Background

The anti–immunoglobulin E therapy, omalizumab, improves asthma control and reduces exacerbations in patients with moderate-to-severe allergic asthma. However, it has been suggested that omalizumab should be reserved for highly allergic patients with multiple allergen sensitivities or perennial-only sensitivities.

Objective

To examine impact of allergy burden, including number and type of allergen sensitivities, on omalizumab response in a real-world setting.

Methods

This post hoc analysis evaluated a subset of omalizumab-treated patients from the Prospective Observational Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab (NCT01922037) who had completed 13 allergen assessments (N=478). Patients were classified by allergen burden (nonsensitized, 1, 2-4, or ≥5 allergen sensitivities) and type of allergen (nonsensitized, seasonal, perennial, or both). Outcome measures included exacerbation rate vs previous year and improvements in lung function and Asthma Quality of Life Questionnaire (AQLQ).

Results

Comparable adjusted exacerbation rates were observed after omalizumab initiation, regardless of number or type of allergen sensitizations (0.56-0.85/y). Improvements in forced expiratory volume in 1 second from baseline at months 6 (0.03-0.09 L) and 12 (–0.08 to 0.08 L) were also similar across subgroups. Least squares mean change in AQLQ from baseline at months 6 (1.0-1.2) and 12 (1.1-1.4) was comparable across patient subgroups, and similar percentages of patients achieved AQLQ minimal clinically important difference of at least a 0.5-point improvement at month 6 (71%-75%), which was maintained or improved to month 12 (71%-89%). In all analyses, 95% confidence intervals overlapped.

Conclusion

Overall findings suggest that patients with allergic asthma achieved comparable improvements across distinct outcome measures after omalizumab therapy in a real-world setting, regardless of number and type of allergen sensitizations.

Trial Registration

ClinicalTrials.gov Identifier: NCT01922037.

中文翻译：

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哮喘患者中奥马珠单抗对过敏原数量和类型的反应

背景

抗免疫球蛋白 E 疗法奥马珠单抗可改善中度至重度过敏性哮喘患者的哮喘控制并减少其恶化。然而，有人建议奥马珠单抗应保留用于具有多种过敏原敏感性或仅常年敏感性的高度过敏患者。

客观的

研究过敏负担对真实世界环境中奥马珠单抗反应的影响，包括过敏原敏感性的数量和类型。

方法

该事后分析评估了来自前瞻性观察研究以评估对奥马珠单抗反应的临床有效性预测因子 (NCT01922037) 的一部分奥马珠单抗治疗患者，这些患者已完成 13 次过敏原评估（N = 478）。根据过敏原负荷（非致敏、1、2-4 或≥5 种过敏原敏感性）和过敏原类型（非致敏、季节性、常年性或两者兼有）对患者进行分类。结果指标包括与前一年相比的恶化率以及肺功能和哮喘生活质量问卷 (AQLQ) 的改善。

结果

无论过敏原致敏的数量或类型如何（0.56-0.85/年），在奥马珠单抗开始后观察到可比的调整后恶化率。在第 6 个月（0.03-0.09 L）和第 12 个月（–0.08 至 0.08 L）时，从基线开始 1 秒内用力呼气量的改善在各亚组中也相似。在第 6 个月 (1.0-1.2) 和第 12 个月 (1.1-1.4) 时，AQLQ 相对于基线的最小二乘平均变化在患者亚组中具有可比性，并且相似百分比的患者达到 AQLQ 最小临床重要差异，即在一个月时至少有 0.5 点改善6 (71%-75%)，维持或改善至第 12 个月 (71%-89%)。在所有分析中，95% 的置信区间重叠。

结论

总体研究结果表明，无论过敏原致敏的数量和类型如何，在真实环境中接受奥马珠单抗治疗后，过敏性哮喘患者在不同结果指标上均取得了可比的改善。

试用注册

ClinicalTrials.gov 标识符：NCT01922037。