'Breakthrough' treatment for peanut allergy awaits FDA check

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‘Breakthrough’ treatment for peanut allergy awaits FDA check

Peanut allergy makes life more difficult for the millions of people who live with it. “Possible traces” of peanuts in foods pose a constant hidden threat for them, but a newly developed treatment could soon help people with peanut allergy become more confident in their food choices.

Peanut allergy may soon become less of a concern thanks to an effective new treatment.

Information provided last year by specialists from the American College of Allergy, Asthma, and Immunology (ACAAI) indicates that almost 2.5 percent of all children in the United States may live with peanut allergy.
This number represents a 21 percent increase in the number of possible peanut allergies in childhood since 2010, the specialists also found.
A critical challenge for those living with peanut allergy is distinguishing between food products that are 100 percent safe to eat, and those that may trigger an allergy episode.
For some people, the allergy can be significant enough to lead to anaphylaxis, a severe, life-threatening reaction. Many food items may contain traces of peanuts because the factories that produce them also handle peanuts.
However, a new treatment developed by experts from research institutions across the world hopes to help individuals with this type of food allergy. The treatment aims to build up enough tolerance to peanuts so that people with a peanut allergy can handle accidental exposure without any problems.
“We’re excited about the potential to help children and adolescents with peanut allergy protect themselves against accidentally eating a food with peanut in it,” says study author Dr. Stephen Tilles, who is also past president of ACAAI, and consulting advisor for the biotech company Aimmune Therapeutics.
The researchers presented their results today at the ACAAI Annual Scientific Meeting in Seattle, WA. These findings also appear in The New England Journal of Medicine.

Participants see increase in tolerance

“Because there is no approved treatment for peanut allergy, the standard of care has been a strict elimination diet and the timely administration of rescue medications in case of an allergic reaction on accidental exposure,” the study authors write.
“However, despite vigilance, accidental exposures may occur and cause reactions of unpredictable severity, even with small amounts of allergen, leading to a lifelong risk of severe reactions,” they continue.
The recent study tested the effectiveness of a new oral immunotherapy for peanut allergy called AR101, which is “a […] peanut-derived, oral biologic drug that delivers a target daily maintenance dose of 300 [milligrams] of peanut protein,” as the researchers explain in the study paper.

The research team worked with participants aged from 4 to 55 years old, though most of these fell in the 4 to 17 age range. All of the participants lived with peanut allergy.
At the beginning and the end of the study, the volunteers undertook an oral food challenge so that the scientists could establish the severity of their allergic reactions.
Of the total number of participants, two-thirds received AR101, while a third received a placebo. Each person received their assigned substance in increasing doses until they reached the maintenance dose — they continued to take this amount tor the duration of the study.
The researchers found that by the end of the study, 80 percent of the participants successfully reached the daily maintenance dose, which was the equivalent of about one peanut.
As Dr. Tilles explains, many participants saw a significant increase in their tolerance to peanuts. “Our hope when we started the study was that by treating patients with the equivalent of one peanut per day, many would tolerate as much as two peanuts,” the study author says.
“We were pleased to find that two-thirds of the people in the study were able to tolerate the equivalent of two peanuts per day after 9 to 12 months of treatment, and half the patients tolerated the equivalent of four peanuts.” Dr. Stephen Tilles.

Treatment may soon become available

Moreover, participants reported far fewer side effects throughout the trial than the researchers had predicted. No more than 6 percent of the participants experienced gastrointestinal side effects that caused them to leave the trial, while as many as one-third of the volunteers only experienced mild side effects.
As Dr. Tilles points out, “Reactions from the oral challenges at the end of the study were much milder than prior to treatment.”
“On average, the participants were able to tolerate a 100-fold higher dose of peanut at the end of the study than they did at the beginning. In addition, the symptoms caused by the 100-fold higher dose at the end of [the] study were milder than the symptoms on the lower dose at the beginning of the study,” he adds.
However, “This is not a quick fix, and it doesn’t mean people with peanut allergy will be able to eat peanuts whenever they want,” notes another one of the study’s authors, Dr. Jay Lieberman, who is vice chair of the ACAAI Food Allergy Committee.
“But,” he says, “it is definitely a breakthrough.” He also expresses the hope that very soon, the US Food and Drug Administration (FDA) will review the treatment, and that it may be more widely available “in the second half of 2019.”
“If that happens,” Dr. Lieberman adds, “people who receive and are able to tolerate this treatment should be protected from accidental exposures.”

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‘Breakthrough’ treatment for peanut allergy awaits FDA check

Participants see increase in tolerance

Treatment may soon become available

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