Omalizumab在慢性自發性蕁麻疹的治療角色

The Role of Omalizumab in the Treatment of Chronic Spontaneous Urticaria

鄭傑夫(Jie-Fu Zheng) ； 陳長宏(Chang-Hung Chen)

《內科學誌》 32卷6期 (2021/12) Pp. 417-430

https://doi.org/10.6314/JIMT.202112_32(6).04

摘要

慢性自發性蕁麻疹，又稱為慢性原發性蕁麻疹，定義為六週以上不明原因反覆自然產生的風疹塊或血管性水腫。根據目前治療指引，慢性自發性蕁麻疹的第1線治療是第2代抗組織胺，而對於標準劑量反應不佳的患者，可增加抗組織胺劑量最高到標準劑量4倍。然而即使增加抗組織胺的使用劑量，仍有將近4分之1的患者無法獲得明顯改善。根據第3期臨床試驗所呈現出的顯著療效與安全性，歐洲藥品管理局、美國食品藥品監督管理局，與台灣衛生福利部食品藥物管理署相繼於2014年核准omalizumab作為附加治療，用於經標準劑量的抗組織胺治療而仍有症狀、年齡在12歲到75歲之間的慢性自發性蕁麻疹患者。更長期的研究與實際的臨床觀察進一步支持omalizumab在慢性自發性蕁麻疹的療效與安全性。在症狀控制與生活品質改善方面，omalizumab 300 mg的效果都比omalizumab 150 mg來得更好。雖然許多患者在停藥後症狀會復發，但大部分患者重新接受omalizumab治療後可以再次獲得良好控制。屬於不同分子機轉型的患者對於omalizumab的治療反應可能有所不同。目前在孕婦、小於12歲的慢性自發性蕁麻疹患者，以及物理性蕁麻疹患者的治療方面，仍有待進一步研究來評估其安全性與效果。臨床醫師也必須注意到曾有少數慢性自發性蕁麻疹患者在接受omalizumab治療後發生過敏性休克。

關鍵字

慢性自發性蕁麻疹（Chronic spontaneous urticaria） ； 慢性原發性蕁麻疹（Chronic idiopathic urticaria） ； Omalizumab ； 過敏性休克（Anaphylaxis）

並列摘要

Chronic spontaneous urticaria, also known as chronic idiopathic urticaria, is defined by the presence of recurrent wheels, angioedema, or both, for a period of six weeks or longer. According to the latest guidelines, the first-line treatment of chronic spontaneous urticaria is second-generation antihistamines, which may be updosed to four times the approved dose as the second-line treatment. However, nearly one quarter of patients still respond poorly to updosed antihistamines. Based on phase III studies, which showed the significant efficacy and safety of omalizumab in chronic spontaneous urticaria, European Medicines Agency, U.S. Food and Drug Administration, and Taiwan Food and Drug Administration approved omalizumab as add-on therapy of chronic spontaneous urticaria in adults and adolescents 12 years of age and older who remain symptomatic despite antihistamine treatment. Studies of long-term use of omalizumab in chronic idiopathic urticaria as well as real-world studies further supported the efficacy and safety of omalizumab in chronic spontaneous urticaria. Regarding symptoms control and quality of life improvement, omalizumab 300 mg has better efficacy than omalizumab 150 mg. Although relapses are common after omalizumab is stopped, re-treatment can effectively control symptoms most of time. In addition, patients of different endotypes may respond differently to omalizumab treatment. Further studies are needed to evaluate the efficacy and safety of omalizumab in pregnant women, children under 12 years of age, and in physical urticaria. Physicians should also note that few patients had anaphylaxis after receiving omalizumab.