Journal of Dermatological Treatment · Available online 13 Jul 2026 · In press · DOI 10.1080/09546634.2026.2694909
Yu Wang, Chengzhi Lv, Bin Yang, Zigang Xu, Lin Ma, Lixiong Gu, Zhiming Li, Niu Xiang, Xiaoyong Man, Juan Su, Liming Wu, Min Shu, Sirao Wang, Yujia Song, Yumeng Ren, Yuling Shi
Objective Chronic spontaneous urticaria (CSU) is a burdensome skin disorder that may remain inadequately controlled with standard H1 antihistamines (H1 AHs). Evidence on adolescents with CSU is limited. This 16-week study evaluated the safety and effectiveness of omalizumab in Chinese adolescents (≥12 to <18 years) with CSU who remained symptomatic despite H1 AH treatment (treatment period: 12 weeks; safety follow-up: 4 weeks).Methods Safety assessments and routine clinical evaluations were performed. Effectiveness and quality of life were analyzed using the weekly urticaria activity score (UAS7), weekly itch severity score (ISS7), Urticaria Control Test (UCT), and Children’s Dermatology Life Quality Index (CDLQI).Results All 55 enrolled participants completed the study. Twenty-two participants (40.0%) experienced ≥1 treatment-emergent adverse event (TEAE). No serious adverse events, adverse events of special interest, deaths, or TEAEs leading to treatment discontinuation occurred. At Week 12, changes from baseline in ISS7 and UAS7 were −11.73 and −25.07, respectively; 70.9% participants achieved well-controlled CSU (UCT ≥ 12). The absolute mean change in CDLQI was −9.7 (relative improvement at Week 12: −81.5%).Conclusions Omalizumab demonstrated a favorable safety profile and clinically meaningful effectiveness in Chinese adolescents with CSU who remained symptomatic despite H1 AH therapy and is a valuable option for this underrepresented population.
Abstract from DOAJ. Public domain (CC0 1.0).
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Wang, Y., Lv, C., Yang, B., et al. (2026). Safety and effectiveness of omalizumab for chronic spontaneous urticaria inadequately controlled with H1 antihistamines in Chinese adolescents: a real-world, prospective, multicenter study. Journal of Dermatological Treatment. https://doi.org/10.1080/09546634.2026.2694909