Efficacy and Safety of Dupilumab in AD Across Diverse Pediatric Populations: A Q&A With Elaine Siegfried, MD

At the 34th Annual Congress of the European Academy of Dermatology and Venereology (EADV), which took place September 17-20 in Paris, research was presented titled “Dupilumab Safety and Efficacy Up to 3 Years Across Racial Subgroups in Pediatric Patients Aged 6 Months to 11 Years With Atopic Dermatitis.” There were several conclusions of note to this research. Among them, by week 152 of an open-label extension analysis of dupilumab (NCT02612454) (Dupixent; Sanofi/Regeneron), treatment resulted in "consistent decreases in disease signs and symptoms" for both White and non-White patient groups. In addition, discontinuation rates were higher in the Asian, Black/African American, and Other patient subgroup compared with the White patient subgroup by week 152—but these differences in discontinuation rates simply might reflect a contrast in sample size between subgroups.

In this interview with The American Journal of Managed Care^® (AJMC^®), Elaine Siegfried, MD, who presented the research at the conference, speaks to why it is necessary to collect data on atopic dermatitis among a diverse patient population and where research in this space needs to head next for a greater understanding of nonclinical barriers affecting patient access to treatment and clinical trial participation. Siegfried is a professor of pediatrics and dermatology in the Department of Pediatrics, Division of Dermatology, Saint Louis University School of Medicine, and past president and director of the American Board of Dermatology.

This transcript was lightly edited for clarity.

AJMC: Can you address the importance of data collection for atopic dermatitis treatments, particularly for pediatric patients from racial or ethnic minority groups?

SIEGFRIED: Atopic dermatitis presents differently in patients with skin of color, so it’s important to understand how treatments impact signs and symptoms of disease across patients with different skin tones. There are currently limited long-term data on disease characteristics and treatment response across children with skin of color.

AJMC: Considering racial differences in atopic dermatitis (eg, presentation, prevalence, and severity), what specific pathological mechanisms or treatment gaps must be addressed to meet the unique needs of diverse patient populations?

SIEGFRIED: In patients with darker skin tones, not only do the type and location of lesions vary, but hardened lesions, dryness, dyspigmentation, and greater disease severity are all more common than in those with lighter skin tones. Also, because of differences in disease manifestation, atopic dermatitis can be misdiagnosed in patients with skin of color, leading to underestimates of prevalence. Therefore, it’s important to assess that targeted treatments can improve disease across patient subgroups.

AJMC: Please tell us about the study you presented at EADV. What were your goals for gathering these data?

SIEGFRIED: To further understand how dupilumab affects children with atopic dermatitis from different racial backgrounds, we conducted a post hoc analysis on data from the pivotal trials in children aged 6 months to 11 years with moderate to severe atopic dermatitis. We assessed key efficacy and safety outcomes in patients with skin of color (Asian, Black/African American, or Other) compared with White patients.

AJMC: Although dupilumab treatment resulted in meaningful improvements for all pediatric racial subgroups, what were some of the most significant differences observed at baseline and throughout the study between your 2 groups?

SIEGFRIED: Overall, baseline disease characteristics were relatively balanced between the 2 subgroups, but pediatric patients with skin of color had slightly more severe disease, which is what we typically see in clinical practice as well. Throughout the course of the study across all end points, however, we were pleased to see similar efficacy and safety outcomes for patients with skin of color and White patients. The treatment discontinuation rate may have been higher in the non-White patient group, but discontinuations due to lack of efficacy or adverse events were similar and occurred in less than 2% of patients in either group at 3 years.

AJMC: Can you speak to the percentage improvements seen in both subgroups, as well as if there were unexpected results?

SIEGFRIED: The results were as expected, with consistent improvements in signs and symptoms of disease with dupilumab that we have seen across racial subgroups in adult and adolescent patients. In patients with skin of color, Body Surface Area and Eczema Area and Severity Index reductions from baseline were 80% and 86%, respectively, vs 86% and 90% for White patients. Across the racial subgroups, these were clinically meaningful reductions in body surface area affected and disease severity.

AJMC: Since lack of efficacy and adverse events accounted for very few treatment discontinuations, what were some of the primary reasons patients from both groups left the study?

SIEGFRIED: The higher withdrawal rates in patients with skin of color may have been due to the overall differences in population sizes between the 2 groups, with 154 patients with skin of color vs 400 White patients. Other reasons for discontinuation included withdrawal of consent, access to treatment outside of the study, logistical challenges, or caregiver decisions.

AJMC: What might be the next steps for research to further optimize treatment and minimize common treatment-emergent adverse events like allergic conjunctivitis or nasopharyngitis in these diverse pediatric populations?

SIEGFRIED: In the study, the rates of allergic conjunctivitis and nasopharyngitis were comparable between the 2 groups. Overall, dupilumab has a well-established long-term safety profile and is generally well tolerated across age groups. As with any medicine, patients should talk to their doctors if they experience an adverse event while on treatment.

AJMC: How might future research contribute to a more nuanced understanding of the socioeconomic, cultural, or other factors that may have influenced trial participation for patients of a racial minority?

SIEGFRIED: While my research primarily focuses on clinical outcomes associated with dermatological conditions, delving into these factors is a highly valuable and necessary avenue for future research. Understanding these specific barriers could equip clinicians with the knowledge to better tailor care and how to provide care for unique patient needs.