Nemolizumab Shows Rapid, Sustained Efficacy in Atopic Dermatitis

In the ARCADIA long-term extension study, nemolizumab (Nemluvio; Galderma) demonstrated tolerable efficacy and safety outcomes for the treatment of moderate-to-severe atopic dermatitis, with no new safety signals identified compared to results from the ARCADIA 1 (NCT03985943) and ARCADIA 2 (NCT03989349) clinical trials. The results confirm nemolizumab’s use in increasing improvements in symptoms, such as itch and skin lesions, with prolonged treatment up to 2 years.¹ The findings were presented at the Revolutionizing Atopic Dermatitis (RAD) 2025 conference held in Nashville, Tennessee.¹

Image credit: Evgeniya Primavera | stock.adobe.com

“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 [are] pivotal to this, highlighting the profound impact this innovative treatment can have on atopic dermatitis well into the future,” said Baldo Scassellati Sforzolini, MD, PhD, global head of research and development at Galderma, in a news release.¹

Nemolizumab for Atopic Dermatitis

Atopic dermatitis, also referred to as eczema, is a common, chronic, and flaring inflammatory skin disease that causes irritating skin lesions and constant itch, impacting over 230 million individuals globally. Symptoms of the disease can include dry, cracked skin; itchiness; rash on swollen skin; small, raised bumps; oozing and crusting; thickened skin; darkening of the skin around the eyes; and raw, sensitive skin from scratching.^1,2

Nemolizumab is identified as a monoclonal antibody that exclusively targets IL-31 receptor alpha, inhibiting the signaling of IL-31—a neuroimmune cytokine that initiates itch and inflammation in atopic dermatitis. The FDA approved nemolizumab in December 2024 for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not controlled by topical prescription therapies among individuals 12 and older. Nemolizumab also received FDA approval in August 2024 as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis.³

Overview of ARCADIA Clinical Trial

A total of 1900 individuals with moderate-to-severe atopic dermatitis for up to 5 years were included in the long-term ARCADIA extension trial. The participants were newly enrolled adolescents or individuals who completed the initial or maintenance period in the phase 2 and phase 3b ARCADIA 1 and ARCADIA 2 clinical trials.¹

The results demonstrated that at week 104 of the interim analysis, more than 85% of evaluable individuals achieved a 75% reduction in eczema area and severity index. Nearly 85% and 70% achieved around a 4-point improvement in itch, including being itch-free or nearly itch-free, respectively, according to the SCORing atopic dermatitis visual analog scale pruritus score. Additionally, improvements in sleep also reflected those in itch.¹

Further results found that after using the investigator’s global assessment score, approximately 60% of individuals reached clearance or almost-clearance of skin lesions. Lastly, individuals’ quality of life was measured by the dermatology life quality index and was reported to improve over time.¹

Significantly, nemolizumab was well tolerated in long-term atopic dermatitis treatment, with no new safety concerns. The findings emphasize nemolizumab’s swift response in treating atopic dermatitis symptoms, along with its long-term effectiveness in prurigo nodularis, as demonstrated in the OLYMPIA open-label extension trial (NCT04204616).¹

“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,” Jonathan Silverberg, lead investigator of the ARCADIA clinical program and professor of dermatology at George Washington University School of Medicine and Health Sciences, said in the news release. "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 2 years, add another layer of confidence to that."¹

REFERENCES

1. RAD 2025: Long-term data on Nemluvio® (nemolizumab) demonstrate its favorable safety profile and sustained and increased improvements in itch and skin lesions in patients with atopic dermatitis up to two years. Galderma. News release. June 6, 2025. Accessed June 16, 2025. https://www.galderma.com/news/rad-2025-nemluvio

2. Mayo Clinic. Atopic Dermatitis. News release. May 15, 2024. Accessed June 16, 2025. https://www.mayoclinic.org/diseases-conditions/atopic-dermatitis-eczema/symptoms-causes/syc-20353273

3. Ferruggia K. Nemolizumab Granted FDA Approval For Moderate-to-Severe Atopic Dermatitis. Pharmacy Times. December 16, 2024. Accessed June 16, 2025.https://www.pharmacytimes.com/view/nemolizumab-granted-fda-approval-for-moderate-to-severe-atopic-dermatitis