Data from Two Studies Confirm Quality of Life and Psychosocial Burden of Living with Peanut Allergy
--APPEAL 2: Struggle to Avoid Accidental Peanut Exposure Negatively Impacts Quality of Life for Patients and Families--
--Phase 3 PALISADE Follow-on Study Analysis: Improvements in Quality of Life for Peanut-Allergic Patients after Continued AR101 Treatment--
“Across Europe, individuals and families are failing to cope with peanut
allergy through a strategy of avoidance of peanuts,” said Audrey
DunnGalvin, Ph.D., investigator of both APPEAL 1 and APPEAL 2 and a
lecturer in the
APPEAL 2 was conducted to gather qualitative data to build upon the findings of APPEAL 1, the first European multi-country quantitative study to assess the psychosocial burden and impact on daily activities in peanut-allergic individuals and their families.
The results of APPEAL 2 amplify the findings of APPEAL 1, showing that peanut allergy affects the lives of peanut-allergic individuals both emotionally and socially, as well as their relationships and daily coping behaviors as they attempt to avoid peanuts and prepare for a reaction in the event of an accidental exposure. Furthermore, peanut-allergic individuals are more likely to experience feeling different, isolated, and restricted of social activities as compared with caregivers, who more often experience stress and adverse impacts on work and career. Both those with peanut allergy and caregivers experience anxiety, worry, sadness, and annoyance, and reported their lives are adversely affected by peanut avoidance, reactions to peanuts, and the fear of reacting to peanuts.
Separately, data from the six-month open-label extension study of PALISADE showed that children receiving the therapeutic dose of AR101 (300 mg/day) for an additional 28 weeks reported improvements in all domains of the Food Allergy Quality of Life Questionnaire (FAQLQ), as well as in the self-reported food allergy specific independent measure (FAIM). The mean (95% CI) change in self-reported FAQLQ domains was greater than the estimated minimal important difference (MID), or the smallest benefit that a patient would say is valuable. Furthermore, improvements over time in domains of FAQLQ and FAIM may reflect the need for the patients and caregivers to adjust to their desensitization status. These improvements in quality of life are consistent with recent findings from a two-year longitudinal study of changes in quality of life due to peanut oral immunotherapy and represent the first data from a clinical trial showing positive changes in food allergy-related quality of life.
“We are encouraged that daily dosing with AR101 in the open-label
extension trial resulted in important and clinically meaningful
improvements in disease-specific quality-of-life measures in children
with peanut allergy,” said Prof. Jonathan Hourihane, MB, BCh., BAO,
investigator with the PALISADE trial and Professor of
About the APPEAL Studies
APPEAL 1 (Allergy to Peanuts ImPacting Emotions And Life 1) collected data from 1,846 participants in eight European countries and was the first pan-European quantitative, cross-sectional survey that explored the psychosocial impacts of living with PA with use of a novel questionnaire. APPEAL 2 (Allergy to Peanuts ImPacting Emotions And Life 2), was the first qualitative evaluation of the impact of living with peanut allergy conducted across multiple European countries. Researchers interviewed 146 individuals with moderate-to-severe peanut allergies– 39 adults ages 18 to 30 years, 39 adolescents ages 13 to 17 years, and 24 children ages 8 to 12 years, as well as 44 caregivers of peanut-allergic individuals ages 4 to 17 years. The goal of the study was to identify concepts important to peanut-allergic individuals and their parents/caregivers, as well as to compare and contrast the impact of peanut allergy between countries and groups.
About the PALISADE Open-Label Extension Trial
A total of 110 children ages 4 to 17 with peanut allergy participated in a six-month open-label extension trial of daily AR101 maintenance therapy after they had completed the double-blind, placebo-controlled, Phase 3 PALISADE trial. Of these, 68 children and 93 parents/caregivers completed an age-appropriate Food Allergy Quality of Life Questionnaire (FAQLQ) at screening and after the open-label extension. At screening, 67.3% of participants had experienced one or more anaphylactic reactions to peanut allergy in their lifetime.
The international, randomized, double-blind, placebo-controlled Phase 3
PALISADE (Peanut Allergy oral Immunotherapy Study
of AR101 for Desensitization) trial evaluated the efficacy
and safety of AR101 in patients with peanut allergy. PALISADE was
conducted at 66 sites in 10 countries in
Patients enrolled in PALISADE underwent a dose escalation period of approximately 22 weeks to reach a therapeutic dose of 300 mg per day of AR101 or placebo, then continued with the daily therapeutic dose at 300 mg per day of AR101 or placebo for approximately six months. At that point, patients underwent an exit DBPCFC, which tested consecutive doses of 3, 10, 30, 100, 300, 600 and 1,000 mg of peanut protein, given 20 to 30 minutes apart, and associated with only mild symptoms. Both the entry and exit DBPCFCs used an independent, blinded assessor. Following the completion of the exit DBPCFC, patients were unblinded and eligible to rollover or crossover into the follow-on ARC004 clinical trial, as appropriate.
Full results from the PALISADE trial were published in the
About Peanut Allergy
Peanut allergy is one of the most common food allergies, affecting more
than 6 million people in the U.S. and
AR101 is a new, peanut-derived investigational oral biologic drug for use in oral immunotherapy in patients with peanut allergy. The drug, which is manufactured in accordance with current Good Manufacturing Practices (cGMP), delivers a daily dose of peanut protein with a consistent protein profile, analyzed to ensure reliable major allergen content. The amount of active ingredient in each AR101 capsule is controlled to ensure minimal variability of allergen content across doses of a given strength. AR101 is administered as an oral powder in graduated doses in pull-apart capsules or foil-laminate sachets. The contents are mixed thoroughly with a few spoonfuls of age-appropriate, unheated food of the patient’s choice.
Aimmune’s Biologics License Application (BLA) for AR101 was accepted for
review by the
About Aimmune Therapeutics
Statements contained in this press release regarding matters that are
not historical facts are “forward-looking statements” within the meaning
of the Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results may
differ materially from those expressed or implied by such
forward-looking statements. Such statements include, but are not limited
to, statements regarding: Aimmune’s expectations regarding the potential
benefits of AR101, including relief from emotional and other factors
that negatively impact quality of life; Aimmune’s expectations regarding
the review of the BLA for AR101 by the
This press release concerns AR101, a product candidate that is under clinical investigation, and AR201, a product candidate that Aimmune expects will be under clinical investigation in 2019. Neither AR101 nor AR201 has been approved for marketing by the FDA or the European Medicines Agency (EMA). AR101 and AR201 are currently limited to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated.
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