Galderma reports three-year ARCADIA data showing sustained Nemluvio benefits in atopic dermatitis, including improvements in skin lesions, itch and quality of life.
Written By: Kalyani Boharapi,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Galderma is presenting new three-year data from the ARCADIA long-term extension (LTE) study (NCT03989206) showing sustained efficacy and a consistent safety profile for Nemluvio® (nemolizumab) in adults and adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD). The findings are being presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026 in Vienna, Austria.
Sustained Improvements Through Week 152
The ARCADIA open-label long-term extension study is evaluating the long-term safety and efficacy of Nemluvio in adults and adolescents aged 12 years and older with moderate-to-severe atopic dermatitis for up to 200 weeks.
The extension study includes patients from earlier nemolizumab studies, including the pivotal ARCADIA 1 (NCT03985943) and ARCADIA 2 (NCT03989349) trials, as well as other eligible participants. The Week 152 findings reported at EADV 2026, however, are results from the ARCADIA long-term extension study rather than separate three-year results from ARCADIA 1 or ARCADIA 2.
At Week 152, Nemluvio was associated with sustained improvements across several measures of disease burden, including skin lesions, itch, sleep disturbance, and quality of life. Based on observed-case analyses, up to 91% of patients achieved EASI-75, representing at least a 75% improvement in eczema severity, while up to 75% achieved EASI-90, corresponding to at least a 90% improvement.
Up to 67% of patients achieved clear or almost clear skin, defined by an Investigator’s Global Assessment (IGA) score of 0 or 1.
The treatment was also associated with improvements in itch, an important symptom of atopic dermatitis. Up to 88% of patients achieved clinically meaningful itch relief, while up to 73% reached an itch-free or nearly itch-free state. Clinically meaningful improvements in dermatology-related quality of life were reported in up to 92% of patients.
Three-Year Safety Profile Remains Consistent
The safety profile of Nemluvio remained consistent with previous findings through three years of treatment, with no new safety signals identified compared with previous long-term extension study interim analyses.
According to Professor Jonathan Silverberg, lead investigator of the ARCADIA clinical program, the findings showed that improvements in skin symptoms, itch, sleep disturbance, and quality of life were maintained over time, while the safety profile remained well characterized.
Additional Analyses from ARCADIA and OLYMPIA
Galderma is also presenting additional analyses from the ARCADIA LTE and OLYMPIA LTE (NCT04204616) studies.
A post-hoc analysis of these two long-term extension studies found that Nemluvio maintained a favorable and well-tolerated cutaneous safety profile over two years in patients with moderate-to-severe atopic dermatitis and prurigo nodularis.
The OLYMPIA long-term extension study, evaluates long-term nemolizumab treatment in patients with prurigo nodularis. A separate descriptive analysis of patient-reported outcomes from this extension study showed sustained and clinically meaningful improvements through Week 148 across multiple dimensions of prurigo nodularis burden, including itch, pain, sleep disturbance, and quality of life.
Sleep Disturbance Improves with Nemluvio
Additional analyses from the ARCADIA and OLYMPIA clinical trials examined sleep disturbance, an important component of the burden associated with atopic dermatitis and prurigo nodularis.
The analyses showed clinically meaningful improvements in sleep disturbance with Nemluvio compared with placebo. They also found that sleep disturbance was closely associated with itch intensity and skin lesion severity in patients with atopic dermatitis and prurigo nodularis.
Importantly, these findings are reported from the broader ARCADIA and OLYMPIA clinical trial programs rather than being described by Galderma as an analysis of the two long-term extension studies specifically. The EADV presentation is titled “Comparative effects of itch, skin lesion severity and nemolizumab on sleep disturbance in atopic dermatitis and prurigo nodularis.”
Nemluvio and IL-31 Signaling
Nemluvio (nemolizumab) is a monoclonal antibody that inhibits signaling mediated by interleukin-31 (IL-31), a neuroimmune cytokine involved in itch, inflammation, epidermal dysregulation, and fibrosis.
Nemluvio was originally developed by Chugai Pharmaceutical Co., Ltd. Galderma obtained exclusive worldwide development and commercialization rights outside Japan in 2016. In Japan, nemolizumab is marketed as Mitchga® and is approved for prurigo nodularis and pruritus associated with atopic dermatitis.
In the United States, Nemluvio 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 the disease is not adequately controlled with topical prescription therapies.
Nemluvio is approved for atopic dermatitis and/or prurigo nodularis in more than 40 countries, with additional regulatory reviews ongoing.
The three-year ARCADIA long-term extension findings provide longer-term data on the durability of clinical improvements with nemolizumab in moderate-to-severe atopic dermatitis. The additional ARCADIA LTE and OLYMPIA LTE analyses further characterize the treatment’s longer-term safety and effects on symptoms and quality of life in atopic dermatitis and prurigo nodularis.
Reference
EADV 2026: Galderma’s new data show sustained improvements with Nemluvio® (nemolizumab) for up to three years in patients with moderate-to-severe atopic dermatitis, Galderma, 30 September 2026
Efficacy and Safety of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis, ClinicalTrials.gov ID NCT03985943
Efficacy & Safety of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis, ClinicalTrials.gov ID NCT03989349
Long-term Safety and Efficacy of Nemolizumab with Moderate-to-severe Atopic Dermatitis, ClinicalTrials.gov ID NCT03989206
A Long-term Study of Nemolizumab (CD14152) in Participants with Prurigo Nodularis (PN), ClinicalTrials.gov ID NCT04204616
About the Writer
Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.