Determination of Biopsy Yield That Optimally Detects Eosinophilic Gastritis and/or Duodenitis in a Randomized Trial of Lirentelimab.
Determination of Biopsy Yield That Optimally Detects Eosinophilic Gastritis and/or Duodenitis in a Randomized Trial of Lirentelimab.
复制标题
DOI：
10.1016/j.cgh.2021.05.053
复制
发表时间：
2022-03
期刊：
影响因子：
--
通讯作者：
Genta RM
中科院分区：
文献类型：
--
作者：
Dellon ES;Gonsalves N;Rothenberg ME;Hirano I;Chehade M;Peterson KA;Falk GW;Murray JA;Gehman LT;Chang AT;Singh B;Rasmussen HS;Genta RM
嗜酸性粒细胞性胃炎 (EG) 和嗜酸性粒细胞十二指肠炎 (EoD) 的特征是慢性胃肠道 (GI) 症状以及胃肠道中嗜酸性粒细胞和肥大细胞数量或活化的增加，可能未被充分诊断。我们的目的是使用 lirentelimab (AK002) 随机试验的筛选数据来确定 EG 和 EoD 的比率以及优化检测所需的活检数量，lirentelimab (AK002) 是一种针对 siglec-8 的抗体，可消耗嗜酸性粒细胞并抑制肥大细胞。我们还描述了 EG 和 EoD 的内镜特征和症状。具有中度至重度胃肠道症状的受试者每天通过经过验证的患者报告的结果调查问卷进行评估，并接受内窥镜检查，并进行系统的胃和十二指肠活检方案和组织病理学评估。 EG诊断需要在≥5个hpfs中存在≥30个嗜酸性粒细胞/高倍视野(eos/hpf)，并且EoD需要在≥3个hpfs中≥30个eos/hpf。我们分析了 EG 和 EoD 的诊断率以及组织学、内窥镜和临床结果。在 88 名符合症状标准的受试者中，72 名被发现患有 EG 和/或 EoD (EG/EoD)，包括先前未诊断为 EG/EoD 的患者。我们发现胃肠道嗜酸性粒细胞增多是斑片状的，诊断需要进行多次活检——每个受试者平均只有 2.6/8 个胃活检和 2.2/4 个十二指肠活检符合 EG/EoD 阈值。需要对 8 个胃活检和 4 个十二指肠活检中的多个非重叠 hpf 进行评估，以捕获 100% 的 EG/EoD 病例。内镜检查结果和症状严重程度均与嗜酸性粒细胞计数无关。在对参加利伦替利单抗治疗 EG/EoD 临床试验的中重度胃肠道症状患者的分析中，我们发现胃和十二指肠活检中嗜酸性粒细胞增多。需要对至少 8 个胃活检和 4 个十二指肠活检中的嗜酸性粒细胞进行计数才能识别 EG/EoD 患者，以便他们能够接受适当的治疗。 NCT03496571
Eosinophilic gastritis (EG) and eosinophilic duodenitis (EoD), characterized by chronic gastrointestinal (GI) symptoms and increased numbers or activation of eosinophils and mast cells in the GI tract, are likely underdiagnosed. We aimed to determine rates of EG and EoD and number of biopsies required to optimize detection using screening data from a randomized trial of lirentelimab (AK002), an antibody against siglec-8 that depletes eosinophils and inhibits mast cells. We also characterized endoscopic features and symptoms of EG and EoD. Subjects with moderate-to-severe GI symptoms, assessed daily through a validated patient-reported outcome questionnaire, underwent endoscopy with a systematic gastric and duodenal biopsy protocol and histopathologic evaluation. EG diagnosis required presence of ≥30 eosinophils/high-powered field (eos/hpf) in ≥5 hpfs and EoD required ≥30 eos/hpf in ≥3 hpfs. We analyzed diagnostic yields for EG and EoD and histologic, endoscopic, and clinical findings. Of 88 subjects meeting symptom criteria, 72 were found to have EG and/or EoD (EG/EoD), including patients with no prior diagnosis of EG/EoD. We found that GI eosinophilia was patchy and that examination of multiple biopsies was required for diagnosis—an average of only 2.6/8 gastric biopsies and 2.2/4 duodenal biopsies per subject met thresholds for EG/EoD. Evaluation of multiple non-overlapping hpfs in each of 8 gastric and 4 duodenal biopsies was required to capture 100% of EG/EoD cases. Neither endoscopic findings nor symptom severity correlated with eosinophil counts. In an analysis of patients with moderate-to-severe GI symptoms participating in a clinical trial of lirentelimab for EG/EoD, we found eosinophilia to be patchy in gastric and duodenal biopsies. Counting eosinophils in at least 8 gastric and 4 duodenal biopsies is required to identify patients with EG/EoD, so they can receive appropriate treatment. NCT03496571
登录
查看更多内容
DOI：
10.1016/j.dld.2014.11.009
发表时间：
2015-03
期刊：
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
影响因子：
--
作者：
Reed C;Woosley JT;Dellon ES
通讯作者：
Dellon ES
影响因子：
3.1
作者：
Alhmoud, Tarik;Hanson, Joshua Anspach;Parasher, Gulshan
通讯作者：
Parasher, Gulshan
影响因子：
14.2
作者：
Abonia, J. Pablo;Blanchard, Carine;Butz, Bridget Buckmeier;Rainey, Heather F.;Collins, Margaret H.;Stringer, Keith;Putnam, Philip E.;Rothenberg, Marc E.
通讯作者：
Rothenberg, Marc E.
影响因子：
9.8
作者：
Shah, Ameesh A.;Kagalwalla, Amir F.;Hirano, Ikuo
通讯作者：
Hirano, Ikuo
影响因子：
14.2
作者：
Caldwell, Julie M.;Collins, Margaret H.;Stucke, Emily M.;Putnam, Philip E.;Franciosi, James P.;Kushner, Jonathan P.;Abonia, J. Pablo;Rothenberg, Marc E.
通讯作者：
Rothenberg, Marc E.