ORENCIA® (abatacept) | Orencia Clinical Trial

ORENCIA in clinical trials

ORENCIA^® (abatacept) has been proven to reduce signs and symptoms in adults with moderate to severe RA, including those who have not been helped enough by other medications for RA, such as:

methotrexate
Enbrel ^® (etanercept)
Humira^® (adalimumab)
Remicade^® (infliximab)

Patients taking ORENCIA^® were studied in several clinical trials. Here are details on 3 of them:

Trial 1: This study tested ORENCIA IV with 638 adults who had moderate to severe RA and who had not responded well enough to methotrexate (MTX). Patients were given either ORENCIA IV plus MTX or MTX alone. At 6 months, patients’ signs and symptoms were measured, and at 1 year, their physical function and joint damage were assessed.

Trial 2: This study tested ORENCIA IV with 389 adults with moderate to severe RA who had not responded well enough to a TNF* blocker (eg, Enbrel^®, Humira^®, and Remicade^®). Patients were given either ORENCIA IV plus a nonbiologic DMARD^† or a nonbiologic DMARD alone. Their signs and symptoms and their physical function were measured at 6 months.

Trial 3: This study compared ORENCIA self-injection and ORENCIA IV with 1,457 patients who had moderate to severe RA and had not responded well enough to MTX. Patients were given ORENCIA self-injection + MTX or ORENCIA IV + MTX.

^*TNF: tumor necrosis factor.
^†DMARD: disease-modifying antirheumatic drug.

Improvement in daily activities

ORENCIA^® (abatacept) helped improve physical function, including things such as dressing, grooming, and walking.

• Trial 1 results: At 1 year, of those who received ORENCIA IV plus MTX, 64% had improvement in physical function, compared to 39% of patients who received MTX alone.

• Trial 2 results: At 6 months, of the patients who received ORENCIA IV and a nonbiologic DMARD, 47% had improvement in physical function, compared to 23% of those who received a nonbiologic DMARD alone.

• Trial 3 results: At 6 months, improvement in signs and symptoms as well as reported side effects were comparable for ORENCIA self-injection and ORENCIA IV.

Your results may vary.

Safety Information about 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.

Reduce the pain
ORENCIA^® (abatacept) helped reduce RA pain.

• Trial 1 results: After 6 months, patients on ORENCIA IV plus MTX averaged a 42% reduction in pain. Those on MTX alone averaged a 3% reduction.

Trial 2 results: At 6 months, researchers assessed their physical function and their signs and symptoms, including pain. Patients on ORENCIA IV plus a nonbiologic DMARD averaged a 28% reduction in pain. Those on a nonbiologic DMARD alone averaged a 6% reduction.

• Trial 3 results: At 6 months, improvement in signs and symptoms as well as reported side effects were comparable for ORENCIA self-injection and ORENCIA IV.

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

ORENCIA^® (abatacept) Important Safety Information

Indication and Usage
ORENCIA^® (abatacept) is a prescription medicine that reduces signs and symptoms in adults with moderate to severe rheumatoid arthritis (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 can also 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. It is important to tell your healthcare provider if you think you have any infections.

Important Safety Information About ORENCIA^{^®} (abatacept)

Before you receive treatment with ORENCIA, a lyophilized powder for intravenous infusion or a solution for subcutaneous (under the skin) injection, you should tell your healthcare provider about all your medical conditions including if you:

	have any kind of infection even if it is small (such as an open cut or sore) or an infection that is in your whole body (such as the flu).
	have an infection that will not go away or a history of infections that keep coming back.
	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 dry 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.
	have or have had viral hepatitis. Before you use ORENCIA, your healthcare provider may examine you for hepatitis.
	have a history of chronic obstructive pulmonary (lung) disease (COPD).
	are scheduled to have surgery.
	are allergic to any of the following ingredients in ORENCIA for infusion: abatacept, maltose, monobasic sodium phosphate, and sodium chloride for administration or the ingredients in ORENCIA injection: abatacept, sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, and water for injection.
	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.
	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 subcutaneous injection (injected under the skin) does not contain maltose; therefore, you do not need to change the way you monitor your blood sugar if you are taking ORENCIA subcutaneously.
	are pregnant, planning to become pregnant, or are thinking about becoming pregnant. It is not known if ORENCIA can harm your unborn baby.
	are breast-feeding. You will need to decide to either breast-feed or receive treatment with ORENCIA, but not both.
	take any other kinds of medicine, including prescription and nonprescription medicines, vitamins, and herbal supplements.
	are taking other biologic medicines to treat RA such as: Enbrel® (etanercept), Humira® (adalimumab), Remicade® (infliximab), Kineret® (anakinra), Rituxan® (rituximab), Simponi® (golimumab), Cimzia® (certolizumab pegol), 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^® (abatacept)

ORENCIA can cause serious side effects including:

	Serious infections. Serious infections, including rare but fatal infections, can occur. ORENCIA can make you more likely to get infections or make the infection that you have get worse. 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 on the day of treatment or the day after receiving ORENCIA. Tell your healthcare provider or get emergency medical help right away if you have hives, swollen face, eyelids, lips, tongue, throat 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, pneumonia, 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.

Please read the Patient Information in the Full US Prescribing Information.

ORENCIA is a registered trademark, and "Oh, Yes I Can!", THE CIRCLE, THE ORENCIA^® (abatacept) COPAY PROGRAM, and the Satisfaction RAter are trademarks of
Bristol-Myers Squibb. All other trademarks are the property of their respective owners.

427US11WA19301 Sep/11