Humira
What is Humira?
Humira (also known by its generic name adalimumab) is a biologic medication approved in October 2005 by the U.S. Food and Drug Administration (FDA) for the treatment of psoriatic arthritis. In 2008 it was approved for treating psoriasis, and it is also approved for treating rheumatoid arthritis. For more information about biologics as a class of treatment, please see the For more information about biologics as a class of treatment, please see the biologics section.
Key features
- FDA-approved for psoriasis and psoriatic arthritis
- Patients give themselves an injection under the skin every other week
- Patients should be screened for latent (hidden) tuberculosis (TB) before taking Humira
- Long-term side effects still being evaluated
How does it work?
Humira blocks tumor necrosis factor-alpha (TNFalpha), a chemical "messenger" in the immune system that signals other cells to cause inflammation. There is too much TNF-alpha in the skin of people with psoriasis and the joints of people with certain types of arthritis.
TNF-alpha can also lead to increased immune system activity through the activation of immune cells, including T cells. T cells are a type of white blood cell in the body; in psoriasis, once T cells are mistakenly activated, they can trigger inflammation and other immune responses and fuel the development of psoriasis lesions.
Humira helps lower the amount of TNF-alpha, thus interrupting the inflammatory cycle of psoriasis and psoriatic arthritis and leading to improvement in symptoms for many people who take it.
Who is a candidate?
Humira is prescribed for people with moderate to severe psoriasis and active psoriatic arthritis.
Who should not take Humira?
- People with active serious infections or a history of recurrent infections
- People with a history of heart failure
- People with multiple sclerosis or other similar types of demyelinating neurologic diseases
- Children—the medication has not been approved for children
Caution is advised for people who experience any numbness or tingling, or have ever had a disease that affects the nervous system.
Caution is also advised for the elderly, due to the already increased risk of infection for this age group.
The impact of Humira on pregnant women or developing fetuses is not known, nor is it known if
the medication passes into breast milk in nursing women. Humira should only be given to pregnant
or nursing women if there is a clear medical need, and if this decision is reached by a patient and doctor together.
How is it used?
Patients take Humira at home by giving themselves an injection under the skin, similar to diabetes patients who give themselves insulin injections. The recommended dose for patients with psoriatic arthritis is 40 mg every other week. Humira is designed to be taken continuously to maintain improvement.
The medication can be prescribed by itself or in combination treatment with methotrexate, a systemic medication prescribed for psoriasis and psoriatic arthritis. In clinical studies, people taking Humira in combination with methotrexate for rheumatoid arthritis experienced more disease improvement than patients taking Humira or methotrexate alone. It is also safe to take Humira with pain relievers, such as NSAIDs, that are often taken for arthritis.
What are the side effects?
Common side effects in psoriatic arthritis patients included upper respiratory tract infections, injection site reactions and high blood pressure.
According to the product label information, in studies of rheumatoid arthritis patients, the most common side effects included:
- upper respiratory infections
- abdominal pain
- headache
- rash
- injection site reactions
- urinary tract infection
These side effects were generally mild and did not cause most patients to stop taking Humira. These events happened most often after the first dose of Humira and may decrease after additional doses.
Humira treatment should not be started in someone with an active infection, and is not recommended for someone with a history of recurring infections. People taking Humira should be monitored for signs of infection, and if a serious infection develops, the medication should be stopped.
TB, invasive fungal infections and other serious infections have been reported in Humira patients; some of the infections have been fatal. The infections often occurred in patients who were also using other medications that affect the immune system.
People should be evaluated for latent TB infections by getting a TB skin test prior to treatment with Humira. Doctors may also order a chest X-ray before starting treatment. Hidden TB must be treated first, before people can begin taking Humira.
There have been rare reports of central nervous system disorders in association with the use of Humira. Doctors are advised to use caution in considering the use of Humira in patients with preexisting or the recent onset of central nervous system disorders, including multiple sclerosis.
Some patients have developed lupus-like symptoms that receded after their treatment was stopped. People taking Humira are advised to call their doctor right away if they develop chest pains that do not go away, shortness of breath, joint pain, or a rash on their cheeks or arms that is sensitive to the sun.
The FDA has reviewed the association between TNF-alpha medications, such as Humira, and an
increased risk of developing lymphoma, a type of cancer. The FDA concluded there is not enough data to know if these medications contributed to higher risk.
Humira's safety and side effects continue to be monitored by Abbott and the FDA.
For detailed information on side effects and safety, talk to your doctor.
How do I get Humira?
Humira is available by prescription. Once a person and his or her doctor make the decision that Humira is an appropriate treatment, a determination of insurance coverage will need to be made, and preauthorization from the insurance company will likely be needed.
Abbott has a special program where patients and doctors can get help with insurance questions and other issues. For more information, call 866.4.HUMIRA (866.448.6472) or visit www.humira.com.
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How much does it cost?
In general, biologics tend to be expensive; the cost of each drug can vary between $10,000 and $25,000 per year (or more), based on the dosage and treatment regimen prescribed by your doctor. Most insurance companies cover this medication for its approved indications: psoriatic arthritis and rheumatoid arthritis. If a person's health insurance will cover Humira, the exact amount of coverage will vary. Some patients may be fully covered for Humira; others may be partially covered or, in some cases, may have to pay a percentage of the total cost out of pocket.
Abbott has a patient assistance program to help provide discounted medications to people who qualify, based on income levels and other factors. More information about this program can be obtained by calling 866.4.HUMIRA (866.448.6472).
Updated February 2008
Some of the links above take you off the Psoriasis Foundation Web site. The Psoriasis Foundation does not endorse or accept any responsibility for the content of external Web sites. Click here for complete terms of use.
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