Drug Already on Market May Be a Boon to Gout Patients

Arcalyst Used in Tandem With Another Drug Helped Prevent Painful Gout Flare-ups

By Salynn Boyles
WebMD Health News

Reviewed By Louise Chang, MD

Jan. 5, 2012 -- A drug already on the market for some rare conditions may be able to help many people with the far more common condition of gout.

More than 6 million Americans have experienced gout, an excruciatingly painful form of arthritis that comes on suddenly, leaving sufferers miserable and often unable to walk until the attacks subside.

Gout occurs when uric acid builds up in the body, leading crystals to form that lodge in the joints, often in the big toe. Uric acid levels can increase in the body for many reasons, including diets rich in shellfish, some meats, and alcohol.

Drugs that lower uric acid levels can treat gout over time, but these drugs can cause flares of the painful condition for weeks and even months after they are started.

Now, new research shows that gout sufferers treated with weekly injections of the drug Arcalyst (also known as rilonacept) were much less likely to have painful flares than patients who did not get the drug after beginning allopurinol, a traditional uric acid-lowering treatment used for gout.

The drug appeared to be safe and well tolerated, and it could be a needed alternative to available treatments, such as the commonly prescribed gout drug colchicine, says researcher H. Ralph Schumacher, MD, of the University of Pennsylvania and the VA Medical Center in Philadelphia.

Colchicine can cause nausea, diarrhea, and other gastrointestinal symptoms, and many patients can't tolerate it, Schumacher tells WebMD.

“For people who can't take colchicine and who find other drugs ineffective, rilonacept is a very effective alternative,” he says.

Gout No Longer ‘Disease of Kings'

Gout has historically been known as the “disease of kings” because of its association with the aforementioned foods and drinks once enjoyed only by the rich, such as red meat (especially organ meats), shellfish, and alcohol.

These foods and liquids have high levels of the substance purine, and uric acid is produced by the body when purine is broken down.

Drinking alcohol, being overweight, and taking certain medication, such as diuretics, can make you more likely to have gout.

Gout attacks often occur at night with the sudden onset of throbbing joint pain. The joint feels hot and looks red and swollen, and the pain is often so intense that even a sheet touching the afflicted area is unbearable.

A single joint is usually involved, but occasionally multiple joints are involved during a flare.

Attacks can last from a few days to a few weeks, but if uric acid levels remain high, they are likely to recur within months or years.

Men suffer from gout more than women, but its incidence is increasing among both sexes and is no longer considered a disease of the wealthy.

Fewer Gout Flares in Arcalyst Patients

The newly published study included 83 patients with gout who were starting uric acid-lowering therapy with the drug allopurinol.

Roughly half the patients were also treated with weekly injections of Arcalyst while half got weekly placebo injections.

Arcalyst is approved for the treatment of a group of rare, inherited inflammatory diseases known as cryopyrin-associated periodic syndromes. It works by targeting and neutralizing a protein that is involved in inflammation.

Over 12 weeks of treatment, 45% of the placebo-treated patients experienced gout flares compared to just under 15% of patients treated with Arcalyst.

Over three months of treatment, six flares occurred in the Arcalyst group compared to 33 in the placebo group.

The study was funded by the drug's developer, Regeneron Pharmaceuticals Inc. of Tarrytown, N.Y.

Gout Doctor: ‘Head-to-Head Study Needed'

Study co-investigator Robert Terkeltaub, MD, of the San Diego VA Medical Center and the University of California, San Diego, says the treatment may prove to be a good choice in combination with uric acid-lowering drugs for patients who also have diabetes or kidney disease and cannot take colchicine.

Rheumatologist Avram Goldberg, MD, of New York's North Shore-LIJ Health System says studies are needed comparing Arcalyst with colchicine and other drugs used for gout attacks.

“It would be nice to know if this drug works better than colchicine,” he tells WebMD. “I would like to see a head-to-head comparison.”

Goldberg says it is also not clear if patients will be receptive to a once-a-week shot.

“Gout attacks leave patients miserable, so they may readily accept weekly shots to prevent them,” he says. “But that remains to be seen.”


Gout Attack Symptoms, Causes, Treatment, and Diet See Slideshow

Schumacher, H.R. Arthritis & Rheumatism, Jan. 5, 2012.

H. Ralph Schumacher, MD, professor of medicine, University of Pennsylvania School of Medicine; VA Medical Center, Philadelphia.

Robert Terkeltaub, MD, interim chief of the division of rheumatology and immunology, University of California, San Diego; San Diego VA Medical Center.

Avram Goldberg, MD, attending rheumatologist, North Shore-LIJ Health System, Lake Success, N.Y.

News release, Regeneron Pharmaceuticals Inc.

Morbidity and Mortality Weekly Report, Arthritis Data and Statistics, 2010.

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