AM J CLIN DERMATOL:使用Dupilumab的特异性皮炎患者无需开展实验室监测

2021-07-22 MedSci原创 MedSci原创

特异性皮炎(AD)是一种慢性、复发性、炎症性皮肤病,伴有显著的皮肤干燥和瘙痒。通常情况下,若采用全身免疫抑制剂治疗,则需要进行实验室检查。

特异性皮炎(AD)是一种慢性、复发性、炎症性皮肤病,伴有显著的皮肤干燥和瘙痒。通常情况下,若采用全身免疫抑制剂治疗,则需要进行实验室检查。而此前针对重度特异性皮炎的成年患者开展的一项随机对照临床试验结果分析发现,Dupiluma临床使用前后血液学、血清化学和尿液分析的参数均无重要变化,支持在没有常规实验室监测的情况下使用Dupiluma。

本篇文献报告了在中重度特异性皮炎的青少年患者中,一项3期、随机、双盲、安慰剂对照试验的实验室检验结果。

研究方法

研究对象为12~18岁的中重度特异性皮炎青少年,随机1:1:1分配为3组,持续16周的治疗,包括每2周(q2w)的安慰剂治疗;或者每2周(q2w)的皮下注射Dupiluma 200/300 mg(基线体重< 60 kg的患者200mg;基线体重≥ 60 kg的患者300mg);每4周(q4w)Dupiluma 300 mg。实验室评估包括血液学、血清化学和尿液分析参数。后续的统计数据分析采用安全性分析集。

结果

在该研究中,共有250名患者接受了治疗并被纳入分析,并且治疗期间不存在停止或退出研究的情况。分别接受安慰剂、dupilumab 200/300 mg q2w和dupilumab 300 mg q4w治疗的患者中,有4.7%、2.4%和4.8%的患者的实验室异常报告为治疗紧急不良事件。

所有治疗组的平均嗜酸性粒细胞计数在基线时均升高。其中,采用两种dupilumab方案的患者(而非安慰剂组)均显示平均嗜酸性粒细胞计数短暂地轻度高于基线水平,到第16周恢复至接近基线值。乳酸脱氢酶的平均水平在基线时趋向于正常的上限,并随着治疗而降低;与安慰剂治疗的患者相比,dupilumab治疗的患者下降更大。而其他实验室参数没有任何有意义的变化

图:血液学,相对于基线的平均变化:a红细胞、b血小板、c白细胞、d嗜酸性粒细胞、g中性粒细胞;e嗜酸性粒细胞随时间变化中位数;f绝对嗜酸性粒细胞计数随时间变化的方框图

结论

在青少年的特异性皮炎患者中,没有发现实验室参数有临床意义的变化,与在成年患者中观察到的结果相似。这项研究的结果表明,在dupilumab治疗之前或治疗期间,不需要对青少年进行常规实验室监测。

 

原文出处:Siegfried EC, Bieber T, Simpson EL, Paller AS, Beck LA, Boguniewicz M, Schneider LC, Khokhar FA, Chen Z, Prescilla R, Mina-Osorio P, Bansal A. Effect of Dupilumab on Laboratory Parameters in Adolescents with Atopic Dermatitis: Results from a Randomized, Placebo-Controlled, Phase 3 Clinical Trial. Am J Clin Dermatol. 2021 Mar;22(2):243-255. doi: 10.1007/s40257-020-00583-3. Epub 2021 Mar 3. PMID: 33655423; PMCID: PMC7973645.

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