For moderate to severe rheumatoid arthritis (RA)

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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.

ORENCIA reduces signs and symptoms in children and adolescents 6 years of age and older with moderate to severe polyarticular JIA. ORENCIA may be used alone or with methotrexate (MTX).

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For Healthcare Professionals

My Results with ORENCIA

Clinical trial results and how ORENCIA® (abatacept) may help you

ORENCIA was studied in several clinical trials in patients for whom either methotrexate (MTX) or a TNF blocking agent such as Enbrel® (etanercept), Humira® (adalimumab), or Remicade® (infliximab) did not work well enough.

ORENCIA has been studied in approximately 2,000 patients to see how well it would work in people with moderate to severe RA who have not been helped enough by the treatments they have taken.


For patients who are not helped enough by MTX

In clinical trials, ORENCIA was shown to improve pain and physical function

improvement in pain and physical function

Learn More

Learn More

It is important to note that every patient is different. How you respond to treatment may vary from how other patients respond.

MTX, methotrexate.

TNF, tumor necrosis factor.

Selected Important Safety Information

ORENCIA can cause serious side effects including:

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.


For patients who have not been helped enough by a TNF-blocker

In clinical trials, ORENCIA was shown to improve pain and physical function

improvement in pain and physical function

Learn More

Learn More

It is important to note that every patient is different. How you respond to treatment may vary from how other patients respond.

DMARD, disease-modifying antirheumatic drug.

TNF, tumor necrosis factor.

Selected Important Safety Information

ORENCIA can cause serious side effects including:

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 or while using ORENCIA.


For patients who have not been helped enough by MTX: ORENCIA IV or ORENCIA SC self-injection

 

Selected Important Safety Information

ORENCIA can cause serious side effects including:

Important Safety Information

Serious infections. ORENCIA can make you more likely to get infections or make the infection that you have get worse. Some patients 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.

Vaccinations. You should not receive ORENCIA with certain types of vaccines. ORENCIA may cause some vaccinations to be less effective.

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 or while using ORENCIA.

Cancer (malignancies). Certain kinds of cancer have been reported in patients receiving ORENCIA. It is not known if ORENCIA increases your chance of getting certain kinds of cancer.

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 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, planning to become pregnant, or are thinking about becoming pregnant. It is not known if ORENCIA can harm your unborn baby.

Breastfeeding: You will need to decide to either breastfeed or receive treatment with ORENCIA, but not both.

If you Take Any Other Kinds of Medicine, including prescription and nonprescription 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 patients 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 or while using ORENCIA.
  • Vaccinations. You should not receive ORENCIA with certain types of vaccines. ORENCIA may cause some vaccinations to be less effective.
  • Respiratory problems in patients 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 patients receiving ORENCIA. It is not known if ORENCIA increases your chance of getting certain kinds of cancer.

Common side effects with ORENCIA 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.

Note concerning ORENCIA SC: It is not known if ORENCIA for SC injection is safe and effective in children under 18 years of age.

Please click here to read the Patient Information in the Full Prescribing Information.

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Clinical Trial 1

Clinical Trial 1 studied how well ORENCIA® (abatacept) IV worked in patients who weren’t helped enough by methotrexate (MTX). Signs and symptoms were measured at 6 months, and physical function and joint damage were assessed at 1 year.

Patients continued to take MTX during the trial, but stopped taking other disease-modifying antirheumatic drugs (DMARDs) before beginning the study.

What were the study groups?

Patients were randomly assigned into 2 groups. One group received ORENCIA IV in addition to MTX, and the other group received only MTX:

ORENCIA IV Group
(424 patients)

Received ORENCIA IV + MTX

Control Group
(214 patients)

Received MTX only

Neither patients nor their doctors knew which of these two groups they were assigned to.

Who participated in the trial?

clinical trial 1 participation

It is important to note that every patient is different. How you respond to treatment may vary from how other patients respond.

close

Clinical Trial 2

Clinical Trial 2 studied how well ORENCIA® (abatacept) IV worked in patients who weren’t helped enough by tumor necrosis factor blockers (TNF-blockers). Signs and symptoms as well as physical function were measured at 6 months.

Before beginning the study, patients stopped using TNF-blockers they were taking, but continued to take a background DMARD during the trial.

What were the study groups?

Patients were randomly assigned into 2 groups. One group received ORENCIA IV in addition to their DMARD treatment, and the other group
received only DMARDs:

ORENCIA IV Group
(256 patients)

Received ORENCIA IV +
non-biologic DMARDs

Control Group
(133 patients)

Received non-biologic
DMARDs only

Neither patients nor their doctors knew which of these two groups they were assigned to.

Who participated in the trial?

clinical trial 2 participation

It is important to note that every patient is different. How you respond to treatment may vary from how other patients respond.

close

Clinical Trial 3

Clinical Trial 3 compared how well ORENCIA® (abatacept) IV and ORENCIA self-injection worked in adults with moderate to severe RA who weren’t helped enough by methotrexate (MTX). Signs and symptoms as well as physical function were measured at 6 months.

Before beginning the study, patients stopped taking all disease-modifying antirheumatic drugs (DMARDs), but continued to take MTX during the trial.

What were the study groups?

Patients were randomly assigned into 2 groups. One group received ORENCIA IV with MTX, and the other group received ORENCIA self-injection with MTX:

ORENCIA IV Group
(678 patients)

Received ORENCIA IV
+ MTX

Control Group
(693 patients)

Received ORENCIA
self-injection + MTX

Neither patients nor their doctors knew which of these two groups they were assigned to.

Who participated in the trial?

clinical trial 3 participation

ORENCIA IV vs Self-injection

Results were similar between ORENCIA IV and ORENCIA self-injection treatments at 6 months.
On average:

ORENCIA IV and ORENCIA self-injection

It is important to note that every patient is different. How you respond to treatment may vary from how other patients respond.

close

Improvement in Pain

Patients' pain levels (0-100) were recorded throughout the trial. This table shows the average level of pain in each trial group at the start of the trial compared to 6 months later.

improvement pain scale

At 6 months, the ORENCIA IV group saw a greater improvement in pain than the control group.

close

Improvement in Physical Function

Patients' physical function scores from the HAQ-DI* questionnaire were recorded throughout the trial. This table shows the average HAQ-DI scores in each trial group at the start of the trial compared to 1 year later.

improvement physcial function scale

At 6 months, the ORENCIA IV group saw a greater improvement
in physical function than the control group.

*HAQ-DI stands for Health Assessment Questionnaire Disability Index. It is a questionnaire that patients fill out about how much difficulty they had in the past week with daily activities like dressing and grooming.

Selected Important Safety Information

ORENCIA can cause serious side effects including:

Respiratory problems in patients with COPD. You may get certain respiratory problems more often if you receive ORENCIA and have COPD including: worsened COPD, cough, or trouble breathing.

close

Improvement in Pain

Patients' pain levels (0-100) were recorded throughout the trial. This table shows the average level of pain in each trial group at the start of the trial compared to 6 months later.

improvement pain scale

At 6 months, the ORENCIA IV group saw a greater improvement in pain than the control group.

Selected Important Safety Information

ORENCIA can cause serious side effects including:

Vaccinations. You should not receive ORENCIA with certain types of vaccines. ORENCIA may cause some vaccinations to be less effective.

close

Improvement in Physical Function

Patients' physical function scores from the HAQ-DI* questionnaire were recorded at the start and end of the trial. This table shows the average HAQ-DI scores in each trial group at the start of the trial compared to 6 months later.

improvement physcial function scale

At 6 months, the ORENCIA IV group saw a greater improvement
in physical function than the control group.

*HAQ-DI stands for Health Assessment Questionnaire Disability Index. It is a questionnaire that patients fill out about how much difficulty they had in the past week with daily activities like dressing and grooming.

Selected Important Safety Information

ORENCIA can cause serious side effects including:

Respiratory problems in patients with COPD. You may get certain respiratory problems more often if you receive ORENCIA and have COPD including: worsened COPD, cough, or trouble breathing.

close

What does ‘improvement in pain’ mean?

A patient’s assessment of their pain levels is a core part of the American College of Rheumatology (ACR) criteria. The ACR criteria are a well-accepted measure of patient improvement in clinical trials.

How ‘improvement in pain’ is calculated

‘Improvement in pain’ was calculated by comparing patient’s pain levels at the beginning of the trial to patient’s pain levels at a set time in the trial (e.g., at 6 months).

How physical pain is measured

Physical pain is measured by having patients pick a relative pain level along a “visual analog scale” (VAS) from 0 to 100.

pain scale

Selected Important Safety Information

ORENCIA can cause serious side effects including:

Vaccinations. You should not receive ORENCIA with certain types of vaccines. ORENCIA may cause some vaccinations to be less effective.

close

What does ‘improvement in physical function’ mean?

A patient's assessment of their physical function is a core part of the American College of Rheumatology (ACR) criteria. The ACR criteria are a well-accepted measure of patient improvement in clinical trials.

How ‘improvement in physical function’ is calculated

‘Improvement in physical function’ was calculated by comparing patient’s Health Assessment Questionnaire Disability Index (HAQ-DI) score at the beginning of the trial to patient's physical function at a set time in the trial (e.g., at 6 months).

How physical function is measured

Physical function is determined by the HAQ-DI questionnaire that patients fill out. A score is calculated based on questions about the difficulty patients had in the past week with activities in 8 categories, and what kind of aids they may be using for each. Scores can range from 0 to 3.

physical function scale