Department of Medicine, Division of Allergy and Immunology, University of South Florida, Tampa, Fla.
Department of Internal Medicine and Division of Immunology/Allergy Section, University of Cincinnati, Cincinnati, Ohio.
J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):743-50.e1. doi: 10.1016/j.jaip.2015.04.015. Epub 2015 Jun 6.
Data from the 3 omalizumab pivotal trials in patients with chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU) represent the largest database of patients reported to date with refractory disease (omalizumab, n = 733; placebo, n = 242).
The objective of this study was to compare results from ASTERIA I and II, which included only approved doses of H1-antihistamine as background therapy based on regulatory authority requirements, to those from GLACIAL, which permitted higher doses of H1-antihistamines as well as other types of background therapy, in a post hoc analysis.
Efficacy data from the placebo, omalizumab 150-mg, and omalizumab 300-mg treatment arms of ASTERIA I and II were pooled and analyzed (n = 162 and n = 160, respectively). The 300-mg treatment arm analyses were compared with the analysis of data from GLACIAL (n = 252) using analysis of covariance models. The key efficacy endpoint was change from baseline to week 12 in mean weekly itch severity score (ISS); other endpoints were also evaluated. Safety data were pooled from all 3 studies.
Mean ISS was significantly reduced from baseline at week 12 in the pooled ASTERIA I and II omalizumab 150- and 300-mg treatment arms and in the GLACIAL omalizumab 300-mg arm. The weekly ISS reduction magnitude at week 12 was similar between the omalizumab 300-mg groups in the ASTERIA I and II pooled and GLACIAL studies. Similar treatment effect sizes were observed across multiple endpoints. Omalizumab was well tolerated and the adverse-event profile was similar regardless of background therapy for CIU/CSU. The overall safety profile was generally consistent with omalizumab therapy in allergic asthma.
Omalizumab 300 mg was safe and effective in reducing CIU/CSU symptoms regardless of background therapy.
在慢性特发性荨麻疹/慢性自发性荨麻疹（CIU/CSU）患者的 3 项奥马珠单抗关键试验中获得的数据代表了迄今为止报告的难治性疾病患者最大的数据库（奥马珠单抗，n=733；安慰剂，n=242）。
本研究的目的是比较 ASTERIA I 和 II 研究的结果，这些研究仅根据监管机构的要求将批准剂量的 H1 抗组胺药作为背景治疗纳入，而 GLACIAL 研究则允许使用更高剂量的 H1 抗组胺药和其他类型的背景治疗，这是一项事后分析。
将 ASTERIA I 和 II 安慰剂、奥马珠单抗 150mg 和奥马珠单抗 300mg 治疗组的疗效数据进行汇总和分析（n=162 和 n=160）。使用协方差分析模型，将 300mg 治疗组分析结果与 GLACIAL（n=252）的数据进行比较。主要疗效终点是从基线到第 12 周平均每周瘙痒严重程度评分（ISS）的变化；还评估了其他终点。所有 3 项研究的安全性数据均进行了汇总。
在汇总的 ASTERIA I 和 II 奥马珠单抗 150mg 和 300mg 治疗组和 GLACIAL 奥马珠单抗 300mg 组中，从基线到第 12 周，平均每周 ISS 显著降低。在 ASTERIA I 和 II 汇总研究和 GLACIAL 研究中，奥马珠单抗 300mg 组在第 12 周时每周 ISS 降低幅度相似。在多个终点观察到相似的治疗效果大小。奥马珠单抗耐受性良好，且不良事件谱与 CIU/CSU 的背景治疗无关。总体安全性概况与奥马珠单抗治疗变应性哮喘基本一致。
奥马珠单抗 300mg 可安全有效地减轻 CIU/CSU 症状，无论背景治疗如何。
