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

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.