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Data from the LIBERTY AD ADOL trial showed that adolescent patients with moderate-to-severe atopic dermatitis treated with the biologic reported decreases in total and allergen-specific IgE levels for cat dander, peanuts, and more.
New data on the monoclonal antibody dupilumab (Dupixent) suggested that treatment with the medication for 16 weeks resulted in a considerable reduction in blood levels of total and allergen-specific immunoglobulin E (IgE) in adolescent patients 12-17 years old with moderate-to-severe atopic dermatitis.
The findings were presented at the 2021 American College of Allergy, Asthma, and Immunology (ACAAI) Scientific Meeting in New Orleans during the session “Dupilumab Decreases Total and Allergen-Specific IgE in Adolescents with Moderate-to-Severe Atopic Dermatitis”.
Investigators led by Eric L. Simpson, MD, Oregon Health and Science University, Portland, Oregon, noted that most patients with atopic dermatitis and other atopic diseases have increased IgE levels in addition to increased sensitization to various common allergies.
With their session, “Dupilumab Decreases Total and Allergen-Specific IgE in Adolescents with Moderate-t0-Severe Atopic Dermatitis”, Simpson and colleagues reported the change in total and specific IgE serum levels in pediatric patients aged 12-17 years with moderate-to-severe atopic dermatitis.
Simpson and fellow investigators utilized data from LIBERTY AD ADOL, an international, randomized, placebo controlled, double-blind, multi-center, phase 3 trial which evaluated the efficacy and safety of dupilumab monotherapy every 2 or 4 weeks for a total of 16 weeks.
Adolescents were randomized 1:1:1 to dupilumab 300 mg every 4 weeks (300 mg-q4w), dupilumab 200 mg/300 mg every 2 weeks(-q2w), and a placebo group.
A total of 251 patients were enrolled in the study.
Of those patients, 84 were enrolled in the dupilumab 300 mg-q4w group, while 82 and 85 were enrolled in the dupilumab 200 mg/300 mg-q2w and placebo groups, respectively.
Investigators evaluated median interquartile range (IQR) values and percent changes form baseline in total and allergen-specific IgE over the course of 16 weeks.
Simpson and colleagues reported that baseline median (IQR) total IgE levels (kU/L) were similar across all groups (300mg-q4w: 3,482.0 [728.0-10,000.0]; 200mg/300mg-q2w: 3,739.5 [1,699.0-9,517.0]; placebo: 3,983.0 [813.0-10,931.0]).
Additionally, significantly greater decreases in total and allergen-specific IgE levels for cat dander, cow’s milk, egg white, peanut, and dust mite were observed in dupilumab-treated vs placebo-treated adolescents at week 16.
Allergen-specific IgE levels mostly remained above the level(0.35kU/L) used as a cutoff to diagnose specific sensitization in individuals at Week 16, and treatment-emergent adverse events of food allergy were reported for 3 patients during the study period (2 placebo/1 dupilumab q2w)
Overall, dupilumab was well tolerated in the LIBERTY AD ADOL trial 1, and data were consistent with the known dupilumab safety profile observed in adults
Incidences of treatment emergent adverse events (TEAEs) were similar across treatment groups, and food allergy treatment-emergent adverse events were reported for 3 patients during the study period. Specifically, the placebo group reported 2 mild events, while the dupilumab 200 mg or 300 mg-q2w had 1 severe event.
The team concluded that dupilumab treatment for 16 weeks resulted in a marked reduction in blood levels of total and specific IgE in adolescents aged 12-17 years with moderate-to-severe atopic dermatitis.
However, they added that “the clinical relevance and impact of serum IgE levels on clinical allergies is not currently known” and added that the associated clinical benefits of dupilumab should be further investigated.