The final research results for a new treatment for
protection against accidental exposure to peanut was presented this weekend at
the American College of Allergy, Asthma and Immunology (ACAAI) Annual
Scientific Meeting and published in the New England Journal of Medicine. The results show it is possible
for some people with peanut allergy to protect themselves from accidental
ingestion by building up their tolerance to peanut over time.

“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 allergist Stephen Tilles, MD, ACAAI past
president, study co-author, and consulting advisor for Aimmune Therapeutics.
“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.
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 nine to 12 months of
treatment, and half the patients tolerated the equivalent of four

Study participants ranged in age from 4 to 55 years, most
were 4 to 17, and all had peanut allergy. One third of the participants were
given a placebo, while the remaining two-thirds were given peanut protein
powder in increasing amounts until reaching the “maintenance dose” –
the dose they stayed on for the remainder of the study. The maintenance does
was the equivalent of one peanut daily.

“This is not a quick fix, and it doesn’t mean people
with peanut allergy will be able to eat peanuts whenever they want,” says
allergist Jay Lieberman, MD, vice chair of the ACAAI Food Allergy Committee and
study co-author. “But it is definitely a breakthrough. The hope would be
to have a treatment available in the second half of 2019. If that happens,
people who receive and are able to tolerate this treatment should be protected
from accidental exposures.”

All those in the study received peanut protein as part of an
oral food challenge (OFC). A person in an OFC is given a very small dose of the
food by mouth under the supervision of a board-certified allergist to test for
a severe reaction. OFCs are considered the gold standard for testing food

“Reactions from the oral challenges at the end of the
study were much milder than prior to treatment,” says Dr Tilles. “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 study were milder
than the symptoms on the lower dose at the beginning of the study.”

Facts about this pivotal study:

  • More participants and more detailed data than all prior oral
    immunotherapy studies combined
  • Fewer severe allergic reactions requiring epinephrine during
    oral food challenges
  • Fewer side effects than anticipated – e.g. only six percent
    dropped out of the study due to gastrointestinal side effects; Also, one-third
    of patients completed the study with no more than mild side effects along the
  • 80% of participants successfully reached daily
    maintenance dose of the equivalent of one peanut.

There are currently no approved treatment options for peanut
allergy. If this treatment is approved by the FDA, it will be available by
prescription, and people with peanut allergy will need to remain on it to stay
protected against accidental consumption. Once someone stops the treatment,
there is no longer a protective effect.


Reference: AR101
Oral Immunotherapy for Peanut Allergy. The PALISADE Group of Clinical
Investigators. NEJM. Published 18 November 2018.