Common Immune-Related Adverse Events of Immune Checkpoint Inhibitors in the Gastrointestinal System: A Study Based on the US Food and Drug Administration Adverse Event Reporting System.
Common Immune-Related Adverse Events of Immune Checkpoint Inhibitors in the Gastrointestinal System: A Study Based on the US Food and Drug Administration Adverse Event Reporting System.
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DOI：
10.3389/fphar.2021.720776
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发表时间：
2021
影响因子：
5.6
通讯作者：
Yang H
中科院分区：
文献类型：
--
作者：
Bai X;Jiang S;Zhou Y;Zhen H;Ji J;Li Y;Ruan G;Yang Y;Shen K;Wang L;Li G;Yang H
免疫检查点抑制剂（ICI）已经彻底改变了癌症治疗;然而，胃肠道（GI）系统中的免疫相关不良事件（irAE）经常发生。在本研究中，数据来自2014年7月至2020年12月期间的美国食品和药物管理局不良事件报告系统。在我们的研究中，结肠炎、肝胆疾病和胰腺炎被确定为irAE。采用具有信息成分（IC）的报告优势比（ROR）进行不成比例分析。在选定的时间段内，共报告了70，330起不良事件，其中4，075起记录与ICI相关。据报道，ICI会增加GI毒性，结肠炎、肝胆疾病和胰腺炎的ROR 025分别为17.2、6.7和2.3。抗CTLA-4治疗的结肠炎、肝胆疾病和胰腺炎风险高于抗PD-1（ROR 025分别为2.6、1.3和1.1）或抗PD-L1治疗（ROR 025分别为4.8、1.3和1.3）。Logistic分析显示女性患者更易发生肝胆疾病和胰腺炎（校正比值比，1.16和1.52;均P < 0.05）。一致地，根据多变量logistic分析，多种治疗是结肠炎（校正比值比2.52，p < 0.001）、肝胆疾病（校正比值比2.50，p < 0.001）和胰腺炎（校正比值比2.29，p < 0.001）的强风险因素。该药物警戒分析表明，所有3种GI irAE的风险均与ICI治疗相关。比较分析为选择接受ICI治疗的患者的GI irAE提供了支持性见解。
Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment; however, immune-related adverse events (irAEs) in the gastrointestinal (GI) system commonly occur. In this study, data were obtained from the US Food and Drug Administration adverse event reporting system between July 2014 and December 2020. Colitis, hepatobiliary disorders, and pancreatitis were identified as irAEs in our study. Reporting odds ratio (ROR) with information components (IC) was adopted for disproportionate analysis. A total of 70,330 adverse events were reported during the selected period, 4,075 records of which were associated with ICIs. GI toxicities have been reportedly increased with ICI, with ROR025 of 17.2, 6.7, and 2.3 for colitis, hepatobiliary disorders, and pancreatitis, respectively. The risks of colitis, hepatobiliary disorders, and pancreatitis were higher with anti-CTLA-4 treatment than that with anti-PD-1 (ROR025 2.6, 1.3, and 1.1, respectively) or anti-PD-L1 treatment (ROR025 4.8, 1.3, and 1.3, respectively). Logistic analysis indicated that hepatobiliary disorders and pancreatitis more frequently occurred in female patients (adjusted odds ratio, 1.16 and 1.52; both p < 0.05). Consistently, polytherapy was a strong risk factor for colitis (adjusted odds ratio 2.52, p < 0.001), hepatobiliary disorders (adjusted odds ratio 2.50, p < 0.001), and pancreatitis (adjusted odds ratio 2.29, p < 0.001) according to multivariate logistic analysis. This pharmacovigilance analysis demonstrated an increased risk of all three GI irAEs associated with ICI therapies. The comparative analysis offered supportive insights on selecting GI irAEs for patients treated with ICIs.
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DOI：
10.1056/nejmoa1504030
发表时间：
2015-07-02
期刊：
The New England journal of medicine
影响因子：
--
作者：
Larkin J;Chiarion-Sileni V;Gonzalez R;Grob JJ;Cowey CL;Lao CD;Schadendorf D;Dummer R;Smylie M;Rutkowski P;Ferrucci PF;Hill A;Wagstaff J;Carlino MS;Haanen JB;Maio M;Marquez-Rodas I;McArthur GA;Ascierto PA;Long GV;Callahan MK;Postow MA;Grossmann K;Sznol M;Dreno B;Bastholt L;Yang A;Rollin LM;Horak C;Hodi FS;Wolchok JD
通讯作者：
Wolchok JD
免疫检查点抑制剂的内分泌毒性：利用美国食品和药物管理局不良事件报告系统进行的真实世界研究
影响因子：
10.9
作者：
Zhai, Yinghong;Ye, Xiaofei;He, Jia
通讯作者：
He, Jia
影响因子：
7.2
作者：
Davies M;Duffield EA
通讯作者：
Duffield EA
影响因子：
10.3
作者：
Friedman, Claire F.;Clark, Varina;Postow, Michael A.
通讯作者：
Postow, Michael A.
影响因子：
7.4
作者：
Valpione S;Pasquali S;Campana LG;Piccin L;Mocellin S;Pigozzo J;Chiarion-Sileni V
通讯作者：
Chiarion-Sileni V