Omalizumab for Injection (Enyitan®) in Elderly Patients with Chronic Spontaneous Urticaria: Maintenance of Treatment Goals - A 6-Month Retrospective Follow-Up of Real-World Evidence.

Abstract

Introduction: Chronic spontaneous urticaria (CSU) can be particularly burdensome for older adults. Real-world evidence regarding the use of omalizumab in this growing demographic remains limited. This study evaluated the effectiveness and safety of domestic omalizumab for injection (Enyitan®) in elderly patients with CSU under real-world conditions.

Methods: In this retrospective, single-center, observational cohort study, 71 CSU patients aged ≥65 years with moderate-to-severe disease activity were treated with omalizumab (Enyitan®, 300 mg every 4 weeks) between January and February 2025. Primary outcome was the proportion of patients achieving well-controlled disease (UAS7 ≤ 6) at week 24. Secondary outcomes included changes in UAS7, Itch Severity Score (ISS), Wheal Score (WS), Urticaria Control Test (UCT), and Dermatology Life Quality Index (DLQI). Safety was assessed via adverse events (AEs) and laboratory parameters.

Results: Of 62 patients completing the 24-week study, 88.7% achieved a UAS7 ≤ 6. ISS and WS scores similarly improved (p < 0.001). UCT scores increased from 5.2 ± 2.1 to 14.8 ± 3.2, and DLQI scores decreased from 15.6 ± 4.3 to 3.1 ± 2.8 (both p < 0.001). Treatment was well-tolerated; only mild, transient AEs were reported, predominantly injection-site reactions (9.7%) and headache (3.2%).

Conclusion: Domestic omalizumab (Enyitan®) demonstrated rapid, sustained effectiveness and a favorable safety profile in elderly patients with H1-antihistamine-resistant CSU, supporting its use as a first-line biologic therapy in this vulnerable population.