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for Allergy and Asthma Research, and OUtMATCH co-lead study investigator. “The OUtMATCH study demonstrated that anti-IgE therapy increased
most patients’ threshold for an allergic reaction,” she added. “This presents an important new treatment option for patients and families in its potential to reduce the risk of allergic reactions from accidental exposures they may face in day-to-day life.”
Caution Warranted
As noted, Xolair isn’t a cure, and patients who take it must continue to avoid foods they are allergic to. Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergen- cy treatment of allergic reactions, including anaphylaxis. There are 160 differ- ent foods that cause IgE-mediated food allergy.
Still, detailed results from the OUtMATCH study showed treatment with Xolair increased, for a majority of trial participants, the amount of peanuts, tree nuts, egg, milk, and wheat they consumed without an aller- gic reaction, dramatically lessening the results of accidental ingestion or cross-contamination.
Xolair is a drug (in the class of drugs called monoclonal antibodies) that binds to IgE, the antibody type that triggers allergic reactions, and blocks IgE from binding to its receptors.
Xolair’s safety and efficacy in reducing allergic reactions in subjects with food allergies was established in one multi-center, double-blind, placebo-con- trolled study of 168 pediatric and adult subjects who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut, or walnut. Researchers randomly gave subjects either Xolair or placebo treat- ment for 16 to 20 weeks.
The primary measure of Xolair’s efficacy was the percentage of subjects who were able to eat a single dose (600 milligrams or greater) of peanut protein (equivalent to 2.5 peanuts) without moderate to severe allergic symp- toms, such as moderate to severe skin, respiratory, or gastrointestinal symp- toms, at the end of the treatment course.
Of those who received Xolair, 68% (75 of 110 subjects) were able to eat the single dose of peanut protein without moderate to severe allergic symp- toms, compared to 6% (3 of 55 subjects) who received placebo. Of note, however, 17% of subjects receiving Xolair had no significant change in the amount of peanut protein tolerated (they could not tolerate 100 mg or more
of peanut protein). As a result, continuation of strict allergen avoidance is still necessary, despite treatment with Xolair.
The key secondary measures of efficacy were the percentage of subjects who were able to consume a single dose (1,000 milligrams or greater) of cashew, milk, or egg protein without moderate to severe allergic symptoms at the end of the treatment course. For cashew, 42% who received Xolair achieved this endpoint, compared to 3% who received placebo.
For milk, 66% who received Xolair achieved this endpoint, compared to 11% who received placebo. For egg, 67% who received Xolair achieved this endpoint, compared to none of the 19 who received placebo. As a result, Xolair treatment is approved for certain patients with one or more IgE-medi- ated food allergies.
Optimistic Outlook
In the U.S., Genentech and Novartis Pharmaceuticals Corp. have worked together to develop and co-promote Xolair.
“Xolair offers patients and families an important new treatment option that can help redefine the way food allergies are managed and reduce the often-serious allergic reactions that can result from exposure to food aller- gens,” said Dr. Levi Garraway, Genentech’s chief medical officer and head of Global Product Development. “We look forward to bringing this treatment to the food-allergy community who have long awaited an advancement.”
Other allergy experts are equally hopeful.
“As more and more people are affected by food allergies, the need for a new approach to help prevent serious and often life-threatening allergic reac- tions and emergencies is critical,” said Sung Poblete, CEO of Food Allergy Research and Education. “As someone with food allergies, I know firsthand the significant impact they can have on people and their loved ones, and I share in the community’s excitement for this approval.”
Kenneth Mendez, president and CEO of the Asthma and Allergy Founda- tion of America, added that “the stress of living with food allergies can weigh heavily on people and their families, particularly when navigating events like children’s birthday parties, school lunches, and holiday dinners with friends and family. Given the growing prevalence of food allergies, this news offers hope to the many children and adults who may benefit from a new way to help manage their food allergies.” BW
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