早期类风湿关节炎中不同 COBRA 样强化缓解诱导方案的两年成本效益：对实用随机对照 CareRA 试验的搭车研究。

Two-year cost-effectiveness of different COBRA-like intensive remission induction schemes in early rheumatoid arthritis: a piggyback study on the pragmatic randomised controlled CareRA trial.

机构信息

Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Flanders, Belgium

Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, Maastricht, The Netherlands.

出版信息

Ann Rheum Dis. 2020 May;79(5):556-565. doi: 10.1136/annrheumdis-2019-216874. Epub 2020 Apr 2.

DOI:10.1136/annrheumdis-2019-216874

PMID:32241795

Abstract

OBJECTIVES

To evaluate the cost-effectiveness of treat-to-target strategies among recently diagnosed patients with rheumatoid arthritis (RA) using methotrexate (MTX) and a step-down glucocorticoid (GC) scheme (COBRA Slim) compared with (1) this combination with either sulphasalazine (COBRA Classic) or leflunomide (COBRA Avant-Garde) in high-risk patients and (2) MTX without GCs (Tight-Step-Up, TSU) in low-risk patients.

METHODS

The incremental cost-utility was calculated from a healthcare perspective in the intention-to-treat population (n=379) of the 2-year open-label pragmatic randomised controlled Care in early RA trial. Healthcare costs were collected prospectively through electronic trial records. Quality-adjusted life years (QALYs) were estimated using mapping algorithms for EuroQoL-5 Dimension. Multiple imputation was used to handle missing data and bootstrapping to calculate CIs. Robustness was tested with biological disease-modifying antirheumatic drugs at biosimilar prices.

RESULTS

In the high-risk group, Classic (∆k€1.464, 95% CI -0.198 to 3.127) and Avant-Garde (∆k€0.636, 95% CI -0.987 to 2.258) were more expensive compared with Slim and QALYs were slightly worse for Classic (∆-0.002, 95% CI -0.086 to 0.082) and Avant-Garde (∆-0.009, 95% CI -0.102 to 0.084). This resulted in the domination of Classic and Avant-Garde by Slim. In the low-risk group, Slim was cheaper (∆k€-0.617, 95% CI -2.799 to 1.566) and QALYs were higher (∆0.141, 95% CI 0.008 to 0.274) compared with TSU, indicating Slim dominated. Results were robust against the price of biosimilars.

CONCLUSIONS

The combination of MTX with a GC bridging scheme is less expensive with comparable health utility than more intensive step-down combination strategies or a conventional step-up approach 2 years after initial treatment.

TRIAL REGISTRATION NUMBER

NCT01172639.

摘要

目的

评估以甲氨蝶呤（MTX）为基础，联合逐渐减停糖皮质激素（GC）方案（COBRA Slim）与（1）联合柳氮磺胺吡啶（COBRA Classic）或来氟米特（COBRA Avant-Garde）治疗高危患者，（2）MTX 不联合 GC（Tight-Step-Up，TSU）治疗低危患者的治疗至达标策略在近期诊断为类风湿关节炎（RA）患者中的成本效果。

方法

采用 2 年开放标签实用随机对照 Care in early RA 试验意向治疗人群（n=379）的数据，从医疗保健角度计算增量成本效用。通过电子试验记录前瞻性收集医疗保健成本。采用 EuroQoL-5 维度映射算法估计质量调整生命年（QALY）。采用多重插补处理缺失数据，采用自举法计算置信区间。采用生物类似物价格下的生物改善病情抗风湿药物进行稳健性测试。

结果

在高危组中，Classic（∆k€1.464，95%CI-0.198 至 3.127）和 Avant-Garde（∆k€0.636，95%CI-0.987 至 2.258）均比 Slim 更昂贵，且 Classic（∆-0.002，95%CI-0.086 至 0.082）和 Avant-Garde（∆-0.009，95%CI-0.102 至 0.084）的 QALY 稍差。这导致 Classic 和 Avant-Garde 被 Slim 主导。在低危组中，Slim 更便宜（∆k€-0.617，95%CI-2.799 至 1.566），且 QALY 更高（∆0.141，95%CI0.008 至 0.274），表明 Slim 占主导地位。结果在生物类似物价格下稳健。