Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial
Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial
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DOI：
10.1186/s13075-019-1837-7
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发表时间：
2019-02-20
影响因子：
4.9
通讯作者：
Stone, John H.
中科院分区：
文献类型：
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作者：
Strand, Vibeke;Dimonaco, Sophie;Stone, John H.
背景 在一项随机对照试验中，每周或每隔一周接受托珠单抗 (TCZ) 治疗并逐渐减量泼尼松的巨细胞动脉炎 (GCA) 患者比接受安慰剂和逐渐减量泼尼松治疗的患者获得了更高的持续缓解率。现报告该试验患者的健康相关生活质量 (HRQOL)。 方法对每周皮下注射 TCZ 162mg 加 26 周泼尼松逐渐减量 (TCZ-QW+Pred-26) 或安慰剂加 26 周或 52 周泼尼松逐渐减量治疗的患者进行 SF-36 PCS 和 MCS 以及领域评分、PtGA 和 FACIT-疲劳的探索性分析(PBO+Pred-26 或 PBO+Pred-52)。这些分析是对有反应和无反应的患者进行的，包括达到主要结果的患者和经历过发作并接受逃逸泼尼松剂量的患者。结果基线 SF-36 PCS、MCS 和领域评分较低，表明与 GCA 相关的 HRQOL 受损。第 52 周时，TCZ-QW+Pred-26 组 PCS 评分的最小二乘均值 (LSM) 变化有所改善，但 PBO+Pred 组的情况恶化 (p
BackgroundPatients with giant cell arteritis (GCA) treated with tocilizumab (TCZ) every week or every other week and prednisone tapering achieved superior rates of sustained remission to patients treated with placebo and prednisone tapering in a randomised controlled trial. Health-related quality of life (HRQOL) in patients from this trial is now reported.MethodsExploratory analyses of SF-36 PCS and MCS and domain scores, PtGA and FACIT-Fatigue were performed in patients treated with weekly subcutaneous TCZ 162mg plus 26-week prednisone taper (TCZ-QW+Pred-26) or placebo plus 26-week or 52-week prednisone tapers (PBO+Pred-26 or PBO+Pred-52). These analyses were performed on responder and non-responder patients, including those who achieved the primary outcome and those who experienced flare and received escape prednisone doses.ResultsBaseline SF-36 PCS, MCS and domain scores were low, indicating impaired HRQOL related to GCA. At week 52, least squares mean (LSM) changes in PCS scores improved with TCZ-QW+Pred-26 but worsened in both PBO+Pred groups (p