Preliminary Data on Therapy-Free Remission with Dupilumab for Pediatric Atopic Dermatitis

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A recent study, presented in a poster at the 2024 Society for Pediatric Dermatology Annual Meeting in Toronto, ON, reported that a significant proportion of pediatric patients with moderate to severe atopic dermatitis (AD) achieved and maintained clinical remission with dupilumab (Dupixent; Regeneron and Sanofi), suggesting potential for therapy-free remission in this patient population.¹

Poster authors Paller et al reported preliminary data from a recent open-label extension study on the use of dupilumab in achieving and maintaining clinical remission, even after discontinuation of the drug.

Background and Methods

The study aimed to address the pressing concern among physicians and caregivers about the need for lifelong systemic therapy in young patients with moderate to-severe AD. The primary objective was to evaluate the potential of dupilumab to induce clinical remission and sustain this remission after therapy discontinuation.

This study involved 356 pediatric patients aged 6 to under 18 years, all diagnosed with moderate-to-severe AD. These patients were part of the ongoing LIBERTY AD PED open-label extension study (NCT02612454)² and received weight-tiered dosing of dupilumab over a follow-up period of at least 52 weeks. The dosing regimen was as follows:

• 5 kg to <15 kg: 200 mg every 4 weeks (q4w)
• 15 kg to <30 kg: 300 mg q4w
• 30 kg to <60 kg: 200 mg every 2 weeks (q2w)
• ≥60 kg: 300 mg q2w

Clinical remission was defined as maintaining an Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear) for at least 12 weeks after 40 weeks of dupilumab treatment. Patients who achieved clinical remission discontinued dupilumab and were subsequently monitored for recurrent AD symptoms. Dupilumab treatment was resumed for patients whose IGA score regressed to 2 (mild or greater).

Findings

The study found that 29.4% of adolescents (30/102) and 28.7% of children (73/254) achieved clinical remission with dupilumab. Of these, 43.3% of adolescents (13/30) and 60.3% of children (44/73) were able to maintain remission off therapy. The median duration from drug discontinuation to the last visit off the drug was 18.0 weeks for adolescents and 15.7 weeks for children.

Approximately one-third of the patients achieved sustained remission with dupilumab, and about half of these patients maintained remission even after stopping the therapy. The data suggests that younger patients might have a higher likelihood of achieving and maintaining therapy-free remission.

Conclusions

"These preliminary results are promising as they suggest that 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," according to Paller et al.

However, researchers also noted the need for longer-term observations to determine the durability of these remissions and to better understand the potential for dupilumab to alter the disease course in the long term.

The study, as it is ongoing, is expected to provide further insights into the efficacy and safety of dupilumab in this patient population.

References

1. 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.
2. ClinicalTrials.gov. Identifier NCT02612454. Bethesda, MD: National Library of Medicine (US). Available from: https://clinicaltrials.gov/ct2/show/NCT02612454