Juvenile Idiopathic Arthritis

Taking a Close Look at Juvenile Idiopathic Arthritis

June 09, 2017

  This is intended for U.S. residents 18 years of age and older.
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hen most people think of arthritis affecting a member of their family, they usually think about their parents or grandparents, but children can struggle with arthritis, too. Juvenile Idiopathic Arthritis, or JIA, the most common form of pediatric arthritis, can cause pain, stiffness and swelling that may make it difficult to do everyday things, and may eventually result in disability.2 Early diagnosis of and treatment for JIA may help avoid joint damage.3

“JIA strikes at a time when kids just want to be kids, and do everyday things like participate in gym class at school, or spend time with friends,” said CreakyJoints co-founder and patient advocate Seth Ginsberg. “Managing the physical effects of JIA and finding time for regular doctor’s visits can be a struggle for patients and entire families.”

JIA affects more than 50,000 children in the U.S. alone.1 Potentially involving one or many joints,2 it affects girls two-to-four times more often than boys, and even more so when the onset of disease occurs in the teenage years.4 Symptoms of JIA can include joint pain, swelling, fever, rash, stiffness, fatigue and loss of appetite.2

A new administration option for patients and families facing this difficult disease aims to help. Bristol-Myers Squibb recently introduced a subcutaneous (SC) administration of ORENCIA for patients 2 years of age and older with moderately to severe polyarticular Juvenile Idiopathic Arthritis (JIA). ORENCIA may be used alone or with methotrexate (MTX). In adults, ORENCIA may be used alone or with other RA treatments other than tumor necrosis factor (TNF) antagonists.

In 2008, Bristol-Myers Squibb’s ORENCIA was the first FDA-approved biologic for intravenous use in patients 6 years of age and older with moderately to severe polyarticular JIA.

This new subcutaneous administration option builds on Bristol-Myers Squibb’s commitment to patients, by supporting JIA patients and their families.

 “A JIA diagnosis brings numerous challenges, from symptoms to therapy administration, which is why the community welcomes advancements in research like this new administration option,” said Brian J. Gavin, Vice President, ORENCIA Development Lead at Bristol-Myers Squibb. 

Indication and Important Safety Information for ORENCIA® (abatacept)

 

Indication/Usage

Adult Rheumatoid Arthritis (RA):  ORENCIA® (abatacept) is a prescription medicine that reduces signs and symptoms in adults with moderate to severe RA, including those who have not been helped enough by other medicines for RA.  ORENCIA may prevent further damage to your bones and joints and may help your ability to perform daily activities.  In adults, ORENCIA may be used alone or with other RA treatments other than tumor necrosis factor (TNF) antagonists.

Juvenile Idiopathic Arthritis (JIA):  ORENCIA reduces signs and symptoms in patients 2 years of age and older with moderate to severe polyarticular JIA.  ORENCIA may be used alone or with methotrexate (MTX).

Important Safety Information

Inform your healthcare provider of the following, before you receive treatment with ORENCIA® (abatacept):

Infections:  If you have any kind of infection, even if it is small (such as an open cut or sore), an infection that is in your whole body (such as the flu), an infection that will not go away, or a history of infections that keep coming back.  ORENCIA may make your immune system less able to fight infections, so you may be more likely to get infections or any infection you have may get worse.

Tuberculosis:  If you have had tuberculosis (TB), a positive skin test for TB, or if you recently have been in close contact with someone who has had TB.  If you get any of the symptoms of TB (a cough that does not go away, weight loss, fever, night sweats), call your healthcare provider right away. Before you start ORENCIA, your healthcare provider may examine you for TB or perform a skin test.

If you have or have had Viral Hepatitis. Before you use ORENCIA, your healthcare provider may examine you for hepatitis.

If you have a history of Chronic Obstructive Pulmonary (lung) Disease (COPD).

If you are scheduled to have Surgery.

Allergies to the Ingredients of ORENCIA:  The ingredients of intravenous (IV) ORENCIA are: abatacept, maltose, monobasic sodium phosphate, and sodium chloride for administration.  The ingredients of subcutaneous (SC) ORENCIA are: abatacept, sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, and water for injection.

Vaccinations:  If you have recently received a vaccination or are scheduled for any vaccination.  If you are receiving ORENCIA, and for 3 months after you stop receiving ORENCIA, you should not take live vaccines.

Diabetes:  If you have diabetes and use a blood glucose monitor to check your sugar levels.  The infusion of ORENCIA® (abatacept) contains maltose, a sugar that can give falsely high blood glucose readings with some monitors on the day you receive your infusion.  Your healthcare provider may tell you to use a different way to monitor your blood sugar levels.  ORENCIA for SC injection does not contain maltose; therefore, you do not need to change the way you monitor your blood sugar if you are taking ORENCIA subcutaneously.

Pregnancy:  If you are pregnant, or plan to become pregnant.  It is not known if ORENCIA can harm your unborn baby.  If you took ORENCIA during pregnancy, talk to your healthcare provider before your baby receives any vaccines.

Breastfeeding:  It is not known if ORENCIA passes into your breastmilk.  Talk to your healthcare provider about the best way to feed your baby if you use ORENCIA.

If you Take Any Other Kinds of Medicine, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

If you are Taking Other Biologic Medicines to Treat RA or JIA such as: Enbrel® (etanercept),  Humira® (adalimumab), Remicade® (infliximab), Kineret® (anakinra), Rituxan® (rituximab), Simponi® (golimumab), Cimzia® (certolizumab pegol), or Actemra® (tocilizumab). You may have a higher chance of getting a serious infection if you take ORENCIA with other biologic medicines.

Possible Side Effects of ORENCIA

ORENCIA can cause serious side effects including:

  • Serious infections.  ORENCIA can make you more likely to get infections or make the infection that you have get worse.  Some people have died from these infections.  Call your healthcare provider immediately if you feel sick or get any of the following signs of infection: fever; feel very tired; cough; feel flu-like; or warm, red or painful skin.
  • Allergic reactions.  Allergic reactions can happen to people who use ORENCIA.  Call your healthcare provider or get emergency medical help right away if you have any symptoms of an allergic reaction, which may include hives; swollen face, eyelids, lips, or tongue; or trouble breathing.
  • Hepatitis B infection.  If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use ORENCIA.  Your healthcare provider may do a blood test before you start treatment with ORENCIA.
  • Vaccinations.  You should not receive ORENCIA with certain types of vaccines.  ORENCIA may cause some vaccinations to be less effective.
  • Respiratory problems in people with COPD.  You may get certain respiratory problems more often if you receive ORENCIA and have COPD, including: worsened COPD, cough, or trouble breathing.
  • Cancer (malignancies).  Certain kinds of cancer have been reported in people receiving ORENCIA. It is not known if ORENCIA increases your chance of getting certain kinds of cancer.

Common side effects with ORENCIA® (abatacept) are headache, upper respiratory tract infection, sore throat, and nausea.  Other side effects in children and adolescents may include diarrhea, cough, fever, and abdominal pain.

These are not all the possible side effects of ORENCIA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

There are three ways to receive your dose of ORENCIA, and each way is approved for different ages:

  • ORENCIA prefilled SC syringe is approved for patients 2 years and older
  • ORENCIA IV is approved for patients 6 years and older. ORENCIA IV has not been studied in children younger than 6 years of age.
  • ORENCIA ClickJect Autoinjector has not been studied in children under 18 years of age.

Please talk to your child’s healthcare provider about the best way for your child to receive ORENCIA.

Please click here or visit ORENCIA.com to read the Patient Information in the Full Prescribing Information.

References:

  1. The Arthritis National Research Foundation Website. What is Juvenile Arthritis? Available at: http://www.curearthritis.org/juvenile-arthritis/. Accessed on March 22, 2017.
  2. Centers for Disease Control and Prevention. Arthritis Types. Available at: https://www.cdc.gov/arthritis/basics/types.html. Accessed on February 22, 2017.
  3. American College of Rheumatology Website. Juvenile Arthritis. Available at: http://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Juvenile-Arthritis.  Accessed on February 22, 2017.
  4. Verbsky J, Oberle E, Harris J. Polyarticular juvenile idiopathic arthritis – epidemiology and management approaches. Clinical Epidemiology. 2014:379.
  5. ORENCIA® Prescribing Information. Bristol-Myers Squibb Company, Princeton, NJ. 

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