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

IF 3.9 2区医学 Q2 ALLERGY

World Allergy Organization Journal Pub Date : 2024-08-01 DOI:10.1016/j.waojou.2024.100943

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

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引用次数: 0

Abstract

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 post hoc 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).

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慢性自发性荨麻疹患者的血管性水肿会影响对奥马珠单抗的反应吗？

慢性自发性荨麻疹（CSU）患者除了荨麻疹（麦粒肿）外，还伴有血管性水肿或深层皮肤肿胀，这可能会使疾病治疗变得复杂。有证据表明，奥马珠单抗对伴有血管性水肿的慢性自发性荨麻疹（CSU）患者有效，但尚未评估产生有临床意义的反应的时间。这项事后分析检查了 3 期随机双盲 ASTERIA I 和 ASTERIA II 研究的数据：根据基线时存在（n = 216）或不存在（n = 265）血管性水肿的 CSU 伴荨麻疹患者进行分组。每周荨麻疹活动评分（UAS7）达到最小重要差异（MID，与基线相比变化≥11分）的时间采用卡普兰-梅耶分析法进行分析。在有血管性水肿和无血管性水肿的患者中，奥马珠单抗300毫克的中位MID时间相似。对于无血管性水肿的患者，奥马珠单抗150毫克的中位MID时间与300毫克相似，而血管性水肿患者的中位MID时间较长。因此，伴有血管性水肿的 CSU 患者对奥马珠单抗的反应与剂量有关。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）。

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

World Allergy Organization Journal Immunology and Microbiology-Immunology

CiteScore

9.10

自引率

5.90%

发文量

审稿时长

9 weeks

期刊介绍： The official pubication of the World Allergy Organization, the World Allergy Organization Journal (WAOjournal) publishes original mechanistic, translational, and clinical research on the topics of allergy, asthma, anaphylaxis, and clincial immunology, as well as reviews, guidelines, and position papers that contribute to the improvement of patient care. WAOjournal publishes research on the growth of allergy prevalence within the scope of single countries, country comparisons, and practical global issues and regulations, or threats to the allergy specialty. The Journal invites the submissions of all authors interested in publishing on current global problems in allergy, asthma, anaphylaxis, and immunology. Of particular interest are the immunological consequences of climate change and the subsequent systematic transformations in food habits and their consequences for the allergy/immunology discipline.