Efficacy and Safety of Dupilumab in Children With Peanut Allergy: A Multicenter, Open-Label, Phase II Study
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 all...
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| creator | Sindher, Sayantani B Nadeau, Kari C Chinthrajah, R Sharon Leflein, Jeffrey G Bégin, Philippe Ohayon, Jason A Ponda, Punita Wambre, Erik Liu, Jinzhong Khokhar, Faisal A Akinlade, Bolanle Maloney, Jennifer Orengo, Jamie M Hamilton, Jennifer D Kamal, Mohamed A Hooper, Andrea T Patel, Naimish Patel, Kiran Laws, Elizabeth Mannent, Leda P Radin, Allen R |
| description | 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.
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 |
| format | Article |
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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.
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.
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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.
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.
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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.
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.
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| title | Efficacy and Safety of Dupilumab in Children With Peanut Allergy: A Multicenter, Open-Label, Phase II Study |
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