Data Show Long-term Safety, Clinical Benefit of Dupilumab in Pediatric AD

Dupilumab (Dupixent, Sanofi/Regeneron) is safe and effective for the long-term management of atopic dermatitis in patients as young as six, data from a collection of posters presented at the AAD 2021 VMX show.

One study assessed response to dupilumab treatment using a combination of signs (EASI-50), symptoms (itch NRS), and quality of life (CDLQI). At 16 weeks, almost half of children aged 6-11 years with severe AD experienced improvement on all three measures. 

Additional data show that dupilumab is associated with a rapid improvement of sleep disturbance in children with severe AD as early as two weeks and in adolescents with moderate-to-severe AD as early as one week. 

One year data from a phase 3, open-label extension trial in children with uncontrolled, moderate-to-severe atopic dermatitisshows children aged 6-11 had sustained improvement in overall disease severity and extent and skin clearance for up to one year.

Pediatric dermatologist Amy Paller, MD, who participated in the trials for dupilumab in pediatric AD and presented data at the 2021 VMX, noted that FDA approval for atopic dermatitis was based on the primary endpoint of IGA of Clear or Almost Clear. “This is a pretty high hurdle; it's like an EASI 90,” she says. Post-hoc analysis attempted to ascertain benefit of treatment beyond IGA.  

“Researchers have determined clinically meaningful levels of change for a wide variety of the various scores that we use,” Dr. Paller says. She notes that EASI 50, a reduction in peak pruritis of three and four, and a reduction by six in the children's Dermatology Life Quality Index (DLQI) are all considered clinically meaningful.

“The vast majority of patients aged six to 11 achieved clinically meaningful responses with dupilumab, based on these scores,” Dr. Paller says. “We also did a deeper dive looking at sleep itself, and we can see that sleep is improved by two weeks after starting dupilumab in many children. It's certainly significantly different from what we see with placebo.”

Based on the data and years of clinical experience, Dr. Paller is confident that duplimab is a safe and effective option or children with AD. “I think the beauty for so many of us in pediatric dermatology is that this is a very safe agent. Other than the pain of injection, there's no hesitancy to use it. Looking at what's clinically meaningful—looking at sleep, looking at long-term efficacy—we have even more to discuss with families to convince them that it may be worth going to a systemic agent, even one that you have to give a shot every two to four weeks, because it really can change the life of the child.”