Department of Pediatrics, University of Florida Diabetes Institute, College of Medicine, Gainesville, FL
Department of Pediatrics, University of Florida Diabetes Institute, College of Medicine, Gainesville, FL.
Diabetes. 2021 May;70(5):1021-1028. doi: 10.2337/dbi20-0045. Epub 2021 Feb 25.
Research-based immunotherapy trials seeking to prevent or reverse a number of autoimmune diseases, including type 1 diabetes, have seen near universal suspension due to the coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Diabetes and hyperglycemia are now appreciated as significant risk factors for COVID-19 morbidity and mortality; however, the vast majority of studies have reported on adults. Recent data in children and adolescents with type 1 diabetes suggest no increased risk of COVID-19. Even with immense appreciation for COVID-19 morbidity and mortality, we believe compelling arguments exist to carefully and thoughtfully resume certain type 1 diabetes phase 2-3 immunotherapy trials. In this Perspective, we consider the experience of trials that never halted or have resumed in the oncology and rheumatology fields, and advocate for staged type 1 diabetes immunotherapy trial resumption. With this, we present recommendations to achieve equipoise and mitigate risks for SARS-CoV-2 infection in the weeks surrounding infusion. Given the fact that the COVID-19 pandemic is expected to persist for some time, it is in the best interest of our patients that we find ways to safely move our field forward.
由于严重急性呼吸系统综合征冠状病毒 2(SARS-CoV-2)引起的 2019 年冠状病毒病(COVID-19)大流行,许多旨在预防或逆转包括 1 型糖尿病在内的多种自身免疫性疾病的基于研究的免疫疗法试验已几乎普遍暂停。糖尿病和高血糖现在被认为是 COVID-19 发病率和死亡率的重要危险因素;然而,绝大多数研究都针对成年人。最近关于 1 型糖尿病儿童和青少年的数据表明,他们没有增加感染 COVID-19 的风险。即使我们对 COVID-19 的发病率和死亡率有了极大的认识,我们仍然认为有充分的理由谨慎而周到地恢复某些 1 型糖尿病 2-3 期免疫疗法试验。在本观点中,我们考虑了在肿瘤学和风湿病学领域从未停止或已恢复的试验的经验,并主张分阶段恢复 1 型糖尿病免疫疗法试验。为此,我们提出了在输注前后数周内实现平衡并降低 SARS-CoV-2 感染风险的建议。鉴于 COVID-19 大流行预计将持续一段时间,我们找到安全推进我们领域的方法符合我们患者的最大利益。