Clinical application of the GLOBE and United Kingdom-primary biliary cholangitis risk scores in a trial cohort of patients with primary biliary cholangitis.
Clinical application of the GLOBE and United Kingdom-primary biliary cholangitis risk scores in a trial cohort of patients with primary biliary cholangitis.
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DOI：
10.1002/hep4.1180
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发表时间：
2018-06
影响因子：
5.1
通讯作者：
Hansen BE
中科院分区：
文献类型：
--
作者：
Carbone M;Harms MH;Lammers WJ;Marmon T;Pencek R;MacConell L;Shapiro D;Jones DE;Mells GF;Hansen BE
全球原发性胆汁性胆管炎（PBC）研究组和英国PBC（UK-PBC）联盟已经证明，在预测PBC患者的死亡率或肝移植时，二分反应标准不如连续方程准确。本分析的目的是使用POISE的数据评估地球仪和UK-PBC风险评分的临床效用，POISE是一项研究PBC患者中奥贝胆酸（OCA）的III期试验。使用基线和第12个月的数据（N = 216）计算地球仪和UK-PBC风险评分，以评估OCA与安慰剂相比的预计风险变化。此外，在不符合POISE主要终点的患者中评估了OCA的获益。地球仪和UK-PBC风险评分均预测OCA治疗后死亡和肝移植的长期风险显著降低（P < 0.0001）。OCA 10 mg与安慰剂相比，1年后10年事件风险相对于基线的相对风险降低差异为26%（地球仪）和37%（UK‐PBC）。这些评分还预测，与安慰剂组风险增加相比，接受OCA治疗1年后不符合POISE反应标准的患者风险显著降低（P < 0.0001）。结论：该分析证明了使用地球仪和UK-PBC风险评分评估接受OCA治疗的队列的风险降低。虽然需要在具有临床结局的研究中验证这种风险降低，但本研究强调了这些评分在临床实践和治疗试验中个性化PBC风险预测中的潜在用途。（Hepatology Communications 2018;2：683 - 692）
The GLOBAL Primary Biliary Cholangitis (PBC) Study Group and United Kingdom‐PBC (UK‐PBC) Consortium have demonstrated that dichotomous response criteria are not as accurate as continuous equations at predicting mortality or liver transplantation in PBC. The aim of this analysis was to assess the clinical utility of the GLOBE and UK‐PBC risk scores using data from POISE, a phase 3 trial investigating obeticholic acid (OCA) in patients with PBC. Data (N = 216) at baseline and month 12 were used to calculate the GLOBE and UK‐PBC risk scores to assess the projected change in risk with OCA versus placebo. Additionally, the benefit of OCA was assessed in patients not meeting the POISE primary endpoint. Both the GLOBE and UK‐PBC risk scores predicted a significant reduction in long‐term risk of death and liver transplantation after OCA treatment (P < 0.0001). The differences in the relative risk reduction from baseline in the 10‐year event risk after 1 year for OCA 10 mg versus placebo was 26% (GLOBE) and 37% (UK‐PBC). The scores also predicted a significantly decreased risk in patients treated with OCA who did not meet POISE response criteria after 1 year of treatment compared to an increased risk with placebo (P < 0.0001). Conclusion: This analysis demonstrates the use of the GLOBE and UK‐PBC risk scores to assess risk reduction of a cohort treated with OCA. While validation of this risk reduction in studies with clinical outcomes is needed, this study highlights the potential use of these scores in individualizing risk prediction in PBC both in clinical practice and therapeutic trials. (Hepatology Communications 2018;2:683‐692)
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