Pappas Dimitrios A, John Ani, Curtis Jeffrey R, Reed George W, Karki Chitra, Magner Robert, Kremer Joel M, Shewade Ashwini, Greenberg Jeffrey D
Columbia University, New York, NY, USA.
Genentech, Inc, South San Francisco, CA, USA.
Rheumatol Ther. 2016 Jun;3(1):103-115. doi: 10.1007/s40744-016-0028-0. Epub 2016 Feb 8.
In the United States, the recommended starting dose of intravenous tocilizumab (TCZ) is 4 mg/kg every 4 weeks, with an increase to 8 mg/kg based on clinical response for patients with moderate to severe rheumatoid arthritis; however, data on how TCZ dose is escalated in real life are missing. The objective of this analysis was to describe patterns of early intravenous TCZ dose escalation in a real-world setting using data from the Corrona registry.
All patients enrolled in the comparative effectiveness substudy (CERTAIN) nested within Corrona who initiated TCZ and completed 3- and 6-month study visits were eligible for inclusion. Patients who initiated TCZ 4 mg/kg were categorized into 1 of 2 groups: those who remained on TCZ 4 mg/kg at 3 months (Group 1) and those who escalated to TCZ 8 mg/kg by or at 3 months (Group 2). Changes in clinical disease activity measures were provided.
Of the 213 patients who were eligible for analysis, 86 (40.4%) remained on their initial dose of TCZ 4 mg/kg (Group 1) and 110 (51.6%) were escalated to TCZ 8 mg/kg by or at 3 months (Group 2). Baseline demographic and clinical characteristics were similar between the 2 groups; except in Group 2, patients were older (58.3 vs. 54.0 years) and a lower proportion was female (75.5% vs. 89.4%) than in Group 1. Significant improvements in disease activity measures were observed at 3 and 6 months in both groups, with the majority of patients in both groups achieving moderate or good European League Against Rheumatism response.
Real-world data demonstrated that physicians escalate TCZ dose at varying frequencies. The ability to administer TCZ in varying doses allows physicians to tailor TCZ therapy to disease activity.
ClinicalTrials.gov identifier, NCT01625650.
在美国,静脉注射托珠单抗(TCZ)的推荐起始剂量为每4周4mg/kg,对于中重度类风湿性关节炎患者,根据临床反应可增加至8mg/kg;然而,关于在现实生活中如何增加TCZ剂量的数据尚缺。本分析的目的是利用Corrona注册中心的数据,描述在现实环境中早期静脉注射TCZ剂量增加的模式。
纳入Corrona中比较疗效子研究(CERTAIN)的所有患者,这些患者开始使用TCZ并完成了3个月和6个月的研究访视。开始使用4mg/kg TCZ的患者被分为两组之一:3个月时仍使用4mg/kg TCZ的患者(第1组)和在3个月时或之前增加至8mg/kg TCZ的患者(第2组)。提供了临床疾病活动指标的变化情况。
在213例符合分析条件的患者中,86例(40.4%)仍使用初始剂量4mg/kg的TCZ(第1组),110例(51.6%)在3个月时或之前增加至8mg/kg TCZ(第2组)。两组的基线人口统计学和临床特征相似;除第2组外,患者年龄较大(58.3岁对54.0岁),女性比例低于第1组(75.5%对89.4%)。两组在3个月和6个月时疾病活动指标均有显著改善,两组中的大多数患者达到了欧洲抗风湿病联盟的中度或良好反应。
现实世界数据表明,医生增加TCZ剂量的频率各不相同。能够使用不同剂量的TCZ使医生能够根据疾病活动调整TCZ治疗方案。
ClinicalTrials.gov标识符,NCT01625650。