Reslizumab in children and adolescents with eosinophilic esophagitis: Results of a double-blind, randomized, placebo-controlled trial
Reslizumab in children and adolescents with eosinophilic esophagitis: Results of a double-blind, randomized, placebo-controlled trial
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DOI：
10.1016/j.jaci.2011.11.044
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发表时间：
2012-02-01
影响因子：
14.2
通讯作者：
Liacouras, Chris A.
中科院分区：
文献类型：
--
作者：
Spergel, Jonathan M.;Rothenberg, Marc E.;Liacouras, Chris A.
背景：嗜酸性粒细胞性食管炎是一种慢性变应性疾病，治疗方案不足。动物实验结果表明，IL-5诱导食道内嗜酸性粒细胞运输。目的：我们试图评估reslizumab（一种针对IL-5的中和抗体）在儿童和青少年嗜酸性粒细胞性食管炎中的作用。方法：在第0、4、8和12周，症状严重程度评分为中等或更差，食管活检标本中每高倍视野有24个或更多上皮内嗜酸性粒细胞的患者随机分配接受1、2或3 mg/kg reslizumab或安慰剂的输注。主要疗效指标是第15周（治疗结束）时食管嗜酸性粒细胞峰值计数和医生总体评估评分的变化。结果：226例患者接受了研究药物治疗。在1、2和3 mg/kg reslizumab组和安慰剂组，从基线到治疗结束时食管嗜酸性粒细胞计数峰值的中位降低分别为59%、67%、64%和24%（均P < 0.001）。所有治疗组，包括安慰剂组，在医生的整体评估得分上都有改善；reslizumab组和安慰剂组之间的差异无统计学意义。reslizumab组中最常见的不良事件是头痛、咳嗽、鼻塞和上呼吸道感染。reslizumab组和安慰剂组各有1例和2例患者发生严重不良事件；没有一个被认为与研究药物有关。结论：Reslizumab可显著降低儿童和青少年嗜酸性食管炎患者食管上皮内嗜酸性粒细胞计数。然而，在所有治疗组中均观察到症状的改善，且与食管嗜酸性粒细胞计数的变化无关。[J] .中华过敏症杂志，2012;29(3):456- 463。
Background: Eosinophilic esophagitis is a chronic allergic disease with insufficient treatment options. Results from animal studies suggest that IL-5 induces eosinophil trafficking in the esophagus.Objective: We sought to evaluate the effect of reslizumab, a neutralizing antibody against IL-5, in children and adolescents with eosinophilic esophagitis.Methods: Patients with symptom severity scores of moderate or worse and an esophageal biopsy specimen with 24 or more intraepithelial eosinophils per high-power field were randomly assigned to receive infusions of 1, 2, or 3 mg/kg reslizumab or placebo at weeks 0, 4, 8, and 12. The coprimary efficacy measures were changes in peak esophageal eosinophil count and the physician's global assessment score at week 15 (end of therapy).Results: Two-hundred twenty-six patients received study medication. Median reductions from baseline to the end of therapy in peak esophageal eosinophil counts were 59%, 67%, 64%, and 24% in the 1, 2, and 3 mg/kg reslizumab (all P < .001) and placebo groups, respectively. All treatment groups, including the placebo group, showed improvements in physician's global assessment scores; the differences between the reslizumab and placebo groups were not statistically significant. The most common adverse events in the reslizumab groups were headache, cough, nasal congestion, and upper respiratory tract infection. One patient in each reslizumab group and 2 in the placebo group had serious adverse events; none were considered related to the study medication.Conclusion: Reslizumab significantly reduced intraepithelial esophageal eosinophil counts in children and adolescents with eosinophilic esophagitis. However, improvements in symptoms were observed in all treatment groups and were not associated with changes in esophageal eosinophil counts. (J Allergy Clin Immunol 2012;129:456-63.)