Newswise — DALLAS – Nov. 07, 2023 – Low doses of an immunotherapy taken under the tongue safely achieved desensitization to peanut allergies in children ages 1 to 4 years, according to results of a clinical trial conducted by researchers at UT Southwestern Medical Center, Children’s Medical Center Dallas, and the University of North Carolina School of Medicine.

The findings, which show promise for long-lasting immunologic response, offer the potential for treating a life-threatening condition commonly linked to fatal food-induced anaphylaxis (severe allergic reaction). Peanut allergies affect up to 2% of children in Western countries and are rarely outgrown.

“A small amount of peanut protein sublingual immunotherapy (SLIT) can have a big effect,” said Andrew “Drew” Bird, M.D., Professor of Pediatrics and Internal Medicine and Interim Chief of the Division of Pediatric Allergy and Immunology at UT Southwestern, who participated in the study. “We show it’s sustainable for nearly two-thirds of children undergoing the therapy, with a higher likelihood of success when introduced earlier in life.”

Dr. Bird, Director of the Food Allergy Center at Children’s Medical Center Dallas and a Dedman Family Scholar in Clinical Care at UTSW, said this trial is the first to demonstrate the safety and efficacy of low-dose SLIT for peanut allergies in young children. He researches treatments for life-threatening reactions to foods and is collaborating with colleagues in multiple clinical trials using food proteins for immunotherapy.

The study was published in The Journal of Allergy and Clinical Immunology. In the three-year trial, peanut SLIT produced desensitization and remission of allergic reactions in young children for three months after they stopped the therapy.

Fifty participants with a diverse representation of sex and ethnicity, including 10 at Children’s, were enrolled. During the randomized study, 25 children received 4 milligrams of peanut protein in the SLIT treatment, while the other 25 received a glycerinated saline placebo. Drops of the treatment or placebo products were placed under the children’s tongues daily for three years.

The researchers assessed participants’ desensitization response at month 36, followed by remission evaluation through a double-blind, placebo-controlled food challenge three months after the therapy was discontinued. They found that 60% of the children on SLIT achieved desensitization compared with none on the placebo. Similarly, 48% of those who received SLIT achieved three-month remission compared with none on placebo controls at month 39.

The findings suggest there is a window of opportunity for immune modulation in young children. The highest desensitization rate of 75% was observed among children ages 1 to 2, 50% at ages 2 to 3, and 43% at ages 3 to 4. This trend was similar in the remission rate.

“Few studies have demonstrated the potential for a long-term benefit using any therapy for peanut-allergic children, so it’s exciting to think about safe and feasible treatments in development that could soon be available,” Dr. Bird said. “Larger trials are needed to validate these findings, but this could lead to safe, early interventional therapy that may change the natural history of a disease that is typically lifelong.”

This research was funded by grants from Food Allergy Research and Education (FARE), the National Center for Complementary and Integrative Health (R01-AT-004435), the National Institutes of Health (5T32–AI007062), the National Institute of Allergy and Infectious Diseases (K23AI130408), the Meade Family Pediatric Allergy Research Fund, and the National Center for Advancing Translational Sciences (UL1TR002489).

About UT Southwestern Medical Center

UT Southwestern, one of the nation’s premier academic medical centers, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty members have received six Nobel Prizes and include 26 members of the National Academy of Sciences, 20 members of the National Academy of Medicine, and 13 Howard Hughes Medical Institute Investigators. The full-time faculty of more than 3,100 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide care in more than 80 specialties to more than 120,000 hospitalized patients, more than 360,000 emergency room cases, and oversee nearly 5 million outpatient visits a year.

Journal Link: The Journal of Allergy and Clinical Immunology