AT A GLANCE

Nemolizumab (Nemluvio, Galderma) produces sustained and increased improvements in atopic dermatitis (AD) symptoms, including itch and skin lesions for up to two years with no new safety signals identified, according to data from a new interim analysis of a long-term extension study.

These data were presented in a late-breaker abstract at the Revolutionizing Atopic Dermatitis (RAD) Conference in Nashville, TN.

The ARCADIA long-term extension study was designed to assess the long-term safety and efficacy of Nemluvio in patients with moderate-to-severe atopic dermatitis for up to five years and includes 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 in evaluable patients, the interim analysis shows that:

-  More than 85% achieved a 75% reduction in the Eczema Area and Severity Index (EASI)

-  Approximately 85% and 70% achieved at least a 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. Improvements in sleep mirrored those in itch

-  Approximately 60% reached clearance or almost-clearance of skin lesions when assessed using the Investigator’s Global Assessment (IGA) score

-  Patients’ quality of life improved over time, as measured by the Dermatology Life Quality Index (DLQI)

At Week 4,  49% of patients who entered the long-term extension study naïve to nemolizumab achieved a 75% reduction in the EASI, and 69% achieved at least a four-point improvement in itch when assessed using the SCORAD VAS Pruritus score.

Nemolizumab was well tolerated in the long-term treatment of atopic dermatitis, and no new safety signals were identified.

“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,” says Jonathan Silverberg, MD, PhD, MPH, Director of Clinical Research at The George Washington University School of Medicine and Health Sciences in Washington, DC, in a news release. He is the lead investigator for the Arcadia Clinical Program. “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.”

DRUG AT A GLANCE

Nemolizumab is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of interleukin (IL)-31. It was first approved in August 2024 by the U.S. Food and Drug Administration (FDA) for the treatment of adults with prurigo nodularis. In December 2024, Nemolizumab was also approved by the FDA for the treatment of patients 12 years and older with moderate-to-severe AD, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. To date, Nemluvio is approved for both moderate-to-severe AD and prurigo nodularis by multiple regulatory authorities around the world, including the European Commission. Additional regulatory submissions and reviews are ongoing.