Visaggi Pierfrancesco, Ghisa Matteo, Barberio Brigida, Maniero Daria, Greco Eliana, Savarino Vincenzo, Black Christopher J, Ford Alexander C, de Bortoli Nicola, Savarino Edoardo
Gastroenterology Unit, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Gastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.
Dig Liver Dis. 2023 Feb;55(2):208-222. doi: 10.1016/j.dld.2022.05.004. Epub 2022 May 30.
Eosinophilic gastrointestinal diseases (EGIDs) are chronic inflammatory disorders of the gut, including eosinophilic esophagitis (EoE), gastritis (EoG), duodenitis (EoD), gastroenteritis (EoGE), and colitis (EoC). Available treatments may be ineffective in some patients, and several clinical trials are investigating alternative treatments.
We performed a systematic review of clinical trials to illustrate EGIDs treatment research trends.
We searched clinicaltrials.gov to identify studies investigating EGIDs treatment. For each trial we analysed relevant data, including therapeutic intervention, method of administration, study outcomes, and temporal trends.
For EoE, 66 studies were eligible: 26 testing topical corticosteroids (39.4%), 17 (25.8%) monoclonal antibodies, eight (12.1%) dietary measures, five (7.6%) immunomodulators, one (1.5%) esophageal dilation, and nine (13.6%) other medical treatment strategies. With regard to EoG, EoD, and EoGE, 10 studies were testing monoclonal antibodies (71.5%), one immunomodulators (7.1%), one dietary measures (7.1%), and two other treatments (14.3%). There were no trials for EoC. Ongoing studies on corticosteroids are focused on novel delivery systems, including viscous suspensions, orally disintegrating tablets, or capsules. Increased research on monoclonal antibodies was seen from 2018, with interleukin (IL)-4 receptor-α, IL-5 receptor-α, IL-5, IL-13, IL-15, and Siglec-8 as the targets.
Clinical trials on EGIDs are predominantly investigating corticosteroids or monoclonal antibodies. EGIDs therapeutic landscape will be trasnformed imminently.
嗜酸性粒细胞性胃肠道疾病(EGIDs)是肠道的慢性炎症性疾病,包括嗜酸性粒细胞性食管炎(EoE)、胃炎(EoG)、十二指肠 炎(EoD)、胃肠炎(EoGE)和结肠炎(EoC)。现有治疗方法可能对某些患者无效,多项临床试验正在研究替代治疗方法。
我们对临床试验进行了系统评价,以阐明EGIDs的治疗研究趋势。
我们检索了ClinicalTrials.gov网站,以确定研究EGIDs治疗的研究。对于每项试验,我们分析了相关数据,包括治疗干预、给药方法、研究结果和时间趋势。
对于EoE,有66项研究符合条件:26项试验局部用皮质类固醇(39.4%),17项(25.8%)单克隆抗体,8项(12.1%)饮食措施,5项(7.6%)免疫调节剂,1项(1.5%)食管扩张,9项(13.6%)其他医学治疗策略。关于EoG、EoD和EoGE,有10项研究在试验单克隆抗体(71.5%),1项免疫调节剂(7.1%),1项饮食措施(7.1%),2项其他治疗(14.3%)。没有针对EoC的试验。正在进行的关于皮质类固醇的研究集中在新型给药系统上,包括粘性混悬液、口腔崩解片或胶囊。从2018年起,对单克隆抗体的研究有所增加,以白细胞介素(IL)-4受体-α、IL-5受体-α、IL-5、IL-13、IL-15和Siglec-8为靶点。
关于EGIDs的临床试验主要在研究皮质类固醇或单克隆抗体。EGIDs的治疗前景即将发生改变。