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 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 Charite-Universitaetsmedizin in Berlin.
Maurer has received consulting fees from several drug 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 1 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 risk of serious side effects.
Thirty to 50 percent of patients do not respond to any treatment. ‘‘These patients are miserable, left with welts over their body,’’ 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.
The group treated with 150 milligrams experienced a 57 percent reduction in itching, while those treated with 300 milligrams had a 71 percent reduction. The placebo group 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), an antibody that plays a crucial role in 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 Rosen, a coauthor of the study and medical director for Genentech.