Nemolizumab is a safe and effective treatment, improving the quality of life (QOL) in children with atopic dermatitis (AD) whose pruritus is not improved with topical treatments and antihistamines, according to study results published in the British Journal of Dermatology.
While nemolizumab has been shown to reduce pruritus and improve QOL in patients with AD who are 13 years of age and older, information is limited regarding its efficacy and safety in children aged 6 to 12 years.
Therefore, researchers conducted a 2-part, phase 3, randomized, double-blind, placebo-controlled, multicenter trial to evaluate the efficacy and safety of nemolizumab administered with topical agents in Japanese patients aged 6 to 12 years with AD and moderate to severe pruritis inadequately controlled with topical agents and oral antihistamines. The 16-week study was initiated in September 2020. Following a 14- to 28-day screening period, 89 patients, 100% Asian with a mean (SD) age, 9.1 (1.9) years and mean (SD) AD duration of 8.5 (2.7) years, were randomly assigned in a 1:1 ratio to receive nemolizumab 30 mg (n=45) or placebo (n=44) every 4 weeks. On the day of treatment assignment, patients had a 5-level itch score of 3 or greater for at least 2 days. Patients reported the following allergies: allergic rhinitis, food allergy, allergic conjunctivitis, seasonal allergy and bronchial asthma. All had an inadequate pruritic response with topical corticosteroids or antihistamines. Patients who completed the double-blind period could participate in a 52-week follow-up period.
The primary efficacy endpoint was the change in the self-reported weekly mean 5-level itch score from baseline to week 16. Secondary efficacy endpoints included weekly Average Pruritis Numerical Rating Scale (AP-NRS) scores, daily and weekly 5-level itch scores for pruritis, percent change in Eczema Area and Severity Index scores as well as Patient-Oriented Eczema Measure total scores for atopic dermatitis, and changes in Children’s Dermatology Life Quality Index scores.
Patients (n=45) treated with nemolizumab showed a statistically significant decrease in 5-level itch score from baseline to week 16 compared with those receiving placebo (least-squares mean difference −0.8; 95% CI, −1.1 to −0.5; P <.0001). Daily 5-level itch scores improved in those in the nemolizumab group from the second day after treatment initiation. Additionally, 24.4% of patients in the nemolizumab group achieved a weekly mean 5-level itch score of 1 or lower at week 16, compared with 2.3% of patients in the placebo group (95% CI, 8.9-35.5; P =.0035).
At week 16, more patients treated with nemolizumab achieved a 4-point or greater decrease in the AP-NRS score from baseline compared with placebo-treated patients (41.9% vs 6.8%; 95% CI, 18.5% to 51.6%; P =.0001). A 50% improvement from baseline was also more common in nemolizumab-treated patients (51.1% vs 15.9%; 95% CI, 17.0% to 53.4%; P =.0007), as was a 75% improvement (20.0% vs 0%; 95% CI, 8.3% to 31.7%; P =.0025).
Reported adverse events (AEs) were mostly mild in severity and occurred at a similar frequency between the 2 groups. Among AEs of moderate severity reported, only exacerbation of AD was considered to be related to the study drug. The researchers commented that the overall safety profile of the drug in patients aged 6 to 12 years was comparable to previously reported results for pediatric patients over 13 years old.
Study limitations include the small patient population and the fact that the study was conducted in a single country. Durability and safety of nemolizumab in children older than 16 weeks of age will be confirmed in the long-term extension phase of the study.
The researchers concluded, “These data support the use of nemolizumab as a potential new treatment option for paediatric AD patients whose pruritus has not been sufficiently improved with available therapies.”
This article originally appeared on Dermatology Advisor
Igarashi A, Katsunuma T, Matsumura T, Komazaki H; Nemolizumab-JP04 Study Group. Efficacy and safety of nemolizumab in paediatric patients aged 6-12 years with atopic dermatitis with moderate-to-severe pruritus: results from a phase III, randomised, double-blind, placebo-controlled, multicentre study. Br J Dermatol. Published online July 31, 2023. doi:10.1093/bjd/ljad268