University of Alabama at, Birmingham.
Arthritis Care Res (Hoboken). 2013 Oct;65(10):1707-12. doi: 10.1002/acr.22048.
Treat-to-target (T2T) recommendations suggest that rheumatoid arthritis (RA) patients should strive for remission or low disease activity (LDA). However, it is unclear whether patients experiencing a good response to biologic agents might experience further improvement in patient-reported outcomes (PROs) if they subsequently achieve a lower disease activity state, particularly the T2T goals of LDA or remission.
Using the Consortium of Rheumatology Researchers of North America database, we identified RA patients initiating biologic agents. We restricted the analysis to patients with improvement (Clinical Disease Activity Index [CDAI] improvement of ≥10 units) at 3-6 months (baseline visit; n = 1,368) with a followup visit approximately 9 months later (n = 984). Patients in CDAI remission or with a worsened disease activity category were excluded, leaving 562 eligible patients. PROs (global assessment, pain, and fatigue by 0-10 visual analog scales and disability by the modified Health Assessment Questionnaire [M-HAQ]) were examined at these 2 visits. Mean change in PROs compared achievement of a lower disease activity category versus staying in the same disease activity category, adjusting for potential confounders.
Patients who achieved a lower disease activity category (40% of the eligible cohort, 86% of these achieving LDA or remission) had significantly better improvement in patient pain (-14.9; 95% confidence interval [95% CI] -18.4, -11.6), patient global (-17.5; 95% CI -20.8, -14.3), fatigue (-8.5; 95% CI -15.8, -1.3), and M-HAQ score (-0.13; 95% CI -0.18, -0.08) compared to patients who stayed in the same disease activity category. However, even for patients improving, fewer than half exceeded the minimum clinically important difference for each PRO.
Achievement of a lower disease activity disease state, especially T2T goals, was associated with further improvement in PROs, albeit modest in magnitude.
达标治疗(T2T)建议表明类风湿关节炎(RA)患者应努力达到缓解或低疾病活动度(LDA)。然而,目前尚不清楚如果接受生物制剂治疗的患者随后达到较低的疾病活动状态,特别是达到 T2T 的 LDA 或缓解目标,他们的患者报告结局(PROs)是否会进一步改善。
利用北美风湿病研究联合会数据库,我们确定了开始使用生物制剂的 RA 患者。我们将分析限制在在 3-6 个月(基线访视;n=1368)时改善(临床疾病活动指数[CDAI]改善≥10 单位)的患者中,随后在大约 9 个月后(n=984)进行随访。排除 CDAI 缓解或疾病活动度类别恶化的患者,留下 562 名符合条件的患者。在这两次访视时检查 PROs(0-10 视觉模拟量表的总体评估、疼痛和疲劳以及改良健康评估问卷[M-HAQ]的残疾)。比较达到较低疾病活动类别与保持相同疾病活动类别的 PRO 变化,调整潜在混杂因素。
达到较低疾病活动度类别的患者(符合条件患者队列的 40%,这些患者中有 86%达到 LDA 或缓解)在患者疼痛(-14.9;95%置信区间[95%CI] -18.4,-11.6)、患者总体(-17.5;95%CI -20.8,-14.3)、疲劳(-8.5;95%CI -15.8,-1.3)和 M-HAQ 评分(-0.13;95%CI -0.18,-0.08)方面的改善明显优于保持相同疾病活动度类别的患者。然而,即使对改善的患者而言,也只有不到一半的患者超过了每个 PRO 的最小临床重要差异。
达到较低的疾病活动状态,尤其是达到 T2T 目标,与 PRO 的进一步改善相关,尽管幅度不大。