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Abatacept (Orencia)

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Description

Abatacept (Orencia) is a drug used to treat inflammatory signs of arthritis, such as pain, swelling and prolonged joint stiffness. Abatacept belongs to the biologic class of drugs, which means that it works similarly to natural substances in the immune system.

Like other biologic drugs, abatacept was created with genetic-engineering techniques. It helps decrease inflammation in arthritis.

Fast Facts

  • Abatacept is a second-line drug that often is used when disease-modifying anti-rheumatic drugs, such as methotrexate, and/or other biologic drugs have failed to control inflammatory arthritis.
  • No higher risk of serious infections was reported with abatacept compared to other biologic drugs. Further long-term studies are needed.
  • Reports did not show higher risks of cancer in patients on abatacept. Larger study groups and long-term study will clarify this. Risks in pregnant women are still being studied.

Uses

The Food and Drug Administration approved abatacept for rheumatoid arthritis in 2005 and for children older than 6 years who have juvenile idiopathic arthritis in 2008. Studies with abatacept for the treatment of additional conditions are underway. Abatacept is used to reduce inflammatory symptoms such as swelling, pain and stiffness. In the long term, it is expected to stop joint deformities and, therefore, maintain range of motion.

It is used in moderate to severe arthritis in patients who have not responded to one or more DMARDs, such as methotrexate, or other biologic drugs. This means DMARDs should be tried initially. Abatacept may be used alone or in combination with DMARDs, which gives it more potency, but not with other biologic drugs (such as TNF-alpha blockers). Its use in other diseases is still being studied.

How it works

Unlike other biologic drugs, abatacept does not block inflammatory proteins like TNF-alpha antagonists. Abatacept attaches to the surface of inflammatory cells and blocks communication between these cells. By blocking this communication, abatacept lessens inflammation.

Dosing

Abatacept is an infusion that is given intravenously and followed with more doses 2 and 4 weeks later. Thereafter, infusions are given every 4 weeks in a doctor's office or specialized infusion center. The dosage is adjusted according to the patient's weight. It takes 30 minutes to receive the whole infusion. Blood samples do not need to be monitored between infusions. Recently, a self-injectable (sub-cutaneous) formulation of abatacept has been approved. Studies have shown this formulation to be as safe and effective as the infusion.

Time to effect

Studies showed better results 6 months after every 4th week of uninterrupted infusion. Relief of symptoms, however, can be felt even after the first or second infusion.

Side effects

The most common side effects reported were those associated with headaches, common colds, sore throat and nausea. Children may have diarrhea, cough, fever and abdominal pain. During the infusion, very few patients have reported having allergic reactions, but most are given medication to prevent any reaction.

The most important side effect is the risk of developing a serious infection, including pneumonia that requires hospitalization, tuberculosis and others. Therefore, patients are tested for possible tuberculosis with a skin test before starting this drug. Abatacept should not be used together with other biologic therapy, because the combination can increase the risk of contracting a serious infection.

The likelihood of developing cancer has not been shown to be higher in patients on abatacept compared to patients with other drugs. Nevertheless, larger reports should demonstrate if there is any trend of possible cancer risk.

Patients should not receive live vaccines while receiving abatacept or within 3 months of its discontinuation.

Points to remember

  • Abatacept is unique among the biologic drugs in terms of how it works. Therefore, it should be left as an alternative therapy, used whenever other drugs (including DMARDs and other biologic drugs, such as TNF-alpha blockers) have failed. It should not be used as a first-line drug.
  • Abatacept is relatively new on the market, and long-term side effects are still being monitored. Safety was proven in different studies; however, you should report any unexpected symptom experienced while on this drug therapy.
  • This drug is expensive, and its usefulness decreases whenever there is an interruption in its use.
  • Sustained and better relief of symptoms may be experienced the longer abatacept is used. After 2 years of uninterrupted use, patients reported less inflammation.

Drug Interactions

Using two biologic drugs (such as TNF-alpha blockers and abatacept) at the same time carries high risk of developing serious infections. Patients who have previously received another biologic drug, such as a TNF-alpha blocker, can receive abatacept after the first drug has been stopped.

Patients with diabetes mellitus should be aware that sugars in abatacept may cause false high blood sugar levels.

Information to Discuss With Other Health Care Providers

Patients who have been exposed to people with suspected serious infections, such as tuberculosis, should notify their doctors and ask them about the TB skin test before starting or continuing abatacept. Other laboratory tests may be required as well. Patients having symptoms of infection—including fever, cough, or others—should notify their doctors.

Patients should not receive live vaccines while receiving abatacept or within the next 3 months of its discontinuation.

Women who are taking abatacept should discuss birth control methods with their primary doctor or gynecologist. Abatacept should not be given to pregnant women.

For more information

The American College of Rheumatology has compiled this list to give you a starting point for your own additional research. The ACR does not endorse or maintain these websites, and is not responsible for any information or claims provided on them. It is always best to talk with your rheumatologist for more information and before making any decisions about your care.

The Arthritis Foundation
www.arthritis.org

U.S. Food and Drug Administration
www.fda.gov

Updated July 2012

Written by R. Peredo, MD, and reviewed by the American College of Rheumatology Communications and Marketing Committee.

This patient fact sheet is provided for general education only. Individuals should consult a qualified health care provider for professional medical advice, diagnosis and treatment of a medical or health condition.

© 2012 American College of Rheumatology