Orencia® (abatacept) | Orencia Clinical Trial

ORENCIA in clinical trials

See how ORENCIA worked in clinical trials

Patients taking ORENCIA were studied in several clinical trials. These trials determined how rheumatoid arthritis impacted everyday life by measuring things such as dressing, grooming, or walking. Information from two of these trials is included in this section.

One study measured physical function, progression of joint damage as well as signs and symptoms of RA, including pain reduction. This study was conducted in adult patients with moderate to severe RA who had not responded well enough to methotrexate (MTX).

A second study measured physical function and signs and symptoms of RA, including pain reduction. This study was conducted in adult patients with moderate to severe RA who had not responded well enough to a TNF blocker (eg, Enbrel^®, Humira^®, or Remicade^®).

Improvement in daily activities
In one study, patients who did not respond well enough to methotrexate (MTX) were given either ORENCIA and MTX or MTX alone. Of the patients who received ORENCIA and MTX, 64% had improvement in physical function at 1 year, compared to 39% of patients who received MTX alone.

In a second study, patients who did not respond well enough to a TNF blocker (eg, Enbrel^®, Humira^®, or Remicade^®) were given ORENCIA and a nonbiologic DMARD*, or a nonbiologic DMARD alone. Of the patients who received ORENICA and a nonbiologic DMARD, 47% had improvement in physical function at 6 months, compared to 23% of patients who received a nonbiologic DMARD alone.

* Disease-modifying anti-rheumatic drug

Control the advance of joint damage
ORENCIA was also shown to control the advance of joint damage in RA patients. In a study of patients who had not responded well enough to MTX alone, patients were given ORENCIA plus MTX or MTX alone. At 12 months, the patients who received ORENCIA plus MTX had average progression scores that were about 50% lower than those who received MTX alone.

Like all medicines that affect your immune system, ORENCIA can cause serious side effects, including serious infections and allergic reactions. Also, rare cases of certain cancers have been reported.

Reduce the pain
ORENCIA may be able to help reduce the pain you feel in your joints so you have an easier time getting about your daily routine.

In one study, patients who did not respond well enough to MTX were given ORENCIA plus MTX or MTX alone. The group who received ORENCIA plus MTX averaged a 50% reduction in pain at 1 year as compared to a 10% reduction in patients who received MTX alone.

In a second study, patients who did not respond well enough to a TNF blocker were given ORENCIA plus a nonbiologic DMARD or a nonbiologic DMARD alone. Patients who received ORENCIA plus a nonbiologic DMARD averaged a 27% reduction in pain at 6 months, compared to an 8% reduction in pain in patients who received a nonbiologic DMARD alone.

Your results may vary.

Patients taking ORENCIA are at increased risk for developing infections that may be serious, including pneumonia and other infections caused by viruses, bacteria, or fungi. Call your doctor immediately if you feel sick or get any infection during treatment with ORENCIA.

Next section: Talking to your rheumatologist

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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. ORENCIA also reduces signs and symptoms in children and adolescents 6 years of age and older with moderate to severe polyarticular juvenile idiopathic arthritis (JIA).

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 doctor 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, you should tell your doctor 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 doesn't go away, weight loss, fever, night sweats), call your doctor right away. Before you start ORENCIA, your doctor may examine you for TB or perform a skin test.
	have or have had viral hepatitis. Before you use ORENCIA, your doctor 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: abatacept, maltose, monobasic sodium phosphate, or sodium chloride for administration.
	recently received a vaccination or are scheduled for any vaccination. You should not take live vaccines if you are receiving ORENCIA.
	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 doctor may tell you to use a different way to monitor your blood sugar levels.
	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 or JIA such as: Enbrel^® (etanercept), Humira^® (adalimumab), Remicade^® (infliximab), Kineret^® (anakinra) or Rituxan^® (rituximab). 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. Patients receiving ORENCIA have a higher chance of getting infections including pneumonia, and other infections caused by viruses, bacteria, or fungi. Call your doctor 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 doctor or get emergency medical help right away if you have hives, swollen face, eyelids, lips, tongue, throat 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.
	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.

The more common side effects with ORENCIA in both adults and children are headache, upper respiratory tract infection, sore throat, and nausea. Other side effects in children may include diarrhea, cough, fever, and abdominal pain.

Please read the Patient Information in the Full Prescribing Information.

© 2009 Bristol-Myers Squibb. All Rights Reserved.
ORENCIA is a registered trademark, and Oh, yes I can!, The Circle, The ORENCIA Promise Program, and the Satisfaction RAter are trademarks of Bristol-Myers Squibb.

427US07WA38036 Nov/09