Br J Dermatol:Baricitinib 3期临床试验中瘙痒和皮肤严重程度改善对特应性皮炎患者皮肤病生活质量指数的影响

2022-01-25 MedSci原创 MedSci原创

Baricitinib是一种口服,选择性Janus激酶(JAK)1/JAK2抑制剂,在这项分析中,Baricitinib显示出DLQI的显著改善,这项研究强调了瘙痒改善AD患者HRQL的重要性。

 

      Baricitinib是一种口服,选择性Janus激酶(JAK)1/JAK2抑制剂,在一些国家被批准用于治疗全身治疗成人的中度至重度特应性皮炎(AD)。根据三项单药治疗Baricitinib III期随机临床试验(RCTs)的数据,我们进行了一项posthoc中介分析,以评估瘙痒或皮肤严重程度的变化是否介导了安慰剂对健康相关生活质量变化的治疗效果(HRQoL)。

      该分析包括来自BREEZE-AD1(NCT03334396),BREEZE-AD2(NCT03334422),BREEZE-AD5(NCT03435081)的数据。患者被随机分配到BREEZE-AD1和BREEZE-AD2中的每日一次安慰剂,Baricitinib2mg或Baricitinib4mg以及BREEZE-AD5中的安慰剂,Baricitinib1mg或Baricitinib2mg。在这里,我们关注安慰剂,Baricitinib 2 mg和Baricitinib 4 mg的数据。由于BREEZE-AD1和BREEZE-AD2是同时在欧洲,亚洲,拉丁美洲和澳大利亚进行的研究,因此将这些研究的数据汇总在一起进行介体分析。BREEZE-AD5研究在北美进行,其数据分别列出。

     患者大于18岁且AD的1年以上病史。在筛查和基线时,要求患者具有湿疹面积和严重程度指数(EASI)评分≥16,一个有效的调查员全球评估AD(vIGA AD™) 分数≥3,以及涉及的体表面积(BSA)≥10%,来自EASI评估。瘙痒是通过数值分级量表(NRS)中基线的变化来衡量的,范围从0(无瘙痒)到10(可以想象的最严重的瘙痒)。我们评估了瘙痒NRS、EASI皮肤严重程度和皮肤病生活质量指数(DLQI)的周平均值。

     这项特殊分析基于治疗前16周的数据。我们评估了从基线到第4周或第16周的最小二乘均值变化。多重中介模型以第4周或第16周DLQI的变化为因变量,治疗(Baricitinib2 mg、Baricitinib4 mg或安慰剂)为自变量。瘙痒和第4周或16周的EASI是中介变量。与安慰剂相比,对DLQI改变的总体治疗效果可以由瘙痒或EASI来解释,这是间接或中介效应。与安慰剂相比,不能用间接效应计算的总治疗效应是直接效应(图)。在患者停止研究药物或接受抢救治疗后,统计数据。我们对缺失的数据进行了修正后的最后一次观察,并进行了结转分析。采用R3.6.3和R软件包Lavaan(0.6-5版)进行中介分析。

     患者年龄从35岁到40岁不等,其中34%到53%是女性。在所有RCT中,瘙痒NRS的基线平均值约为7±2,EASI约为27±11至34±13,BSA约为41±23%至54±23%,DLQI约为14±7至15±7。大约一半的患者VIGA评分为3,特应性皮炎(SCORAD)评分在64±13到68±13之间。正如之前报道的那样,在大多数基线后DLQI、瘙痒和EASI分析中,Baricitinib2毫克和4毫克与安慰剂相比有显著改善(P<0.05)。1.在DLQI、瘙痒和EASI的大多数基线后分析中,Baricitinib2毫克和4毫克显示出比安慰剂更大的改善(P<0.05)。

    对于在第4周或第16周调查Baricitinib 2 mg或4 mg对安慰剂对DLQI的影响的调解员分析,瘙痒和EASI作为调解员,调解员变量对结果的间接影响,或瘙痒或EASI的改善如何影响DLQI的改善范围为瘙痒43%至52%,EASI 21%至36%。代表Baricitinib对DLQI的所有其他影响的直接影响范围为12%至33%。

     在这项分析中,Baricitinib显示出DLQI的显著改善,在第4周和第16周,瘙痒介导了大约一半的变化。这项研究强调了瘙痒改善AD患者HRQL的重要性,并表明与正在接受治疗的AD患者可见的皮肤表现相比,瘙痒对HRQL的影响更大。

文献来源:Yosipovitch G,  Papp K,  Forman S, The contribution of itch and skin severity improvements to the Dermatology Life Quality Index in patients with atopic dermatitis in Baricitinib phase 3 trials.Br J Dermatol 2022 Jan 18; 

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    2022-12-08 carrotlyl 来自海南省

    Baricitinib

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    2022-01-27 listen318
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    2022-01-25 仁术2021

    不错,学习了。

    0

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