UOC Dermatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Dipartimento di Fisiopatologia Medico-Chirurgica e dei Trapianti, Università degli Studi di Milano, Milan, Italy.
J Eur Acad Dermatol Venereol. 2019 May;33(5):918-924. doi: 10.1111/jdv.15350. Epub 2018 Dec 7.
Chronic spontaneous urticaria (CSU) is defined as spontaneous occurrence of wheals and/or angioedema for ≥6 weeks. Omalizumab is a monoclonal anti-IgE antibody effective in refractory CSU, but its mechanism of action and markers predictive of response remain not completely defined.
To correlate baseline levels of two proposed biomarkers, total IgE (bIgE) and d-dimer (bd-dimer), and clinical parameters to omalizumab response and to relapses after drug withdrawal.
In this retrospective Italian multicentre study, clinical data were collected in 470 CSU patients, and bIgE and bd-dimer were measured in 340 and 342 patients, respectively. Disease activity was determined by Urticaria Activity Score 7 (UAS7) at week 1 and 12 after omalizumab starting. Relapses were evaluated during a 2- and 3-month interval after a first and a second course of treatment, respectively.
bIgE correlated to a good response to omalizumab since levels were significantly higher in responders than non-responders (P = 0.0002). Conversely, bd-dimer did not correlate to response. There was no correlation between both bIgE and d-dimer and either first or second relapse. Disease duration was significantly longer in patients who experienced either first or second relapse (P < 0.0001 and P = 0.0105, respectively), while baseline UAS7 correlated only to first relapse (P = 0.0023).
Our study confirms bIgE as a reliable biomarker predicting response to omalizumab in CSU, while it does not support the usefulness of bd-dimer unlike previous findings. CSU duration before omalizumab and baseline UAS7 may be clinical markers of relapse risk.
慢性自发性荨麻疹（CSU）定义为自发性风团和/或血管性水肿持续≥6 周。奥马珠单抗是一种有效的抗 IgE 单克隆抗体，可用于治疗难治性 CSU，但它的作用机制和预测反应的标志物仍不完全明确。
本研究旨在分析两个潜在生物标志物（总 IgE[bIgE]和 d-二聚体[bd-dimer]）的基线水平与奥马珠单抗治疗反应及停药后复发之间的相关性。
本研究为回顾性意大利多中心研究，共纳入 470 例 CSU 患者，其中 340 例和 342 例患者分别检测了 bIgE 和 bd-dimer。在开始奥马珠单抗治疗后第 1 周和第 12 周，采用荨麻疹活动评分（UAS7）评估疾病活动度。在首次和第二次治疗后 2 个月和 3 个月分别评估复发情况。
bIgE 与奥马珠单抗的良好反应相关，因为与无反应者相比，应答者的 bIgE 水平显著更高（P=0.0002）。相反，bd-dimer 与反应无相关性。bIgE 和 d-二聚体均与首次或第二次复发无相关性。首次或第二次复发的患者疾病持续时间显著更长（P<0.0001 和 P=0.0105），而基线 UAS7 仅与首次复发相关（P=0.0023）。
本研究证实 bIgE 是预测 CSU 患者对奥马珠单抗反应的可靠生物标志物，而与之前的研究结果不同，bd-dimer 并不支持其有用性。奥马珠单抗治疗前 CSU 持续时间和基线 UAS7 可能是复发风险的临床标志物。
