Inoue Seiji, Osawa Tomohiro, Umeda Michi, Yasuda Masahiro, Mizui Takashi, Sugiyama Yasuyuki, Goto Chitoshi
Dept. of Pharmacy, Gifu Municipal Hospital.
Gan To Kagaku Ryoho. 2020 Aug;47(8):1189-1192.
Skin complication caused by anti-programmed cell death-1(PD1)antibody is a typical immune-related adverse event. We designed this study to clarify the correlation between risk factors(patient's background and laboratory data)and skin toxicity( rash and eruption, excluding itch)after administration of either nivolumab or pembrolizumab. From February 2016 to January 2018, we evaluated the clinical outcomes of 54 patients who were administered anti-PD1 antibody. The patients were divided into 2 groups: 9 patients with skin eruption caused by anti-PD1 antibody(skin eruption group)and 45 patients without skin eruption caused by anti-PD1 antibody(non-skin eruption group). Univariate analysis revealed a significant difference in eosinophil counts in both the groups before anti-PD1 antibody administration(>300/µL)(p=0.020). Factors with p<0.2 in the univariate analysis and 4 factors, age(<65 years of age), sex(male), allergy(+), and pembrolizumab, likely to be related to the appearance of skin eruption, were examined by multivariate analysis. Consequently, eosinophil count before anti-PD1 antibody administration(>300/µL)was identified as a risk factor (odds ratio: 9.530, 95% confidence interval: 1.260-71.80). In conclusion, we suggest that cases with an increased eosinophil count before anti-PD1 antibody administration(>300/µL)may be associated with the appearance of skin eruption.
抗程序性细胞死亡蛋白1（PD1）抗体引起的皮肤并发症是一种典型的免疫相关不良事件。我们设计了本研究，以阐明风险因素（患者背景和实验室数据）与使用纳武单抗或派姆单抗后皮肤毒性（皮疹和红斑，不包括瘙痒）之间的相关性。2016年2月至2018年1月，我们评估了54例接受抗PD1抗体治疗患者的临床结局。患者被分为2组：9例由抗PD1抗体引起皮肤红斑的患者（皮肤红斑组）和45例未由抗PD1抗体引起皮肤红斑的患者（非皮肤红斑组）。单因素分析显示，在抗PD1抗体给药前两组的嗜酸性粒细胞计数均有显著差异（>300/µL）（p=0.020）。单因素分析中p<0.2的因素以及4个可能与皮肤红斑出现相关的因素，即年龄（<65岁）、性别（男性）、过敏（+）和派姆单抗，通过多因素分析进行了研究。结果，抗PD1抗体给药前的嗜酸性粒细胞计数（>300/µL）被确定为一个风险因素（比值比：9.530，95%置信区间：1.260-71.80）。总之，我们认为抗PD1抗体给药前嗜酸性粒细胞计数增加（>300/µL）的病例可能与皮肤红斑的出现有关。
