Larmore Cynthia J, Boytsov Natalie N, Gaich Carol L, Zhang Xiang, Araujo Andre B, Rebello Sabrina, Salim Bob A, Reed George W, Harrold Leslie R
Eli Lilly and Company, Indianapolis, IN, USA.
Corrona, LLC, Southborough, MA, USA.
Rheumatol Ther. 2018 Jun;5(1):215-229. doi: 10.1007/s40744-017-0092-0. Epub 2018 Jan 10.
Implementation of a treat-to-target strategy is challenging when the patient and physician prioritize different goals. This study aimed to "translate" improvements in Clinical Disease Activity Index (CDAI) to concepts that resonate with patients (such as pain, fatigue, morning stiffness) by examining the association between changes in disease activity and patient-reported outcomes (PROs) in a national cohort of patients with rheumatoid arthritis (RA) initiating their first biologic treatment.
Patients in the Corrona registry with moderate or high disease activity (M/HDA) (defined by a CDAI score > 10), prior use of at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD), 12-month follow-up, and initiating their first tumor necrosis factor inhibitor (TNFi) between 1 January 2006 through 1 November 2015 were identified. Patients were stratified on the basis of CDAI during follow-up, and changes in PROs were compared with a test of trend using CDAI-defined groups.
Of 1570 patients, 37% achieved sustained remission or low disease activity (remission/LDA), 15% had improving remission/LDA, 12% had worsening M/HDA, and 35% were in sustained M/HDA during 12-month follow-up. Those in sustained remission/LDA had greater magnitude of improvement in physical functioning, pain, fatigue, morning stiffness, patient's global assessment, and quality of life compared with patients in sustained M/HDA (p < 0.001).
Reduction in disease activity was associated with improvements in PROs, with the greatest improvements seen in those who achieved sustained remission/LDA. These results reinforce the benefits of a treat-to-target approach to RA care and may improve dialogue between patients and providers, support shared decision-making, and reduce "clinical inertia."
Corrona, LLC.
当患者和医生优先考虑不同目标时,实施达标治疗策略具有挑战性。本研究旨在通过检查全国性类风湿关节炎(RA)患者队列中疾病活动度变化与患者报告结局(PROs)之间的关联,将临床疾病活动指数(CDAI)的改善“转化”为与患者相关的概念(如疼痛、疲劳、晨僵),这些患者开始接受首次生物治疗。
在Corrona注册中心确定2006年1月1日至2015年11月1日期间疾病活动度为中度或高度(M/HDA)(由CDAI评分>10定义)、既往至少使用过一种传统合成抗风湿药物(csDMARD)、随访12个月且开始接受首次肿瘤坏死因子抑制剂(TNFi)治疗的患者。根据随访期间的CDAI对患者进行分层,并使用CDAI定义的组通过趋势检验比较PROs的变化。
在1570例患者中,37%达到持续缓解或低疾病活动度(缓解/LDA),15%的缓解/LDA有所改善,12%的M/HDA恶化,35%在12个月随访期间处于持续M/HDA状态。与持续M/HDA的患者相比,持续缓解/LDA的患者在身体功能、疼痛、疲劳、晨僵、患者整体评估和生活质量方面的改善幅度更大(p<0.001)。
疾病活动度降低与PROs改善相关,在达到持续缓解/LDA的患者中改善最为明显。这些结果强化了RA达标治疗方法的益处,并可能改善患者与医疗服务提供者之间的沟通,支持共同决策,并减少“临床惰性”。
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