Nemolizumab shows positive results according to a recently published post hoc analysis of a phase 2b trial evaluating the drug vs placebo in adult patients with moderate to severe atopic dermatitis (AD).
In the post-hoc analysis of a phase 2b clinical trial recently published in the Journal of the European Academy of Dermatology and Venereology (JEADV)1, nemolizumab (Galderma) demonstrated significant improvement in itch, sleep, and skin lesions in adult patients with uncontrolled moderate to severe atopic dermatitis (AD).
Nemolizumab is a humanized monoclonal antibody designed to block signaling from the interleukin (IL)-31 receptor, which is thought to play a role in inflammatory diseases such as AD. The drug is currently being evaluated in clinical trials for AD and prurigo nodularis.1
“This post-hoc analysis published in [JEADV] further emphasizes the significant potential of nemolizumab in treating moderate-to-severe [sic] atopic dermatitis,” said Baldo Scassellati Sforzolini, MD, PhD, MBA, global head of R&D at Galderma. “In our continued commitment to advancing dermatology, these findings demonstrate the multitude of potential benefits that nemolizumab could bring to people living with this severe and chronic disease.”
Investigators of the randomized phase 2b trial evaluated the efficacy of nemolizumab compared to placebo in adult patients with moderate to severe AD. Endpoints included a change in Eczema Area and Severity Index (EASI) score at Week 16, Peak Pruritus Numeric Rating Scale (PP‐NRS), Investigator’s Global Assessment (IGA), and changes in sleep and responders with greater than or equal to 4‐point improvement on PP‐NRS.2
Results of the analysis include the following:1
"Atopic dermatitis is a chronic and debilitating disease,” said Jonathan Silverberg, MD, PhD, MPH, lead study author, and director of clinical research at George Washington University School of Medicine and Health Sciences. “We particularly need more treatment options for patients with moderate-to-severe [sic] atopic dermatitis. Results from these analyses build on our previous knowledge of nemolizumab’s efficacy in atopic dermatitis and show the potential benefits that it offers for patients with moderate-to-severe [sic] atopic dermatitis.”