Background

Cedar pollinosis (CP), a common form of seasonal allergic rhinitis (AR), is a substantial medical problem in Japan due to its high prevalence and severe symptoms. Omalizumab (anti-IgE therapy) has previously proven to be effective in CP/AR, but no studies for inadequately controlled severe CP/AR despite standard-of-care (SoC) have been conducted.

Objective

To determine the efficacy of omalizumab added to SoC in patients with inadequately controlled severe CP in a randomized, double-blinded, placebo-controlled, phase III study.

Methods

Adult/adolescent patients with severe CP whose symptoms were inadequately controlled despite nasal corticosteroids plus 1 or more oral medications in the previous 2 seasons were randomized to receive omalizumab (n = 162) or placebo (n = 175). All patients received concomitant antihistamines and nasal corticosteroids as SoC. The primary endpoint was the mean nasal symptom score during the severe symptom period. Secondary endpoints included mean ocular symptom score, quality of life (QoL), and safety.

Results

The SoC + omalizumab treatment had statistically significantly and clinically important lower nasal (least squares mean difference, −1.03, P < .001) and ocular (−0.87, P < .001) symptom scores compared with SoC + placebo, respectively. Differences in scores for individual components of nasal and ocular symptoms were also statistically and clinically significant. SoC + omalizumab also improved QoL scores as overall and in all domains. No unexpected safety signals were observed.

Conclusions

In patients with severe CP, omalizumab added to SoC demonstrated consistent efficacy in improving symptoms and QoL, and was well tolerated. These results indicate that omalizumab could be a promising therapeutic option for severe CP/AR.

中文翻译：

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尽管有护理标准，但奥马珠单抗治疗不足以控制严重的花粉症：一项随机研究。

背景

雪松花粉病（CP）是季节性变应性鼻炎（AR）的常见形式，由于其高患病率和严重症状，在日本是一个严重的医学问题。奥马珠单抗（抗IgE治疗）先前已被证明在CP / AR中有效，但是尽管进行了护理标准（SoC），也没有进行针对控制不当的严重CP / AR的研究。

目的

在随机，双盲，安慰剂对照的III期研究中，确定将omalizumab添加至SoC的患者对重度CP控制不佳的患者。

方法

尽管在过去的两个季节中使用了鼻皮质类固醇加上1种或多种口服药物，但症状仍未得到充分控制的严重CP的成人/青少年患者被随机分配接受奥马珠单抗（n = 162）或安慰剂（n = 175）。所有患者均接受了抗组胺药和鼻皮质类固醇激素（SoC）治疗。主要终点是严重症状期间的平均鼻症状评分。次要终点包括平均眼部症状评分，生活质量（QoL）和安全性。

结果

与SoC +安慰剂相比，SoC + omalizumab治疗分别具有统计学上显着且临床上重要的下鼻（最小二乘均差，−1.03，P <.001）和眼（-0.87，P <.001）症状评分。鼻和眼症状的各个组成部分的得分差异在统计学和临床​​上也很显着。SoC + omalizumab整体和所有领域的QoL得分也有所提高。没有观察到意外的安全信号。

结论

在患有严重CP的患者中，将omalizumab加入SoC表现出持续改善症状和QoL的功效，并且耐受性良好。这些结果表明，omalizumab可能是重度CP / AR的有希望的治疗选择。