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Randomized Controlled Trial
. 2024 Jan;153(1):173-181.e10.
doi: 10.1016/j.jaci.2023.08.032. Epub 2023 Oct 10.

Desensitization and remission after peanut sublingual immunotherapy in 1- to 4-year-old peanut-allergic children: A randomized, placebo-controlled trial

Edwin H Kim  1 , J Andrew Bird  2 , Corinne A Keet  3 , Yamini V Virkud  3 , Lauren Herlihy  3 , Ping Ye  3 , Johanna M Smeekens  3 , Rishu Guo  3 , Xiaohong Yue  3 , Anusha Penumarti  3 , Bahjat Qaqish  4 , Quefeng Li  4 , Michael D Kulis  3 , A Wesley Burks  3
Affiliations
Randomized Controlled Trial

Desensitization and remission after peanut sublingual immunotherapy in 1- to 4-year-old peanut-allergic children: A randomized, placebo-controlled trial

Edwin H Kim et al. J Allergy Clin Immunol. 2024 Jan.

Abstract

Background: Prior studies of peanut sublingual immunotherapy (SLIT) have suggested a potential advantage with younger age at treatment initiation.

Objective: We studied the safety and efficacy of SLIT for peanut allergy in 1- to 4-year-old children.

Methods: Peanut-allergic 1- to 4-year-old children were randomized to receive 4 mg peanut SLIT versus placebo. Desensitization was assessed by double-blind, placebo-controlled food challenge (DBPCFC) after 36 months of treatment. Participants desensitized to at least 443 mg peanut protein discontinued therapy for 3 months and then underwent DBPCFC to assess for remission. Biomarkers were measured at baseline and longitudinally during treatment.

Results: Fifty participants (25 peanut SLIT, 25 placebo) with a median age of 2.4 years were enrolled across 2 sites. The primary end point of desensitization was met with actively treated versus placebo participants having a significantly greater median cumulative tolerated dose (4443 mg vs 143 mg), higher likelihood of passing the month 36 DBPCFC (60% vs 0), and higher likelihood of demonstrating remission (48% vs 0). The highest rate of desensitization and remission was seen in 1- to 2-year-olds, followed by 2- to 3-year-olds and 3- to 4-year-olds. Longitudinal changes in peanut skin prick testing, peanut-specific IgG4, and peanut-specific IgG4/IgE ratio were seen in peanut SLIT but not placebo participants. Oropharyngeal itching was more commonly reported by peanut SLIT than placebo participants. Skin, gastrointestinal, upper respiratory, lower respiratory, and multisystem adverse events were similar between treatment groups.

Conclusion: Peanut SLIT safely induces desensitization and remission in 1- to 4-year-old children, with improved outcomes seen with younger age at initiation.

Keywords: Peanut allergy; SLIT; desensitization; food allergy; food immunotherapy; remission; sublingual immunotherapy.

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Conflict of interest statement

CONFLICTS OF INTEREST

EHK reports advisory board membership with ALK-Abello, Kenota Health, and Ukko Inc; consultancy with AllerGenis, Allergy Therapeutics Ltd, Belhaven BioPharma, Duke Clinical Research Institute, Genentech, Nutricia, and Revolo; and receives grant funding to his institution from the National Center for Complementary and Integrative Health (NCCIH), National Institute of Allergy and Infectious Diseases (NIAID), and Food Allergy Research and Education (FARE). JAB reports consultancy with AllerGenis, Allergy Therapeutics Ltd, Before Brands, DBV Technologies, FARE, Genentech, HAL Allergy, Novartis, and Nutricia; and receives grant funding to his institution from Aimmune Therapeutics, Astellas, DBV Technologies, FARE, Genentech, NIAID, Novartis, Regeneron, and Siolta; CAK is an Associate Editor at the Journal of Allergy and Clinical Immunology; is on the Board of the American Board of Allergy and Immunology; and receives royalties from Up-to-Date. MDK reports consultancy with Ukko, Inc. and receives research support to his institution from NIAID and the US Department of Defense. AWB reports advisory board membership with Aimmune Therapeutics, Consortia TX, and Ukko Inc; consultancy with Allergy Therapeutics Ltd and DBV Technologies; royalties from UpToDate, Elsevier, and Wolter Kluwer; and receives grant funding to his institution from NCCIH, NIAID, FARE, and the Burroughs Wellcome Fund. The remaining authors declare no conflicts of interest.

Figures

Figure 1:
Figure 1:
Participant flow diagram
Figure 2A-B:
Figure 2A-B:
Percentage of participants passing the peanut oral food challenge during the (A) month 36 desensitization DBPCFC and (B) month 39 remission DBPCFC. ITT group includes 25 participants per arm. Per protocol group includes 19 peanut SLIT and 17 placebo participants. ***p = 0.005, ****p < 0.0001.
Figure 3A-D:
Figure 3A-D:
Longitudinal analysis of (A) peanut skin prick test, (B) peanut-specific IgE, (C) peanut-specific IgG4, and (D) peanut-specific IgG4/IgE ratio in the per protocol group. Red lines depict the median values. Values at all time points were compared to baseline. *p < 0.05, **p < 0.01, ***p < 0.001, ****p < 0.0001.
Figure 4A-C:
Figure 4A-C:
Analysis of (A-B) desensitization and (C) remission oral food challenge outcomes by age. Red lines depict the median values. ITT group includes age 1–2 years: 12 participants; 2–3 years: 6 participants; 3–4 years: 7 participants. Per protocol group includes age 1–2 years: 9 participants; 2–3 years: 4 participants; 3–4 years: 6 participants.
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