Glucocorticoid Dosages and Acute-Phase Reactant Levels at Giant Cell Arteritis Flare in a Randomized Trial of Tocilizumab
Glucocorticoid Dosages and Acute-Phase Reactant Levels at Giant Cell Arteritis Flare in a Randomized Trial of Tocilizumab
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DOI：
10.1002/art.40876
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发表时间：
2019-07-03
影响因子：
13.3
通讯作者：
Collinson, Neil
中科院分区：
文献类型：
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作者：
Stone, John H.;Tuckwell, Katie;Collinson, Neil
目的评价巨细胞动脉炎（GCA）患者糖皮质激素剂量和血清学表现。方法GCA患者被随机分配接受双盲给药：tocilizumab (TCZ) 162 mg /周加26周泼尼松逐渐减少（TCZ- qw + Pred-26）， TCZ加26周泼尼松逐渐减少（TCZ- q2w + Pred-26），安慰剂加26周泼尼松逐渐减少（PBO + Pred-26），或安慰剂加52周泼尼松逐渐减少（PBO + Pred-52）。结果测量强的松剂量、c反应蛋白（CRP）水平和耀斑时的红细胞沉降率（ESR）。结果TCZ-QW + Pred-26组100例，TCZ-Q2W + Pred-26组49例，PBO + Pred-26组50例，PBO + Pred-52组51例。在149例接受tcz治疗的患者中，36例（24%）出现急性发作，其中23例（64%）仍在接受强的松治疗（中位剂量2.0 mg/天）。在101例PBO +预治疗患者中，59例（58%）出现耀斑，其中45例（76%）接受强的松治疗（中位剂量5.0 mg/天）。许多耀斑发生在患者服用10毫克/天的强的松时：TCZ组9例（25%），安慰剂组13例（22%）。tcz治疗组33例（92%）和PBO +预处理组20例（34%）发生CRP水平正常的耀斑。超过一半的PBO +预处理患者CRP水平升高而无耀斑。在缓解诱导方面，TCZ和强的松联合使用比单独使用强的松的益处在8周时是明显的。结论大部分GCA发作发生在强的松治疗期间。急性期反应物水平并不是TCZ联合强的松治疗或单独强的松治疗患者急性发作的可靠指标。强的松中加入TCZ有助于早期控制GCA。
Objective This study was undertaken to evaluate glucocorticoid dosages and serologic findings in patients with giant cell arteritis (GCA) flares. Methods Patients with GCA were randomly assigned to receive double-blind dosing with either subcutaneous tocilizumab (TCZ) 162 mg weekly plus 26-week prednisone taper (TCZ-QW + Pred-26), every-other-week TCZ plus 26-week prednisone taper (TCZ-Q2W + Pred-26), placebo plus 26-week prednisone taper (PBO + Pred-26), or placebo plus 52-week prednisone taper (PBO + Pred-52). Outcome measures were prednisone dosage, C-reactive protein (CRP) level, and erythrocyte sedimentation rate (ESR) at the time of flare. Results One hundred patients received TCZ-QW + Pred-26, 49 received TCZ-Q2W + Pred-26, 50 received PBO + Pred-26, and 51 received PBO + Pred-52. Of the 149 TCZ-treated patients, 36 (24%) experienced flare, 23 (64%) of whom were still receiving prednisone (median dosage 2.0 mg/day). Among 101 PBO + Pred-treated patients, 59 (58%) experienced flare, 45 (76%) of whom were receiving prednisone (median dosage 5.0 mg/day). Many flares occurred while patients were taking >10 mg/day prednisone: 9 (25%) in the TCZ groups and 13 (22%) in the placebo groups. Thirty-three flares (92%) in TCZ-treated groups and 20 (34%) in PBO + Pred-treated groups occurred with normal CRP levels. More than half of the PBO + Pred-treated patients had elevated CRP levels without flares. Benefits of the TCZ and prednisone combination over prednisone alone for remission induction were apparent by 8 weeks. Conclusion Most GCA flares occurred while patients were still receiving prednisone. Acute-phase reactant levels were not reliable indicators of flare in patients treated with TCZ plus prednisone or with prednisone alone. The addition of TCZ to prednisone facilitates earlier GCA control.