Disparities Persist in Food Allergen Immunotherapy Trials

Authors of a commentary published in JAMA Network Open highlighted ongoing disparities among participants in clinical trials for food allergen immunotherapies, which limits the generalizability and applicability of trial results.¹

Oral immunotherapy is a growing area of research that involves ingesting increasing doses of the allergen to desensitize the patient’s immune system. The approach trains the immune system not to react to the food, and although recent interest has grown, early accounts of oral immunotherapy reach back to the early 20th century.²

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Patients with food allergies typically access oral immunotherapy through clinical trials or allergists and immunologists in practice. Allergies treated with this approach include milk, egg, peanut, tree nut, wheat, soy, sesame, and baked milk and baked egg. Studies of this approach tend to be small and have varied designs, and protocols for oral immunotherapy also vary between practices.²

“Food oral immunotherapy is an innovative step forward for food allergy management in both children and adults; however, major concerns have arisen regarding the applicability of clinical trial results due to racial and ethnic disparities in trial participants,” the commentary authors wrote.¹

Randomized clinical trials must be designed with the end goal—applicability to patients—in mind. However, when the study participants are not representative of the population that the product is intended to ultimately serve, the applications of the findings and any subsequently developed guidelines are weakened.¹

Recruitment, retention, and racial and ethnic classification efforts are all affected by issues that limit a diverse body of participants. Researchers Suffian et al. identified these barriers and suggested some approaches and short-term solutions, but the commentary authors questioned whether these efforts were enough.¹

According to the commentary, most potential solutions to-date concentrate primarily on downstream influences, such as improvements in clinical care management, inclusion reports for clinical trials, and reclassification focus on how to define individuals’ race and ethnicity through governmental agencies. However, the authors said these approaches fail to change upstream decisions that drive the lack of equality, resulting in disparate outcomes.¹

Instead, the authors recommend multilevel interventions to address health equity and focus on structural and social determinants of health (SDOH) that are underlying these inequities. Although expensive and time consuming, the authors said SDOH must be addressed.¹

“Simply stated, children and adults do not have access to the services they need,” the authors wrote.¹

Firstly, the authors agreed with Suffien et al. that standardized definitions for races and ethnicities must be established, and they must be universally accepted beyond the National Institutes of Health. The authors also urged research bodies to track recruitment and prioritize strategies for equitable recruitment, incorporating community-based participatory research.¹

Alongside these approaches, the authors said clinicians and researchers must comprehensively understand the broader issues at play. Access to care via telemedicine, mobile subspecialists, and other innovative models can help address lack of access to care. Further, clinical reimbursement must be appropriate given the time and expertise required for these interventions.¹

Although these are complex and challenging issues to address, the authors said health inequities in oral immunotherapy clinical trials for food allergens must be addressed in order to reach the full potential of these treatment modalities.¹

“Achieving health equity in [food oral immunotherapy] trials starts with ensuring that every child and adult with suspected IgE-mediated food allergies has access to standard-of-care diagnostics and therapeutics,” the authors concluded. “By addressing this fundamental issue, we can pave the way for higher levels of care and participation in clinical trials for future therapies.”¹

REFERENCES
1. Hoyt AEW, Adeleke SA, Pappalardo AA. Addressing disparities in food allergen immunotherapy trials. JAMA Netw Open. 2024;7(9):e2432612. doi:10.1001/jamanetworkopen.2024.32612

2. Oral Immunotherapy (OIT). Food Allergy Research & Education. Accessed October 24, 2024. https://www.foodallergy.org/resources/oral-immunotherapy-oit