Anti-IL-31 drug shows promise in itch management for atopic dermatitis
A phase-II study of a new systemic therapy for atopic dermatitis has found that the therapy, the anti-interleukin (IL)31 antibody nemolizumab, significantly reduced pruritus in patients with moderate-to-severe disease.
These findings, which the authors say demonstrate the value of targeting the IL-31 receptor A in these patients, were published in The New England Journal of Medicine (Mar. 2, 2017; 376:826–835).
“Nemolizumab is the first drug specifically targeting pruritus. Its use is very convenient to patients with one subcutaneous injection per month,” Professor Thomas Ruzicka, director of the clinic and polyclinic for dermatology and allergology at the Ludwig-Maximilian University in Munich, and first author of the article, said in a press release. “Since IL-31 is involved in a variety of other pruritic skin diseases, the innovative drug has a large potential in dermatology.”
In the randomized, double-blind, placebo-controlled, 12-week trial, adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments were randomized to receive subcutaneous nemolizumab at doses of 0.1 mg, 0.5 mg, or 2.0 mg per kilogram of body weight, or placebo, every 4 weeks, or an exploratory dose of 2.0 mg of nemolizumab per kilogram every 8 weeks.
A percentage decrease from baseline on a pruritus visual-analogue scale at week 12 was the primary endpoint. Secondary end points included changes in Eczema Area and Severity Index (EASI) score, and body-surface area involvement of atopic dermatitis.
A total of 264 patients underwent randomization, and of those 216 (82%) completed the study.
At week 12, among the patients who received nemolizumab every four weeks, changes on the pruritus visual-analogue scale were:
−43.7% in the 0.1-mg group
−59.8% in the 0.5-mg group
−63.1% in the 2.0-mg group
These compared to −20.9% in the placebo group (p<0.01 for all comparisons).
Changes on the EASI were:
−23.0% in the 0.1-mg group
−42.3% in the 0.5-mg group
−40.9% in the 2.0-mg group
These compared to −26.6% in the placebo group.
Changes in body-surface area affected by atopic dermatitis were:
−7.5% in the 0.1-mg group
−20.0% in the 0.5-mg group
−19.4% in the 2.0-mg group
The changes with placebo were −15.7%.
Nine of the 53 (17%) patients receiving nemolizumab every four weeks discontinued treatment in the 0.1-mg group, as did nine of 54 (17%) in the 0.5-mg group, seven of 52 (13%) in the 2.0-mg group, and nine of 53 (17%) in the placebo group.
#Dermatology #Itch #Pruritus #Atopicdermatitis #Chroniceczematousrash #interleukin31