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慢性自发性荨麻疹患者的血管性水肿是否会影响对奥马珠单抗的反应?

Does angioedema in patients with chronic spontaneous urticaria impact response to omalizumab?

作者信息

Casale Thomas B, Trzaskoma Benjamin, Holden Michael, Bernstein Jonathan A, Maurer Marcus

机构信息

Division of Allergy and Immunology, University of South Florida, Tampa, FL, USA.

Genentech, Inc., South San Francisco, CA, USA.

出版信息

World Allergy Organ J. 2024 Aug 5;17(8):100943. doi: 10.1016/j.waojou.2024.100943. eCollection 2024 Aug.

Abstract

UNLABELLED

The presence of angioedema, or deep skin swelling, in addition to hives (wheals) in patients with chronic spontaneous urticaria (CSU) can complicate disease management. There is evidence that omalizumab is effective for patients with CSU with angioedema, but the time to a clinically meaningful response has not been assessed. This analysis examined data from the phase 3, randomized, double-blind ASTERIA I and ASTERIA II studies: patients with CSU with hives were grouped by presence (n = 216) or absence of angioedema (n = 265) at baseline. The time to minimally important difference (MID, change from baseline of ≥11 points) in weekly Urticaria Activity Score (UAS7) was analyzed using Kaplan-Meier analyses. Median time to MID for omalizumab 300 mg was similar in patients with and without angioedema. Median time to MID for omalizumab 150 mg was similar to 300 mg for patients without angioedema, and was longer for patients with angioedema. Therefore, the response to omalizumab for patients with CSU with angioedema was dose dependent. We recommend that the best approach for clinicians, in line with guidelines, would be initial administration of omalizumab 300 mg every 4 weeks for all patients.

CLINICAL TRIALS REGISTRATION

Clinicaltrials.gov NCT01287117 (registered 27 January 2011) and NCT01292473 (registered 7 February 2011).

摘要

未标记

慢性自发性荨麻疹(CSU)患者除了出现荨麻疹(风团)外,若存在血管性水肿或深部皮肤肿胀,会使疾病管理变得复杂。有证据表明奥马珠单抗对伴有血管性水肿的CSU患者有效,但尚未评估达到临床有意义反应的时间。该分析检查了3期随机双盲ASTERIA I和ASTERIA II研究的数据:伴有荨麻疹的CSU患者在基线时按是否存在血管性水肿分组(存在血管性水肿组n = 216,不存在血管性水肿组n = 265)。使用Kaplan-Meier分析方法分析每周荨麻疹活动度评分(UAS7)达到最小重要差异(MID,较基线变化≥11分)的时间。奥马珠单抗300 mg组达到MID的中位时间在有和无血管性水肿的患者中相似。奥马珠单抗150 mg组在无血管性水肿的患者中达到MID的中位时间与300 mg组相似,而在有血管性水肿的患者中则更长。因此,伴有血管性水肿的CSU患者对奥马珠单抗的反应呈剂量依赖性。我们建议,临床医生的最佳做法是,按照指南,对所有患者初始每4周给予300 mg奥马珠单抗。

临床试验注册

Clinicaltrials.gov NCT01287117(2011年1月27日注册)和NCT01292473(2011年2月7日注册)。

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