The patients itch so badly they scratch themselves until they bleed. Some become so depressed they end up on the psychiatrist's couch.
They have psoriasis, a disease that affects more than 4 million people in the U.S. Most have mild symptoms such as lightly flaking skin. But thousands break out in an itchy, crusty rash that makes them miserable.
By next year, four companies are expected to have new biotech drugs on shelves to treat psoriasis, a key growth market that some analysts think could top $1 billion by 2006. The medications -- Amgen Inc.'s Enbrel, Biogen Inc.'s Amevive, Genentech Inc.'s Raptiva and Johnson & Johnson's Remicade -- could vastly improve patients' lives.
The drugs' prices will be high, perhaps as much as $26,000 a year, but they could be a godsend for those suffering from severe psoriasis. Although standard therapies cost only a few thousand dollars a year, they have serious side effects. A chemotherapy drug commonly used for psoriasis can cause liver damage, and prolonged ultraviolet light therapy -- another routine treatment -- can lead to skin cancer. Analyst David Molowa of J.P. Morgan Chase & Co. estimates that 10% of psoriasis patients refuse treatment because the side effects are so bad.
The potential size of the psoriasis market -- Amgen estimates that 1 million patients could benefit from its medication -- is making insurance companies and employers nervous because the drugs will be so expensive.
Insurers may require evidence that patients' have tried cheaper therapies before approving prescriptions for the biotech drugs. Employers already are considering how to shift a large share of the cost of the psoriasis medications to employees, according to pharmacy benefits manager Express Scripts Inc.
Analyst Mark Monane of Needham & Co. said such measures could limit the availability of the biotech drugs to the sickest 100,000 psoriasis patients, at least initially.
Still, drug makers see psoriasis as a potential gold mine because the cause of the disease remains mysterious and most current treatments are only partially effective.
In bad cases, skin cells multiply at an abnormally high rate, causing thick, itchy plaques and flaking. It typically affects the back, elbows, knees and scalp, but large, ring-shaped patches can spread to the entire body.
Although not life-threatening, psoriasis can be disfiguring and emotionally painful. Sean O'Dowd, 37, a defense industry worker who lives in Virginia, said stress caused by his psoriasis broke up his marriage. Because his skin is so itchy, he wears dark-colored shirts so blood stains from his scratching don't show. An outing with his young daughter to a neighborhood pool last summer caused a humiliating stir.
"People actually climbed out when I went into the water," O'Dowd said.
Florida homemaker Darline Higgins, 58, still isn't accustomed to the stares her psoriasis triggers. "A nurse once asked me if I had AIDS. Do you believe it? A nurse."
Dermatologist Alice Gottlieb of New Jersey's Robert Wood Johnson Medical School said about one in 10 psoriasis patients think about suicide, a significant percentage for a disease that isn't fatal. "It is on the level you see in diabetes and cancer," she said.
In January, Biogen's Amevive became the first biotech drug approved for psoriasis, but the company does not have the category to itself. Amgen's Enbrel and Johnson & Johnson's Remicade now are sold for rheumatoid arthritis, and some dermatologists have begun to use them off-label to combat psoriasis.
Amgen, based in Thousand Oaks, expects Enbrel to reach $1.2 billion in sales this year thanks to the arthritis market, but it is racing to get the drug approved officially as a treatment for psoriasis. And J&J; has the same plans for Remicade. Meanwhile, Genentech expects Food and Drug Administration approval of Raptiva by year-end.
Last weekend, the companies began wooing dermatologists at a medical meeting in San Francisco in which they presented data from human tests on the merits of their rival drugs.
The information showed that J&J;'s Remicade probably is the most effective because it improved symptoms in 88% of patients taking the highest dose of the drug. But competitors said the studies aren't directly comparable, and Remicade must be taken intravenously, a drawback for some patients, versus injections for rival medications.
Still, none of the drugs comes without a downside. Amevive destroys white blood cells, so patients' blood counts must be monitored. Raptiva can worsen psoriasis in some patients who abruptly stop taking it. Enbrel and Remicade suppress the immune system, making patients susceptible to infections. The FDA also is weighing a possible link between Enbrel and Remicade and lymph cancer in rheumatoid arthritis patients.
But Gottlieb, who has tested all four drugs on patients, said they are safer than standard psoriasis therapies and can have a dramatic effect on the disease -- one improved patient recently asked her advice on getting a tattoo. She plans to shift all patients with bad psoriasis cases to biotech drugs.
Other dermatologists are less enthusiastic. Few skin doctors are equipped to administer intravenous drugs such as J&J;'s Remicade. And Biogen's Amevive isn't sold through pharmacies, so dermatologists must buy the drug and wait for reimbursement from patients' health plans. Meanwhile, the most effective dose of Amgen's Enbrel to combat psoriasis appears to cost about twice as much as it does when used to treat rheumatoid arthritis.
"Cost is a very big issue," said Washington dermatologist Jay Barnett, an advisor to the International Psoriasis Community, an advocacy group.
Moreover, the drugs' side effects aren't trivial, another reason insurers must be careful about signing off on their use, said Robert Seidman, chief medical officer of WellPoint Health Systems Inc.
WellPoint, parent of Blue Cross of California, requires preauthorization for biotech drugs and wants patients to try cheaper, conventional therapies first.
Biotech companies acknowledge that broad health insurance coverage is critical. Biogen spokeswoman Amy McKnight said the company is making progress with health plans, but its Amevive is new and acceptance takes time.
Patients desperate to end their suffering in all likelihood will pick up a bigger share of the drug tab. Some already have.
Higgins, the Florida psoriasis patient, stopped chemotherapy because tests revealed early signs of liver damage. Then after trying ultraviolet light treatments, she developed skin cancer. She later was hospitalized twice because her psoriasis was so bad.
Unable to use standard therapies, Higgins started taking a low dose of Amgen's Enbrel in January. Her health plan pays for most it, but the drug still will cost Higgins about $4,000 a year. She and her husband Tom, an administrative assistant, have stopped going to restaurants to help cover her drug bills.
But the crusty, red patches that covered most of her body are fading. The other day, her 3-year-old grandson noticed a change. "Grandma," he said. "The boo-boo on your knee is better."