Dupilumab Demonstrates Positive Effects on TCS Use, Growth in Pediatric Patients

Data from the LIBERTY AD PEDS (NCT03345914) phase 3 trial indicated dupilumab (Dupixent; Sanofi and Regeneron) use resulted in less topical corticosteroid (TCS) use and allowed for greater growth in pediatric patients aged 6 -11 years as compared with placebo.¹ The poster was presented at the 2025 Elevate-Derm Fall Conference in Tampa, Florida.

The 16-week placebo-controlled trial included 367 children 6 to 11 years old with severe atopic dermatitis. To determine impact on growth, the investigators compared the number of patients below the 30th height percentiles at baseline with that at week 16. They also examined the number of TCS-free days. For patients with asthma, the investigators also looked at the use of inhaled corticosteroid.

Methods

Participants in the LIBERTY study were randomized in a 1:1:1 ratio to receive placebo or 1 of 2 dupilumab over the 16-week trial. Each arm concomitantly received TCS during the treatment phase. In one dupilumab arm, patients received a subcutaneous injection of 600 mg loading dose on day 1, then 300 mg every 4 weeks from week 4 through week 12. In the other dupilumab arm, patients received a 200 mg or 400 mg loading dose on day 1, then received 100 mg or 200 mg subcutaneous injections of dupilumab, respectively, every 2 weeks through week 14.

Results

For those with shorter stature at baseline, dupilumab was associated with a greater proportion of patients achieving a 5 or more-percentile height improvement as compared with those who received the placebo. Specifically, 31.9% in both dupilumab arms achieved this growth compared with 11.1% in the placebo arm. When including all participants regardless of height at baseline, 20.4% and 15.4% of participants achieved a 5-percentile or more improvement in the dupilumab and placebo arms, respectively.

In addition, patients in the dupilumab groups not only used less TCS than those in the placebo group, but they also had a higher proportion of TCS-free day. The mean TCS dose up to week 16 was 219.1 in the combined dupilumab groups and 292.5 in the placebo group (P=0.034). A more robust difference was seen in the number of TCS-free days. Participants in the dupilumab groups had a mean of 21.4 TCS-free days while those in the placebo group only achieved 12.2 TCS-free days (P < 0.001).

“Dupilumab’s positive effect on growth in patients aged 6 to 11 years during a 16-week placebo-controlled trial appears independent of reduced TCS use or the number of medication-free days vs placebo,” the study authors concluded.

Background

Previous studies have linked atopic dermatitis with diminished growth in pediatric patients. One study, for example, found atopic dermatitis to be associated with shorter stature and higher BMI in early childhood, although they found these issues were attenuated as the children aged and even resolved by the time they reached adolescence.² Long-term use of TCS has also been suspect in impacting growth in pediatric populations. In guidelines for treating atopic dermatitis, the authors noted TCS’s relative safety, yet reported, “There is also some concern for negative effects on linear growth, although reports have given mixed conclusions.” Decline in growth could warrant further conversations and treatment reconsiderations, they added.³

The poster authors likewise acknowledged these issues. “Children with AD have multiple risk factors for impaired growth, lower bone mineral density and fracture risk, including chronic itch-triggered sleep disturbance and chronic inflammation as well as the potential effect of prolonged exposure to corticosteroids,” they wrote. With the impact of TCS on stature in children incompletely understood, the purpose of their work was to shed additional light on this issue.

Have you experienced growth issues in your pediatric patients on TCS? Share your insights with your peers via blinded case discussions via DTEditor@mmhgroup.com.

The poster was originally presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in Paris, France.

References

1. Irvine AD, Poller AS, Siegrfried EC. Growth Improvement in Children 6 to 11 Years With Severe Atopic Dermatitis Treated With Dupilumab Irrespective of TCS Use. Presented at: 6th Annual Elevate-Derm Fall Conference; November 12 – 16, 2025; Tampa, Florida.

2. Nicholas MN, Keown-Stoneman CDG, Maguire JL, Drucker AM. Association Between Atopic Dermatitis and Height, Body Mass Index, and Weight in Children. JAMA Dermatol. 2022;158(1):26–32. doi:10.1001/jamadermatol.2021.4529

3. Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9. PMID: 24813302; PMCID: PMC4326095.