Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.
Roche Products Ltd., Welwyn Garden City, UK.
Arthritis Res Ther. 2019 Feb 20;21(1):64. doi: 10.1186/s13075-019-1837-7.
Patients 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.
Exploratory analyses of SF-36 PCS and MCS and domain scores, PtGA and FACIT-Fatigue were performed in patients treated with weekly subcutaneous TCZ 162 mg 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.
Baseline 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 < 0.001). LSM changes in MCS scores increased with TCZ-QW + Pred-26 versus PBO + Pred-52 (p < 0.001). Treatment with TCZ-QW + Pred-26 resulted in significantly greater improvement in four of eight SF-36 domains compared with PBO + Pred-26 and six of eight domains compared with PBO + Pred-52 (p < 0.01). Improvement with TCZ-QW + Pred-26 met or exceeded minimum clinically important differences (MCID) in all eight domains compared with five domains with PBO + Pred-26 and none with PBO + Pred-52. Domain scores in the TCZ-QW + Pred-26 group at week 52 met or exceeded age- and gender-matched normative values (A/G norms). LSM changes from baseline in FACIT-Fatigue scores increased significantly with TCZ-QW + Pred-26, exceeding MCID and A/G norms (p < 0.001).
Patients with GCA receiving TCZ-QW + Pred-26 reported statistically significant and clinically meaningful improvement in SF-36 and FACIT-Fatigue scores compared with those receiving prednisone only. Improvements in the TCZ-QW + Pred-26 group led to recovery of HRQOL to levels at least comparable to those of A/G-matched normative values at week 52 and exceeded normative values in five of eight domains.
ClinicalTrials.gov, NCT01791153. Date of registration: February 13, 2013.
在一项随机对照试验中，每周或每两周接受托珠单抗（TCZ）治疗并逐渐减少泼尼松剂量的巨细胞动脉炎（GCA）患者达到持续缓解的比例优于接受安慰剂和逐渐减少泼尼松剂量的患者。现在报告了该试验中患者的健康相关生活质量（HRQOL）。
对每周皮下注射 TCZ 162mg 加 26 周泼尼松减量（TCZ-QW + Pred-26）或安慰剂加 26 周或 52 周泼尼松减量（PBO + Pred-26 或 PBO + Pred-52）治疗的患者进行 SF-36 PCS 和 MCS 以及域评分、PtGA 和 FACIT-Fatigue 的探索性分析。这些分析针对应答者和无应答者患者进行，包括达到主要结局的患者和经历发作并接受逃逸泼尼松剂量的患者。
基线 SF-36 PCS、MCS 和域评分较低，表明与 GCA 相关的 HRQOL 受损。在第 52 周时，TCZ-QW + Pred-26 治疗的最小二乘均值（LSM）变化改善，但 PBO + Pred 两组均恶化（p < 0.001）。TCZ-QW + Pred-26 治疗的 MCS 评分 LSM 升高，与 PBO + Pred-52 相比（p < 0.001）。与 PBO + Pred-26 相比，TCZ-QW + Pred-26 治疗导致 8 个 SF-36 域中的 4 个域显著改善，与 PBO + Pred-52 相比 6 个域显著改善（p < 0.01）。与 PBO + Pred-26 相比，TCZ-QW + Pred-26 治疗在所有 8 个域中改善均达到或超过最小临床重要差异（MCID），而在 5 个域中达到或超过 PBO + Pred-26，在 8 个域中均未达到 PBO + Pred-52。TCZ-QW + Pred-26 组第 52 周的域评分达到或超过年龄和性别匹配的正常范围（A/G 正常值）。TCZ-QW + Pred-26 治疗的 FACIT-Fatigue 评分的 LSM 从基线开始的变化显著增加，达到 MCID 和 A/G 正常值（p < 0.001）。
与仅接受泼尼松治疗的患者相比，接受 TCZ-QW + Pred-26 治疗的 GCA 患者报告 SF-36 和 FACIT-Fatigue 评分有统计学意义和有临床意义的改善。TCZ-QW + Pred-26 组的改善导致 HRQOL 恢复到至少与 A/G 匹配的正常水平相当的水平，并且在 8 个域中的 5 个域中超过了正常值。
ClinicalTrials.gov，NCT01791153。注册日期：2013 年 2 月 13 日。
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