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.
Nemolizumab is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of interleukin (IL)-31.
The ARCADIA long-term extension study was designed to assess the long-term safety and efficacy of Nemluvio in patients with moderate-to-severe AD 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.
