Nemolizumab Sustains Atopic Dermatitis Responses Through 3 Years in ARCADIA

Nemolizumab (Nemluvio) maintained improvements in skin lesions, itch, sleep disturbance, and quality of life through 3 years in adults and adolescents with moderate to severe atopic dermatitis in the ARCADIA long-term extension (LTE) study, according to Galderma, which is presenting the findings at the 2026 European Academy of Dermatology and Venereology (EADV) Congress.¹

Nemolizumab is a monoclonal antibody targeting the interleukin-31 (IL-31) receptor α, blocking signaling of a neuroimmune cytokine involved in itch, inflammation, and epidermal dysregulation.¹ The US Food and Drug Administration (FDA) has approved the agent 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 topical prescription therapies provide inadequate control.¹ The pivotal ARCADIA 1 and ARCADIA 2 phase 3 trials established efficacy with concomitant topical therapy at week 16.²

"Coupled with a well-characterized safety profile, these findings add to the robust and growing body of evidence regarding the long-term use of Nemluvio in moderate-to-severe atopic dermatitis," said Jonathan I. Silverberg, MD, PhD, MPH, lead investigator of the ARCADIA clinical program and professor of dermatology, George Washington University School of Medicine and Health Sciences.¹

Nemolizumab efficacy through week 152 in the ARCADIA extension

The open-label ARCADIA LTE study is evaluating the long-term safety and efficacy of nemolizumab for up to 200 weeks in patients aged 12 years and older with moderate to severe atopic dermatitis.³ Matthias Augustin, MD, an ARCADIA investigator, will present the week 152 results in an oral session in Vienna, Austria, on October 1, 2026.¹ Galderma reported the outcomes from observed case analyses.¹

At week 152, up to 91% of patients achieved at least 75% improvement in Eczema Area and Severity Index (EASI-75), and up to 75% achieved EASI-90.¹ Up to 67% of patients reached an Investigator's Global Assessment (IGA) score of 0 or 1, corresponding to clear or almost clear skin.¹

Galderma expressed response rates as maximum ("up to") values, and the release did not include denominators or breakdowns by analysis group. Because the extension is open-label, no placebo comparison is available at this timepoint. In the parent trials, EASI-75 response at week 16 reached 44% (270/620) in ARCADIA 1 and 42% (220/522) in ARCADIA 2 with nemolizumab plus topical therapy.²

Nemolizumab itch, sleep, quality of life, and safety outcomes at 3 years

Up to 88% of patients achieved clinically meaningful itch relief at week 152, and up to 73% reached an itch-free or nearly itch-free state.¹ Up to 92% of patients reported clinically meaningful improvement in dermatology-related quality of life.¹

The safety profile remained consistent with earlier findings through 3 years of treatment, with no new safety signals compared with prior interim LTE analyses, according to Galderma.¹ The release did not report specific adverse event rates or discontinuations. A separate post hoc E-poster analysis of the ARCADIA and OLYMPIA LTE studies characterized the cutaneous safety profile of nemolizumab as favorable and well tolerated over 2 years in atopic dermatitis and prurigo nodularis.¹

New analyses of data from the ARCADIA and OLYMPIA trials identified clinically meaningful improvement in sleep disturbance with nemolizumab compared with placebo.⁴ The analyses also linked sleep disturbance closely to itch intensity and skin lesion severity.⁴ Franz J. Legat, MD, Medical University of Graz, is presenting these findings orally on October 1.¹

Galderma is also presenting a descriptive analysis of OLYMPIA LTE patient-reported outcomes, showing sustained improvement in itch, pain, sleep disturbance, and quality of life in prurigo nodularis through week 148.¹ Nemolizumab is approved for both indications in more than 40 countries, and additional regulatory submissions and reviews are ongoing, according to the company.¹

Frequently Asked Questions

What did the 3-year ARCADIA extension data show for nemolizumab?

At week 152, up to 91% of patients achieved EASI-75, up to 75% achieved EASI-90, and up to 67% achieved IGA 0/1, with no new safety signals, according to Galderma.

How does nemolizumab work?

Nemolizumab is a monoclonal antibody targeting the IL-31 receptor α, blocking signaling of IL-31, a neuroimmune cytokine involved in itch, inflammation, and epidermal dysregulation.

What is nemolizumab approved for?

In the US, nemolizumab is approved for adults with prurigo nodularis and for patients 12 years and older with moderate to severe atopic dermatitis, used with topical corticosteroids and/or calcineurin inhibitors when topical prescription therapies provide inadequate control.

References

1. Galderma. 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. Published September 29, 2026. Accessed September 30, 2026. https://www.businesswire.com/news/home/20260929663019/en/EADV-2026-Galdermas-New-Data-Show-Sustained-Improvements-with-Nemluvio-nemolizumab-for-up-to-Three-Years-in-Patients-With-Moderate-to-severe-Atopic-Dermatitis

2. Silverberg JI, Wollenberg A, Reich A, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 and ARCADIA 2): results from two replicate, double-blind, randomised controlled phase 3 trials. Lancet. 2024;404(10451):445-460. doi:10.1016/S0140-6736(24)01203-0. https://doi.org/10.1016/S0140-6736(24)01203-0

3. Silverberg JI, et al. Long-term safety and efficacy (up to 152 weeks) of nemolizumab in ARCADIA open-label long-term extension study in adults and adolescents with moderate-to-severe atopic dermatitis. Presented at: European Academy of Dermatology and Venereology Congress; September 30-October 3, 2026; Vienna, Austria.

4. Legat FJ, et al. Comparative effects of itch, skin lesion severity and nemolizumab on sleep disturbance in atopic dermatitis and prurigo nodularis. Presented at: European Academy of Dermatology and Venereology Congress; September 30-October 3, 2026; Vienna, Austria.