University of Ioannina, Medical School, Ioannina, Greece.
Novartis AB, Kista, Sweden.
Rhinology. 2021 Dec 1;59(6):501-510. doi: 10.4193/Rhin21.159.
Allergic rhinitis (AR), an IgE mediated inflammatory disease, significantly impacts quality of life of a considerable proportion of the general population. Omalizumab, a humanized monoclonal antibody against IgE, has been evaluated for both seasonal and perennial AR. We aimed to assess the efficacy and safety of omalizumab in randomized controlled trials (RCTs) in inadequately controlled AR.
We conducted a systematic literature search of RCTs evaluating the safety and efficacy of omalizumab in AR. We synthesized evidence for clinical improvement of AR symptoms, quality of life, reduction of the use of rescue medication, and adverse events.
The systematic search returned 289 articles, of which 12 RCTs were eligible for data extraction and meta-analysis. Omalizumab reduced the Daily Nasal Symptom Severity Score (DNSSS) by a summary standardized mean difference of -0.41 points with large heterogeneity; omalizumab significantly reduced the DNSSS both in the 3 cedar pollen-induced AR trials by -0.97 points and to a lower extent in the remaining five non-cedar trials by -0.19 points. Omalizumab also improved the Daily Ocular Symptom Severity Score (DOSSS) by a summary standardized mean difference of -0.30 points with large heterogeneity; the Rhino-conjunctivitis Quality of Life Questionnaire by a summary standardized mean difference of -0.45 points with no heterogeneity and the mean daily consumption of rescue antihistamines by a summary standardized mean difference of -0.21 with large heterogeneity. No statistically significant difference in the occurrence of adverse events was observed between omalizumab and placebo.
Our findings further support the efficacy and safety of omalizumab in the management of patients with allergic rhinitis inadequately controlled with a conventional treatment.
变应性鼻炎（AR）是一种 IgE 介导的炎症性疾病，严重影响相当一部分普通人群的生活质量。奥马珠单抗是一种针对 IgE 的人源化单克隆抗体，已被评估用于季节性和常年性 AR。我们旨在评估奥马珠单抗在未充分控制的 AR 随机对照试验（RCT）中的疗效和安全性。
我们对评估 AR 奥马珠单抗安全性和疗效的 RCT 进行了系统文献检索。我们综合了 AR 症状、生活质量、减少急救药物使用和不良事件临床改善的证据。
系统搜索返回 289 篇文章，其中 12 项 RCT 符合数据提取和荟萃分析的条件。奥马珠单抗使每日鼻部症状严重程度评分（DNSSS）的汇总标准化均数差降低了 -0.41 分，异质性较大；奥马珠单抗显著降低了 3 项 cedar 花粉诱导的 AR 试验中的 DNSSS，降幅为 -0.97 分，而在其余 5 项非 cedar 试验中，降幅较小，为 -0.19 分。奥马珠单抗还使每日眼部症状严重程度评分（DOSSS）的汇总标准化均数差提高了 -0.30 分，异质性较大； Rhinoconjunctivitis 生活质量问卷的汇总标准化均数差提高了 -0.45 分，无异质性；每日急救抗组胺药的平均消耗量提高了 -0.21 分，异质性较大。奥马珠单抗和安慰剂之间不良事件的发生无统计学差异。
我们的研究结果进一步支持奥马珠单抗在常规治疗未能充分控制的变应性鼻炎患者中的疗效和安全性。
