Fresh Insights Suggest Asthma Medication Could Mitigate Severe Reactions in Individuals with Multiple Food Allergies



Recent research reveals promising findings regarding the efficacy of Xolair, an asthma medication, in significantly diminishing severe allergic reactions among individuals with multiple food allergies who experience accidental exposure to these foods.

Published data in the New England Journal of Medicine indicates that regular administrations of Xolair through injections over several weeks have led to a notable reduction in the severity of allergic reactions. This positive outcome has been observed in both adults and children as young as 1 year old, particularly among those allergic to peanuts and other common food allergens such as milk, egg, and wheat.

Last week, the US Food and Drug Administration expanded its approval of omalizumab, commercially known as Xolair, to encompass individuals with food allergies, following an interim analysis of the study.

By incorporating a variety of food allergens into the study, researchers were able to ascertain that Xolair potentially holds the capability to mitigate allergic reactions in instances where individuals are exposed to multiple allergens simultaneously, according to experts.

Dr. Sharon Chinthrajah, a senior author of the study and an associate professor at Stanford University, remarked, "This marks a significant advancement in our field. The daily activities of food allergy patients or parents of such individuals are often fraught with fear and anxiety."

Dr. Chinthrajah highlighted that Xolair offers a degree of protection against accidental exposure for those with food allergies, thereby reducing the risk of anaphylaxis—an acute and potentially life-threatening allergic reaction necessitating immediate medical intervention, including administration of epinephrine.

"I have adolescent patients who, solely due to their peanut allergy, have never dined out in restaurants due to the overwhelming fear of the unknown," remarked Dr. Robert Wood, the principal investigator of the study and the director of the Eudowood Division of Allergy, Immunology, and Rheumatology at Johns Hopkins Children's Center.

Currently, there exists no cure for food allergies, with Palforzia being the sole FDA-approved treatment—an oral immunotherapy tailored for peanut allergies in children aged between 4 and 17 years.

"However, it's important to acknowledge that the majority of our patients don't suffer from peanut allergies alone," Wood emphasized. "Having a treatment that's broadly applicable to various food allergies will offer relief to a significantly larger portion of the food allergy patient population."

Achieving Success in Pediatric Treatment

Xolair, a medication jointly developed and marketed by Genentech and Novartis in the US, received initial approval in 2003 for the treatment of moderate to severe persistent allergic asthma. In order to secure approval for its use in individuals with food allergies, the FDA mandated a phase 3 placebo-controlled trial that encompassed a comprehensive dataset of individuals allergic to peanuts, as peanut allergies rank among the most prevalent food allergies, particularly in children, explains Wood.

The study included a selection of common allergens such as peanuts, cashews, eggs, milk, walnuts, hazelnuts, and wheat, as these represent some of the most prevalent triggers for allergic reactions, according to Wood.

In a study funded by the National Institutes of Health, researchers recruited 180 individuals with a history of peanut allergy and at least two other food allergies. Each participant was randomly assigned to receive either an omalizumab injection or a placebo every two to four weeks for a duration of 16 to 20 weeks.

The vast majority of participants, with only three exceptions, were aged 17 or younger, with adults ranging from 19 to 28 years old, as confirmed by Wood.

During the analysis phase, focus was placed on the 177 participants aged between 1 and 17 years. Wood highlighted that among this group, 68 individuals were aged 5 or below, a demographic that had not been previously studied with Xolair before this trial.

This inclusion of very young participants holds particular significance, as food allergy prevalence peaks between 1 to 2 years of age. Wood emphasized, "To have a substantial number of study participants in the youngest age category was incredibly meaningful." While Xolair's efficacy has been well-documented in asthma treatment over the years, its safety in young children had not been thoroughly examined, making this aspect of the study particularly reassuring.

Of the total participants, 118 received omalizumab, while 59 were administered a placebo.

Following 16 weeks of treatment, the study revealed that approximately 67% (79 out of 118) of participants who received omalizumab successfully met the primary endpoint criteria. This criterion stipulated the ability to tolerate a minimum of 600 milligrams or more of peanut protein, equivalent to approximately 2.5 peanuts. In contrast, only about 7% of participants (four out of 59) who received placebo injections achieved this threshold.

Moreover, within the omalizumab group, approximately 44% were able to consume a cumulative dose of 6,044 milligrams of peanut protein, equivalent to around 25 peanuts, according to the researchers' findings.

Furthermore, individuals who received omalizumab demonstrated greater tolerance to other allergens such as cashew, egg, and milk compared to those in the placebo group, as indicated by the study.

Despite these promising outcomes, the researchers acknowledged certain limitations of the trial. Notably, the study included only three adults, and the majority of the cohort consisted of individuals who were non-Hispanic and White. This demographic composition may potentially limit the generalizability of the results.

Assessing the Safety of Xolair

Assessing the Safety Profile of Xolair According to Dr. Thomas Casale, a professor of medicine and pediatrics at the University of South Florida Tampa and a former president of the American Academy of Allergy Asthma and Immunology, Xolair may offer a safer alternative for certain individuals with food allergies compared to oral immunotherapy treatments. Dr. Casale, who was not involved in the recent study, highlights that Xolair can provide comparable or even superior protection to the FDA-approved peanut medication, Palforzia. Palforzia functions by gradually exposing children to controlled doses of peanut protein until reaching a maintenance level. Xolair differs from oral immunotherapy in that it does not entail direct exposure to a specific allergen. Dr. Casale notes that Xolair has been administered to patients prior to oral immunotherapy treatments to mitigate the risk of adverse events. Distinguishing Xolair as an anti-IgE injection, Dr. Wood underscores that IgE antibodies play a pivotal role in triggering allergic reactions upon exposure to specific allergens like milk or peanuts. Xolair's mechanism of action involves binding to and blocking these IgE antibodies, thereby preventing allergic reactions from occurring. Dr. Wood emphasizes Xolair's safety profile, citing its widespread use among individuals with asthma who also have concurrent food allergies, with positive outcomes observed in managing both conditions. While Xolair may elicit side effects such as reactions at the injection site and fever, as noted by the FDA, its overall safety remains a cornerstone of its clinical utility.

Is It a "Lifelong" Commitment?

Assessing Treatment Options: Is Xolair Worth the Investment? For individuals grappling with severe food allergies alongside moderate to severe allergic asthma, Xolair could emerge as the optimal treatment, suggests Casale. However, for those experiencing milder allergic reactions, the medication's benefits may not justify its cost. In terms of pricing, the estimated list price for Xolair for food allergy treatment ranges from approximately $2,900 for children to $5,000 for adults per month, as outlined by Genentech. Lindsey Mathias, a spokesperson for Genentech, noted, "The actual cost borne by most patients typically tends to be lower, factoring in their insurance coverage and the availability of other financial assistance programs," in a previous statement to CNN. The monthly expenditure may also fluctuate based on individual factors such as body weight and prescribed dosage. Omalizumab injections are administered in doses ranging from 75 to 600 milligrams once every two or four weeks, either by a healthcare professional or through self-injection at home, according to Novartis. The specific dosage and frequency are determined based on the patient's weight.

Chinthrajah emphasizes the necessity for further research to determine the optimal candidates for Xolair and the duration of treatment required. "We have yet to reach a point in the field where we can accurately identify the most severe phenotype and devise effective protective measures," she explains. Individuals uncertain about pursuing Xolair for themselves or their children should engage in a thorough discussion of the advantages and drawbacks with their healthcare provider, advises Casale. "It's important to remember with these biologics: their efficacy is contingent upon regular administration," he highlights. It's crucial to note, Casale adds, that Xolair does not eradicate food allergies, unlike some environmental allergies such as pollen, which individuals may eventually outgrow. "Considering that this medication only remains effective while being administered, opting for it entails a potential commitment to lifelong therapy," he concludes.

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