Subcutaneous nemolizumab may be effective atopic dermatitis treatment

Subcutaneous nemolizumab combined with topical agents reduced pruritus in Japanese patients with atopic dermatitis, according to phase 3 trial results published in the New England Journal of Medicine.

The 16-week, double-blind trial randomly assigned patients 2:1, with 143 patients receiving nemolizumab 60 mg and 72 patients receiving placebo formulated to be identical to nemolizumab but without the active product. Subjects received subcutaneous injections of the active drug or placebo on the date of randomization and every 4 weeks for 16 weeks.

Those on concomitant stable medications for atopic dermatitis, including medium-potency topical glucocorticoids, topical calcineurin inhibitors and oral antihistamines, remained on their medications. Lower-potency topical glucocorticoids and moisturizing or protecting agents were also continued.

Those in the active treatment group had a mean Visual Analogue Scale score change of 42.8% at week 16 compared with 21.4% in the placebo group (P < .001). The mean Eczema Area and Severity Index score changed 45.9% in the treatment group and 33.2% in the placebo group at week 16. The nemolizumab group had 40% of patients with a Dermatology Life Quality Index score of 4 or less compared with 22% of those in the placebo group.

An Insomnia Severity Index score of 7 or less was achieved in 55% of patients in the treatment group and 21% of those in the placebo group.

“Nemolizumab plus topical agents may ameliorate both pruritus and signs of eczema and may lessen the severity of atopic dermatitis by disrupting the itch-scratch cycle,” the study authors wrote.

Injection-related reactions occurred in 8% of subjects in the treatment group and 3% of subjects in the placebo group.

Limitations included the trial’s short treatment duration and Japanese-only patient population.