Janssen Scientific Affairs, LLC. "The data we are presenting at ACR demonstrate our continued commitment to advancing best-in-class science to improve the lives of those living with rheumatologic diseases."
JANSSEN ABSTRACTS TO BE PRESENTED DURING ACR INCLUDE:
Abstracts can be accessed on the ACR 2015 annual meeting website at: http://acrabstracts.org/.
STELARA® (ustekinumab)
- Association Between Improvement in Enthesopathy and Quality of Life: Results from a Phase 3 Trial in Psoriatic Arthritis (Presentation 692)
- Poster presentation: Sunday, November 8, 9:00 am 11:00 am
- All-Cause Mortality and Malignancies in Psoriasis Patients with Psoriatic Arthritis in the Psoriasis Longitudinal Assessment and Registry Study (Presentation 1693)
- Poster presentation: Monday, November 9, 9:00 am 11:00 am
- Serious Infections in Psoriasis Patients with Psoriatic Arthritis in the Psoriasis Longitudinal Assessment and Registry Study (Presentation 1692)
- Poster presentation: Monday, November 9, 9:00 am 11:00 am
- Serum Biomarkers Associated with Disease Activity and Response to Ustekinumab in Patients with Ankylosing Spondylitis (Presentation 1252)
- Poster presentation: Monday, November 9, 9:00 am 11:00 am
- Efficacy and Safety of Ustekinumab in Psoriatic Arthritis Patients with Spondyloarthritis as well as Peripheral Arthritis: Results from 2 Phase 3, Multicenter, Double-blind, Placebo-controlled Studies (Presentation 2856)
- Poster presentation: Tuesday, November 10, 9:00 am 11:00 am
SIMPONI ARIA® (golimumab for infusion)
- Low Disease Activity at 12 Weeks and 24 Weeks is Predictive of Normalized Health-Related Quality of Life in Methotrexate-Experienced Patients with Active Rheumatoid Arthritis Treated with Intravenous Golimumab Plus Methotrexate (Presentation 2658)
- Poster presentation: Tuesday, November 10, 9:00 am 11:00 am
- A Comparison of EQ5D Index from the UK, U.S., and Japan Preference Weights Model, and Mapping Algorithm from Clinical Outcomes in Patients with Rheumatoid Arthritis: Results from Golimumab Intravenous Study (Presentation 2738)
- Poster presentation: Tuesday, November 10, 9:00 am 11:00 am
SIMPONI® (golimumab)
- Treatment Target Status at 6 Months and Long-Term Outcomes at 5 Years: Analysis of Methotrexate-Naive Patients with Rheumatoid Arthritis (Presentation 2743)
- Poster presentation: Tuesday, November 10, 9:00 am 11:00 am
- Comparison of Interferon- Release Assay Versus Tuberculin Skin Test in the Golimumab UC program and the Golimumab SC Rheumatology (RA, PsA, and AS) program (Presentation 2142)
- Oral presentation: Monday, November 9, 4:30 pm 6:00 pm
REMICADE® (infliximab)
- An Examination of Dose Escalation Among Infliximab Users in the US CORRONA RA Registry (Presentation 599)
- Poster presentation: Sunday, November 8, 9:00 am 11:00 am
- Patient Reported Outcome Assessment of Rheumatoid Arthritis Patients Experience with IV Administered Biologic Therapy (Presentation 2642)
- Poster presentation: Tuesday, November 10, 9:00 am 11:00 am
RHEUMATOLOGY DATA
- An Ethnographic Observational Study of the Biologic Initiation Conversation Between Rheumatologists and Biologic Naive Rheumatoid Arthritis Patients (Presentation 2316)
- Poster presentation: Tuesday, November 10, 9:00 am 11:00 am
- Minimal Important Difference in HAQ: A Validation from Health Economic Perspectives in Patient with Rheumatoid Arthritis Using Real-world Data from ADELPHI Database (Presentation 2314)
- Poster presentation: Tuesday, November 10, 9:00 am 11:00 am
- Serum 14-3-3 is an RA Specific Mechanistic Marker (Presentation 2585)
- Poster presentation: Tuesday, November 10, 9:00 am 11:00 am
- What Factors are Associated with Starting an Intravenous vs. Sub-Cutaneous Biologic in Patients with RA? (Presentation 2775)
- Poster presentation: Tuesday, November 10, 9:00 am 11:00 am
- Persistence Among Rheumatoid Arthritis Patients Initiating Intravenous or Subcutaneous Anti-Tumor Necrosis Factor Therapy in a Large U.S. Registry Cohort (Presentation 486)
- Poster presentation: Sunday, November 8, 9:00 am 11:00 am)
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, 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.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) 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.2 While estimates of the prevalence of psoriatic arthritis among people living with psoriasis vary, up to 30 percent may develop inflammatory arthritis.2 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 psoriatic arthritis is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease.3
About Ankylosing Spondylitis
Ankylosing spondylitis (AS) 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.4,5 It is estimated that 0.1 to 1.4 percent of the world's population are living with ankylosing spondylitis.6 The disease affects men more often than women and typically manifests in early adulthood.7 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.4
About STELARA® (ustekinumab)
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.
STELARA® is also approved for the treatment of adult patients (18 years or older) with active psoriatic arthritis. STELARA® can be used alone or in combination with methotrexate (MTX).
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA®.
Important Safety Information (U.S.)
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.
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. 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, cancers, or RPLS
- ever had an allergic reaction to STELARA® or any of its ingredients. Ask your doctor if you are not sure.
- are allergic to latex. The needle cover on the prefilled syringe contains latex.
- have recently received or are scheduled to receive an immunization (vaccine).
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