University of Wisconsin School of Medicine and Public Health, Madison, Wis.
Children's Hospital Colorado, and University of Colorado School of Medicine, Aurora, Colo.
J Allergy Clin Immunol Pract. 2021 Mar;9(3):1201-1211. doi: 10.1016/j.jaip.2020.10.027. Epub 2020 Oct 24.
Frequent exacerbations are associated with greater FEV decline in patients with asthma. The effect of omalizumab versus placebo on lung function in patients experiencing asthma exacerbations has not been previously examined.
To evaluate the relationship between postbaseline (treatment phase) exacerbation status and lung function decline in children, adolescents, and adults treated with omalizumab versus placebo using data from 3 pediatric and adolescent/adult studies.
Changes in percent predicted FEV (ppFEV) and FEV by treatment (omalizumab/placebo) and postbaseline exacerbation status (exacerbators/nonexacerbators) were assessed in patients aged 6 to 11 years (IA05, n = 576) and 12 to 75 years (EXTRA/INNOVATE pooled, n = 1202). Pediatric patients were examined at treatment weeks 12, 24, 28, 40, and 52, and adolescent/adult data at weeks 4, 12, 20, and 28.
Omalizumab-treated patients experienced larger increases in ppFEV and FEV compared with placebo-treated patients in the pediatric and pooled adolescent/adult populations. The response was observed in pediatric exacerbators, with significantly larger increases in ppFEV and FEV at week 12 (mean difference [95% CI], 4.11% [0.93%-7.30%], P = .011 for ppFEV; 80 [10-140] mL, P = .017 for FEV) and week 28 (mean difference [95% CI], 3.65% [0.11%-7.19%], P = .043 for ppFEV; 100 [30-170] mL, P = .007 for FEV). In the adolescent/adult population, both exacerbators and nonexacerbators derived similar benefit with omalizumab compared with placebo.
Findings from this post hoc analysis suggest that omalizumab may confer some protection against lung function decline among patients who experienced exacerbations during treatment.
哮喘患者频繁发作与用力肺活量（FEV）下降较快相关。奥马珠单抗对比安慰剂对哮喘发作患者肺功能的影响此前尚未被研究过。
利用来自 3 项儿科和青少年/成年患者研究的数据，评估奥马珠单抗治疗的患儿、青少年和成年患者中，基于基线后的（治疗阶段）发作状态与肺功能下降之间的关系。
在年龄为 6 岁至 11 岁（IA05，n=576）和 12 岁至 75 岁（EXTRA/INNOVATE 合并分析，n=1202）的患者中，根据治疗（奥马珠单抗/安慰剂）和基于基线后的发作状态（发作患者/无发作患者）评估 %预测 FEV（ppFEV）和 FEV 的变化。儿科患者在治疗第 12、24、28、40 和 52 周，以及青少年/成年患者在第 4、12、20 和 28 周进行评估。
与安慰剂治疗的患者相比，奥马珠单抗治疗的患者在儿科和合并的青少年/成年患者群体中 ppFEV 和 FEV 增加更多。在儿科发作患者中观察到了这种反应，在第 12 周（ppFEV 的平均差值[95%CI]，4.11%[0.93%-7.30%]，P=.011；FEV 的平均差值[95%CI]，80[10-140]mL，P=.017）和第 28 周（ppFEV 的平均差值[95%CI]，3.65%[0.11%-7.19%]，P=.043；FEV 的平均差值[95%CI]，100[30-170]mL，P=.007）时，ppFEV 和 FEV 的增加明显更大。在青少年/成年患者中，与安慰剂相比，奥马珠单抗治疗的发作患者和无发作患者均获得了类似的益处。
本次事后分析的结果表明，奥马珠单抗可能为治疗期间发生发作的患者提供一定的肺功能下降保护。
