从瘙痒到创新：瑞米布替尼在慢性自发性荨麻疹中的新兴作用。
摘要
目的：本文回顾了已发表的关于瑞米布替尼的开发、药理学、疗效及安全性的数据，总结了关键临床研究中的证据及其在慢性自发性荨麻疹治疗中的临床意义。数据来源：在PubMed和ClinicalTrials.gov中进行了自建库至2026年8月的文献检索，使用检索词“RHAPSIDO”、“remibrutinib”、“LOU064”和“chronic spontaneous urticaria”。参考列表中的文章也被纳入以识别可能相关的文献。…
正文 待译
OBJECTIVE: This article reviews the published data encompassing the development, pharmacology, efficacy, and safety of remibrutinib, summarizing data from pivotal clinical studies and clinical relevance in the treatment of chronic spontaneous urticaria. DATA SOURCES: A literature review was conducted in PubMed and ClinicalTrials.gov from inception through August 2026, using terms "RHAPSIDO," "remibrutinib," "LOU064," and "chronic spontaneous urticaria." Articles from reference lists were included to identify potentially relevant literature. STUDY SELECTION AND DATA EXTRACTION: Clinical data and studies were limited to those published in the English language that discussed the safety and efficacy of remibrutinib. DATA SYNTHESIS: The pivotal phase III studies REMIX-1 (n = 470) and REMIX-2 (n = 455) met all primary endpoints at week 12, with Urticaria Activity Score over 7 days (UAS7) reductions of -20.02 and -19.41 versus -13.79 and -11.73 with placebo, parallel improvements in itch and hive severity, and complete absence of itch and hives in 31.1% and 27.9% versus 10.5% and 6.5%. Safety was comparable to placebo, with mild mucocutaneous bleeding (mainly petechiae) the only category significantly more frequent.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:As the first approved oral targeted Bruton's tyrosine kinase (BTK) inhibitor, remibrutinib provides a new therapeutic option in chronic spontaneous urticaria treatment. Clinical practice is improved by the broadened evidence-based management option, which offers an oral pill alternative with no required routine lab monitoring in place of biologic injections. CONCLUSION: Remibrutinib provides a new treatment option with the ability to control symptoms and improve quality of life for patients with difficult-to-treat chronic spontaneous urticaria.
English
OBJECTIVE: This article reviews the published data encompassing the development, pharmacology, efficacy, and safety of remibrutinib, summarizing data from pivotal clinical studies and clinical relevance in the treatment of chronic spontaneous urticaria. DATA SOURCES: A literature review was conducted in PubMed and ClinicalTrials.gov from inception through August 2026, using terms "RHAPSIDO," "remibrutinib," "LOU064," and "chronic spontaneous urticaria." Articles from reference lists were included to identify potentially relevant literature.…