Dupilumab Gets Results Treating Pediatric Atopic Dermatitis

Mark Boguniewicz, MD (National Jewish Health)

In new research presented at American Academy of Allergy, Asthma & Immunology (AAAAI) 2021 Annual Meeting shows the efficacy of dupilumab treating pediatric patients with atopic dermatitis (AD).

A team, led by Mark Boguniewicz, MD, National Jewish Health, evaluated the efficacy of dupilumab with concomitant topical corticosteroids (TCS) for severe atopic dermatitis in pediatric patients with and without comorbid asthma.

LIBERTY AD PEDS Trial

In the LIBERTY AD PEDS randomized, double-blinded, placebo-controlled, phase 3 trial, the researchers assessed the efficacy of dupilumab in combination with TCS in patients between 6-12 years old with severe atopic dermatitis. The history of asthma was self-reported by the patient or caregiver.

The researchers analyzed efficacy outcomes among the patients and calculated values at week 16 with confidence intervals of the difference between dupilumab and placebo using normal approximation. In addition, they analyzed continuous endpoints using multiple imputation with analysis of covariance.

Overall, there were 367 patients in the study, 181 of which had comorbid asthma and 186 of which denied a history of comorbid asthma at baseline.

At baseline 48% of the patients in the dupilumab 4 week group, 52% of the patients in the dupilumab 2 week group, and 49% of the placebo arm had no history of asthma.

Baseline disease characteristics were similar among all treatment groups, as well as between all subgroups of patients regardless of comorbid asthma status.

Safety Profile

In addition, the safety profile in the treatment was consistent with the known dupilumab safety profile for other indications. Atopic dermatitis, skin infections, and herpes viral infections were more commonly found in the placebo groups and conjunctivitis and injection-site reactions were more commonly found in the treatment group.

“Asthma is a common atopic comorbidity in patients aged > 6 to < 12 years with AD, reported by 49% of patients/caregivers in this trial,” the authors wrote. “Dupilumab improved signs and symptoms of AD in children aged > 6 <12 years with and without a history of asthma, demonstrating the efficacy of dupilumab in the presence of this common comorbid atopic condition.”

Adults with Atopic Dermatitis

Last year, researchers found both dupilumab and cyclosporine may be more effective for adults with atopic dermatitis than methotrexate and azathioprine.

Investigators used approximately a half-dozen registries and databases to collect RCT-based data on systemic immunomodulatory therapies for patients with moderate to severe atopic dermatitis, including placebo. RCTs of ≥8 weeks of therapy, including ≥2 doses, were included in assessment.

Dupilumab, dosed at 300 mg every 2 weeks, showed an association with improved patient EASI score versus placebo, with a mean 11.3-point reduction (95% credible interval [CrI], 9.7-13.1).

Both the biologic and cyclosporine were similarly effective versus placebo in skin or symptom clearance of atopic dermatitis. Investigators also observed clinically relevant improvements in POEM score versus placebo with the following therapies:

• Dupilumab, 300 mg every 2 weeks
• Abrocitinib, 100 mg and 200 mg daily
• Upadacitinib, 15 mg and 30 mg daily

The study, “Dupilumab Improves Signs and Symptoms of Severe Atopic Dermatitis in Children Aged 6–11 Years With Comorbid Asthma,” was published online by AAAAI 21.