News Hives May Be Treated With Asthma Drug, Study Shows

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Hives May Be Treated With Asthma Drug, Study Shows
Feb 24th 2013, 20:44

An asthma drug has shown promise in relieving itchiness for patients with chronic hives who do not get relief from traditional antihistamine treatment.

The drug, omalizumab, known by its brand name, Xolair, is a monoclonal antibody approved to treat allergic asthma. In the Phase 3 trial, published online on Sunday in The New England Journal of Medicine, a monthly injection of the drug significantly reduced hives and itchiness.

"This is the magic bullet that patients have been waiting for for the last 40 years," said Dr. Marcus Maurer, the lead author of the study and a professor of dermatology and allergy at Charité-Universitätsmedizin in Berlin. Dr. Maurer has received consulting fees from several pharmaceutical companies, including Genentech and Novartis, which financed the study and are developing the drug.

Dr. Jonathan Bernstein, a professor of medicine and an allergy specialist at the University of Cincinnati, who was not associated with the study, said that it was well designed and that the results were encouraging. "The drug is not a cure, but it will advance our ability to manage these patients," he said.

If approved, omalizumab could bring relief to those who suffer from chronic idiopathic urticaria, which for unknown reasons causes hives, itchiness and often the swelling of lips, tongue and other soft tissues. The symptoms can last for months or often years.

Studies suggest that one in 1,000 people suffer from the condition, though some experts believe that estimate is low. Currently, only nonsedating antihistamines are approved to treat it, and fewer than half of the patients respond to these drugs when prescribed at the approved dosage. If treatment fails, doctors increase the dosage up to four times the licensed dose. Or they prescribe off-label medications, including steroids and immunosuppressant drugs, which come with a high risk of serious side effects.

Thirty percent to 50 percent of patients do not respond to any treatment. "These patients are miserable, left with welts over their body," Dr. Bernstein said. "It can be quite debilitating."

In the study, researchers enrolled 323 patients with moderate to severe chronic idiopathic hives who did not respond to antihistamines. Participants were randomly assigned to receive a monthly injection of 75 milligrams, 150 milligrams or 300 milligrams of the drug or a placebo for 12 weeks. They were followed for four months after treatment stopped.

The group treated with 150 milligrams experienced a 57 percent reduction in itching, while those treated with 300 milligrams had a 71 percent reduction. That was a significant improvement compared with the placebo group, which had a 37 percent reduction in itching. The group that received 75 milligrams had 41 percent less itching, which was not significant compared with the placebo group. The study participants who took the two higher doses also experienced less swelling, and the severity of their hives was reduced.

The drug is thought to deactivate Immunoglobulin E (IgE), a type of antibody that plays a crucial role in the allergic response. These patients may have higher levels of IgE, which binds to immune cells, signaling them to release proteins that cause allergic inflammation, said Dr. Karin Rosén, a co-author of the study and the medical director for Genentech. Xolair binds to IgE, diminishing its ability to force the immune cells into action.

Xolair may cause side effects, including joint inflammation or pain, rash, fever or swollen lymph nodes. For the treatment of allergic asthma, the drug comes with a warning of an increased risk of anaphylactic shock. In pre-marketing clinical trials in patients with asthma, anaphylaxis occurred in 0.1 percent of patients. Xolair also contains a warning for an increased risk of cancer. In the clinical trials for allergic asthma, 0.5 percent of patients treated with Xolair received a cancer diagnosis during the trial compared with 0.2 percent of people in the control group. Subsequent trials have found no association between Xolair and an increased risk of cancer.

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