Janssen Data Presentations At American College of Rheumatology Meeting Showcase Commitment To Rheumatologic Diseases

More than 35 Janssen abstract presentations highlight breadth of rheumatology portfolio and research

Nov 04, 2015, 08:21 ET from Janssen Biotech, Inc.

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 am11:00 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 am11:00 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 am11:00 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 am11:00 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 am11:00 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 am11:00 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 am11:00 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 am11:00 am
  • Comparison of Interferon-ƴ 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 pm6:00 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 am11:00 am
  • Patient Reported Outcome Assessment of Rheumatoid Arthritis Patients Experience with IV Administered Biologic Therapy (Presentation 2642)
    • Poster presentation: Tuesday, November 10, 9:00 am11:00 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 am11:00 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 am11:00 am
  • Serum 14-3-3η is an RA Specific Mechanistic Marker (Presentation 2585)
    • Poster presentation: Tuesday, November 10, 9:00 am11:00 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 am11:00 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 am11:00 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). People who take STELARA® should not receive live vaccines. Tell your doctor if anyone in your house needs a vaccine. The viruses used in some types of vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before taking STELARA® or one year after you stop taking STELARA®.
  • 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
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if STELARA® will harm your unborn baby. You and your doctor should decide if you will take STELARA®
  • are breast-feeding or plan to breast-feed. It is thought that STELARA® passes into your breast milk. You should not breast-feed while taking STELARA® without first talking to your doctor.

Tell your doctor about all the medicines you take, including prescription and 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 prescribed by your doctor
  • 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®. Do not try to inject STELARA® yourself until you or your caregiver has been shown how to inject STELARA® by your doctor or nurse.

Common side effects of STELARA® include: upper respiratory infections, headache, tiredness, joint pain and nausea. 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.

Please read the Full Prescribing Information, including the Medication Guide for STELARA®, and discuss any questions you have with your doctor.

About SIMPONI ARIA® (golimumab for infusion)
SIMPONI ARIA® is an infusible, fully human anti-TNF monoclonal antibody that targets both soluble and transmembrane bioactive forms of TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue.  By binding with and blocking TNF-alpha, SIMPONI ARIA® helps control inflammation. SIMPONI ARIA® also helps to inhibit the progression of further joint damage.  SIMPONI ARIA® is approved for the treatment of adult patients with moderately to severely active RA with the medicine methotrexate. More information about SIMPONI ARIA® is available at www.SimponiARIA.com.

Please see SIMPONI ARIA® U.S. full Prescribing Information and Medication Guide.

Janssen Biotech, Inc. discovered and developed SIMPONI ARIA®.  

Important Safety Information (U.S.)

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

·         weight loss

·         muscle aches

·         warm, red, or painful skin or sores on your body

·         cough

·         diarrhea or stomach pain

·         shortness of breath

·         burning when you urinate or urinate more than normal

·         blood in phlegm

·         feel very tired

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.

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).

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

·         little or no appetite

·         clay-colored bowel movements

·         vomiting

·         dark urine

·         muscle aches

·         fevers

·         chills

·         skin or eyes look yellow

·         stomach discomfort


·         skin rash

Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI ARIA®. 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.

Rarely, people using TNF blockers, including SIMPONI ARIA®, can have nervous system problems such as multiple sclerosis or Guillain-Barre 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.

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.

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.

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.

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 6 months after birth.

The most common side effects of SIMPONI ARIA® include: upper respiratory 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 SIMPONI® (golimumab)
SIMPONI is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. SIMPONI is approved in 67 countries, including the United States where SIMPONI is approved by the United States Food and Drug Administration (FDA) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) with the medicine methotrexate, active psoriatic arthritis alone or with the medicine methotrexate, active ankylosing spondylitis and moderately to severely active ulcerative colitis. SIMPONI is available either through the SmartJect® autoinjector/prefilled pen or a prefilled syringe as a subcutaneously administered injection. For more information about SIMPONI visit www.SIMPONI.com.

Janssen Biotech, Inc. discovered and developed SIMPONI and markets the product in the United States. Janssen pharmaceutical companies market SIMPONI 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 SIMPONI to Mitsubishi Tanabe Pharma Corporation and has retained co-marketing rights in those countries. In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to SIMPONI to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc.

The U.S. full prescribing information for SIMPONI can be accessed at the following link: http://www.simponi.com/sites/default/files/pdf/prescribing-information.pdf.

For further information about SIMPONI outside of the United States, please consult the relevant official product information applicable to that country location.

Important Safety Information (U.S.)

SIMPONI® (golimumab) is a prescription medicine. SIMPONI® 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® and will 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 start SIMPONI® 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

·         weight loss

·         muscle aches

·         warm, red, or painful skin or sores on your body

·         cough

·         diarrhea or stomach pain

·         shortness of breath

·         burning when you urinate or urinate more than normal

·         blood in phlegm

·         feel very tired

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults taking TNF blockers, including SIMPONI®, 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 other TNF blockers 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® have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with SIMPONI®, tell your doctor.

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 taking SIMPONI®should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer).

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF-blocker medicines, such as SIMPONI®. Some of these cases have been fatal. Your doctor should do blood tests before and after you start treatment with SIMPONI®. 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

·         little or no appetite

·         clay-colored bowel movements

·         vomiting

·         dark urine

·         muscle aches

·         fevers

·         chills

·         skin or eyes look yellow

·         stomach discomfort


·         skin rash

Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI®. 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 or swelling of your lower legs or feet.

Rarely, people using TNF blockers, including SIMPONI®, 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.

Serious liver problems can happen in people using TNF blockers, including SIMPONI®. 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®. 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.

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, and/or legs.

New or worse psoriasis symptoms may occur. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus.

Tell your doctor if you are pregnant, planning to become pregnant or are breastfeeding or have a baby and were using SIMPONI® 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.

Tell your doctor if you are allergic to rubber or latex. The needle cover contains dry natural rubber.

Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI® such as hives, swollen face, breathing trouble, or chest pain. Some reactions can be serious and life-threatening.

Common side effects of SIMPONI® include: upper respiratory tract infection, reaction at site of injection, and viral infections.

Please read the Full Prescribing Information and Medication Guide for SIMPONI® 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 1.5 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 RA, when administered in combination with methotrexate. 
  • Reducing signs and symptoms in patients with active ankylosing spondylitis.
  • Reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatric patients with moderately to severely active Crohn's 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 Crohn's disease. 
  • Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active UC who have had an inadequate response to conventional therapy.
  • Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis. 
  • Treatment of adult patients with chronic severe plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

REMICADE® is unique among available anti-TNF-alpha biologic therapies. It is the only anti-TNF-alpha biologic administered directly by caregivers in the clinic or office setting. REMICADE® is a two-hour infusion administered every 6 or 8 weeks (indication-dependent), following a standard induction regimen that requires treatment at weeks 0, 2 and 6. As a result, REMICADE® patients may require as few as six treatments each year as maintenance therapy.

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:

  • 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-Barre 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 before the baby receives any vaccine because of an increased risk of infection for up to 6 months after your last dose of REMICADE® you received during your pregnancy.
  • 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.
  • Lymphoma, or any other cancers in adults and children.
  • Skin cancer—any changes in or growths on your skin.
  • Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
  • Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
  • 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.
  • Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
  • 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 more common side effects with REMICADE® are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.

Please read the Medication Guide for REMICADE® and discuss it with your doctor. (Requires Adobe® Acrobat® Reader®. Click here to download.)

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 are dedicated to addressing and solving some of the most important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolic diseases. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to people throughout the world.

Janssen Biotech, Inc.; Janssen Scientific Affairs, LLC; and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.com for more information. Follow us on Twitter at www.twitter.com/JanssenUS.

References

  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. (last accessed October 2015).
  2. National Psoriasis Foundation. About Psoriasis: Statistics. Available at: http://www.psoriasis.org/learn_statistics. (last accessed October 2015).
  3. National Psoriasis Foundation. About Psoriatic Arthritis. Available at: http://www.psoriasis.org/psoriatic-arthritis. (last accessed October 2015).
  4. Spondylitis Association of America. Treatment of Ankylosing Spondylitis & Related Diseases. Available at http://www.spondylitis.org/Learn-About-Spondyloarthritis/Treatment (last accessed October 2015).
  5. Arthritis Foundation. Ankylosing Spondylitis. Available at http://www.arthritis.org/about-arthritis/types/ankylosing-spondylitis (last accessed October 2015).
  6. Dean LE, et al. Global prevalence of ankylosing spondylitis. Rheumatology 2014;53:650–657.
  7. Mayo Clinic. Ankylosing Spondylitis. Available at http://www.mayoclinic.org/diseases-conditions/ankylosing-spondylitis/basics/definition/con-20019766?p=1 (last accessed October 2015).

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SOURCE Janssen Biotech, Inc.



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