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FDA Panel Scrutinizes Safety Of 4 RA Drugs
Abbott Laboratories Provides Drug Free of Charge
| FDA Panel Scrutinizes Safety Of 4 RA Drugs | |
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The risk versus benefit of Arava, Enbrel, Remicade, and Humira is reconsidered
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The Arthritis Advisory Committee met on March 4-5, 2003 to reconsider the safety of 4 popular rheumatoid arthritis (RA) drugs. The association of liver failure with use of Arava and the association of lymphoma with anti-TNF drugs Enbrel, Remicade, and Humira was debated by the advisory committee which makes recommendations to the FDA.
Arava, which was first marketed in 1998 for the treatment of rheumatoid arthritis, works similarly to methotrexate which is considered the standard treatment for RA. A consumer advocacy group, Public Citizen, has implored the FDA to revisit the safety issue of Arava, citing 54 cases of liver failure in the United States and eight deaths linked to the drug. Public Citizen petitioned the FDA to ban Arava in March 2002. Some FDA officials agreed with the position taken by Public Citizen and issued a memo accordingly in November 2002. However, the Arthritis Advisory Committee concluded differently by a unanimous vote (12-0) on March 5, 2003, stating that the benefits of Arava outweigh its risks. The Arthritis Advisory Committee also voted that effectiveness data supports Aventis' latest claim that Arava improves physical function in rheumatoid arthritis patients, in addition to its current indication for relieving the signs and symptoms of RA and retarding structural damage. Aventis is the maker of Arava.
The FDA also is trying to establish whether there is a link between the use of Enbrel, Remicade, and Humira and 170 cases of lymphoma reported since 1998. The Arthritis Advisory Committee has concluded that more data is needed to determine if there is causality between the use of the anti-TNF drugs and lymphoma. Recommending that the potential problem should be monitored and recognizing that it is a process which may take years before a final conclusion is reached, the advisory committee noted that the drugs label should reflect a warning. The drug manufacturers maintain that the patients have already received sufficient warning. Amgen manufactures Enbrel, while Johnson & Johnson manufactures Remicade. Humira, the newest of the anti-TNF drugs, is made by Abbott Laboratories.
Since rheumatoid arthritis patients get lymphoma at a two to three times higher rate than the general population because the disease itself increases the risk, it is difficult to determine the role played by the drugs. Only 29 of the 170 reported cases of lymphoma occurred during a formal study which could be fully analyzed. While all three makers of the anti-TNF drugs continue to study the issue, they maintain that the drugs benefits outweigh the risks.
It is clear that for the 2 million people who suffer with rheumatoid arthritis, various treatment options are needed, since not all drugs work equally for all patients. The aforementioned four drugs have benefited thousands of rheumatoid arthritis sufferers tremendously. Still, the safety profile of each drug must allow the patient a comfort zone when weighing pros and cons, benefits and risks.
Abbott Laboratories Provides Drug Free of Charge
In an extraordinary move, Abbott Laboratories announced that all Medicare-eligible seniors without prescription drug coverage could receive its newly-approved rheumatoid arthritis drug at no cost until a drug benefit is passed for Medicare.
Humira (adalimumab) was recently approved by the Food and Drug Administration (FDA) for the reduction of signs and symptoms of rheumatoid arthritis in adults who have had "insufficient response" to one or more traditional disease modifying antirheumatic drugs (DMARDs); the drug was also approved for inhibiting structural damage associated with the disease.
The Humira Medicare Assistance Program is the first of its kind and guarantees that Medicare-eligible seniors will have access to the drug even if they lack prescription drug coverage. Qualified seniors should speak to their physicians if they are interested; patients will receive Humira directly from their healthcare provider as long as they are eligible.
Abbott is also offering reimbursement information support through its Humira Resource Center; here, people with rheumatoid arthritis can discover more about prescription coverage for Humira through private insurance, federal or state assistance programs, and through other Abbott programs. Patients who meet certain financial criteria are eligible for Abbott's Patient Assistance Program, which provides Humira at no cost.
Humira is not without risks; patients using the medication have developed cases of tuberculosis (frequently disseminated or extra pulmonary at clinical presentation). Serious infections and sepsis (including fatalities) have been associated with Humira and other TNF-blocking agents. However, many of these infections arose in patients taking concomitant immunosuppressive therapy, which could make them more vulnerable to infections.
TNF-blocking agents (including Humira) have also been associated with other invasive opportunistic fungal infections and demyelinating disease. The most common side effects observed in clinical trials included upper respiratory infection, injection site pain, headache, rash and sinusitis.
For more information, call 1-866-4-HUMIRA.
Additions to the
Formulary
Adalimumab (Humira®)
Medication Category: Arthritis Drugs
Formulary Status: On-formulary
with step-therapy (ST) for patients with inadequate response or intolerance to
methotrexate
Humira® is a new subcutaneous
injectable product, most similar to etanercept (Enbrel®), for moderate to severe
rheumatoid arthritis in patients who have had an inadequate response to other
medications. Efficacy and safety appear similar to Enbrel®. Humira® has a dosing
advantage (given every two weeks rather than twice weekly). Costs also appear
similar ($1,400 AWP per month), but Humira® will be more costly if the dose is
increased. Prescribing information is available at
http://www.rxabbott.com/pdf/humira.pdf
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