Igarashi Atsuyuki, Katsunuma Toshio, Nagano Yuko, Komazaki Hiroshi
Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.
Igarashi Dermatology Higashi Gotanda, Tokyo, Japan.
Br J Dermatol. 2025 Apr 28;192(5):837-844. doi: 10.1093/bjd/ljae458.
A phase III clinical trial in Japanese children aged 6-12 years with atopic dermatitis (AD) and inadequately controlled moderate-to-severe pruritus found that 16 weeks of nemolizumab treatment [30 mg every 4 weeks (Q4W)] was clinically effective and tolerable, with early improvement in pruritus and associated skin signs and a positive impact on patient quality of life (QoL).
To report the findings from the long-term extension period of the study, and evaluate the efficacy and safety profiles of nemolizumab when administered concomitantly with topical agents over 68 weeks.
The study included a 16-week randomized placebo-controlled double-blind parallel-group period during which patients received nemolizumab 30 mg or placebo Q4W; those who completed this period could enter a 52-week long-term treatment period during which all patients received nemolizumab Q4W. Efficacy endpoints assessed treatment impact on pruritus, AD signs and QoL. Treatment-emergent adverse events (TEAEs) were tabulated to evaluate long-term safety. The study was registered with the Japan Registry of Clinical Trials (jRCT2080225289).
Among the 89 paediatric patients evaluated, efficacy outcome measures showed a tendency toward improvement between weeks 16 and 68, and sustained efficacy during the subsequent follow-up period after treatment cessation. At week 68, among patients who received nemolizumab treatment throughout the study, the mean (SD) change from baseline in the 5-level itch score was -1.8 (0.8), the mean (SD) percentage change from baseline in the Average Pruritus Numerical Rating Scale score was -65.9 (25.0), and the mean (SD) percentage change from baseline in the Eczema Area and Severity Index score was -77.1 (23.1). Data from the Dermatitis Family Impact questionnaire indicated that the burden of housework on family members and parent/caregiver fatigue were reduced and the sleep quality of family members was improved by week 16, with further improvement at week 68. The overall safety profile was similar to that recorded in nemolizumab-treated patients aged ≥ 13 years, with no late-onset TEAEs seen over long-term treatment.
These data confirm the safety of long-term nemolizumab for paediatric patients with AD, and demonstrate improvements in pruritus, skin symptoms, and patient and caregiver QoL over 68 weeks of treatment.
一项针对6至12岁患有特应性皮炎（AD）且中度至重度瘙痒控制不佳的日本儿童的III期临床试验发现，奈莫利单抗治疗16周（每4周30mg）在临床疗效和耐受性方面表现良好，瘙痒及相关皮肤症状早期改善，对患者生活质量（QoL）有积极影响。
报告该研究长期延长期的结果，并评估奈莫利单抗与局部用药联合使用68周的疗效和安全性。
该研究包括一个为期16周的随机安慰剂对照双盲平行组阶段，在此期间患者接受每4周一次的30mg奈莫利单抗或安慰剂治疗；完成该阶段的患者可进入为期52周的长期治疗阶段，在此期间所有患者接受每4周一次的奈莫利单抗治疗。疗效终点评估了治疗对瘙痒、AD体征和QoL的影响。列出治疗中出现的不良事件（TEAE）以评估长期安全性。该研究已在日本临床试验注册中心（jRCT2080225289）注册。
在评估的89名儿科患者中，疗效指标在第16周和第68周之间显示出改善趋势，并且在治疗停止后的后续随访期内疗效持续。在第68周时，在整个研究中接受奈莫利单抗治疗的患者中，5级瘙痒评分相对于基线的平均（标准差）变化为-1.8（0.8），平均瘙痒数字评定量表评分相对于基线的平均（标准差）百分比变化为-65.9（25.0），湿疹面积和严重程度指数评分相对于基线的平均（标准差）百分比变化为-77.1（23.1）。来自皮炎家庭影响问卷的数据表明，到第16周时家庭成员的家务负担和父母/照顾者的疲劳减轻，家庭成员的睡眠质量得到改善，在第68周时进一步改善。总体安全性与≥13岁接受奈莫利单抗治疗的患者记录的安全性相似，长期治疗期间未出现迟发性TEAE。
这些数据证实了奈莫利单抗对儿科AD患者长期治疗的安全性，并表明在68周的治疗中瘙痒、皮肤症状以及患者和照顾者的QoL均有改善。
