Peer-reviewed article
Efficacy and Safety of Dupilumab in Children With Peanut Allergy: A Multicenter, Open‐Label, Phase II Study
Sayantani Sindher, Kari Christine Nadeau, R. Sharon Chinthrajah, Jeffrey G. Leflein, Philippe Bégin et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study tested whether dupilumab, a monoclonal antibody medication, could help children with peanut allergy become safer around peanut exposure. Twenty-four children aged 8-17 in the US and Canada received dupilumab injections for 24 weeks. Although the drug reduced certain immune markers and was well tolerated, it did not help children tolerate peanut protein during challenge testing, with only 8% meeting the primary safety goal.
Key points
- Only 2 of 24 participants (8.3%) passed the food challenge test with at least 444 mg of peanut protein after 24 weeks of dupilumab treatment
- Most participants (62.5%) experienced mild to moderate adverse events during treatment
- At the final food challenge, 33% had grade 2 allergic reactions and 42% required adrenaline rescue medication
- Dupilumab reduced total and peanut-specific IgE levels by 54% and 49% respectively, but did not change peanut-specific IgG4
- The study concluded that dupilumab monotherapy for 24 weeks did not improve desensitization to peanut exposure
Limitations
This was an open-label study without a control group, so the results cannot account for placebo effects or natural variation. The small sample size (n=24) and short 24-week duration limit the ability to detect longer-term effects or generalize findings to broader populations.
Abstract
BACKGROUND: Peanut allergy is a potentially life-threatening food allergy in children. This study explored whether dupilumab, a human monoclonal immunoglobulin (Ig)G4 antibody that blocks the activity of interleukin (IL)-4/IL-13, improved safety and desensitization to peanut exposure in children with peanut allergy. METHODS: A Phase II, 24-week, multicenter, single-arm, open-label, proof-of-concept study was conducted in the USA and Canada (NCT03793608). Children/adolescents with peanut allergy received subcutaneous dupilumab 300 mg (≥ 60 kg) or 200 mg (≥ 20 to < 60 kg) every 2 weeks. The primary endpoint was the proportion of participants who passed a double-blind placebo-controlled food challenge (DBPCFC) with ≥ 444 mg (cumulative) of peanut protein at week 24. Secondary endpoints included safety measures (Consortium of Food Allergy Research grading system) and change from baseline in peanut-specific (ps)-IgG4, total IgE, and ps-IgE. RESULTS: Twenty-four participants enrolled and received dupilumab: 75.0% were male, 79.2% were white, mean (standard deviation) age was 11.7 (3.3) years. Most (95.8%) participants had not received allergen immunotherapy. Two participants (8.3%) achieved the primary endpoint and passed the DBPCFC at week 24. Fifteen participants (62.5%) reported 66 treatment-emergent adverse events, all being mild or in moderate intensity. At the week 24 DBPCFC, 8 participants (33.3%) had a grade 2 allergic reaction (no grade 3 or above); 10 (41.7%) used adrenaline as a rescue medication. Dupilumab treatment resulted in a median reduction of total and ps-IgE of -54% and -49%, respectively, and a 0% change in ps-IgG4. CONCLUSIONS: Dupilumab monotherapy treatment for 24 weeks did not improve desensitization to peanut exposure after food challenge.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Subcutaneous dupilumab injections (300 mg or 200 mg every 2 weeks for 24 weeks)
- Population
- 24 children and adolescents with confirmed peanut allergy, mean age 11.7 years, in USA and Canada
Key finding
2 of 24 participants (8.3%) achieved the primary endpoint of passing double-blind placebo-controlled food challenge with ≥444 mg peanut protein