Injection‐Related Pain During Nemolizumab Treatment With Standardized Vibration‐and‐Cooling Analgesia in Children With Atopic Dermatitis: A Real‐World Observational Study

ABSTRACT Background/Objectives Injection pain and needle‐related anxiety may limit acceptance and continuation of biologic therapy in children with atopic dermatitis (AD). Real‐world data on injection pain during nemolizumab treatment is limited. We aimed to longitudinally quantify injection pain during nemolizumab treatment under standardized vibration‐and‐cooling analgesia and evaluate early clinical outcomes. Methods This retrospective observational cohort study enrolled children aged 6–12 years with moderate‐to‐severe AD who had completed 16 weeks of nemolizumab treatment (30 mg every 4 weeks) between June 2024 and July 2025. All injections were administered with standardized vibration‐and‐cooling analgesia. Injection pain was assessed immediately after each injection using the Wong–Baker FACES Pain Rating Scale (0–10). Secondary outcomes included the Peak Itch Numeric Rating Scale (NRS), Patient‐Oriented Eczema Measure (POEM), and Eczema Area and Severity Index (EASI) scores. Results The 13 children provided 62 of 65 planned pain ratings. Injection pain was consistently minimal (median 0; interquartile range [IQR] 0–2); no child reported severe pain (score ≥ 8). At Week 16, the median EASI reduction was 87.5% (IQR, 73.7–90.3); EASI‐75 was achieved by 9 of 13 (69.2%) participants. Median peak itch NRS improved by 5.0 points (IQR, 3.0–6.0), and median POEM improved by 7.0 points (IQR, 4.0–12.0). No serious adverse events occurred. Conclusion Under standardized vibration‐and‐cooling analgesia, nemolizumab administration was associated with minimal injection pain and substantial early clinical improvement; these findings do not represent the intrinsic injection pain of nemolizumab without analgesia.