Hansa Biopharma AB, Lund, Sweden.
United Network for Organ Sharing, Richmond, Virginia, USA.
Clin Transplant. 2023 May;37(5):e14946. doi: 10.1111/ctr.14946. Epub 2023 Mar 13.
At the start of 2020, the kidney waiting list consisted of 2526 candidates with a calculated panel reactive antibody (CPRA) of 99.9% or greater, a cohort demonstrated in published research to have meaningfully lower than average access to transplantation even under the revised kidney allocation system (KAS).
This was a retrospective analysis of US kidney registrations using data from the OPTN [Reference (https://optn.transplant.hrsa.gov/data/about-data/)]. The period-prevalent study cohort consisted of US kidney-alone registrations who waited at least 1 day between April 1, 2016, when HLA DQ-Alpha and DP-Beta unacceptable antigen data became available in OPTN data collection, to December 31, 2019. Poisson rate regression was used to model deceased donor kidney transplant rates per active year waiting and using an offset term to account for differential at-risk periods. Median time to transplant was estimated for each IRR group using the Kaplan-Meier method. Sensitivity analyses were included to address geographic variation in supply-to-demand ratios and differences in dialysis time or waiting time.
In this study, we found 1597 additional sensitized (CPRA 50-<99.9%) candidates with meaningfully lower than average access to transplant when simultaneously taking into account CPRA and other factors. In combination with CPRA, candidate blood type, Estimated Post-Transplant Survival Score (EPTS), and presence of other antibody specificities beyond those in the current, 5-locus CPRA were found to influence the likelihood of transplant.
In total, this suggests approximately 4100 sensitized candidates are on the waiting list who represent a community of disadvantaged patients who may benefit from progressive therapies and interventions to facilitate incompatible transplantation. Though associated with higher risks, such interventions may nevertheless be more attractive than remaining on dialysis with the associated accumulation of mortality risk over time.
2020 年初,肾脏候补名单上有 2526 名候选人,其计算出的 panel reactive antibody(CPRA)为 99.9%或更高,这一队列在已发表的研究中显示,即使在修订后的肾脏分配系统(KAS)下,他们的移植机会也明显低于平均水平。
这是对美国肾脏登记处使用 OPTN 数据(参考)进行的回顾性分析。该时期流行的研究队列由美国仅肾脏注册者组成,他们在 2016 年 4 月 1 日(OPTN 数据收集开始提供 HLA DQ-Alpha 和 DP-Beta 不可接受抗原数据)之后至少等待了 1 天,至 2019 年 12 月 31 日。我们使用泊松比率回归模型来模拟每个活跃等待年份的已故供体肾脏移植率,并使用偏移项来考虑不同的风险期。使用 Kaplan-Meier 方法估计每个 IRR 组的移植中位时间。敏感性分析包括解决供应与需求比的地理差异以及透析时间或等待时间的差异。
在这项研究中,我们发现了 1597 名额外的致敏(CPRA 50-<99.9%)候选者,当同时考虑 CPRA 和其他因素时,他们的移植机会明显低于平均水平。候选者的血型、移植后估计生存评分(EPTS)以及除当前 5 位点 CPRA 之外的其他抗体特异性的存在与 CPRA 一起,被发现影响移植的可能性。
总的来说,这表明候补名单上大约有 4100 名致敏候选者,他们代表了一个弱势患者群体,他们可能受益于渐进治疗和干预措施,以促进不相容的移植。尽管存在较高的风险,但与随着时间的推移累积死亡风险而继续进行透析相比,这些干预措施可能仍然更具吸引力。