Real-world analysis comparing systemic therapies show dupilumab better improves EASI and quality of life among affected children.
Monoclonal antibody dupilumab (Dupixent) provided greater atopic dermatitis symptom improvement while remaining more tolerable among treated pediatric patients compared to methotrexate or cyclosporin in the same population, according to new interim data from the PEDISTAD trial.
In observational registry findings presented at the 2022 Fall Clinical Dermatology Meeting this week, a team of multinational investigators observed that the IL-4 and IL-13 targeting biologic therapy—recently indicated by the US Food and Drug Administration (FDA) for every pediatric age of atopic dermatitis patients—provides improved care among children based on measures of symptom relief and health-related quality of life.
Led by Amy S. Paller, MD, of the departments of dermatology and pediatrics at the Northwestern University Feinberg School of Medicine, investigators sought to analyze the impact of systemic therapies dupilumab, methotrexate, and cyclosporine treatment on objective measures of disease severity in children with moderate-to-severe atopic dermatitis.
Their analysis used interim findings from the ongoing, real-world PEDISTAD trial: an international, longitudinal 5-year registry assessing treatment patterns and disease course in patients with atopic dermatitis aged <12 years old.
“Children with moderate-to-severe atopic dermatitis and their caregivers experience a substantial impairment of quality of life, daily functioning, social interactions, and mental health,” investigators wrote. “Dupilumab improved the signs and symptoms of atopic dermatitis, and quality of life in patients aged ≥6 months to <12 years with moderate-to-severe atopic dermatitis in a phase 3 randomized clinical trial.”
The observed interim PEDISTAD data included 2 years’ follow-up data on the 3 systemic therapies, including their impacting on patient Eczema Area and Severity Index (EASI) total score, percentage of affected body surface area (BSA), and Patient-Oriented Eczema Measure (POEM). Paller and colleagues additionally used assessments of treatment-emergent adverse events (TEAEs).
The analysis included 144 patients receiving 300 mg dupilumab every 2 weeks over a median 8.1 months, 114 receiving methotrexate over 13.0 months, and 121 receiving cyclosporine over 10.7 months. Mean patient age was approximately 7 years old. A majority of patients were white. Each treatment arms’ baseline EASI score was <20; BSA involvement was approximately 40%.
Paller and colleagues observed significant improvements from baseline EASI in both the dupilumab arm (59.1%; P <.0001) and methotrexate arm (34.0%; P <.0001). The cyclosporine mean improvement difference of 3.3% was not statistically significant.
Similarly, dupilumab and methotrexate arms reported significant mean improvements in POEM from baseline, while cyclosporine did not.
All 3 treatment arms reported significant improvements in BSA scores versus baseline:
Regarding safety outcomes, dupilumab was associated with the lowest rate of AEs among patients (18.1%), followed by methotrexate (29.8%) then cyclosporine (31.4%). Discontinuation rates were only 8.3% among patients treated with dupilumab, versus 28.9% and 43.0% for methotrexate and cyclosporine, respectively.
“In this interim analysis of the PEDISTAD study in patients with atopic dermatitis aged <12 years, dupilumab led to greater improvement in atopic dermatitis signs and symptoms, with fewer treatment discontinuation and adverse events,” investigators concluded.
The study, “Real-world treatment outcomes for up to 2 years in patients aged less than 12 years with inadequately controlled moderate-to-severe atopic dermatitis,” was presented at Fall Clinical 2022.