Article highlights
- A study explored peanut SLIT in children aged 1 to 4 years to alleviate peanut allergies, which significantly impact their quality of life.
- Conducted at UNC and UTSW, the double-blind, placebo-controlled study enrolled 50 participants, randomized to receive peanut SLIT or placebo SLIT, assessing desensitization and remission rates.
- Peanut SLIT participants showed significant improvement, reaching a median cumulative tolerated dose (CTD) of 4443 mg at 36 months, while the placebo group's CTD was 143 mg, demonstrating desensitization and remission.
- Younger children (1-2 years) demonstrated higher desensitization and remission rates, emphasizing the importance of early intervention.
- The study suggests that peanut SLIT is a safe and effective method for desensitizing and achieving remission in young children with peanut allergies.
The primary outcome of desensitization and remission using peanut sublingual immunotherapy (SLIT) in children aged 1 to 4 years was observed in a study recently published in The Journal of Allergy and Clinical Immunology.
Developing early in life, peanut allergy affects approximately 1% to 2% of children in Western nations, requiring vigilance to avoid ingestion. This vigilance, combined with anxiety and social isolation, can be a significant burden for patients and their families, often leading to a decreased quality of life.
Investigators designed a multicenter, double-blind, randomized, placebo-controlled study (NCT02304991) of peanut SLIT for 36 months in peanut-allergic children aged 1 to 4 years. The study was conducted at the University of North Carolina (UNC) and the University of Texas Southwestern (UTSW). A positive reaction during a double-blind, placebo-controlled food challenge (DBPCFC) to 1000 mg peanut protein was required to be randomized.
A history of severe anaphylaxis to peanut defined as hypoxia, hypotension, or neurologic compromise, eosinophilic or other inflammatory gastrointestinal disease, along with severe asthma were key exclusion criteria.
Individuals were randomly assigned (1:1) to receive the study drug with either peanut SLIT or placebo SLIT. Oat flour was used as a placebo during DBPCFC. Liquid peanut extract (5000 mg/mL peanut protein) from Greer Laboratories made up the study drug. Pure glycerinated saline solution with an added caramel coloring comprised the placebo SLIT.
At entry of the DBPCFC, all participants underwent a 1000 mg cumulative challenge; 6 doses (3, 10, 30, 100, 300, and 557 mg peanut protein) administered 10 to 20 minutes apart. Oat flour in the placebo group was administered in identical doses by weight. At month 36, the DBPCFC was performed to a cumulative dose of 4443 mg, and administered in 7 doses (3, 10, 30, 100, 300, 1000, and 3000 mg). At the 36-month DBPCFC, participants with a cumulative tolerated dose (CTD) of at least 443 mg were instructed to stop the study drug and continue peanut avoidance for 3 months. To assess for remission, a final month 39 DBPCFC was conducted. If the participant ingested all doses and completed 2 hours of observation without meeting stopping criteria, the DBPCFC was scored as a pass.