Nemolizumab Data at RAD 2026 Shed Light on Long-Term Itch Control, Pediatric Benefit

Long-term extension and pediatric pharmacokinetic data for nemolizumab (Nemluvio) in atopic dermatitis presented at the Revolutionizing Atopic Dermatitis (RAD) 2026 Conference show more than 90% of EASI-75 responders maintained response through 104 weeks, partial skin responders at Week 16 continued improving through 2 years, and weight-based pediatric dosing in children aged 2 to 11 years achieved pharmacokinetic exposures matching adults and adolescents.^1,2,3

"Data from these analyses indicate that the safety in these subgroups was consistent with the overall safety profile of nemolizumab with no new signals emerging over the extended follow-up,” wrote Jonathan Silverberg, MD, MPH, and investigators who led the 104-week analysis. “In addition, one-third of patients discontinued treatment during the study period, suggesting that long-term benefit may be achievable for many patients."

LTE maintenance data: IGA and EASI responses sustained at 2 years

In the ARCADIA long-term extension (LTE) study (NCT03989206), post-hoc analyses examined outcomes in patients with partial or minimal skin response at Week 16 of the ARCADIA 1 and ARCADIA 2 phase 3 trials who rolled over to open-label nemolizumab 30 mg Q4W plus optional topical therapy.

Partial skin responders (N=290) showed EASI-75 rates rising from approximately 29.5% at LTE baseline to 83.8% at Week 80 and 75.7% at Week 104. Minimal skin responders (N=207) showed a similar trajectory with EASI-75 reaching 72.2% at Week 80 and 64.7% at Week 104.

In the cohort-level maintenance analyses from the LTE, among patients who had already achieved IGA 0/1, EASI-75, or EASI-90 at LTE baseline, over 80% maintained IGA 0/1 at Week 104, over 90% maintained EASI-75 response, and over 90% maintained EASI-90 response through Week 104.² Safety was consistent with the established nemolizumab profile, atopic dermatitis flares, nasopharyngitis, COVID-19, and upper respiratory infections were the most common adverse events.

Pediatric pharmacokinetics, safety, and efficacy in children aged 2-11 years

A phase 2, multicenter, open-label pharmacokinetic and safety study enrolled 109 children with moderate-to-severe atopic dermatitis across 3 cohorts:

• Cohort 1 (ages 7-11, high-dose; n=36)
• Cohort 1.1 (ages 7-11, low-dose; n=37)
• Cohort 2 (ages 2-6, low-dose; n=36)

Dose levels were weight-based, with 5, 10, or 15 mg Q4W in low-dose cohorts and 10, 20, or 30 mg in the high-dose cohort, and given with background TCS plus or minus topical calcineurin inhibitors for up to 52 weeks.

Systemic exposures trough nemolizumab concentrations in Cohorts 1.1 and 2 matched those observed in adults and adolescents from the ARCADIA program, confirming the extrapolation strategy underpinning the pediatric development plan.

Efficacy outcomes at Week 16 in Cohorts 1.1 and 2 included EASI-75 in 73.0% and 69.4% of patients, IGA success (IGA 0/1 with ≥2-point improvement) in 40.5% and 47.2%, and PP-NRS ≥4-point itch improvement in 59.5% and 72.2% of patients, respectively. Itch relief was observed as early as Week 1. All responses were sustained through Week 52.

Safety in the pediatric cohorts was favorable: no serious treatment-emergent adverse events (TEAEs) occurred, and only 2 severe TEAEs were reported across all 109 children. EASI-50 and EASI-90 improvements at Week 4 were sustained through Week 52 in all 3 cohorts. The findings are intended to support regulatory applications for the pediatric AD indication.

References

1. Silverberg JI, Stein Gold L, Thaçi D, et al. Continuous response with nemolizumab: efficacy and safety up to 104 weeks in patients with moderate-to-severe atopic dermatitis with partial and non-response in skin at 16 weeks. Presented at: Revolutionizing Atopic Dermatitis; Nashville, TN; June 17-19, 2026.

2. Thaçi D, Tauber M, Papp KA, et al. Long-term (up to 104 weeks) maintenance of itch and skin responses with nemolizumab treatment in patients with moderate-to-severe atopic dermatitis. Presented at: Revolutionizing Atopic Dermatitis; Nashville, TN; June 17-19, 2026.

3. Eichenfield LF, Zdybski J, Reich A, et al. Pharmacokinetics, safety, and efficacy of nemolizumab in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis. Presented at: Revolutionizing Atopic Dermatitis; Nashville, TN; June 17-19, 2026.