Efficacy and safety of nemolizumab in paediatric atopic dermatitis: A 24‐week real‐world case series

In atopic dermatitis (AD), pruritus is a key symptom that significantly affects patients' quality of life.1 In children, chronic itch can also disrupt sleep and interfere with normal development.2 Nemolizumab is a humanized monoclonal antibody binding interleukin (IL)-31 receptor A.3 IL-31 is implicated in the pathogenesis of itch and contributes to epidermal barrier disruption and inflammation in AD. Clinical trials in paediatric patients have shown that nemolizumab is effective in reducing pruritus and rash of AD with a favourable safety profile.4 Long-term experience data with nemolizumab in AD have also been reported, supporting sustained efficacy and acceptable safety with extended treatment.5 However, real-world data on its use in children aged <13 years remain limited. We conducted a single-centre prospective case series in a real-world setting involving 14 paediatric patients aged 6–12 years with moderate-to-severe AD who continued to experience refractory itch despite treatment with topical corticosteroids and oral antihistamines. All patients received subcutaneous nemolizumab 30 mg every 4 weeks in combination with topical corticosteroids of mid- to high potency. Clinical assessments were performed at Weeks 0, 4, 8, 12, 16 and 24, using total and regional eczema area and severity index (EASI) and peak pruritus numerical rating scale (PP-NRS). Study visits were scheduled every 4 weeks to align with the dosing interval. We thus did not assess the clinical data earlier than Week 4. This case series was conducted in accordance with the Declaration of Helsinki (2004) and approved by the ethics committees of Nippon Medical School and Nippon Medical School Chiba Hokusoh Hospital. Written informed consent was obtained from all parents or legal guardians of patients. Baseline demographics, comorbidities, clinical indexes and prior systemic therapy are summarized in Table 1. The patients were aged mean ± standard deviation (SD) 9.2 ± 1.9 years with 17.7 ± 3.9 kg/m2 of body mass index and 28.6% of male proportion. Baseline EASI and PP-NRS scores were mean ± SD 21.8 ± 8.8 and 7.8 ± 1.9, respectively. Four patients had previously been treated with dupilumab. Mean total and regional (head and neck, trunk, upper and lower limbs) EASI and PP-NRS scores decreased continuously through Week 24 (Figure 1a). At Week 4, mean percentage reductions from baseline of total EASI and PP-NRS were 39.6% and 51.8%, respectively. The proportions of patients achieving EASI 50, EASI 75, EASI 90 and PP-NRS4 were 50%, 7.1%, 0% and 61.5% at Week 4, respectively (Figure 1b). At Week 24, mean percentage reductions from baseline of total EASI and PP-NRS were 81.3% and 83.9%, respectively. The proportions of patients achieving EASI 50, EASI 75, EASI 90 and PP-NRS4 were 100%, 75%, 25% and 87.5% at Week 24, respectively (Figure 1b). Effectiveness and safety outcomes at Week 24 are summarized in Table 1. No serious adverse events (AEs) were reported. One patient experienced worsening of AD, which resolved with topical corticosteroids, and did not lead to the discontinuation of nemolizumab. These real-world findings are consistent with those of randomized trials of nemolizumab that demonstrated significant improvements in pruritus and skin lesions with a favourable safety profile in children aged 6–12 years, including longer-term data.4, 6 In this 24-week prospective case series of 14 children with moderate-to-severe AD, nemolizumab was associated with substantial reductions in itch and eczema across body regions without serious AEs. These findings support the clinical utility of nemolizumab in paediatric AD and complement evidence from paediatric randomized trials. This work is partly supported by 2024 scholarship grants from Maruho Takagi Dermatology Foundation and Torii Pharmaceutical Co., Ltd. Hidehisa Saeki, Teppei Hagino and Naoko Kanda received lecture fees from Maruho. The other authors have no conflicts of interest to be disclosed. This study was conducted in accordance with the Declaration of Helsinki, and approved by the Ethics Committee of Nippon Medical School Chiba Hokusoh Hospital and Nippon Medical School. Informed consent was obtained from all the subjects involved in the study. The data that support the findings of this study are available from the corresponding author upon reasonable request.