A Real-World Precision Medicine Program Including the KidneyIntelX Test Effectively Changes Management Decisions and Outcomes for Patients With Early-Stage Diabetic Kidney Disease.

IF 3 Q1 PRIMARY HEALTH CARE Journal of Primary Care and Community Health Pub Date : 2024-01-01 DOI:10.1177/21501319231223437
Joji Tokita, David Lam, Aida Vega, Stephanie Wang, Leonard Amoruso, Tamara Muller, Nidhi Naik, Shivani Rathi, Sharlene Martin, Azadeh Zabetian, Catherine Liu, Catherine Sinfield, Tony McNicholas, Fergus Fleming, Steven G Coca, Girish N Nadkarni, Roger Tun, Mike Kattan, Michael J Donovan, Arshad K Rahim
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Abstract

Introduction/objective: The KidneyIntelX is a multiplex, bioprognostic, immunoassay consisting of 3 plasma biomarkers and clinical variables that uses machine learning to predict a patient's risk for a progressive decline in kidney function over 5 years. We report the 1-year pre- and post-test clinical impact on care management, eGFR slope, and A1C along with engagement of population health clinical pharmacists and patient coordinators to promote a program of sustainable kidney, metabolic, and cardiac health.

Methods: The KidneyIntelX in vitro prognostic test was previously validated for patients with type 2 diabetes and diabetic kidney disease (DKD) to predict kidney function decline within 5 years was introduced into the RWE study (NCT04802395) across the Health System as part of a population health chronic disease management program from [November 2020 to April 2023]. Pre- and post-test patients with a minimum of 12 months of follow-up post KidneyIntelX were assessed across all aspects of the program.

Results: A total of 5348 patients with DKD had a KidneyIntelX assay. The median age was 68 years old, 52% were female, 27% self-identified as Black, and 89% had hypertension. The median baseline eGFR was 62 ml/min/1.73 m2, urine albumin-creatinine ratio was 54 mg/g, and A1C was 7.3%. The KidneyIntelX risk level was low in 49%, intermediate in 40%, and high in 11% of cases. New prescriptions for SGLT2i, GLP-1 RA, or referral to a specialist were noted in 19%, 33%, and 43% among low-, intermediate-, and high-risk patients, respectively. The median A1C decreased from 8.2% pre-test to 7.5% post-test in the high-risk group (P < .001). UACR levels in the intermediate-risk patients with albuminuria were reduced by 20%, and in a subgroup treated with new scripts for SGLT2i, UACR levels were lowered by approximately 50%. The median eGFR slope improved from -7.08 ml/min/1.73 m2/year to -4.27 ml/min/1.73 m2/year in high-risk patients (P = .0003), -2.65 to -1.04 in intermediate risk, and -3.26 ml/min/1.73 m2/year to +0.45 ml/min/1.73 m2/year in patients with low-risk (P < .001).

Conclusions: Deployment and risk stratification by KidneyIntelX was associated with an escalation in action taken to optimize cardio-kidney-metabolic health including medications and specialist referrals. Glycemic control and kidney function trajectories improved post-KidneyIntelX testing, with the greatest improvements observed in those scored as high-risk.

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包括 KidneyIntelX 检测在内的真实世界精准医学计划有效改变了早期糖尿病肾病患者的管理决策和治疗效果。
简介/目标:KidneyIntelX 是一种多重生物诊断免疫测定,由 3 种血浆生物标志物和临床变量组成,利用机器学习预测患者 5 年内肾功能逐渐下降的风险。我们报告了测试前后 1 年对护理管理、eGFR 斜率和 A1C 的临床影响,以及人口健康临床药剂师和患者协调员参与促进可持续肾脏、代谢和心脏健康计划的情况:KidneyIntelX体外预后测试之前已在2型糖尿病和糖尿病肾病(DKD)患者中进行过验证,可预测5年内肾功能的下降。对在 KidneyIntelX 项目后随访至少 12 个月的测试前和测试后患者进行了全面评估:共有 5348 名 DKD 患者接受了 KidneyIntelX 检测。中位年龄为 68 岁,52% 为女性,27% 自认为是黑人,89% 患有高血压。基线 eGFR 中位数为 62 ml/min/1.73 m2,尿白蛋白-肌酐比值为 54 mg/g,A1C 为 7.3%。49% 的病例的 KidneyIntelX 风险等级为低,40% 为中,11% 为高。在低危、中危和高危患者中,SGLT2i、GLP-1 RA 或转诊至专科医生的新处方分别占 19%、33% 和 43%。高风险组的 A1C 中位数从检测前的 8.2% 降至检测后的 7.5%(P 2/年),高风险患者的 A1C 中位数从-4.27 毫升/分钟/1.73 平方米/年降至-4.27 毫升/分钟/1.73 平方米/年(P = .0003),中度风险患者的 A1C 中位数从-2.65 降至-1.04,低风险患者的 A1C 中位数从-3.26 毫升/分钟/1.73 平方米/年降至+0.45 毫升/分钟/1.73 平方米/年(P 结论:KidneyIntelX 的部署和风险分层与优化心肾代谢健康的行动升级有关,包括药物治疗和专家转诊。KidneyIntelX检测后,血糖控制和肾功能轨迹均有所改善,高风险人群的改善幅度最大。
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来源期刊
CiteScore
4.80
自引率
2.80%
发文量
183
审稿时长
15 weeks
期刊最新文献
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