Galderma announced compelling two-year data from the ARCADIA long-term extension study of Nemluvio (nemolizumab) in moderate-to-severe atopic dermatitis, presented at the Revolutionizing Atopic Dermatitis (RAD) Conference on June 6-7, 2025. The interim analysis demonstrates sustained and increased improvements across multiple clinical outcomes, reinforcing the drug's therapeutic potential for long-term management of this chronic inflammatory skin condition.
Robust Long-Term Efficacy Outcomes
The ARCADIA long-term extension study, designed to assess safety and efficacy up to five years, enrolled more than 1,900 patients who either completed the initial or maintenance period in ARCADIA 1 or 2, a previous phase II/IIIb study, or were newly enrolled adolescent patients. At week 104, the interim analysis revealed impressive efficacy outcomes:
More than 85% of evaluable patients achieved a 75% reduction in the Eczema Area and Severity Index (EASI), a key measure of disease severity. Approximately 85% and 70% of patients achieved at least four-point improvement in itch and being itch-free or nearly itch-free, respectively, when assessed using the SCORing Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Pruritus score. Sleep improvements mirrored those observed in itch relief.
Approximately 60% of patients reached clearance or almost-clearance of skin lesions when assessed using the Investigator's Global Assessment (IGA) score, while patients' quality of life improved over time as measured by the Dermatology Life Quality Index (DLQI).
Rapid Onset and Sustained Benefits
The data reinforce Nemluvio's rapid onset of action, with significant improvements observed as early as week 4. Among patients who entered the long-term extension study naïve to Nemluvio, 49% achieved a 75% reduction in EASI and 69% achieved at least four-point improvement in itch when assessed using the SCORAD VAS Pruritus score at this early timepoint.
"With Nemluvio now being launched in several countries, it's so encouraging that we continue to see its robust evidence base expand. Long-term data is pivotal to this, highlighting the profound impact this innovative treatment can have in atopic dermatitis well into the future," said Dr. Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma.
Favorable Safety Profile Maintained
The long-term treatment data demonstrate that Nemluvio was well tolerated, with no new safety signals identified during the extended treatment period. This consistent safety profile builds on data from the phase III ARCADIA program, providing additional confidence for clinicians considering long-term treatment strategies.
Professor Jonathan Silverberg, lead investigator of the ARCADIA clinical program and Professor of Dermatology at George Washington University School of Medicine and Health Sciences, emphasized the clinical significance: "The relentless itch of atopic dermatitis is not just a symptom; it's a constant burden that disrupts sleep, concentration, and the simple joys of life. Nemolizumab has demonstrated its impact on both itch and skin lesions in atopic dermatitis extensively over the years, and these new data, demonstrating its benefit up to two years, add another layer of confidence to that."
Addressing Significant Unmet Need
Atopic dermatitis affects more than 230 million people worldwide and represents the most common inflammatory skin disease, impacting almost four times more people than psoriasis. The condition is characterized by persistent itch and recurrent skin lesions, with 87% of patients seeking freedom from itch and prioritizing speed of itch relief.
Nemluvio represents a novel therapeutic approach as the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31. This neuroimmune cytokine drives itch and is involved in inflammation and skin barrier dysfunction in atopic dermatitis. The drug is also distinguished as the first and only biologic approved for both atopic dermatitis and prurigo nodularis with four-week dosing intervals from treatment initiation, with the option to extend to eight-week dosing intervals for appropriate atopic dermatitis patients.
Regulatory Status and Market Access
Nemluvio received FDA approval in August 2024 for adults with prurigo nodularis, followed by approval in December 2024 for patients 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 alone. The drug is now approved for both indications by multiple regulatory authorities worldwide, including the European Commission, with additional regulatory submissions and reviews ongoing.
The drug was initially developed by Chugai Pharmaceutical Co., Ltd., with Galderma obtaining exclusive worldwide development and marketing rights in 2016, except in Japan where it is marketed as Mitchga for prurigo nodularis and pruritus associated with atopic dermatitis across pediatric, adolescent, and adult populations.
