'Disease of kings,' gout's on rise in U.S.

Lonnie Matthews, a retired building-maintenance engineer in Burlington, N.C., has something in common with King Henry VIII, Isaac Newton and Benjamin Franklin. He has gout.

Often called the "disease of kings" because of its association with the rich foods and copious alcohol once available only to aristocrats, gout is staging a middle-class comeback as American society grows older and heavier.

The rising tide of gout — an extremely painful arthritis of the big toe and other joints — is leading the pharmaceutical industry to rediscover what it had considered a disease of the past. Companies are racing to improve upon decades-old generic drugs that do not work well for everyone.

Already this year the Food and Drug Administration (FDA) has approved the first new gout drug in more than 40 years, Uloric, from Takeda Pharmaceutical.

Another new drug, Krystexxa, made by Savient Pharmaceuticals of East Brunswick, N.J., will be reviewed for possible approval by an FDA advisory committee Tuesday.

Several other companies are testing drugs in clinical trials.

"It's kind of like the forgotten disease," said Barry Quart, chief executive of one of those companies, Ardea Biosciences of San Diego.

Ardea discovered accidentally that an AIDS drug it was developing might work against gout. Now the company has shifted its focus to gout, envisioning annual sales of $1 billion if its drug is successful.

That would mean a huge increase in spending on gout medicines, which had sales of $53.4 million last year, according to IMS Health, a health-care information company. Uloric, the drug from Takeda, sells for at least $4.50 a daily pill compared with 10 cents to 50 cents for the most commonly used generic, allopurinol.

Experts say 2 million to 6 million Americans have gout. Although it becomes more common as people age, some men develop gout in their 40s and 50s, or younger. It is three to four times as common in men as in women, in part because estrogen is thought to protect premenopausal women from the illness.

Various studies suggest the number of cases in the United States has as much as doubled in the past three decades.

"We have accumulated a lot of people with severe disease," said Dr. Robert Terkeltaub, section chief of rheumatology at the Veterans Affairs Medical Center in San Diego and a consultant to some of the companies developing gout drugs.

The typical case these days, is "not going to be someone who looks like Henry VIII," he said. "Now it's going to be some 80-year-old lady with congestive heart failure."

One of the severe cases is Matthews, who had controlled his disease for many years with allopurinol. But when he developed renal problems in 2006, he stopped taking allopurinol because it can be harmful to those with bad kidneys.

After that, he was bedridden or in a wheelchair and in such excruciating pain that he said he contemplated suicide. "It was like having a toothache so bad you can't stand it, all over your body," he said.

Matthews, 76, said he found relief as a participant in a clinical trial of Savient's Krystexxa, the drug up for review by the FDA.

In the early stages, gout attacks, which can last several days and are excruciating, occur rarely. But over time, the frequency increases and people can develop disabling lumps of the chalky white crystals, called tophi.

Many patients are reluctant to admit they have the disease because of its association with gluttony. "It's part of society's view of gout that this is something self-inflicted," said Dr. N. Lawrence Edwards, professor of medicine at the University of Florida.