Trial of Tocilizumab in Giant-Cell Arteritis
Trial of Tocilizumab in Giant-Cell Arteritis
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DOI：
10.1056/nejmoa1613849
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发表时间：
2017-07-27
影响因子：
158.5
通讯作者：
Collinson, N.
中科院分区：
文献类型：
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作者：
Stone, J. H.;Tuckwell, K.;Collinson, N.
背景当糖皮质激素逐渐减少时，巨细胞动脉炎通常会复发，长期使用糖皮质激素与副作用有关。在这项为期一年的试验中，我们随机将251名患者按2：1：1：1的比例随机分配给251名患者，每周或每隔一周皮下注射妥西珠单抗(剂量162 mg)，联合26周强的松治疗，或安慰剂联合强的松治疗26周或52周。主要结果是，与接受26周强的松减量治疗的安慰剂组相比，每组在52周时的持续非糖皮质激素缓解率。关键的次要结果是每个tocilizumab组与接受52周强的松减量治疗的安慰剂组相比的缓解率。结果每周服用tocilizumab和隔周服用tocilizumab的患者52周持续缓解率分别为56%和53%，而26周强的松组和52周强的松组的持续缓解率分别为14%和18%(P
BACKGROUNDGiant-cell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is associated with side effects. The effect of the interleukin-6 receptor alpha inhibitor tocilizumab on the rates of relapse during glucocorticoid tapering was studied in patients with giant-cell arteritis.METHODSIn this 1-year trial, we randomly assigned 251 patients, in a 2: 1: 1: 1 ratio, to receive subcutaneous tocilizumab (at a dose of 162 mg) weekly or every other week, combined with a 26-week prednisone taper, or placebo combined with a prednisone taper over a period of either 26 weeks or 52 weeks. The primary outcome was the rate of sustained glucocorticoid-free remission at week 52 in each tocilizumab group as compared with the rate in the placebo group that underwent the 26-week prednisone taper. The key secondary outcome was the rate of remission in each tocilizumab group as compared with the placebo group that underwent the 52-week prednisone taper. Dosing of prednisone and safety were also assessed.RESULTSSustained remission at week 52 occurred in 56% of the patients treated with tocilizumab weekly and in 53% of those treated with tocilizumab every other week, as compared with 14% of those in the placebo group that underwent the 26-week prednisone taper and 18% of those in the placebo group that underwent the 52-week prednisone taper (P