Department of Rheumatology, Université Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, Le Kremlin Bicêtre, France.
Faculty of Medicine, Assistance Publique-Hopitaux de Paris, Hôtel Dieu Hospital, Centre of Clinical Epidemiology, University of Paris Descartes, Paris, France.
Ann Rheum Dis. 2014 Dec;73(12):2074-81. doi: 10.1136/annrheumdis-2013-203586. Epub 2013 Jul 29.
To evaluate the effect of adding a 10-week treatment of adalimumab to a standardised treatment with corticosteroids on the ability to taper more rapidly corticosteroid doses in patients with newly diagnosed giant cell arteritis (GCA).
Patients included in this double-blind, multicentre controlled trial were randomly assigned to receive a 10-week subcutaneous treatment of adalimumab 40 mg every other week or placebo in addition to a standard prednisone regimen (starting dose 0.7 mg/kg per day). The primary endpoint was the percentage of patients in remission on less than 0.1 mg/kg of prednisone at week 26. Analysis was performed by intention to treat (ITT).
Among the 70 patients enrolled (adalimumab, n=34; placebo, n=36), 10 patients did not receive the scheduled treatment, seven in the adalimumab and three in the placebo group. By ITT, the number of patients achieving the primary endpoint was 20 (58.9%) and 18 (50.0%) in the adalimumab and placebo arm, respectively (p=0.46). The decrease in prednisone dose and the proportion of patients who were relapse free did not differ between the two groups. Serious adverse events occurred in five (14.7%) patients on adalimumab and 17 (47.2%) on placebo, including serious infections in three patients on adalimumab and five on placebo. Two patients died in the placebo arm (septic shock and cancer) and one in the adalimumab group (pneumonia).
In patients with newly diagnosed GCA, adding a 10-week treatment of adalimumab to prednisone did not increase the number of patients in remission on less than 0.1 mg/kg of corticosteroids at 6 months.
NCT00305539.
评估在标准皮质类固醇治疗基础上加用阿达木单抗 10 周治疗对新诊断的巨细胞动脉炎（GCA）患者更快减少皮质类固醇剂量的能力。
这项双盲、多中心对照试验纳入的患者被随机分配，接受阿达木单抗（每两周皮下注射 40mg）或安慰剂治疗 10 周，同时接受标准泼尼松方案（起始剂量为 0.7mg/kg/天）。主要终点是在第 26 周时泼尼松剂量小于 0.1mg/kg 的患者比例。分析采用意向治疗（ITT）。
在纳入的 70 例患者中（阿达木单抗组 34 例，安慰剂组 36 例），有 10 例患者未接受计划治疗，阿达木单抗组 7 例，安慰剂组 3 例。按 ITT 分析，阿达木单抗组和安慰剂组达到主要终点的患者分别为 20 例（58.9%）和 18 例（50.0%）（p=0.46）。两组患者的泼尼松剂量减少和无复发患者比例无差异。阿达木单抗组有 5 例（14.7%）患者和安慰剂组有 17 例（47.2%）患者发生严重不良事件，包括阿达木单抗组 3 例和安慰剂组 5 例严重感染。安慰剂组有 2 例患者死亡（感染性休克和癌症），阿达木单抗组有 1 例患者死亡（肺炎）。
在新诊断的 GCA 患者中，在泼尼松治疗基础上加用 10 周阿达木单抗治疗不能增加在 6 个月时泼尼松剂量小于 0.1mg/kg 的缓解患者比例。
NCT00305539。
