Dupilumab Treatment of Atopic Dermatitis Safe for Up to 5 Years in Children, Adults

A recent analysis of both pediatric and adult patients suffering from moderate-to severe atopic dermatitis treated with dupilumab for up to 5 years demonstrated that the medication is well tolerated and acceptably safe across these age cohorts.1

This analysis was covered in an abstract posted during the Revolutionizing Atopic Dermatitis Conference Mid-Year Virtual Update on December 8, 2024. The abstract was titled ‘Integrated safety of dupilumab up to 5 years for the treatment of moderate‑to‑severe atopic dermatitis in infants, children, adolescents, and adults,’ and it was authored in part by Richard Langley, MD, of Dalhousie University’s department of medicine.

Langley et al.’s analysis was conducted to assess dupilumab’s safety, with or without the concurrent use of topical corticosteroids (TCS), as a treatment for adults and infants with moderate-to-severe atopic dermatitis. The drug was first approved in 2017 by the US Food and Drug Administration (FDA) for the inflammatory skin condition.2

“Atopic dermatitis (AD) is a chronic pruritic and inflammatory disease that is highly prevalent in both adult and pediatric patients and requires long-term treatment; thus, safety is an important consideration for physicians and patients/caregivers when making decisions on treatment options,” Langley and colleagues wrote.1

Trial Design and Findings

Data regarding over 6,000 individuals were evaluated throughout this analysis, with more than 7,000 patient-years of dupilumab exposure included from previous randomized, double-blind, placebo-controlled clinical trials (RCTs). They also included data from open-label extension trials (OLEs), with treatment durations of all studies extending up to 5 years.

Eight phase 3 clinical studies evaluating dupilumab exposure among patients with atopic dermatitis were what the analysis was based upon. These data included findings from the LIBERTY AD SOLO 1, SOLO 2, CHRONOS, PEDS, ADOL, PRESCHOOL Part B, OLE, and PED-OLE studies.

Throughout these RCTs, investigators had assessed different age cohorts and durations of dupilumab implementation, such as a 52-week RCT assessing adults with TCS; a set of five RCTs lasting 16 weeks and involving children aged 6 months - 11 years using concomitant TCS and those aged 12 years and older without TCS use; and 2 long-term OLEs spanning up to 5 years for adults and 1 year for those in the pediatric and adolescent age cohorts.

Langley and colleagues noted that adverse events (AEs) had been reported as the number and percentage of individuals reporting 1 or more AEs. Additionally, they were reported as the number of events per 100 patient-years to account for varying durations of exposure across each of these analyses.

It was expressed by the research team that total exposure to the medication exceeded 7,000 patient-years. They added that the longest documented duration of therapy use had been 1,938 days in the adult OLE.

Treatment-emergent adverse event (TEAE) occurrence among individuals being treated with dupilumab for atopic dermatitis was reported by the investigators as being generally comparable to or lower than that TEAEs seen among subjects in the placebo cohorts across all age cohorts.

In terms of serious AEs, some of which included infections and various skin conditions, they were shown to be less common and noted less frequently among those given dupilumab as opposed to the placebo.

Specifically, the investigative team highlighted that the results of the 16-week RCTs indicated serious TEAEs had been reported among 0.8% compared to 3.0% of infants/children. They also noted that they were seen among 2.0–2.2% compared to 4.6% of adults/adolescents and 3.2–3.6% compared to 5.1% in the 52-week RCT, respectively.

Most TEAEs were also shown to be mild to moderate, and the team added that they had not necessitated treatment discontinuation.

Conjunctivitis as well as reactions and the injection sites were found by the investigators to have been seen more frequently among those in the dupilumab treatment arm, though there were no anaphylactic reactions connected to dupilumab. Overall, they found that the data suggested that the longer-term studies aligned with safety data from shorter-term analyses.

“This comprehensive analysis of pediatric and adult patients with moderate-to severe [atopic dermatitis] treated with dupilumab for up to 5 years confirms that dupilumab is well tolerated, with an acceptable safety profile across all age groups,” they concluded.1

References

1. Langley R, Khokhar F, Rossi A, et al. Integrated safety of dupilumab up to 5 years for the treatment of moderate‑to‑severe atopic dermatitis in infants, children, adolescents, and adults. Presented as part of the 2024 Revolutionizing Atopic Dermatitis Mid-Year Virtual Update. December 8, 2024.
2. Office of the Commissioner. FDA approves New Eczema Drug Dupixent. U.S. Food and Drug Administration. March 28, 2017. Accessed August 8, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-new-eczema-drug-dupixent.