Janssen Presenting Data From Its Expanding Rheumatology Portfolio At The 2019 Annual Meeting Of The American College Of Rheumatology
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:
-- Plenary Abstract 807: Guselkumab, an Anti-interleukin-23p19 Monoclonal
Antibody, in Patients with Active Psoriatic Arthritis Who Were
Biologic-Naïve or Prior TNF inhibitor-Treated: Week 24 Results of a
Phase 3, Randomized, Double-blind, Placebo-controlled Study.
-- Late-breaker Abstract L13: Guselkumab, an Anti-interleukin-23p19
Monoclonal Antibody, in Biologic-naïve Patients with Active Psoriatic
Arthritis: Week 24 Results of the Phase 3, Randomized, Double-blind,
Placebo-controlled Study.
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):
-- Abstract 861: Cutaneous Lupus Erythematosus Disease Area & Severity
Index (CLASI) Demonstrates Thresholds for Detection of Treatment
Response in a Phase-2, Placebo-Controlled Trial of Ustekinumab in SLE.
-- Abstract 1767: Biomarker Profiling Reveals Novel Mechanistic Insights
into Ustekinumab Therapeutic Responses in Systemic Lupus Erythematosus.
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)
-- Abstract 1332: United States Rheumatology Practice-Based Real-World
Evidence of Infusion Reactions in Rheumatoid Arthritis Patients Treated
with Intravenous Golimumab or Infliximab: Impact of Prior Biologic
Exposure and Methotrexate Utilization
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
Guselkumab, an Anti-interleukin-23p19
Sunday, November 10
Monoclonal Antibody, in Patients with Active
11:00 am - 12:30 pm
(Plenary Psoriatic Arthritis Who Were Biologic-Naïve
Session) or Prior TNF inhibitor-Treated: Week 24
Results of a Phase 3, Randomized, Double-
blind, Placebo-controlled Study
--- ---
Abstract 1494
Guselkumab was More Effective than
Monday, November 11
Secukinumab in Patients with Plaque
9:00-11:00 am
(Poster) Psoriasis and the Subset of Patients with
Self-Reported Psoriatic Arthritis in the
Randomized, Double-blind, Head-to-head
Comparison Study ECLIPSE over 1 Year
--- ---
Abstract L13
Guselkumab, an Anti-interleukin-23p19
Tuesday, November 12
Monoclonal Antibody, in Biologic-naïve
9:00-11:00 am
(Late-breaker Patients with Active Psoriatic Arthritis: Week
ePoster) 24 Results of the Phase 3, Randomized,
Double-blind, Placebo-controlled Study
--- ---
STELARA (ustekinumab)
---
Abstract 2
Baseline Cytotoxic Gene Expression in the
Sunday, November 10
Blood Associates with Ustekinumab
9:00-11:00 am
(Poster) Response in SLE
--- ---
Abstract 244
Real-World Evidence Associated With the
Sunday, November 10
Treatment of Systemic Lupus Erythematosus
9:00-11:00 am
(Poster) in the USA, UK, France, and Germany: A
Structured Review
--- ---
Abstract 676
Cluster Profiling of Patients in a Real-World
Sunday, November 10
Data Set With Systemic Lupus
9:00-11:00 am
(Poster) Erythematosus and Their Associate
Treatments
--- ---
Abstract 861
Cutaneous Lupus Erythematosus Disease
Sunday, November 10
Area & Severity Index (CLASI) Demonstrates
2:30-4:30 pm
(Oral Presentation) Thresholds for Detection of Treatment
Response in a Phase-2, Placebo-Controlled
Trial of Ustekinumab in SLE
--- ---
Abstract 1124
The Direct and Indirect Costs of Illness
Monday, November 11
Associated With Systemic Lupus
9:00-11:00 am
(Poster) Erythematosus in the USA, UK, France, and
Germany: A Structured Review
--- ---
Abstract 1496
Comparative Effectiveness of Ustekinumab
Monday, November 11
and TNF Inhibitors In Patients with Psoriatic
9:00-11:00 am
(Poster) Arthritis in a Real-world, Multicenter Study
--- ---
Abstract 1537
Concomitant Treatment With Methotrexate
Monday, November 11
Does Not Increase the Efficacy of
9:00-11:00 am
(Poster)
Ustekinumab or TNF Inhibitors In
Psoriatic Arthritis: Results From a Real-world,
Multicenter Study
--- ---
Abstract 1539
Ustekinumab and TNF Inhibitors Similarly
Monday, November 11
Improve Patient-perceived Impact of
9:00-11:00 am
(Poster)
Psoriatic Arthritis But Differentially Affect the
Scale Subdomains: Results from a European
Observational Cohort Study
--- ---
Abstract 1611
Systemic Lupus Erythematosus Registries:
Monday, November 11
Are the Measures Captured in the Real World
9:00-11:00 am
(Poster) Similar to Those in Clinical Trials?
--- ---
Abstract 1767
Biomarker Profiling Reveals Novel
Monday, November 11
Mechanistic Insights into Ustekinumab
2:30-4:30 pm
(Oral Presentation) Therapeutic Responses in Systemic Lupus
Erythematosus
--- ---
Abstract 2444
Real-world Treatment Patterns among
Tuesday, November 12
Patients with Psoriatic Arthritis Treated
9:00-11:00 am
(Poster) with Biologic Therapies
--- ---
Abstract 2571
Early Improvement in SLEDAI-2K Responder
Tuesday, November 12
Index-50 Predicts SRI-4 Response in a
9:00-11:00 am
(Poster) Randomized Placebo-Controlled Trial of
Ustekinumab (UST) in Systemic Lupus
Erythematosus
--- ---
SIMPONI ARIA (golimumab) infusion
---
Abstract 1204
Improvements in Health-Related Quality of
Monday, November 11
Life in Psoriatic Arthritis Patients Treated
9:00-11:00 am
(Poster) with Intravenous Golimumab, an Anti-TNF-
alpha Monoclonal Antibody: 1-Year Results of
a Phase 3 Trial
--- ---
Abstract 1258
Effects of Intravenous Golimumab, an Anti-
Monday, November 11
TNF Monoclonal Antibody, on Health-
9:00-11:00 am
(Poster) Related Quality of Life in Patients with
Ankylosing Spondylitis: 1-Year Results of a
Phase III Trial
--- ---
Abstract 1417
Long-Term Effectiveness and Safety of
Monday, November 11
Infliximab, Golimumab and Golimumab-IV in
9:00-11:00 am
(Poster) Rheumatoid Arthritis Patients from a
Prospective Observational Registry
--- ---
Abstract 1418
Predictors of Response, Adverse Events and
Monday, November 11
Treatment Retention in RA Patients Treated
9:00-11:00 am
(Poster) with Either Subcutaneous- or Intravenous-
Golimumab in a Prospective, Observational
Registry
--- ---
Abstract 1479
Multi-Symptom Impact on the EQ5D Index in
Monday, November 11
Bio-naïve Active Psoriatic Arthritis Patients:
9:00-11:00 am
(Poster) An Analysis Through Week 24 of the GO-
VIBRANT Study
--- ---
Abstract 1542
Long-Term Effectiveness and Safety of
Monday, November 11
Infliximab and Golimumab in Ankylosing
9:00-11:00 am
(Poster) Spondylitis Patients from a Prospective
Observational Registry
--- ---
Abstract 1543
Long-Term Effectiveness and Safety of
Monday, November 11
Infliximab, Golimumab and Ustekinumab in
9:00-11:00 am
(Poster) Psoriatic Arthritis Patients from a Prospective
Observational Registry
--- ---
Abstract 1544
Predictors of Response, Adverse Events and
Monday, November 11
Treatment Retention in Ankylosing
9:00-11:00 am
(Poster) Spondylitis Patients Treated with Golimumab
in a Prospective, Observational Registry
--- ---
Abstract 1552
Clinically Meaningful Improvement in Skin
Monday, November 11
and Nail Psoriasis in Bio-naïve Active
9:00-11:00 am
(Poster) Psoriatic Arthritis Patients Treated with
Intravenous Golimumab: Results through
Week 52 from a Phase 3 Study
--- ---
AWARE Study Analyses
---
Abstract 1332
United States Rheumatology Practice-Based
Monday, November 11
Real-World Evidence of Infusion Reactions in
9:00-11:00 am
(Poster) Rheumatoid Arthritis Patients Treated with
Intravenous Golimumab or Infliximab:
Impact of Prior Biologic Exposure and
Methotrexate Utilization
--- ---
Abstract 1365
Construct Validation of PROMIS Short Form
Monday, November 11
and Profile-29 T-Scores with SF-36 in
9:00-11:00 am
(Poster) Rheumatoid Arthritis Patients Treated for 1
year: Results from a Real World Evidence-
Based Study in the United States
--- ---
Others
---
Abstract 1203
Psychometric Evaluation of the Patient-
Monday, November 11
Reported Outcome Measure FACIT-Fatigue in
9:00-11:00 am
(Poster) Rheumatic Arthritis and Psoriatic Arthritis: A
Literature Review
--- ---
Abstract 1403
CDAI Analysis of Dose Escalation in the
Monday, November 11
START Trial of Infliximab for Rheumatoid
9:00-11:00 am
(Poster) Arthritis
--- ---
Abstract 2445
Enthesitis, Dactylitis, and Axial Disease in
Tuesday, November 12
Psoriatic Arthritis (PsA): Impact on Patient
9:00-11:00 am
(Poster) Quality of Life and Work Productivity
--- ---
Abstract 2489
Differences in Clinical Characteristics, Quality
Tuesday, November 12
of Life, Disability, and Work Productivity in
9:00-11:00 am
(Poster) Psoriatic Arthritis Patients by Gender:
Findings From a Cross-sectional Survey in
the US and Europe
--- ---
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(®).
-- Tell your healthcare provider right away if you have an infection or
have symptoms of an infection, including:
-- fever, sweats, or chills
-- muscle aches
-- weight loss
-- cough
-- warm, red, or painful skin or sores on your body different from your
psoriasis
-- diarrhea or stomach pain
-- shortness of breath
-- blood in your phlegm (mucus)
-- burning when you urinate or urinating more often than normal
Before using TREMFYA(®), tell your healthcare provider about all of your medical conditions, including if you:
-- have any of the conditions or symptoms listed in the section "What is
the most important information I should know about TREMFYA(®)?"
-- have an infection that does not go away or that keeps coming back.
-- have TB or have been in close contact with someone with TB.
-- have recently received or are scheduled to receive an immunization
(vaccine). You should avoid receiving live vaccines during treatment
with TREMFYA(®).
-- are pregnant or plan to become pregnant. It is not known if TREMFYA(®)
can harm your unborn baby.
-- are breastfeeding or plan to breastfeed. It is not known if TREMFYA(®)
passes into your breast milk.
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.
-- 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 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 with 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. 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:
-- 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). People who take STELARA(®) should not receive live vaccines.
Tell your doctor if anyone in your house needs a live vaccine. The
viruses used in some types of live 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 receiving STELARA(®)
or one year after you stop receiving STELARA(®).
-- have any new or changing lesions within psoriasis areas or on normal
skin.
-- are receiving or have received allergy shots, especially for serious
allergic reactions.
-- receive or have received phototherapy for your psoriasis.
-- are pregnant or plan to become pregnant. It is not known if STELARA(®)
can harm your unborn baby. You and your doctor should decide if you will
receive STELARA(®).
-- are breastfeeding or plan to breastfeed. It is thought that STELARA(®)
passes into your breast milk. Talk to your doctor about the best way to
feed your baby if you receive STELARA(®).
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(®):
-- Use STELARA(®) exactly as your doctor tells you to.
-- STELARA(®) is intended for use under the guidance and supervision of
your doctor. In children 12 years and older, it is recommended that
STELARA(®) be administered by a healthcare provider. If your doctor
decides that you or a caregiver may give your injections of STELARA(®)
at home, you should receive training on the right way to prepare and
inject STELARA(®). Your doctor will determine the right dose of
STELARA(®) for you, the amount for each injection, and how often you
should receive it. Do not try to inject STELARA(®) yourself until you
or your caregiver have been shown how to inject STELARA(®) by your
doctor or nurse.
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:
-- fever, sweat, or chills
-- muscle aches
-- warm, red, or painful skin or sores on your body
-- diarrhea or stomach pain
-- cough
-- shortness of breath
-- blood in phlegm
-- weight loss
-- burning when you urinate or urinate more than normal
-- feel very tired
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(®):
-- cough that does not go away
-- low grade fever
-- weight loss
-- loss of body fat and muscle (wasting)
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:
-- feel very tired
-- dark urine
-- skin or eyes look yellow
-- little or no appetite
-- vomiting
-- muscle aches
-- clay-colored bowel movements
-- fever
-- chills
-- stomach discomfort
-- skin rash
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:
-- Reducing signs and symptoms and inducing and maintaining clinical
remission in adult patients with moderately to severely active disease
who have had an inadequate response to conventional therapy.
-- Reducing the number of draining enterocutaneous and rectovaginal
fistulas and maintaining fistula closure in adult patients with
fistulizing disease.
Pediatric Crohn's Disease:
-- Reducing signs and symptoms and inducing and maintaining clinical
remission in pediatric patients with moderately to severely active
disease who have had an inadequate response to conventional therapy.
Ulcerative Colitis:
-- Reducing signs and symptoms, inducing and maintaining clinical remission
and mucosal healing, and eliminating corticosteroid use in adult
patients with moderately to severely active disease who have had an
inadequate response to conventional therapy.
Pediatric Ulcerative Colitis:
-- Reducing signs and symptoms and inducing and maintaining clinical
remission in pediatric patients with moderately to severely active
disease who have had an inadequate response to conventional therapy.
Rheumatoid Arthritis in combination with methotrexate:
-- Reducing signs and symptoms, inhibiting the progression of structural
damage, and improving physical function in patients with moderately to
severely active disease.
Ankylosing Spondylitis:
-- Reducing signs and symptoms in patients with active disease.
Psoriatic Arthritis:
-- Reducing signs and symptoms of active arthritis, inhibiting the
progression of structural damage, and improving physical function.
Plaque Psoriasis:
-- Treatment of adult patients with chronic severe (i.e., extensive and/or
disabling) plaque psoriasis who are candidates for systemic therapy and
when other systemic therapies are medically less appropriate.
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:
-- Tuberculosis (TB) or have been near someone who has TB. Your doctor will
check you for TB with a skin test. If you have latent (inactive) TB, you
will begin TB treatment before you start REMICADE(®).
-- Lived in a region where certain fungal infections like histoplasmosis or
coccidioidomycosis are common.
-- Infections that keep coming back, have diabetes or an immune system
problem.
-- Any type of cancer or a risk factor for developing cancer, for example,
chronic obstructive pulmonary disease (COPD) or had phototherapy for
psoriasis.
-- Heart failure or any heart condition. Many people with heart failure
should not take REMICADE(®).
-- Hepatitis B virus (HBV) infection or think you may be a carrier of HBV.
Your doctor will test you for HBV.
-- Nervous system disorders (like multiple sclerosis or Guillain-Barré
syndrome).
Also tell your doctor if you:
-- Use the medicines Kineret (anakinra), Orencia (abatacept) or Actemra
(tocilizumab) or other medicines called biologics used to treat the same
problems as REMICADE(®).
-- Are pregnant, plan to become pregnant, are breast-feeding, or have a
baby and were using REMICADE(®) during your pregnancy. Tell your baby's
doctor about your REMICADE(®) use. If your baby receives a live vaccine
within 6 months after birth, your baby may develop infections with
serious complications that can lead to death.
-- Recently received or are scheduled to receive a vaccine. Adults and
children taking REMICADE(® )should not receive live vaccines or
treatment with a weakened bacteria (such as BCG for bladder cancer)
while taking REMICADE(®).
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:
-- Infections (like TB, blood infections, pneumonia)--fever, tiredness,
cough, flu, or warm, red or painful skin or any open sores. REMICADE(®)
can make you more likely to get an infection or make any infection that
you have worse.
-- Reactivation of HBV--feeling unwell, poor appetite, tiredness, fever,
skin rash and/or joint pain.
-- Lymphoma, or any other cancers in adults and children.
-- Skin cancer--any changes in or growths on your skin.
-- Cervical cancer--your doctor may recommend that you be regularly
screened. Some women with rheumatoid arthritis, particularly those over
60, have developed cervical cancer.
-- Heart failure--new or worsening symptoms, such as shortness of breath,
swelling of your ankles or feet, or sudden weight gain.
-- Other heart problems within 24 hours of infusion, including heart
attack, low blood flow to the heart, or abnormal heart rhythm--chest
discomfort or pain, arm pain, stomach pain, shortness of breath,
anxiety, lightheadedness, dizziness, fainting, sweating, nausea,
vomiting, fluttering or pounding in your chest, and/or a fast or a slow
heartbeat.
-- Liver injury--jaundice (yellow skin and eyes), dark brown urine,
right-sided abdominal pain, fever, or severe tiredness.
-- Blood disorders--fever that doesn't go away, bruising, bleeding or
severe paleness.
-- Nervous system disorders--numbness, weakness, tingling, changes in your
vision or seizures.
-- Stroke within 24 hours of infusion--numbness or weakness of the face,
arm or leg, especially on one side of the body; sudden confusion,
trouble speaking or understanding; sudden trouble seeing in one or both
eyes; sudden trouble walking; dizziness; loss of balance or
coordination; or a sudden, severe headache.
-- Allergic reactions during or after the infusion--hives, difficulty
breathing, chest pain, high or low blood pressure, and fever or chills.
-- Delayed allergic reactions (3 to 12 days after infusion)--fever, rash,
headache, sore throat, muscle or joint pain, swelling of the face and
hands, or difficulty swallowing.
-- Lupus-like syndrome--chest discomfort or pain that does not go away,
shortness of breath, joint pain, rash on the cheeks or arms that gets
worse in the sun.
-- Psoriasis--new or worsening psoriasis such as red scaly patches or
raised bumps on the skin that are filled with pus.
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.
Media contacts:
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Mobile: 609-468-8356
kmclaugh@its.jnj.com
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Mobile: 267-303-3857
caberra@its.jnj.com
Investor Contacts:
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Johnson & Johnson
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Johnson & Johnson
Office: 732-524-3922
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