Critical Path Institute, Tucson, Arizona, USA.
Université de Paris, Cité, Institut national de la santé et de la recherche médicale, U970, PARCC, Paris Translational Research Centre for Organ Transplantation, Paris, France.
Am J Transplant. 2023 Oct;23(10):1496-1506. doi: 10.1016/j.ajt.2023.04.018. Epub 2023 Sep 18.
New immunosuppressive therapies that improve long-term graft survival are needed in kidney transplant. Critical Path Institute's Transplant Therapeutics Consortium received a qualification opinion for the iBOX Scoring System as a novel secondary efficacy endpoint for kidney transplant clinical trials through European Medicines Agency's qualification of novel methodologies for drug development. This is the first qualified endpoint for any transplant indication and is now available for use in kidney transplant clinical trials. Although the current efficacy failure endpoint has typically shown the noninferiority of therapeutic regimens, the iBOX Scoring System can be used to demonstrate the superiority of a new immunosuppressive therapy compared to the standard of care from 6 months to 24 months posttransplant in pivotal or exploratory drug therapeutic studies.
在肾脏移植中，需要新的免疫抑制疗法来提高长期移植物存活率。Critical Path Institute 的移植治疗学联盟通过欧洲药品管理局对药物开发新方法的资格认定，获得了 iBOX 评分系统作为肾脏移植临床试验新型次要疗效终点的资格意见。这是第一个针对任何移植适应证的合格终点，现在可用于肾脏移植临床试验。虽然目前的疗效失败终点通常显示治疗方案的非劣效性，但 iBOX 评分系统可用于在关键性或探索性药物治疗研究中，在移植后 6 个月至 24 个月期间，证明新的免疫抑制疗法相对于标准治疗的优越性。
