Janssen to Present Data Across Broad Rheumatology Portfolio and Immunology Pipeline at the 2016 American College of Rheumatology Meeting

HORSHAM, Pa., Nov. 3, 2016  /PRNewswire/ -- Janssen Biotech, Inc. announced today that 28 abstracts will be presented at the 2016 American College of Rheumatology (ACR) Annual Meeting taking place in Washington, D.C. from November 11-16, 2016. Data from the extensive rheumatology portfolio including new Phase 3 study results evaluating SIMPONI ARIA® (golimumab) infusion in adults with active ankylosing spondylitis (AS); a pooled safety analysis of STELARA® (ustekinumab) in psoriatic arthritis (PsA), Crohn's disease, and psoriasis; and real world data of patients with rheumatoid arthritis (RA) on REMICADE® (infliximab) will be presented. Pipeline presentations of note include results from a Phase 2a study evaluating guselkumab, a novel anti-interleukin (IL)-23 monoclonal antibody (mAb) in the treatment of adults with active PsA and results from a Phase 3 study evaluating sirukumab*, an IL-6 mAb, in the treatment of moderately to severely active RA. Several posters highlighting research in systemic lupus erythematosus (SLE) will also be presented.

"At Janssen, we are committed to addressing the unmet needs of patients living with rheumatic diseases today, and in the future through our continued efforts in research and development of therapies with novel mechanisms of action and different delivery systems," said Andrew Greenspan, M.D., Vice President, Janssen Scientific Affairs, LLC. "We're proud to present the latest data at the American College of Rheumatology meeting from our portfolio and pipeline, including new data for SIMPONI ARIA® in the treatment of patients with ankylosing spondylitis."

JANSSEN ABSTRACTS TO BE PRESENTED DURING ACR INCLUDE:

Abstracts can be accessed on the ACR 2016 Annual Meeting website at: http://acrabstracts.org/.

SIMPONI ARIA® (golimumab) infusion

• Safety and Efficacy of Intravenous Golimumab in Adult Patients with Active Ankylosing Spondylitis: Results through Week 28 (Presentation 56212)
  • Oral Presentation: Sunday, November 13, 4:30 pm – 6:00 pm
• Real World United States-based Clinical Experience with Prior Biologic Use Among First Time Golimumab Intravenous and Infliximab Treated Rheumatoid Arthritis Patients (Presentation 55984)
  • Poster Presentation: Sunday, November 13, 9:00 am – 11:00 am
• Efficacy and Safety of Intravenous Golimumab Plus Methotrexate in Patients 65 Years and Younger and Those Greater than 65 Years of Age-A Post Hoc Analysis (Presentation 56208)
  • Poster Presentation: Sunday, November 13, 9:00 am – 11:00 am
• Patient Characteristics and Medication Utilization Patterns of Infliximab-treated Rheumatoid Arthritis Patients Subsequently Transitioned to Intravenous Golimumab (Presentation 56707)
  • Poster Presentation: Sunday, November 13, 9:00 am – 11:00 am

STELARA® (ustekinumab)

• An Integrated Safety Data Analysis Across All Phase II and Phase III Clinical Programs for Ustekinumab in Psoriatic Arthritis, Crohn's Disease, and Psoriasis (Presentation 1726)
  • Poster presentation: Monday, November 14, 9:00 am – 11:00 am

REMICADE® (infliximab)

• Disease Activity Trends After Dose Escalation of Infliximab (Remicade) – Results From the US Corrona Registry (Presentation 55991)
  • Poster Presentation: Sunday, November 13, 9:00 am – 11:00 am
• A Descriptive Analysis of Real-World Treatment Patterns of Innovator Infliximab (Remicade) and Biosimilar Infliximab in a Treatment Naïve Turkish Rheumatologic Disease Population (Presentation 58565)
  • Poster Presentation: Monday, November 14, 9:00 am – 11:00 am
• A Descriptive Analysis of Real-world Treatment Patterns in a Turkish Rheumatology Population That Continued Innovator Infliximab (Remicade) Therapy or Switched to Biosimilar Infliximab (Presentation 58557)
  • Poster Presentation: Tuesday, November 15, 9:00 am – 11:00 am

Guselkumab (Anti-IL23 mAb)

• Efficacy and Safety Results of Guselkumab, an Anti-IL-23 Monoclonal Antibody, in Patients With Active Psoriatic Arthritis Over 24 weeks: a Phase 2a, Randomized, Double-blind, Placebo-controlled Study (Presentation 4L)
  • ACR Late-breaking Abstract Oral Presentation: Tuesday, November 15, 2016; 4:30 pm – 6:00 pm

Sirukumab* (Anti-IL6 mAb)

• In Vitro Cellular Profiling of Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, Reveals a Distinct Phenotypic Signature Compared to Tocilizumab, an Anti-IL-6 Receptor Monoclonal Antibody (Presentation 57359)
  • Poster Presentation: Monday, November 14, 9:00 am – 11:00 am
• Analysis of a Phase 3 Study Evaluating the Efficacy of Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, Across Subgroups in Patients With Active Rheumatoid Arthritis Despite Treatment With Disease-Modifying Anti-Rheumatic Drugs (Presentation 59004)
  • Poster Presentation: Monday, November 14, 9:00 am – 11:00 am
• Prediction of Inhibition of Radiographic Progression by Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Anti-Rheumatic Drug Treatment: Results of a Global, Phase 3 Trial (Presentation 59324)
  • Poster Presentation : Tuesday, November 15, 9:00 am – 11:00 am
• Consistent Pharmacodynamic Effects of Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, on Serum Analytes Across Four Phase 3 Clinical Trials in Rheumatoid Arthritis (Presentation 59542)
  • Poster Presentation: Monday, November 14, 9:00 am – 11:00 am
• Treatment With Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, Improves Fatigue and Health-Related Physical and Emotional Well Being in Patients With Active Rheumatoid Arthritis Refractory to Conventional or Biologic Therapy: Results of Two Global, Placebo-Controlled, Phase 3 Trials (Presentation 57844)
  • Poster Presentation: Monday, November 14, 9:00 am – 11:00 am
• Efficacy and Safety of Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF Therapy: Results From a Randomized, Double-Blind, Placebo-Controlled, Global, Phase 3 Study (Presentation 59233)
  • Oral Presentation: Wednesday, November 16, 11:00 am – 12:30 pm
• Efficacy of Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, Based Upon Prior Use of Non-Anti-TNF Biologics in Patients With Active Rheumatoid Arthritis Despite Anti-TNF Therapy: Results From a Global Phase 3 Study (Presentation 59315)
  • Oral Presentation: Wednesday, November 16, 11:00 am – 12:30 pm
• Sirukumab, an Anti–IL-6 Cytokine Monoclonal Antibody, Significantly Improves Physical Function and Reduces Morning Stiffness in Patients With Active Rheumatoid Arthritis Despite Anti-TNF Therapy: Results From a Global, Randomized, Placebo-Controlled, Phase 3 Trial (Presentation 57645)
  • Poster Presentation: Monday, November 14, 9:00 am – 11:00 am
• Efficacy and Safety of Monotherapy With Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, Compared With Adalimumab Monotherapy in Biologic-Naive Patients With Active Rheumatoid Arthritis: Results of a Global, Randomized, Double-Blind, Parallel-Group, Phase 3 Study (Presentation 57374)
  • Oral Presentation: Wednesday, November 16, 11:00 am – 12:30 pm
• Network Meta-Analysis to Assess the Relative Efficacy of Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, in Combination Therapy for Patients With Active Rheumatoid Arthritis Despite Conventional Disease-Modifying Anti-Rheumatic Drugs (DMARDs) (Presentation 59357)
  • Poster Presentation: Monday, November 14, 9:00 am – 11:00 am

SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

• Blood And Kidney Molecular Profiles Distinguish Individuals With Lupus Nephritis From Other Kidney Disorders (Presentation 2064)
  • Oral Presentation: Monday, November 14, 4:30 pm – 6:00 pm
• Results From a Phase 0 Longitudinal Clinical Trial in Cutaneous Lupus Erythematosus: Analysis of the Type 1 Interferon (IFN) Signature in the Skin and Blood and Its Relationship With Disease Activity Scores and Autoantibody Profiles (Presentation 2857)
  • Poster Presentation: Tuesday, November 15, 9:00 am – 11:00 am
• Introducing a Novel SLE-Specific Interferon-1 (IFN-1) Inhibitor CNTO 6358: Laying the Groundwork for Precision Medicine in Lupus (Presentation 770)
  • Poster Presentation: Sunday, November 13, 9:00 am – 11:00 am
• Broad Autoantibody Profiling in Ethnically Diverse SLE Cohorts Reveals a Set of Conserved Autoantibodies That are Correlated to a Type 1 Interferon Signature (Presentation 2816)
  • Poster Presentation: Tuesday, November 15, 9:00 am – 11:00 am
• Comparative Analysis of Anti-Nuclear Antibody Testing Using Blinded Replicate Samples Reveals Variability Between Commercial Testing Laboratories (Presentation 2809)
  • Poster Presentation: Tuesday, November 15, 9:00 am – 11:00 am

HEALTH ECONOMICS AND OUTCOMES RESEARCH DATA

• Updated Results for Serious Infections in Psoriasis Patients With Psoriatic Arthritis in the Psoriasis Longitudinal Assessment and Registry Study (Presentation 56212)
  • Poster Presentation: Monday, November 14, 9:00 am – 11:00 am
• Updated Results for All-cause Mortality and Malignancies in Psoriasis Patients With Psoriatic Arthritis in the Psoriasis Longitudinal Assessment and Registry Study (Presentation 56211)
  • Poster Presentation: Monday, November 14, 9:00 am – 11:00 am 
• Physician/Site Staff Assessments Contribute to High Placebo Response in Rheumatoid Arthritis Clinical Trials (Presentation 55935)
  • Poster Presentation: Tuesday, November 15, 9:00 am – 11:00 am
• Utilization Patterns of Subcutaneously Administered Biologic Medications Within a Sample of Rheumatoid Arthritis Patients (Presentation 59885)
  • Poster Presentation: Tuesday, November 15, 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 which effects 125 million people worldwide.⁶ An estimated 600,000 Americans—and more than 12 million people worldwide—have PsA.⁵ While estimates of the prevalence of psoriatic arthritis among people living with psoriasis vary, up to 30 percent may develop inflammatory arthritis.¹ The disease causes pain, stiffness and swelling in and around the joints and commonly appears between the ages of 30 and 50, but can develop at any time.² Though the exact cause of psoriatic arthritis is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease.² 

About Ankylosing Spondylitis
Ankylosing spondylitis is a chronic, immune-mediated disease that causes enthesitis, or inflammation where ligaments and muscles attach to bones, most commonly those within the spine. It is the primary disease in a group of arthritis-related diseases known as spondylitis, spondyloarthropathy or spondyloarthritis.³ The disease affects men more often than women and typically manifests in early adulthood.⁴ In contrast to mechanical low back pain, low back pain and stiffness with ankylosing spondylitis worsen after a period of rest or upon waking up in the morning and improve after exercise, a hot bath or a shower.³

About Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) also known as lupus is a chronic, complex and prevalent autoimmune disease that affects more than 1.5 million Americans⁷ and 5 million people worldwide.⁸ In lupus, the immune system, which is designed to protect against infection, creates antibodies that attack the body's own tissues and organs — the kidneys, brain, heart, lungs, blood, skin, and joints. Lupus is difficult to diagnose because symptoms come and go, mimic those of other diseases, and there is no single laboratory test that can definitively diagnose it. More than 90 percent of those with lupus are women, mostly between the ages of 15 to 44 and women of color are two to three times more at risk for lupus than Caucasians.⁷

About Guselkumab
Guselkumab is an investigational human monoclonal antibody with a novel mechanism of action that targets the protein interleukin (IL)-23 and is in Phase 3 development as a subcutaneously administered therapy for the treatment of moderate to severe plaque psoriasis. A Phase 2 study evaluating guselkumab in the treatment of moderately to severely active psoriatic arthritis is also ongoing.

About Sirukumab*
Sirukumab is an investigational human monoclonal IgG1 kappa antibody in Phase 3 development for the treatment of adult patients with moderately to severely active RA. Sirukumab targets the cytokine IL-6, a naturally occurring protein that is believed to play a role in autoimmune conditions like RA. In December 2011, Janssen and GSK entered into a licensing and co-development collaboration agreement, initially for RA. Under the terms, Janssen has exclusive rights to commercialize sirukumab in Asia Pacific, Europe, the Middle East and Africa, while GSK retains commercialization rights in North, Central and South America.* Prior to the agreement, Janssen had been developing sirukumab for RA.  U.S. and European Union regulatory filings for RA were announced in September 2016 and in Japan in October 2016. 

About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us on Twitter at https://twitter.com/JanssenGlobal.

About SIMPONI ARIA® (golimumab) infusion
SIMPONI ARIA^® is a tumor necrosis factor (TNF) blocker indicated in the U.S. for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate.

More information about SIMPONI ARIA® is available at www.SimponiARIA.com.

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

IMPORTANT SAFETY INFORMATION
SIMPONI ARIA® (golimumab) can lower your ability to fight infections. Serious and sometimes fatal events may occur. There have been reports of serious infections including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that have spread throughout the body. Other possible serious side effects may include lymphoma, a rare and fatal cancer called hepatosplenic T-cell lymphoma, skin cancer, other cancers, hepatitis B, heart failure, nervous system problems, lupus-like symptoms, or allergic reactions. To learn more about these and other risks, please read the Important Safety Information, and the Medication Guide, and talk with your doctor.

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, 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 than normal
• feel very tired

CANCER
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults receiving TNF blockers, including SIMPONI ARIA®, the chances for getting lymphoma or other cancers may increase. Hepatosplenic T-cell lymphoma, a rare and fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking a TNF blocker with azathioprine or 6-mercaptopurine. You should tell your doctor if you have had or develop lymphoma or other cancers.

Some people treated with SIMPONI ARIA® developed skin cancer. Tell your doctor if any changes in the appearance of your skin or growths on your skin occur during or after your treatment with SIMPONI ARIA®. Your doctor should periodically examine your skin, especially if you have a history of skin cancer.

USE WITH OTHER DRUGS
Tell your doctor about all the medications you take including ORENCIA (abatacept), KINERET (anakinra), ACTEMRA (tocilizumab), RITUXAN (rituximab), or another TNF blocker, or if you are scheduled to or recently received a vaccine. People receiving SIMPONI ARIA^® should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer).

HEPATITIS B INFECTION
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are receiving TNF-blocker medicines, such as SIMPONI ARIA®. Some of these cases have been fatal. Your doctor should do blood tests before and after you start treatment with SIMPONI ARIA®. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:

• feel very tired
• clay-colored bowel movements
• dark urine
• fevers
• skin or eyes look yellow
• little or no appetite
• vomiting
• muscle aches
• 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 or are breastfeeding or have a baby and received SIMPONI ARIA® during pregnancy. Tell your baby's doctor before your baby receives any vaccine because of an increased risk of infection for up to six months after birth.

COMMON SIDE EFFECTS
The most common side effects of SIMPONI ARIA® include: upper respiratory infection, viral infections, bronchitis, high blood pressure, and rash.

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 STELARA® (ustekinumab)
STELARA® is a human interleukin-12 and -23 antagonist indicated in the U.S. for the treatment of adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy, active psoriatic arthritis (PsA), alone or in combination with methotrexate, moderately to severely active Crohn's disease (CD) who have failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed a tumor necrosis factor (TNF) blocker or failed or were in intolerant to treatment with one or more TNF.

IMPORTANT SAFETY INFORMATION 
STELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects including:

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. 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 such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.

Before receiving STELARA®, tell your doctor if you:

• 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. Talk to your doctor about the best way to feed your baby if you take 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 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, nausea, itching, vomiting, vaginal yeast infections, urinary tract infections, and redness at the injection site. These are not all of the possible side effects with STELARA®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.

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 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 (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-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 six 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.
• 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.

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. Accessed October 2016.
2.     National Psoriasis Foundation. About Psoriatic Arthritis. Available at: http://www.psoriasis.org/psoriatic-arthritis. Accessed October 2016.
3.     Arthritis Foundation. Ankylosing Spondylitis. Available at http://www.arthritis.org/about-arthritis/types/ankylosing-spondylitis. Accessed October 2016.
4.     Mayo Clinic. Ankylosing Spondylitis. Available at http://www.mayoclinic.org/diseases-conditions/ankylosing-spondylitis/basics/definition/con-20019766?p=1. Accessed October 2016.
5.     Spondylitis Association of America. Living with Psoriatic Arthritis (PsA): An Overview Of PsA: Available at http://www.spondylitis.org/About-Spondylitis/Psoriatic-Arthritis
6.     World Psoriasis Day. Available at: http://www.worldpsoriasisday.com/web/page.aspx?sid=8538. Accessed October 2016.
7.     Lupus Research Institute. Lupus Fact Sheet. Available at http://www.lupusresearchinstitute.org/lupus-facts/lupus-fact-sheet. Accessed on September 6, 2016.
8.     Lupus Foundation of America. About Us, Statistics on Lupus. Available at http://www.lupus.org/about/statistics-on-lupus. Accessed October 2016.

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SOURCE Janssen Biotech, Inc.

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