Courtesy Patty Schaeffer
Patty Schaeffer suffers from chronic idiopathic urticaria, or hives. She shows some of the hives in this 2007 photo. An asthma drug called Xolair has eased her symptoms.
Patty Schaeffer finally resorted to a wire brush when the itching got too bad. “You know those wire hair brushes with the little balls on the ends of the wires? I pulled off all those balls and just used the wire brush itself,” Schaeffer says.
But nothing eased the maddening itch and the red, swollen hives until she signed up for a clinical trial of an asthma drug called Xolair. She is one of the 53 percent of patients who got almost complete relief from regular injections of the drug.
“The first time I got the shot, the next morning I woke up and it was the first time in years I did did not have a hive on my body,” says Schaeffer, a 48-year-old county worker in Westminster, Md. “Needless to say, I came screaming out of the bedroom.”
Schaeffer’s doctor, Dr. Sarbjit Saini of Johns Hopkins Medicine, and colleagues reported their findings at a meeting in San Antonio on Sunday of the American Academy of Allergy, Asthma & Immunology and in the New England Journal of Medicine.
Schaeffer had what’s known as chronic idiopathic urticaria, which means, in effect, chronic itching with no known cause. She is one of the millions of people who are not helped by any drugs -- not antihistamines, not steroids, not even immune system suppressants. The body acts like it's allergic to something, but doctors cannot find a cause.
Saini’s one of several groups of doctors who independently tried Xolair, known generically as omalizumab, to treat patients with chronic itch and hives. Many of them are really miserable, he says.
“Other people always think they have something infectious,” he said in a telephone interview.
Schaeffer thought she had a spider bite when she woke up in 2001 with a swollen spot on the back of her head. “It was itchy. It went away. Then it came back.” The hives got progressively worse.
“In a couple of years I had hives on my body every single day. It was awful,” Schaeffer said.
She went to allergists. She changed her diet. She changed her laundry detergent. She stopped using dryer sheets. Nothing worked. ”I would wake up with bruises because I broke the blood vessels from scratching so hard,” she says.
Schaeffer is not alone. This kind of chronic itching affects one percent of the U.S. population at any given time, Saini says.
The first line of treatment is antihistamines, and many people end up taking several. That’s what Schaeffer did. She took Benadryl, Allegra, Zyrtec and a steroid called prednisone. Nothing really helped, she says. “Some take daily oral corticosteroids and even transplant drugs like cyclosporin,” Saini said. “Most of these drugs are fairly toxic.”
Meanwhile, Saini and his team had been studying what was going on in the bodies of these patients. They don’t have an obvious allergic trigger, although their bodies are acting as if there is one. In an allergic reaction, the body overproduces a compound called histamine, and an immune system protein called IgE is to blame. Xolair is a monoclonal antibody, a genetically engineered immune system protein, that attaches to IgE and makes it settle down.
The cells that carry histamine in the body, called mast cells, seemed to be overactive on both patients with allergic asthma and chronic hives, he said. “That’s why we attempted this therapy.”
They approached the company that makes Xolair, a joint venture of Genentech and Novartis. After some small trials, they launched a bigger trial of 323 people around the world. They calibrated patients’ symptoms at first, coming up with an itch scale that went from 1 to 21 and measuring how badly their sleep was disturbed.
The researchers randomly assigned their patients to get either a dummy injection, 75 mg of Xolair, 150 mg or 300 mg, once a month for three months.
Even the patients who got placebos reported feeling less itchy at first -- their itch scores fell from an average of 14 to about 9, and stayed there. Those who got the highest dose of Xolair, 300 mg, reported much less itchiness -- from 14 down to 4 by the seventh week. After 13 weeks, the itching returned. Those who got half that dose reported their itching fell more gradually, to about 5 or 6, before going back up to about 10 after four and a half months.
Schaeffer says the hives come back if she doesn’t get the injections regularly. “I am not completely hive-free,” she says. “But now I get maybe one or two and the next day they are gone. They are nothing compared to what they were.”
More study will be needed to show if the drug is safe and to get a better idea of whom it might help. Too few patients were treated in this trial. And it’s expensive: $1,200 to $1,600 a dose.
“But Xolair is approved for children as young as 12, and is safe in pregnancy. We have a lot of experience with it,” Saini says.
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