Off-Treatment Remission Achieved with Dupilumab for Pediatric AD

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A recent study, presented at Fall Clinical 2024 in Las Vegas, Nevada, from October 24 to 27, reported that pediatric and adolescent patients with moderate to severe atopic dermatitis achieved clinical remission with dupilumab (Dupixent; Regeneron and Sanofi).¹ The extension trial also demonstrated that remission was maintained even after several weeks of treatment discontinuation.

Pediatric patients with AD have high disease burden, with physicians and caregivers expressing concerns about long-term systemic treatment. These concerns may be alleviated thanks to research supporting the possibility of disease remission.

Background

Initial data was presented earlier this year at the Society for Pediatric Dermatology Annual Meeting in Toronto, ON.² These preliminary results were promising, according to the study authors.

“Early and effective intervention with dupilumab could potentially modify the course of atopic dermatitis in pediatric patients, offering them a chance at prolonged periods without the need for ongoing therapy," the researchers wrote.

The LIBERTY AD PEDS trial (NCT03345914) tested the efficacy of dupilumab when used along with a topical corticoid steroid (TCS). A total of 367 patients aged 6 to 11 years were split into 3 groups. The first group began a placebo and TCS regimen. The second group took 300 mg of dupilumab every 4 weeks with a TCS. The final group took either 100 mg or 200 mg of dupilumab every 2 weeks with a TCS.

The LIBERTY AD ADOL (NCT03054428) did not utilize supplemental TCSs when analyzing the safety of dupilumab at different dosages. These 251 patients were between the ages of 12 and 17 and were split into a placebo group, a group taking 300 mg of dupilumab every 4 weeks and a third group taking either 200 mg or 300 mg of dupilumab every 2 weeks. Both of these were phase 3 double-blind trials that lasted approximately 16 weeks.

Methods and Materials

These patients were then transferred into the LIBERTY-AD PED-OLE trial (NCT02612454), an open-label extension study. Over 600 patients (321 from LIBERTY AD PEDS, 294 from LIBERTY AD ADOLS, and 2 other studies) were included in these next steps. Some patients transitioned directly from the parent studies while others had a time lapse in between. Participants were between the ages of 6 to 17 and had completed at least 52 weeks of follow-up.

The trial focused on patients who were given 300 mg of dupilumab every 4 weeks along with a TCS. Clinical remission was defined as maintaining an Investigator’s Global Assessment (IGA) score of 0 or 1 for at least 12 weeks after 40 weeks on dupilumab. Conversely, remission off treatment was defined as maintaining an IGA score of 0 or 1 for at least 12 weeks after stopping the drug. A score of 0 or 1 equated to clear or almost clear skin.

Results

In pediatric patients (ages 6 to 11), 28.7% achieved clinical remission. Of these participants, about 60% reached off treatment remission while almost 40% needed to reintroduce the drug. The median follow-up of therapy was 15.7 weeks.

In adolescent patients (ages 12 to 17), 29.4% achieved clinical remission. Of these participants, 43.3% reached off treatment remission while 56.7% needed to reinitiate dupilumab treatment. For this age group, the median follow-up off therapy was 18 weeks.

Conclusion

Overall, about one-third of patients achieved clinical remission on dupilumab and nearly half of these patients maintained remission off treatment for at least 12 weeks after stopping the drug. The incidence of remission off treatment is higher in younger patients compared to adolescents.

“Early intervention with targeted therapies during infancy and childhood may have the potential to impact AD disease trajectory and associated atopic morbidities, and promote long-term remission,” according to Seigfried et al.

References

1. Siegfried EC, Bieber T, Paller AS, et al. Clinical Remission and Off-Treatment Remission in Pediatric Patients with Moderate-to-Severe Atopic Dermatitis Treated with Dupilumab: Open-Label Extension Study Preliminary. Poster presented at the 44th Annual Fall Clinical Dermatology Conference. Las Vegas, Nevada. October 24 to 27, 2024. 

2. Paller AS, Siegfried EC, Bieber T, et al. New hope for pediatric atopic dermatitis: Preliminary data on therapy-free remission with dupilumab. Poster presented at the 2024 Society for Pediatric Dermatology Annual Meeting, July 11-14; Toronto, ON.