Ronconi Giulia, Dondi Letizia, Calabria Silvia, Dondi Leonardo, Dell'Anno Irene, Casoli Lucia, Valsecchi Diletta, Bonavita Ornella, Nettis Eustachio, Martini Nello, Piccinni Carlo
Fondazione ReS (Ricerca e Salute)- Research and Health Foundation, Via dei Due Macelli 48, Roma, 00187, Italy.
Novartis Farma SpA - Viale Luigi Sturzo, Milano, 43 20154, Italy.
BMC Health Serv Res. 2025 Jul 23;25(1):969. doi: 10.1186/s12913-025-13122-9.
Chronic spontaneous urticaria (CSU) is a disorder of skin and mucosal tissues lasting at least 6 weeks. Treatments are primarily addressed to reduce symptoms; therefore, patients still experience poor living conditions and high unmet needs. This retrospective observational study was aimed to describe patients newly diagnosed with CSU, their healthcare resource utilization and related economic burden through Italian administrative healthcare data.
From a large Italian administrative healthcare database (˜5.5 million inhabitants/year), in- and outpatients newly diagnosed with CSU from January 1, 2016, to December 31, 2021 (index date) were identified through specific algorithms. Drug dispensations, overnight hospitalizations, emergency department (ED) accesses, local outpatient specialist care and direct costs charged to the Italian National Health Service (SSN) were described throughout the first follow-up year. Also, CSU exacerbations were assessed throughout the available follow-up/patient (variable based on the accrual year and up to December 31 2022).
Patients newly diagnosed with CSU in Italy were 1,707. The median (IQR) age was 36 (18;55) years with twice as many females as males. Cardiometabolic diseases were the most common comorbidities. Throughout the first follow-up year: 72.9% patients were treated with second-generation H1-antihistamines (mainly cetirizine), 19.5% with omalizumab; concomitantly, 55.5% received oral corticosteroids (OCS), and 25.0% non-steroidal antiinflammatory drugs. At least one CSU exacerbation occurred in 81.2% patients; of them, only one third were treated with omalizumab on average 10.9 months following exacerbation. New users of omalizumab during the available follow-ups were 30.6% patients. On average, 1.6 overnight hospitalizations occurred to 16.8% of patients mainly because of urticaria and angioedema. At least one local outpatient specialist service was performed to 78.6% patients; 63.3% were examined by a specialist, on average 3 times during the first year. The mean per patient annual total expenditure was €1901, of which 45.4% was due to pharmaceuticals.
During the first year following the new CSU diagnosis, a lower than recommended antihistamines dispensation while an elevated use of OCS and a low and delayed omalizumab initiation after CSU exacerbation were observed, suggesting the urgent need to optimize treatment management to limit the burden on patients and healthcare systems.
慢性自发性荨麻疹（CSU）是一种皮肤和黏膜组织疾病，病程至少持续6周。治疗主要旨在减轻症状；因此，患者的生活条件仍然较差，未满足的需求较高。这项回顾性观察性研究旨在通过意大利行政医疗保健数据描述新诊断为CSU的患者、他们对医疗资源的利用情况以及相关的经济负担。
从一个大型意大利行政医疗保健数据库（每年约550万居民）中，通过特定算法识别出2016年1月1日至2021年12月31日（索引日期）新诊断为CSU的门诊和住院患者。在首个随访年度内描述了药物配给、过夜住院、急诊科就诊、当地门诊专科护理以及向意大利国家医疗服务体系（SSN）收取的直接费用。此外，在整个可用随访期/患者中评估了CSU的病情加重情况（该变量基于应计年份，截至2022年12月31日）。
意大利新诊断为CSU的患者有1707例。中位（四分位间距）年龄为36（18；55）岁，女性人数是男性的两倍。心脏代谢疾病是最常见的合并症。在首个随访年度内：72.9%的患者接受第二代H1抗组胺药治疗（主要是西替利嗪），19.5%的患者接受奥马珠单抗治疗；同时，55.5%的患者接受口服糖皮质激素（OCS）治疗，25.0%的患者接受非甾体抗炎药治疗。81.2%的患者至少发生了一次CSU病情加重；其中，只有三分之一的患者在病情加重后平均10.9个月接受奥马珠单抗治疗。在可用随访期间，30.6%的患者是奥马珠单抗的新使用者。平均而言，16.8%的患者有1.6次过夜住院，主要原因是荨麻疹和血管性水肿。78.6%的患者至少接受了一次当地门诊专科服务；63.3%的患者接受了专科医生检查，第一年平均检查3次。每位患者每年平均总支出为1901欧元，其中45.4%用于药品。
在新诊断为CSU后的第一年，观察到抗组胺药配给低于推荐量，而OCS使用量增加，且CSU病情加重后奥马珠单抗启动率低且延迟，这表明迫切需要优化治疗管理，以减轻患者和医疗系统的负担。
