Background

The dominant allergen in cat dander, Felis domesticus allergen 1 (Fel d 1), is a persistent trigger for allergic rhinitis and asthma symptoms.

Objective

We evaluated the efficacy of Fel d 1 monoclonal antibodies (REGN1908/1909) in preventing cat allergen–induced early asthmatic responses (EARs) in cat-allergic patients with mild asthma.

Methods

Patients were randomized to single-dose REGN1908/1909 600 mg (n = 29) or placebo (n = 27). The FEV₁ was measured for up to 4 hours in a cat allergen environmental exposure unit up to 85 days after dosing. Assessments included between-group differences in change from baseline in FEV₁ area under the curve (AUC; 0-2 hours) and incidence of EAR (FEV₁ reduction ≥20%). Trial registration: NCT03838731.

Results

Single-dose REGN1908/1909 significantly prevented reductions in FEV₁ on days 8, 29, 57, and 85. Most REGN1908/1909 patients did not have an EAR by 4 hours (the last time point tested). In contrast, placebo-treated patients experienced a ≥20% mean FEV₁ reduction on days 8, 29, 57, and 85 after dosing, with most experiencing an EAR within 1 hour. REGN1908/1909-treated patients tolerated 3-fold higher allergen quantities (P < .05 at all time points) versus placebo. REGN1908/1909 substantially reduced skin test reactivity to cat allergen versus placebo at all time points tested (nominal P < .001). REGN1908/1909 was generally well tolerated; no serious adverse events or deaths were reported.

Conclusion

Single-dose REGN1908/1909 significantly prevented reductions in FEV₁ in cat-allergic patients with mild asthma on cat allergen environmental exposure unit exposure at 8 days and up to 85 days after dose.

中文翻译：

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REGN1908/1909 在环境暴露单元中预防了猫过敏原引起的早期哮喘反应

背景

猫皮屑中的主要过敏原Felis domesticus过敏原 1 (Fel d 1) 是过敏性鼻炎和哮喘症状的持续诱因。

客观的

我们评估了 Fel d 1 单克隆抗体 (REGN1908/1909) 在预防猫过敏性轻度哮喘患者中猫过敏原诱发的早期哮喘反应 (EAR) 的功效。

方法

患者被随机分配到单剂量 REGN1908/1909 600 mg (n = 29) 或安慰剂组 (n = 27)。FEV ₁在给药后长达 85 天的猫过敏原环境暴露单元中测量长达 4 小时。_{评估包括 FEV 1}曲线下面积（AUC；0-2 小时）和 EAR 发生率（FEV ₁降低≥20%）相对于基线变化的组间差异。试用注册号：NCT03838731。

结果

单剂量 REGN1908/1909 在第 8、29、57 和 85 天显着防止 FEV ₁降低。大多数 REGN1908/1909 患者在 4 小时（最后一个测试时间点）时没有出现 EAR。相比之下，接受安慰剂治疗的患者在给药后第 8、29、57 和 85 天平均 FEV _{1降低≥20%，大多数患者在 1 小时内发生 EAR。} 接受 REGN1908/1909 治疗的患者耐受的过敏原数量是安慰剂的 3 倍（所有时间点P < .05）。与安慰剂相比，REGN1908/1909 在所有测试时间点都显着降低了对猫过敏原的皮肤测试反应性（标称P  < .001）。REGN1908/1909 一般耐受性良好；没有报告严重的不良事件或死亡。

结论

单剂量 REGN1908/1909 显着阻止了猫过敏的轻度哮喘患者在给药后 8 天和长达 85 天的猫过敏原环境暴露单位暴露中 FEV _{1的降低。}