Department of Rheumatology, Erasmus MC, Rotterdam, the Netherlands.
Department of Rheumatology, Erasmus MC, Rotterdam, the Netherlands; Department of Rheumatology, Maasstad Hospital, Rotterdam, the Netherlands.
Semin Arthritis Rheum. 2020 Jun;50(3):423-431. doi: 10.1016/j.semarthrit.2020.02.011. Epub 2020 Feb 29.
To determine the impact of a disease flare on patient reported outcome measures (PROMs) in rheumatoid arthritis (RA) patients, who are tapering treatment.
Data were used from the TARA trial; a multicenter, randomized controlled trial in which RA patients, with a well-controlled disease (DAS≤2.4 and SJC≤1) for at least 6 months, gradually tapered their DMARDs. PROMs of patients with a flare (DAS>2.4 and/or SJC>1) were compared every three months before and after a flare with their own norm values. Linear Mixed Models were used to investigate whether a disease flare influenced functional ability (HAQ-DI), fatigue (BRAF-MDQ), quality of life (EQ-5D and SF36), anxiety and depression (HADS), morning stiffness, general health (GH) and worker productivity, and if so, the duration was determined. For unemployment and sick leave we used descriptive statistics.
A flare negatively influenced GH, morning stiffness, HAQ-DI, EQ-5D, BRAF-MDQ, and the SF36 physical component scale and this effect lasted >3 months. Except for the HAQ-DI, effect sizes exceeded the minimum clinically important differences (MCIDs). For the physical outcomes effects lasted >6 months. Worker productivity was not significantly affected by a flare.
A disease flare influenced patients' lives, the largest effect was seen in the physical outcomes, and lasted 6 months. Although on a group level effect sizes for the separate PROMs were not always significant or larger than specific MCIDs, a disease flare can still be of great importance for individual patients.
确定疾病活动对正在减少治疗的类风湿关节炎(RA)患者报告的结局测量(PROMs)的影响。
数据来自 TARA 试验;这是一项多中心、随机对照试验,其中 RA 患者的疾病得到了很好的控制(DAS≤2.4 和 SJC≤1)至少 6 个月,逐渐减少 DMARDs 的用量。与自身正常值相比,在疾病活动(DAS>2.4 和/或 SJC>1)前后每三个月比较一次患者的 PROMs。线性混合模型用于研究疾病活动是否影响功能能力(HAQ-DI)、疲劳(BRAF-MDQ)、生活质量(EQ-5D 和 SF36)、焦虑和抑郁(HADS)、晨僵、一般健康(GH)和工作生产力,如果有影响,确定持续时间。对于失业和病假,我们使用描述性统计。
疾病活动负性影响 GH、晨僵、HAQ-DI、EQ-5D、BRAF-MDQ 和 SF36 身体成分量表,这种影响持续时间>3 个月。除了 HAQ-DI,效应大小超过了最小临床重要差异(MCIDs)。对于身体结果,影响持续时间>6 个月。工作生产力不受疾病活动的显著影响。
疾病活动影响患者的生活,最大的影响见于身体结果,持续时间为 6 个月。尽管在群体水平上,单独的 PROMs 的效应大小并不总是显著或大于特定的 MCIDs,但疾病活动对个别患者仍然非常重要。