A novel oral immunotherapy drug—derived from peanut protein—could help treat people who are allergic to the nut, a study has found.
Controlled ingestion of peanut protein could help build tolerance in peanut allergy sufferers, researchers said.
“The results of this landmark trial are likely to lead to the first FDA-approved treatment for food allergy in 2019,” said Christina Ciaccio, an associate professor at the University of Chicago in the US.
Researchers in 10 countries across North America and Europe conducted the trial, known as the Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization trial (PALISADE).
Of 496 eligible participants ages 4 to 17, 372 received the AR101 oral medication, while the remainder received a placebo drug.
At the end of the trial, more than two-thirds of the group taking the active drug were able to tolerate a dose of peanut protein equivalent to about two peanut kernels.
According to the study, oral immunotherapy for peanut allergy has been recommended against in most clinical settings because past trials have been limited by small sample sizes and differing methodologies.
The PALISADE trial has shown, however, that oral immunotherapy is a reasonable treatment option.
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Participants of the PALISADE trial were instructed to continue the standard of care for peanut allergy, which meant eliminating peanuts from their diets and carrying self-injectable epinephrine (an emergency medical treatment for accidental exposure).
Qualifying participants started with a one-day supervised increase in dosage from 0.5 mg of peanut protein up to 6 mg, an increase every two weeks from 3 mg to 240 mg and a 24-week “maintenance phase” at 300 mg.
When adverse reactions occurred, the study protocol allowed for adjustments to the dosing schedule. Compared to the placebo group, participants who took AR101 had less severe allergy symptoms.