Study highlights disparities in access to new pediatric food allergy treatment, omalizumab - Children's National

Pediatric food allergy (FA) is a common chronic health condition that can place a significant burden on children and their families. Managing food allergies often requires constant vigilance, and accidental exposures remain common despite careful allergen avoidance efforts. Now, a newly approved treatment called omalizumab is beginning to change that landscape.

In a recent study published in Pediatric Allergy and Immunology, experts from Children's National examined the demographic profiles and medical histories of pediatric patients who chose to start omalizumab, a food allergy treatment approved by the Food and Drug Administration in 2024.

This study provides early real-world insights into which patients are pursuing omalizumab and highlights important questions about health equity and access to this promising therapy.

The big picture

Using data from the Children's National Food Allergy Clinic, researchers reviewed the records of 56 children who started omalizumab and compared them with 3,112 food allergy patients seen during the same period.

"Since FDA approval in 2024, clinicians have begun to offer omalizumab as a therapeutic option for pediatric FA," said Tiffany Kichline, Phd, pediatric psychologist and lead author of the study. "However, little is known about the uptake of this treatment among FA patients."

What is known is the viability of the treatment. Omalizumab is a monoclonal antibody that blocks circulating IgE antibodies associated with allergic reactions. In a landmark clinical trial, 67% of food allergy patients who received omalizumab for four months were able to tolerate small amounts of multiple food allergens without experiencing an allergic reaction, reducing their risk from accidental exposures.

Key insights

Researchers found that children starting omalizumab were often those with more severe allergy histories. More than 91% had multiple food allergies, and nearly 73% had experienced anaphylaxis.

The study also identified significant demographic differences. Patients who started omalizumab were more likely to identify as White (69.6% versus 26.0% of the overall clinic population), less likely to identify as Black (8.9% versus 37.8%) and less likely to identify as Hispanic (7.1% versus 20.0%). In addition, nearly 90% of patients who started omalizumab had private insurance, compared with 55.3% of the overall clinic population.

These findings raise important questions about potential barriers to treatment awareness, access and uptake. Researchers say a better understanding of these disparities could help inform efforts to ensure equitable access to new food allergy therapies.

What's next?

Additional studies are needed to better understand how omalizumab affects quality of life and psychosocial outcomes for patients and families. Researchers suggest the treatment may help reduce anxiety related to accidental allergen exposure and ease some of the day-to-day burden associated with managing food allergies.

Future research should also explore whether differences in omalizumab uptake are related to factors such as patient knowledge, treatment burden, cost or access to care. Understanding these factors will be critical to ensuring equitable implementation and dissemination of this new treatment.

Additional Children's National authors include William J. Sheehan, MD, Hemant Sharma, MD, MHS, Linda Herbert, PhD, and Kimberly Burfeind, BA.

Read the full study, Racial and socioeconomic disparities exist in pediatric food allergy patients pursuing omalizumab.