Biologic and small molecule therapies in chronic spontaneous urticaria: an update.

IF 2.6 4区医学 Q2 ALLERGY

Current Opinion in Allergy and Clinical Immunology Pub Date : 2025-10-01 Epub Date: 2025-08-01 DOI:10.1097/ACI.0000000000001095

Bettina Wedi

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引用次数: 0

Abstract

Purpose of review: Many new treatment options for chronic spontaneous urticaria have been clinically tested in recent years. This narrative review presents the current status of substances furthest along in development.

Recent findings: After decades in which only H1 antihistamines were available for treatment, omalizumab was approved as an add-on therapy in 2014. Meanwhile, the first omalizumab biosimilar, CT-P39, has been approved (EMA in March 2024, US FDA in March 2025). Moreover, dupilumab received approval in Japan since February 2024 and in the USA since April 2025. Following publication of two positive phase 3 trials, Remibrutinib was submitted for approval to the EMA and FDA in February 2025. Several anti-KIT mAbs are in clinical trials, the most advanced of which is barzolvolimab with two ongoing phase 3 trials. Ligelizumab, benralizumab and the MRGPRX2 antagonist EP-262 are not being further developed in the chronic spontaneous urticaria (CSU) indication.

Summary: The rapid increase in clinical trials in the field of CSU has already led to a significant improvement in treatment options beyond anti-IgE therapy with omalizumab in Japan and the USA, and further approvals of biologics and small molecules are expected shortly. It is expected that with a wider range of different approved therapeutic approaches, the treatment of CSU will have to be tailored to the urticaria subtype or patient profile in the future.

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慢性自发性荨麻疹的生物和小分子治疗：最新进展。

综述目的：近年来，许多治疗慢性自发性荨麻疹的新方法已经进行了临床试验。这篇叙事性评论介绍了目前发展最快的物质的现状。最近的发现：几十年来，只有H1抗组胺药可用于治疗，2014年，omalizumab被批准作为一种附加治疗。同时，首个omalizumab生物仿制药CT-P39已获批（EMA于2024年3月，美国FDA于2025年3月）。此外，dupilumab于2024年2月在日本获得批准，于2025年4月在美国获得批准。在两项阳性3期试验发表后，Remibrutinib于2025年2月提交给EMA和FDA批准。一些抗kit单克隆抗体正在临床试验中，其中最先进的是barzolvolimab，正在进行两项3期试验。利利珠单抗、贝那利珠单抗和MRGPRX2拮抗剂EP-262在慢性自发性荨麻疹（CSU）适应症中尚未进一步开发。摘要：CSU领域临床试验的快速增加已经导致了omalizumab在日本和美国抗ige治疗之外的治疗选择的显着改善，并且预计不久将进一步批准生物制剂和小分子药物。预计随着越来越多的不同的治疗方法被批准，CSU的治疗将在未来根据荨麻疹亚型或患者情况量身定制。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Current Opinion in Allergy and Clinical Immunology 医学-过敏

CiteScore

5.90

自引率

3.60%

发文量

109

审稿时长

6-12 weeks

期刊介绍： This reader-friendly, bimonthly resource provides a powerful, broad-based perspective on the most important advances from throughout the world literature. Featuring renowned guest editors and focusing exclusively on one to three topics, every issue of Current Opinion in Allergy and Clinical Immunology delivers unvarnished, expert assessments of developments from the previous year. Insightful editorials and on-the-mark invited reviews cover key subjects such as upper airway disease; mechanisms of allergy and adult asthma; paediatric asthma and development of atopy; food and drug allergies; and immunotherapy.