Dupilumab shows efficacy, safety in infants, young children with atopic dermatitis

Key takeaways:

• Significantly more patients in the dupilumab group experienced improvements in Investigator Global Assessment scores compared with the placebo group.
• The dupilumab group also experienced significantly greater improvements in quality - of - life scores including sleep and itch compared with the placebo group.
• Dupilumab and placebo treatment had similar safety profiles and occurrences of treatment -emergent adverse events.

Dupilumab significantly improved the signs and symptoms of moderate to severe atopic dermatitis as well as quality of life among patients aged 6 months to younger than 6 years, according to a study published in The Lancet.

The monoclonal antibody was well tolerated and had an acceptable safety profile as well, Amy S. Paller, MD, Walter J. Hamlin professor of dermatology and chair of the department of dermatology at Northwestern University Feinberg School of Medicine, and colleagues wrote.

Amy S. Paller

“The ability to take this drug will significantly improve the quality of life for infants and young children who suffer tremendously with this disease,” Paller, who also is a pediatric dermatologist at Ann and Robert H. Lurie Children’s Hospital of Chicago, said in a Northwestern University press release.

The randomized, double-blind, placebo-controlled, parallel-group LIBERTY AD PRESCHOOL part b, phase 3 study involved 162 patients aged 6 months to younger than 6 years with moderate to severe AD and inadequate response to topical corticosteroids enrolled from 31 hospitals, clinics and academic institutions across Europe and North America.

The population included 83 patients (median age, 4.2 years; 53% boys) randomly assigned to dupilumab (Dupixent, Sanofi Genzyme/Regeneron) and 79 patients (median age, 3.8 years; 70% boys) assigned to placebo. Dupilumab was administered subcutaneously every 4 weeks for a 16-week treatment period in 200 mg (baseline patient weight, 5 kg to < 15 kg) or 300 mg ( 15 kg to < 30 kg) doses.

All patients also received a low-potency topical corticosteroid treatment regimen of hydrocortisone acetate 1% cream.

All patients in the study had an Investigator Global Assessment (IGA) score of 3 or 4 at baseline. After 16 weeks, 28% (n = 23) of the patients in the dupilumab group and 4% (n = 3) of the patients in the placebo group had an IGA score of 0 or 1 — the study’s primary endpoint — which equated to a significant difference of 24% (95% CI, 13-34; P < .0001). These improvements were seen as early as week 4.

Also, 53% (n = 44) of the dupilumab group and 11% (n = 8) of the placebo group experienced a 75% improvement from baseline in Eczema Area and Severity Index (EASI-75), a significant difference of 42% (95% CI, 29-55; P < .0001). These improvements were observed as early as week 2.

Improvements in EASI scores and itch numerical rating scale (NRS) in the dupilumab group began as early as week 1 and continued through week 16, the researchers wrote.

Plus, the dupilumab group experienced significant improvements in their least-squares mean change from baseline in skin pain NRS, Children’s Dermatology Life Quality Index, Infants’ Dermatitis Quality of Life Index and Dermatitis Family Index compared with the placebo group.

Treatment with dupilumab benefitted caregivers as well, as patients and their caregivers alike in the dupilumab group both experienced significantly greater sleep quality than the placebo group, according to the researchers.

“Preschoolers who are constantly scratching, awake multiple times a night with their parents, irritable and markedly curtailed in their ability to do what other children their ages can do improved to the extent that they sleep through the night, change their personalities and have a normal life, as babies and children should,” Paller said.

The dupilumab (74%) and placebo (64%) groups experienced similar overall incidence of treatment-emergent adverse events during the treatment period.

AD exacerbation, nasopharyngitis and upper respiratory tract infections were the three most common treatment-emergent adverse events, with no serious treatment-emergent adverse events in the dupilumab group.

“Up to now, all we have had to treat more severe eczema is immune-suppressing medications, such as oral steroids, which we try to avoid in children because they are associated with so many side effects and thus are not a preferred treatment for a chronic skin disease,” Paller said.

Overall, the researchers wrote, more than half of the children on dupilumab experienced a reduction of 75% or more in signs of AD in addition to very significant reductions in itch and improved sleep.

“The effect for most of these younger children is dramatic and at least as good as we’ve seen with the risky immunosuppressant medications,” Paller said.

Reference:

• Infants, young children finally get relief from eczema’s terrible itch. https://www.eurekalert.org/news-releases/964771. Published Sept. 16, 2022. Accessed Sept. 16, 2022.