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预测美泊利单抗治疗儿童嗜酸性食管炎的组织学反应的因素。

Predictors of histologic response to mepolizumab in pediatric eosinophilic esophagitis.

机构信息

Department of Medicine (Division of Gastroenterology) and Farncombe Family Digestive, Health Research Institute, McMaster University, Hamilton, ON, Canada.

出版信息

Eur J Gastroenterol Hepatol. 2023 Oct 1;35(10):1131-1136. doi: 10.1097/MEG.0000000000002623. Epub 2023 Jul 31.

Abstract

BACKGROUND

Eosinophilic esophagitis (EoE) is a chronic, allergic disease of the esophagus. Current treatment options are limited. One experimental therapy is antibodies against interleukin-5 (IL-5). However, it is unknown why some patients respond to anti-IL-5 treatment whereas others do not. We sought to delineate predictors of histologic response to anti-IL-5 therapy in pediatric EoE.

METHODS

This post hoc analysis of a multicenter, double-blind clinical trial (ClinicalTrial.gov identifier: NCT00358449) evaluated mepolizumab for the treatment of EoE in pediatric patients. Predictors were assessed for their association with a histologic response at week 12 of treatment. A histologic response was defined as either <15 eosinophils per hpf or a reduction in peak eosinophil counts by ≥50%. Predictors on univariate analysis with P  < 0.10 were included in multivariate logistic regression models. Statistical significance for multivariate comparisons was set at P  < 0.05.

RESULTS

Patients with a higher BMI were more likely to attain histologic response at week 12, defined as <15 eosinophils per hpf [aOR, 1.31; 95% confidence interval (CI), 1.07-1.60; P  = 0.008]. Higher BMI (aOR, 1.70; 95% CI, 1.06-2.74; P  = 0.029) and signs of exudate plaques on endoscopy (aOR, 18.30; 95% CI, 2.11-158.53; P  = 0.008) were significant predictors of histologic response at week 12 where a histologic response was defined as a reduction in peak eosinophil counts by ≥50.

CONCLUSION

Higher BMI and signs of exudative plaques on endoscopy may be predictors of histologic response in pediatric EoE patients treated with antibodies against IL-5. Further studies are needed to validate our findings.

摘要

背景

嗜酸性食管炎(EoE)是一种慢性、过敏的食管疾病。目前的治疗选择有限。一种实验性治疗方法是针对白细胞介素-5(IL-5)的抗体。然而,尚不清楚为什么有些患者对抗 IL-5 治疗有反应,而有些患者没有。我们旨在确定预测嗜酸性食管炎患儿对抗 IL-5 治疗的组织学反应的因素。

方法

这是一项多中心、双盲临床试验(ClinicalTrials.gov 标识符:NCT00358449)的事后分析,评估了美泊利单抗治疗儿科 EoE 的效果。在治疗的第 12 周评估了预测因素与组织学反应的关系。组织学反应定义为每高倍镜视野下的嗜酸性粒细胞<15 个或峰值嗜酸性粒细胞计数减少≥50%。单变量分析中 P 值<0.10 的预测因素被纳入多变量逻辑回归模型。多变量比较的统计学显著性设定为 P 值<0.05。

结果

BMI 较高的患者在第 12 周时更有可能达到组织学反应,定义为每高倍镜视野下的嗜酸性粒细胞<15 个[优势比(aOR),1.31;95%置信区间(CI),1.07-1.60;P=0.008]。BMI 较高(aOR,1.70;95%CI,1.06-2.74;P=0.029)和内镜下渗出性斑块的迹象(aOR,18.30;95%CI,2.11-158.53;P=0.008)是第 12 周组织学反应的显著预测因素,定义为峰值嗜酸性粒细胞计数减少≥50%。

结论

较高的 BMI 和内镜下渗出性斑块的迹象可能是接受白细胞介素-5 抗体治疗的儿科 EoE 患者组织学反应的预测因素。需要进一步的研究来验证我们的发现。

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