Monoclonal antibody led to sustained improvements in itch sleep and skin lesions in adult patients

Investigational monoclonal antibody (mAb) nemolizumab demonstrated long-lasting benefits in adult patients with uncontrolled atopic dermatitis, according to new results from a Phase IIa study. 

 

A post hoc analysis of a Phase IIa study of nemolizumab in adult patients with moderate-to-severe atopic dermatitis, published in the Journal of the European Academy of Dermatology and Venereology (JEADV), found that the mAb led to ‘rapid and sustained’ improvements in itch, sleep and skin lesions. 

 

Specifically, patients treated with nemolizumab experienced itch relief within 48 hours of treatment (-22.8% versus -12.3%), with this improvement sustained over the trial, achieving greater treatment benefit at week 16 (-68.5% vs -30.9%). 

 

Patients treated with nemolizumab also had rapid improvement of sleep disturbance from day three of treatment (-26.6% vs -9.0%), which improved further at week 16 (-76.0% vs -36.5%). 

 

The study also detailed clinically meaningful reductions of 75% Eczema Area and Severity Index (EASI) observed at week 16 in 50.0% of nemolizumab-treated patients, compared to 15.9% for those in the placebo group. 

 

In the nemolizumab group, 90% reductions of EASI were observed in 36% of participants compared to 6.8% of placebo patients. 

 

The investigational drug was also found to be safe and well tolerated – the most common adverse events observed were nasopharyngitis and upper respiratory tract infection. 

 

"Atopic dermatitis is a chronic and debilitating disease. We particularly need more treatment options for patients with moderate-to-severe atopic dermatitis,” said Jonathan Silverberg, lead author, director of clinical research, George Washington University School of Medicine and Health Sciences. 

 

“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 atopic dermatitis,” he added. 

 

Nemolizumab, developed by Galderma, was granted breakthrough therapy designation by the US Food and Drug Administration (FDA) in December 2019 for the treatment of pruritus associated with prurigo nodularis.