Manti Sara, Giallongo Alessandro, Papale Maria, Parisi Giuseppe Fabio, Leonardi Salvatore
Pediatric Respiratory Unit, Department of Clinical and Experimental Medicine, San Marco Hospital, University of Catania, Via Santa Sofia 78, 95123 Catania, Italy.
Pediatric Unit, Department of Human and Pediatric Pathology "Gaetano Barresi", AOUP G. Martino, University of Messina, Via Consolare Valeria, 1, 98124 Messina, Italy.
J Clin Med. 2022 Jul 30;11(15):4453. doi: 10.3390/jcm11154453.
H1-antihistamines (H1AH) represent the current mainstay of treatment for chronic spontaneous urticaria (CSU). However, the response to H1AH is often unsatisfactory, even with increased doses. Therefore, guidelines recommend the use of omalizumab as an add-on treatment in refractory CSU. This paved the way for the investigation of targeted therapies, such as monoclonal antibodies (mAbs), in CSU. A literature review was conducted including papers published between 2009 and 2022 and ongoing trials about the efficacy and safety of mAbs as treatment for CSU. Twenty-nine articles, a trial with preliminary results, and seventeen ongoing or completed clinical trials on the use of mAbs in CSU were included. Randomized controlled trials (RCTs), meta-analysis, and real-life studies have proven the effectiveness and safety of omalizumab as a third-line treatment in refractory CSU. However, a percentage of patients remain unresponsive to omalizumab. Therefore, other mAbs, targeting different pathways, have been used off-label in case series and others are under investigation in RCTs. Most of them have showed promising results. Omalizumab remains the best choice to treat refractory CSU. Although results from other mAbs seem to be encouraging to achieve symptom control in refractory CSU, thus improving patients' QoL, RCTs are needed to confirm their effectiveness and safety.
H1抗组胺药（H1AH）是目前治疗慢性自发性荨麻疹（CSU）的主要药物。然而，即使增加剂量，对H1AH的反应往往也不尽人意。因此，指南建议将奥马珠单抗作为难治性CSU的附加治疗药物。这为在CSU中研究靶向治疗，如单克隆抗体（mAb），铺平了道路。我们进行了一项文献综述，纳入了2009年至2022年发表的关于mAb治疗CSU的疗效和安全性的论文以及正在进行的试验。其中包括29篇文章、一项有初步结果的试验以及17项关于在CSU中使用mAb的正在进行或已完成的临床试验。随机对照试验（RCT）、荟萃分析和真实世界研究已证明奥马珠单抗作为难治性CSU三线治疗的有效性和安全性。然而，仍有一定比例的患者对奥马珠单抗无反应。因此，其他针对不同途径的mAb已在病例系列中被超适应证使用，还有一些正在RCT中进行研究。其中大多数已显示出有前景的结果。奥马珠单抗仍然是治疗难治性CSU的最佳选择。尽管其他mAb的结果似乎令人鼓舞，有望在难治性CSU中实现症状控制，从而改善患者的生活质量，但仍需要RCT来证实它们的有效性和安全性。
