Division of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Department of Pediatrics, University of Cincinnati, Cincinnati, Ohio.
Division of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
J Allergy Clin Immunol. 2022 Mar;149(3):844-853. doi: 10.1016/j.jaci.2021.12.768. Epub 2021 Dec 22.
The US Food and Drug Administration hosted a workshop on July 21, 2021, to discuss the disease characteristics, natural history, and end points to assess treatment benefit in patients with eosinophilic gastrointestinal disorders (EGIDs) beyond eosinophilic esophagitis (EoE). Notably, EGIDs beyond EoE, such as eosinophilic gastritis, eosinophilic enteritis, and eosinophilic colitis, herein referred to as non-EoE EGIDs, are understudied relative to EoE. This workshop provided a forum for open discussion among stakeholders-medical professionals (including their societies and research groups), Food and Drug Administration representatives, an industry representative, and a patient representative-to facilitate drug development. Experts in many disciplines related to EGIDs, including allergy, immunology, epidemiology, gastroenterology, and pathology, and both adult and pediatric clinicians contributed. Herein, we discuss some of the insights of the material presented at the meeting and present perspectives on moving the field forward toward drug approval.
美国食品和药物管理局于 2021 年 7 月 21 日举办了一场研讨会，讨论了嗜酸性粒细胞性胃肠病（EGIDs）的疾病特征、自然史和终点，以评估除嗜酸性食管炎（EoE）以外的 EGIDs 患者的治疗获益。值得注意的是，与 EoE 相比，EGIDs 中的其他疾病（如嗜酸性胃炎、嗜酸性肠炎和嗜酸性结肠炎）研究较少，此处统称为非 EoE EGIDs。该研讨会为利益相关者（包括其学会和研究小组）、食品和药物管理局代表、行业代表和患者代表提供了一个公开讨论的论坛，以促进药物开发。包括过敏、免疫学、流行病学、胃肠病学和病理学在内的许多与 EGIDs 相关学科的专家以及成人和儿科临床医生都做出了贡献。在此，我们讨论了会议上提出的一些材料的见解，并就推动该领域朝着药物批准的方向前进提出了一些观点。
