Safety and effectiveness of omalizumab for chronic spontaneous urticaria inadequately controlled with H1 antihistamines in Chinese adolescents: a real-world, prospective, multicenter study.

Abstract

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.