Department of Veterans Affairs, Dallas VA Medical Center and Rheumatic Diseases Division, University of Texas Southwestern Medical Center, Dallas, TX 75390-8884, USA.
Clin Exp Rheumatol. 2009 Nov-Dec;27(6):926-34.
To define the characteristics of a population of veterans with rheumatoid arthritis (RA) who have stopped or switched their first biologic agent, and to assess if measures of disease activity are predictors in the decision to alter the regimen.
A retrospective analysis of the VA electronic medical record system identified RA patient demographic and disease activity parameters from 1999 to 2007. Demographic data included age, race/ethnicity, sex, and tobacco use. Disease-specific data included date of RA onset, past DMARD therapies, prednisone use, as well as the disease activity score (DAS-28) and the health assessment questionnaire (HAQ) at each clinic visit. The use of six biologicals (infliximab, etanercept, adalimumab, abatacept, rituximab, anakinra) was identified in order to compare those who continued with the medication to those discontinuing or switching to another biological. Descriptive and parametric statistics were applied to define differences between the two groups.
Of 454 RA patients identified, 212 have been on a biologic agent at one point in time, and 100 patients (47%) had either stopped or switched their first biologic agent. Among these 100 patients, the most common reasons for stopping or switching a biologic agent were adverse events (in 48%) and inefficacy (43%) Adverse events included malignancies (23% of 48 patients), rash (23%), infections (18.8%), and cardiac complications (18.8%). When comparing the 100 patients versus the 112 that did not stop or switch their first agent, the DAS-28 correlated significantly with a change of regimen with an OR 2.1 (p<0.001). The HAQ score had an OR of 2.0 (p<0.04).
RA patients who continue taking their initial biologic medication have similar age, RA disease duration, ethnicity, and smoking status to those requiring switching or discontinuation. The DAS28 and HAQ scores significantly correlated with stopping or switching of a first biologic agent. Adverse event rates were high and their distributions differed in this population compared to previous studies of younger Caucasian females.
定义停止或更换第一代生物制剂的类风湿关节炎(RA)退伍军人人群的特征,并评估疾病活动度的衡量指标是否可预测改变治疗方案的决策。
对 VA 电子病历系统进行回顾性分析,从 1999 年至 2007 年获取 RA 患者的人口统计学和疾病活动参数。人口统计学数据包括年龄、种族/民族、性别和吸烟情况。疾病特异性数据包括 RA 发病日期、过去的 DMARD 治疗、泼尼松使用情况以及每次就诊时的疾病活动评分(DAS-28)和健康评估问卷(HAQ)。确定了六种生物制剂(英夫利昔单抗、依那西普、阿达木单抗、阿巴西普、利妥昔单抗、阿那白滞素)的使用情况,以便将继续使用药物的患者与停止或更换为另一种生物制剂的患者进行比较。应用描述性和参数统计来定义两组之间的差异。
在 454 名 RA 患者中,有 212 名患者曾在某一时间使用过生物制剂,有 100 名患者(47%)已停止或更换其第一代生物制剂。在这 100 名患者中,停止或更换生物制剂的最常见原因是不良事件(48%)和无效(43%)。不良事件包括恶性肿瘤(48 名患者中的 23%)、皮疹(23%)、感染(18.8%)和心脏并发症(18.8%)。将 100 名患者与未停止或更换第一代药物的 112 名患者进行比较时,DAS-28 与治疗方案的改变显著相关,比值比为 2.1(p<0.001)。HAQ 评分的比值比为 2.0(p<0.04)。
继续使用初始生物制剂的 RA 患者与需要更换或停止用药的患者相比,年龄、RA 发病时间、种族和吸烟状况相似。DAS28 和 HAQ 评分与第一代生物制剂的停药或更换显著相关。不良事件发生率较高,且与之前针对年轻白种女性的研究相比,其分布情况不同。