New ARCADIA and OLYMPIA LTE data show nemolizumab sustained skin clearance and itch relief for up to 3 years in atopic dermatitis and prurigo nodularis.
Nemolizumab (Nemluvio) maintained deep skin clearance and itch responses for up to 3 years in adults and adolescents with
Nemolizumab is the first approved monoclonal antibody specifically targeting and inhibiting interleukin-31 (IL-31) signaling. In the US, it is approved for adults with prurigo nodularis and for patients aged 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors, when disease is not adequately controlled with topical prescription therapies.
Sarina Elmariah, MD, a dermatologist and itch specialist at the University of California San Francisco, described the 3-year results as encouraging and noted they add to the growing evidence supporting meaningful long-term outcomes with nemolizumab in atopic dermatitis.
The post hoc analysis evaluated 295 patients aged 12 years and older who achieved a clinical response at Week 16 in the ARCADIA trials and continued treatment through the maintenance and LTE phases. Deep skin clearance was assessed using Investigator’s Global Assessment (IGA) scores of 0 or 1 and at least 90% or 100% improvement from baseline in the Eczema Area and Severity Index (EASI).
At Week 56, 77% of early responders achieved clear skin or at least a 90% improvement in disease severity. These responses were maintained through Week 152, when 76% achieved IGA 0/1, 80% achieved EASI-90, and 50% achieved complete skin clearance (EASI-100). At Week 152, 80% of patients were also itch-free or nearly itch-free, and nemolizumab was well tolerated with no new safety signals.
A separate prespecified interim analysis of the overall ARCADIA LTE population included 1903 adults and adolescents. Based on observed case analyses through Week 152, up to 91% of patients achieved EASI-75, up to 75% achieved EASI-90, and up to 67% achieved IGA 0/1. Up to 88% experienced clinically meaningful itch relief, up to 73% reached an itch-free or nearly itch-free state, and up to 92% reported clinically meaningful improvements in dermatology-related quality of life.
A descriptive analysis of the OLYMPIA LTE study showed sustained improvements in itch, pain, sleep disturbance, quality of life, and overall health status in adults with prurigo nodularis through Week 148. Among 508 patients enrolled at Week 48, more than 85% achieved clinically meaningful itch improvement, and about three-quarters reached an itch-free or nearly itch-free state.
In addition, 60% of patients reported no prurigo nodularis-associated pain, 85% achieved clinically meaningful improvements in sleep disturbance, and 91% experienced clinically meaningful improvements in quality of life. As in atopic dermatitis, no new safety signals were identified.
Galderma is also presenting phase 2 data in children aged 2 to 11 years with moderate-to-severe atopic dermatitis, in which pediatric doses produced pharmacokinetic exposure similar to adults and adolescents, with clinically meaningful reductions in skin lesions and itch sustained up to Week 52.
Bill Andriopoulos, PhD, head of global medical affairs at Galderma, said patients and physicians increasingly expect more from treatment than temporary symptom relief, and he described the data as reinforcing nemolizumab’s potential for durable disease control.
Editor’s note: This summary has been edited for grammar and clarity using artificial intelligence tools.
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