Pediatric Nemolizumab Study Reports Improvements in Atopic Dermatitis Through 52 Weeks
Key Takeaways
- In a phase 2, open-label study of 109 children aged 2 to 11 years with moderate-to-severe atopic dermatitis, weight-based nemolizumab given every 4 weeks with topical therapy was associated with improvements in skin lesions and itch.
- At week 16, EASI 75 responses occurred in 73.0% of children aged 7 to 11 years receiving the lower-dose regimen and 69.4% of those aged 2 to 6 years; 4-point itch improvements occurred in 59.5% and 72.2%, respectively.
- No serious treatment-emergent adverse events were reported through 52 weeks, although adverse events were common. The uncontrolled design limits attribution of outcomes to nemolizumab alone.
Weight-based nemolizumab administered with topical therapy was associated with improvements in skin lesions and itch in children aged 2 to 11 years with moderate-to-severe atopic dermatitis (AD), according to phase 2 findings presented at the 2026 Fall Clinical Dermatology Conference.
Lawrence F. Eichenfield, MD, and colleagues reported results from a multicenter, open-label study (NCT04921345) involving 109 children whose AD was inadequately controlled with topical treatments. Nemolizumab, an IL-31 receptor alpha antagonist, was administered every 4 weeks alongside topical corticosteroids, with or without topical calcineurin inhibitors.
The study enrolled 36 children aged 7 to 11 years in a higher-dose cohort, 37 aged 7 to 11 years in a lower-dose cohort, and 36 aged 2 to 6 years in a lower-dose cohort. Doses were assigned by body weight, and efficacy and safety were followed through week 52.
Skin Clearance, Itch and Safety Outcomes
At week 16, 73.0% of patients in the lower-dose 7-to-11-year cohort and 69.4% in the 2-to-6-year cohort achieved at least 75% improvement in Eczema Area and Severity Index (EASI) 75 scores. Investigator’s Global Assessment (IGA) success occurred in 40.5% and 47.2%, respectively. A reduction of at least 4 points on the Peak Pruritus Numerical Rating Scale occurred in 59.5% and 72.2%, respectively. Improvements were reported through week 52.
Treatment-emergent adverse events occurred in 83.3%, 86.5%, and 88.9% of the three cohorts, respectively. No serious treatment-emergent adverse events or treatment discontinuations due to adverse events were reported; two patients experienced severe events.
The investigators reported that systemic exposures in the lower-dose cohorts were comparable with those previously observed in adults and adolescents.
The poster authors summarized the findings as supporting potential pediatric use, though further evaluation is needed to establish comparative efficacy and safety.