Rheumatology Department, Pitié Salpêtrière hospital, Sorbonne Université - Assistance Publique Hôpitaux de Paris, Paris, France.
Faculty of Medicine, Saint-Joseph University, Beirut, Lebanon.
Rheumatology (Oxford). 2021 Dec 24;61(1):337-344. doi: 10.1093/rheumatology/keab261.
The Flare Assessment in RA (FLARE-RA) self-administered questionnaire aims to identify patients who had flare in the interval between two consultations. This study aimed to establish a threshold for FLARE-RA score to identify RA flare.
The Tocilizumab SubCutAneous study evaluated the efficacy and safety of s.c. tocilizumab (TCZ) to patients with active RA. Disease activity was assessed with the DAS28ESR at baseline and at week 2 (W2), W4, W12 and W24. The FLARE-RA questionnaire was administered at W12 and W24. Patient satisfaction, assessed at baseline and W24 with the Patient Acceptable Symptom State (PASS), was used as a surrogate marker of no flare. A correlation was sought between the FLARE-RA score at W12 and W24 and the area under the receiver operating characteristic (ROC) curve (AUC) for monthly DAS28ESR. The optimal FLARE-RA cut-off below which patient satisfaction reached the PASS was explored with an ROC curve.
A total of 139 patients were included (mean age 57.3 ± 13.8 years, 74.1% women, mean RA duration 10.8 ± 9.2 years, mean DAS28ESR 5.8 ± 1.1). The correlation between the FLARE-RA score and DAS28ESR AUC was moderate at all times: ρ = 0.41 at W12 (P < 0.0001) and 0.51 at W24 (P < 0.0001). The optimal cut-off for the FLARE-RA score to identify absence of flare (i.e. an acceptable situation based on the PASS) was 2.3 with an AUC of 0.81.
FLARE-RA and DAS28ESR assessment differ; we propose a FLARE-RA cut-off of 2.3, below which the situation (i.e. without flare) is acceptable for patients.
RA flares 评估（FLARE-RA）自我管理问卷旨在确定两次就诊之间出现 flares 的患者。本研究旨在确定 FLARE-RA 评分的阈值，以识别 RA flares。
托珠单抗皮下注射研究评估了皮下注射托珠单抗（TCZ）治疗活动性 RA 患者的疗效和安全性。在基线和第 2 周（W2）、第 4 周（W4）、第 12 周（W12）和第 24 周（W24）时使用 DAS28ESR 评估疾病活动度。在 W12 和 W24 时使用 FLARE-RA 问卷进行评估。在 W24 时使用患者可接受的症状状态（PASS）评估患者满意度，作为无 flares 的替代标志物。在 W12 和 W24 时，寻求 FLARE-RA 评分与每月 DAS28ESR 的受试者工作特征（ROC）曲线下面积（AUC）之间的相关性。使用 ROC 曲线探讨 FLARE-RA 评分低于多少时患者满意度达到 PASS。
共纳入 139 例患者（平均年龄 57.3±13.8 岁，74.1%为女性，平均 RA 病程 10.8±9.2 年，平均 DAS28ESR 5.8±1.1）。在所有时间点，FLARE-RA 评分与 DAS28ESR AUC 之间的相关性均为中度：在 W12 时为 ρ=0.41（P<0.0001），在 W24 时为 ρ=0.51（P<0.0001）。确定无 flares （即基于 PASS 可接受的情况）的 FLARE-RA 评分最佳截断值为 2.3，其 AUC 为 0.81。
FLARE-RA 和 DAS28ESR 评估不同；我们建议 FLARE-RA 截断值为 2.3，低于该值时患者情况（即无 flares）可接受。
