Boden Elisa K, Canavan James B, Moran Christopher J, McCann Katelyn, Dunn William A, Farraye Francis A, Ananthakrishnan Ashwin N, Yajnik Vijay, Gandhi Roopali, Nguyen Deanna D, Bhan Atul K, Weiner Howard L, Korzenik Joshua R, Snapper Scott B
Division of Gastroenterology, Virginia Mason Medical Center, Seattle, WA.
Benaroya Research Institute, Seattle, WA.
Crohns Colitis 360. 2019 Jul;1(2):otz009. doi: 10.1093/crocol/otz009. Epub 2019 Jun 7.
The aim of this study was to determine the immunologic effects and safety of oral anti-CD3 in patients with ulcerative colitis (UC).
An open-label pilot study of orally delivered anti-CD3 was performed in patients with moderate-to-severe UC. The primary end points were changes in immunologic parameters and evaluation for safety.
Six subjects received oral OKT3. Biologic effects of oral anti-CD3 included significantly increased proliferation in response to anti-CD3 and anti-inflammatory gene expression profile in peripheral blood mononuclear cells. No serious treatment-related adverse events occurred.
Orally delivered anti-CD3 resulted in immunologic changes in patients with UC.
本研究旨在确定口服抗CD3对溃疡性结肠炎(UC)患者的免疫作用及安全性。
对中重度UC患者进行了一项口服抗CD3的开放标签试点研究。主要终点是免疫参数的变化及安全性评估。
6名受试者接受了口服OKT3。口服抗CD3的生物学效应包括外周血单核细胞对抗CD3反应的增殖显著增加以及抗炎基因表达谱变化。未发生严重的治疗相关不良事件。
口服抗CD3可使UC患者出现免疫变化。