RA after Vioxx: What Now? - Amid the confusion over COX-2 inhibitors and naproxen, here's some straight talk on how to treat rheumatoid arthritis - Drug Topics

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RA after Vioxx: What Now?
Amid the confusion over COX-2 inhibitors and naproxen, here's some straight talk on how to treat rheumatoid arthritis


Drug Topics


Treating rheumatoid arthritis is challenging enough as it is without the latest studies linking COX-2 inhibitors, often used as adjunct therapy, with an increased heart risk. These studies have left many RA patients and physicians a bit apprehensive about continuous high-dose therapy.


New directions after Vioxx
And then, just before Christmas, the Food & Drug Administration released a statement that patients who were taking naproxen in a study to prevent Alzheimer's disease showed some evidence of increased risk of cardiovascular events. Finally, a recent survey commissioned by the Arthritis Foundation found that even with current advances in treatment, 70%of RA patients receiving treatment are still impaired every day and nearly 70% experience pain daily. Without a doubt, RA is still a disease of unmet challenges.

What is RA? RA is a formidable disease. Not only does it cripple patients, reduce quality of life, and lead to premature death, but the medications used to treat RA—disease-modifying antirheumatic drugs (DMARDs), biologic response modifiers, and steroids—can be toxic, causing severe adverse reactions. Further vexing patients and insurers is the fact that the newer therapeutic additions for RA—the biologic response modifiers—are quite expensive.

An autoimmune disease, RA affects 2.1 million Americans, 1.5 million of whom are women. Although it can occur at any age, it is most prevalent between the fourth and sixth decades of life. RA is characterized by chronic inflammation that begins in the lining of the joints and leads to pain, stiffness, redness, and swelling. As it progresses, patients often become disabled. Ten years after the disease onset, less than 50%of working-age adults with RA are still employed. Costs of RA, including medical costs and lost wages, are estimated at more than $3 billion annually.


Drugs used in RA and toxicities requiring monitoring
Over the past decade, new guidelines have been developed for better management of RA and drugs that show therapeutic promise continue to move through clinical trials. The use of DMARDs has been refined and a number of biologic response modifiers—adalimumab (Humira, Abbott Laboratories), anakinra (Kineret, Amgen), etanercept (Enbrel, Amgen), and infliximab (Remicade, Centocor)—have gained approval from the FDA. These new choices, coupled with a better understanding of the disease, have altered the strategy for RA management and are likely to improve long-term outcomes.

"For years, people have preached the concept of nonsteroidal anti-inflammatory drugs first, and a trial of several of them before going on to other agents and more aggressive treatment," stated Arthur Schuna, M.S., FASHP, clinical pharmacy coordinator, William S. Middleton Memorial VA Medical Center, Madison, Wis., and clinical professor of pharmacy at the University of Wisconsin. "We now know that's not a good idea. People with definite RA who don't get treated early [with DMARDs] have worse outcomes, and they are less likely to respond to treatment." NSAIDs continue to have a role in RA treatment, but because they do not alter the course of the disease or prevent joint destruction, they are no longer recommended for use as the solo therapy.

DMARDs, conversely, have demonstrated the potential to limit the structural damage to the joints. These drugs also offer additional benefits. The evidence for the DMARD methotrexate shows that RA patients treated with it have a significantly lower mortality rate than patients not treated. Despite the initial concerns about the potential toxicity of the DMARDs in the early years of their use, appropriate use has demonstrated an acceptable safety profile.


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