Calzari Paolo, Chiei Gallo Alessandra, Barei Francesca, Bono Eleonora, Cugno Massimo, Marzano Angelo Valerio, Ferrucci Silvia Mariel
Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy.
Department of Pathophysiology and Transplantation, Università Degli Studi di Milano, 20122 Milan, Italy.
J Clin Med. 2024 Sep 21;13(18):5610. doi: 10.3390/jcm13185610.
: Omalizumab, an anti-IgE monoclonal antibody, is an effective treatment for patients with chronic spontaneous urticaria (CSU) resistant to antihistamines, but about 10% are unresponsive. Our aim was to assess the effectiveness, safety, and drug survival (DS) of omalizumab by considering clinical and laboratory characteristics. : We conducted a retrospective study on 296 patients with severe CSU treated with omalizumab. Disease activity, comorbidities, and serum levels of total IgE and anti-thyroid autoantibodies were evaluated over a period of up to 8 years. DS was analyzed using unadjusted Kaplan-Meier survival curves. When applicable, the risk of discontinuation was assessed using Cox regression analysis. : Out of 296 patients, 118 (40.4%) were early responders, 72 (25.0%) were late responders, 76 (26.0%) were partial responders, and 25 (8.6%) were non-responders. Early responders were more likely to be patients without associated inducible urticaria ( = 0.021, χ = 9.692), without autoimmune thyroiditis ( = 0.007, χ = 12.037), and those with higher IgE levels ( = 0.039, χ = 8.385). Overall, DS was 53.5% at 8 years, primarily due to clinical remission. DS due to inefficacy and clinical remission were 83.9% and 62.1%, respectively, at 8 years. No patients discontinued omalizumab due to adverse events. Patients with normal IgE levels ( = 0.012, HR = 4.639, CI: 1.393-15.445) and those with autoimmune thyroiditis ( = 0.028, HR = 3.316, CI: 1.128-8.718) had a higher risk of discontinuing omalizumab due to inefficacy. : This study confirms the long-term effectiveness and safety of omalizumab in the treatment of CSU over a period of up to 8 years. Most patients discontinued omalizumab due to clinical remission, while only 5.1% discontinued it due to ineffectiveness.
奥马珠单抗是一种抗IgE单克隆抗体，对于对抗组胺药耐药的慢性自发性荨麻疹（CSU）患者是一种有效的治疗方法，但约10%的患者无反应。我们的目的是通过考虑临床和实验室特征来评估奥马珠单抗的有效性、安全性和药物留存率（DS）。
我们对296例接受奥马珠单抗治疗的重度CSU患者进行了一项回顾性研究。在长达8年的时间里评估疾病活动度、合并症以及总IgE和抗甲状腺自身抗体的血清水平。使用未调整的Kaplan-Meier生存曲线分析DS。在适用时，使用Cox回归分析评估停药风险。
在296例患者中，118例（40.4%）为早期反应者，72例（25.0%）为晚期反应者，76例（26.0%）为部分反应者，25例（8.6%）为无反应者。早期反应者更可能是没有相关诱导性荨麻疹的患者（P = 0.021，χ² = 9.692）、没有自身免疫性甲状腺炎的患者（P = 0.007，χ² = 12.037）以及IgE水平较高的患者（P = 0.039，χ² = 8.385）。总体而言，8年时的DS为53.5%，主要是由于临床缓解。8年时因无效和临床缓解导致的DS分别为83.9%和62.1%。没有患者因不良事件停用奥马珠单抗。IgE水平正常的患者（P = 0.012，HR = 4.639，CI：1.393 - 15.445）和患有自身免疫性甲状腺炎的患者（P = 0.028，HR = 3.316，CI：1.128 - 8.718）因无效停用奥马珠单抗的风险更高。
本研究证实了奥马珠单抗在长达8年的时间里治疗CSU的长期有效性和安全性。大多数患者因临床缓解停用奥马珠单抗，而仅有5.1%的患者因无效停用。
