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Pills to treat non-food allergies on horizon

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In general, immunotherapy for non-food allergies requires multiple shots and is, well, a big pain. That could ultimately change, with two companies hoping to soon launch an under-the-tongue remedy in the United States.

“It takes probably three years, at least, of immunotherapy to produce a good and lasting result,” says Dr. Harold Nelson, an allergist at National Jewish Health in Denver. “An awful lot of people get tired of it.”

Safety also remains an issue. A recent survey of allergists found that three severe reactions occurred for every 100,000 injections. No doctor reported a fatality during the study period — from mid-2008 to mid-2009 — but the researchers estimated that there had been one death per year in the six years preceding the survey. The report was published in the June Annals of Allergy, Asthma & Immunology.

“The fatal reactions have almost all been in patients with asthma,” said Nelson, noting that he suggests patients get their asthma under control before starting any course of immunotherapy.

Sublingual immunotherapy — via a simple tablet or droplets placed under the tongue — could solve the hassle factor and reduce the safety problem, though immunotherapy of any kind remains a long way from acceptance in treating food allergies.

Trial results

Two companies, Merck and Stallergenes, recently completed U.S. clinical trials of sublingual tablets.

In March, Merck announced trial results for a hay fever tablet that is marketed in Europe as Grazax. Researchers treated 345 children and teens with either Grazax or a placebo. Those on the treatment required significantly fewer allergy medications and reported significantly fewer symptoms than those in the placebo group.

“It was pretty dramatic,” says study leader Dr. Michael Blaiss, an allergist at the University of Tennessee Health Science Center in Memphis (Blaiss is also a consultant for Merck and a member of the company’s speaker’s bureau). More important, he added, there were no serious allergic reactions.

Merck plans to file for Food and Drug Administration approval of Grazax late this year or in early 2011. The company is also working on sublingual treatments for ragweed and dust mite allergies.

In April, Stallergenes announced the results from a U.S. trial of its grass allergy tablet, Oralair. Researchers studied 473 adults with hay fever, giving some Oralair and some a placebo. Those who took Oralair had significantly fewer symptoms and needed fewer symptom-reducing drugs. Stallergenes also plans to file for FDA approval.

Pill versus shot

Such therapy makes up nearly half of immunotherapy in Europe, according to Dr. Linda Cox, an allergist in Fort Lauderdale, Fla. In the U.S., however, it’s far from mainstream. Approximately 6% of American allergists provide sublingual drops off-label, she says.

Reactions to sublingual immunotherapy tend to be milder than to the injectable form, often amounting to itchy or swollen lips with the first few doses. Patients can therefore safely take the therapy at home. According to a 2003 review by the nonprofit Cochrane Collaboration, sublingual immunotherapy is safe and can reduce symptoms for inhaled allergens such as pollen and animal dander.

A simple pill at home may appeal to more people than a regular doctor’s appointment, but it is not known if sublingual therapy is as effective as allergy shots. Few studies have compared the treatments head-to-head.

And it’s likely that only a limited number of allergens will be available in tablets, Nelson says, so people allergic to certain compounds or multiple substances will still be stuck with the needle.

health@latimes.com

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