Food allergies are a poorly understood group of immune-mediated conditions that leave many of those affected susceptible to serious allergic reactions and the psychosocial burdens of living with a chronic, unpredictable, disruptive and life-threatening disorder.
According to Food Allergy Research and Education (FARE), the leading patient advocacy organization, approximately 32 million Americans are now affected by food allergies, which are the leading cause of anaphylaxis in children. This represents a rapid and substantial increase in prevalence over the preceding decades, a real change that is likely driven by a complex set of genetic and environmental influences.
Emory University and Children’s Healthcare of Atlanta (Emory+Children’s) are committed to addressing this public health crisis, establishing the Food Allergy Center at Emory+Children’s for the study and treatment of food allergies in 2018 and recruiting Dr. Brian Vickery, a recognized expert in the field, as its first director. The short-term goal for the center is to become a national leader in food allergy within five years, and we are well on our way toward this goal. Within a year of its founding, the center joined the Food Allergy Research & Education (FARE) Clinical Network as a Clinical Research Center of Distinction, one of only 19 nationwide to earn this award. The goal over time is to build a world-class organization that establishes Atlanta as a global hub for innovation in allergic diseases research.
The mission of the Emory+Children’s Food Allergy Center is to perform impactful research and deliver high-quality, high-value, patient-centered care to have transformative impact on the lives of those affected by food allergy in the Southeast and beyond. There are four core domains of the center’s mission that recognize the complex ecosystem in which clinical care and research intersect to improve outcomes for patients.
The first domain is to provide state-of-the-art clinical care to patients with food allergies and related conditions. An example of this cutting-edge care is peanut oral immunotherapy (OIT) with Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp), the first drug to be approved by the FDA for the active treatment of any food allergy.
Dr. Vickery led the groundbreaking Phase 3 PALISADE clinical trial that demonstrated the safety and efficacy of this treatment and ultimately led to the drug’s approval, publishing the results in The New England Journal of Medicine in 2018. Dr. Vickery and the Children’s Healthcare of Atlanta Allergy team subsequently treated the first patient in the United States in early 2020 when Palforzia became commercially available (see sidebar). While not a cure for the peanut allergy, Palforzia offers robust protection to peanut-allergic patients by shifting their allergen threshold levels to 1000 mg or even 2000 mg (equivalent to roughly four or eight whole peanuts, respectively) of peanut protein after a year on treatment. This translates to an approximately 100-fold improvement on average, which provides families peace of mind by greatly reducing the risk of anaphylaxis.
Advancing clinical care treatment options with rigorously tested treatments like Palforzia – and the many future treatments that will follow it – is only made possible by the work of researchers and the selfless participation of brave families who participate in scientifically sound clinical trials.
The second domain of the group’s mission is to create and disseminate new knowledge through research. Of the six current active clinical trials at Children’s, three are industry-sponsored and target children with a peanut allergy. The fourth trial is an innovative study of children and adults with multiple food allergies being conducted by the prestigious NIH-supported Consortium of Food Allergy Research (CoFAR), which the Emory+Children’s site was invited to join for this project.
This trial, “OUtMATCH: Omalizumab as monotherapy and as adjunct therapy to multi-allergen OIT in food-allergic children and adults,” is a Phase 3, randomized, double-blind, placebo-controlled trial of the asthma drug omalizumab (Xolair) alone and combined with multi-food oral immunotherapy (OIT) that is being conducted at 10 leading food allergy centers nationwide. The study team is actively seeking eligible patients who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut or walnut) that might be interested in participating. (See sidebar for additional information about this study and how to refer patients for this or future clinical trials.)
Clinical trial visits are conducted in the Center for Advanced Pediatrics, located at the Children’s campus at 1400 Tullie Road in Atlanta. The Center for Advanced Pediatrics is a 260,000-square-foot outpatient clinic facility that brings together more than 20 pediatric specialties under one roof enabling care coordination for our complex patient population. The six-bed Pediatric Research Unit is located on the 5th floor of the center and includes specialized nursing staff, laboratory facilities, state-of-the-art equipment and an investigational drug pharmacy. Food allergy studies are conducted by a team of dedicated investigators, coordinators and nurses led by Dr. Vickery.
Dr. Vickery and his team have exciting plans to expand their research to include novel treatments for peanut and additional types of food allergies. They hope to extend beyond the current allergen immunotherapy paradigm to include innovative newer technologies such as immunomodulatory biologics (monoclonal antibodies) and small molecule drugs. Studies beginning later this year will focus on new methods for diagnosis and prevention of food allergies, eczema and other atopic conditions.
Much of this work is already occurring in collaboration with the asthma research group at Emory led by Dr. Anne Fitzpatrick; many current opportunities exist for those with asthma to participate in research. Other ongoing collaborations with investigators associated with Georgia Tech include early studies exploring the applications of new technologies such as microneedles, nanoparticles and wearable devices. Finally, in collaboration with Dr. Will Sharp and the Multidisciplinary Feeding Team at Children’s, our group is pursuing observational and interventional studies to better understand and treat the considerable psychological and social impacts caused by food allergies that negatively affect quality of life.
In the future, the group will add expertise in basic and translational research to explore the inner workings of the human immune system in order to improve understanding of the pathophysiology of food allergies and anaphylaxis.
The last two domains of the Center’s mission are to advocate for children, including those who are historically underrepresented, through stakeholder engagement at all levels and to provide a world-class training experience for the next generation of clinicians and scholars. We encourage learners at any level from high school through the postdoctoral years to contact us if interested. You can also stay informed about the program by following Dr. Vickery on Twitter and Instagram @ATLergist, or by visiting the research group’s website, www.bit.ly/ATLergist.
Food Allergy Clinical Trials at Children’s Healthcare of Atlanta
Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants; clinicaltrials.gov entry NCT03881696
Actively seeking patients ages 1-55 who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut or walnut)
Peanut Oral Immunotherapy Study of Early Intervention for Desensitization; NCT03736447
Closed to Enrollment
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age; NCT3211247
Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy); NCT03682770
Enrolling by invitation
Long-term Safety Study of AR101 in Subjects Who Participated in a Prior AR101 Study; NCT03292484
Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children; NCT03859700
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