Dupilumab improves atopic dermatitis outcomes among children, adolescents
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Dupilumab appeared effective and well-tolerated among children and adolescents with moderate to severe atopic dermatitis, according to a study published in The Journal of Allergy and Clinical Immunology: In Practice.
Efficacy and safety also showed consistency across age, sex and race/ethnicity, Benjamin Ungar, MD, of the department of dermatology at Icahn School of Medicine at Mount Sinai, and colleagues wrote.
“We treat many children and adolescent patients with atopic dermatitis at Mount Sinai, and we saw an opportunity to provide additional insight and data into the real-world use of dupilumab in these age groups,” Ungar told Healio. “This is particularly important as our cohort includes a diverse patient population.”
The retrospective, observational study examined the records of 89 children and adolescents (56% female) aged 18 years and younger treated for moderate to severe AD at the Icahn department of dermatology between March 2017 and September 2021.
The patients had a mean age of AD onset of 4.1 years (SD, ± 4.2 years; range, < 1 month to 15 years) and a mean duration of AD symptoms of 9.3 years (SD, ± 4.3 years). Demographics included 47% European American, 18% Hispanic/Latin American, 16% Asian American, 16% African American and 2% of two or more races.
At baseline, these patients had a mean Body Surface Area (BSA) score of 49.1 (standard deviation [SD], ± 24), a mean Investigator’s Global Assessment (IGA) score of 37 (SD, ± 11.6) and a mean Eczema Area and Severity Index (EASI) score of 3.4 (SD, ± 0.5).
All patients were receiving topical corticosteroids at baseline and 44.9% had been treated with a systemic immunosuppressant such as prednisone, cyclosporine or methotrexate.
Also, 74.2% had one or more atopic comorbidity at baseline, including 57.3% with allergic rhinitis and/or conjunctivitis, 50.6% with food allergies and 33.7% with asthma.
The patients received dupilumab (Dupixent, Sanofi Genzyme/Regeneron) in doses of 300 mg every 2 weeks (61.8%), 200 mg every 2 weeks (28.1%) or 300 mg every 4 weeks (5.6%). Mean age at initiation was 12.6 years (SD, ± 2.9 years), and mean duration was 1.3 years (SD, ± 0.9 years), with 73 patients receiving dupilumab for 3 months or longer.
Between weeks 12 and 24, those 73 patients experienced mean decreases of 63.1% (SD, ± 29.2%) in BSA, 39.6% (SD, ± 29.9%) in IGA and 59.6% (SD, ± 30.7%) in EASI compared with baseline (all, P < .001).
The 47 patients receiving treatment between weeks 36 and 48 experienced mean decreases of 81.9% (SD, ± 19.4%) in BSA, 60.8% (SD, ± 27.6%) in IGA and 77% (SD, ± 25.6%) in EASI compared with baseline (all, P < .001).
According to the researchers, longer treatment was associated with more significant clinical improvements.
The 23 patients receiving treatment for 1 year or longer experienced mean decreases of 89.1% (SD, ± 10.8%) in BSA, 72.5% (SD, ± 12.2%) in IGA and 89.1% (SD, ± 7.2%) in EASI compared with baseline (all, P < .001).
Additionally, all the patients who received dupilumab for 1 year or longer achieved a 75% improvement in their EASI scores, and 60.8% achieved a 90% improvement. Every patient also achieved an IGA of 0/1, or “clear” or “almost clear” alleviation in AD symptoms.
“Overall, our results were not too surprising, as they are in line with our clinical experience and other reports, but they are significant, providing additional support for use of dupilumab in pediatric patients as a safe and effective treatment approach,” Ungar said.
Further, 67% of the patients with asthma, 45.5% of the patients with food allergy and 17.6% of the patients with allergic rhinitis saw improvements in these conditions after a minimum of 3 months of receiving dupilumab as well.
Also, clinical improvements in BSA, IGA and EASI had no significant associations with demographics including age, sex or race/ethnicity, nor were there any significant associations between these factors and incidences of adverse events.
The 39 patients using systemic immunosuppressants all discontinued them because they did not see any satisfactory improvements or because they experienced successful AD symptom control with dupilumab.
Further, 30.3% stopped using topical corticosteroids because they had achieved satisfactory AD symptom control with dupilumab and corticosteroid-sparing agents, and 32.5% were able to stop their topical calcineurin inhibitors and 15.7% ceased crisaborole (Eucrisa, Pfizer).
Only 13.5% of patients experienced adverse events, according to the researchers, including conjunctivitis (5.6%) and joint pain (2.2%). There were no life-threatening adverse events such as anaphylaxis or allergic reactions.
Noting that location, prescriber’s assessment and insurance coverage may influence treatment selection and clinical response, the researchers concluded that dupilumab was both effective and well-tolerated in treating AD regardless of demographics or existing atopic comorbidities.
“Doctors can use these findings to approach treating pediatric patients with moderate to severe atopic dermatitis with confidence that dupilumab is safe and effective,” Ungar said.
“There may be some doctors who are hesitant to use a systemic treatment, but hopefully they will find these results to be reassuring that they can appropriately treat moderate to severe patients systemically with dupilumab,” he continued.
Meanwhile, the researchers also called for additional, long-term multicenter studies in pediatric populations.
“The likely next step in this research is to assess outcomes in terms of both clinical responses and side effects over longer periods of time in this patient population,” Ungar said.
For more information:
Benjamin Ungar, MD, can be reached at benjiungar@gmail.com.
Perspective
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Jonathan Silverberg, MD, PhD, MPH
These results are clinically significant, but not surprising. They are consistent with what has been seen in the clinical trials of dupilumab across different age groups. They also are generally consistent with my own experience.
Further, these results contribute to the growing body of real-world evidence supporting the effectiveness of dupilumab in pediatric and adult atopic dermatitis.
However, it would be nice to understand whether there are specific patient subsets that respond to dupilumab more rapidly or robustly than others. Several research groups around the world are now studying this important question.
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