Université Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, INSERM U1012, Le Kremlin Bicêtre, France.
Arthritis Care Res (Hoboken). 2013 Aug;65(8):1358-64. doi: 10.1002/acr.21991.
The European League Against Rheumatism (EULAR) Sjögren's Syndrome (SS) Disease Activity Index (ESSDAI) and the EULAR SS Patient-Reported Index (ESSPRI) were recently developed. We aimed to determine whether patients' symptoms differed between patients with and without systemic involvement and if the disease-specific indices correlated with each other in primary SS.
Fifteen French centers included 395 primary SS patients in the Assessment of Systemic Signs and Evolution in Sjögren's Syndrome Cohort. At enrollment, physicians completed the ESSDAI, the SS Disease Activity Index (SSDAI), and the Sjögren's Systemic Clinical Activity Index (SCAI), and patients completed the ESSPRI, the Sicca Symptoms Inventory, and the Profile of Fatigue and Discomfort. All scores were compared between patients with and without systemic involvement. Correlations between scores of systemic activity and patients' symptoms were obtained.
At enrollment, 120 (30.4%) patients had never experienced systemic complication and 155 (39.2%) patients and 120 (30.4%) patients had, respectively, only past or current systemic manifestations. Past or current systemic patients had higher levels of symptoms, except dryness. The ESSDAI did not correlate with the patient-scored ESSPRI (rho = 0.06, P = 0.30), whereas the SSDAI and the SCAI, which include subjective items, did correlate (rho = 0.28 and 0.25, respectively; P < 0.0001 for both).
Alterations of common patient-reported outcomes are present in all patients with primary SS, including those with systemic complications. However, patient symptoms and systemic complications are 2 different facets of primary SS. Therefore, the use of both systemic and patients' indices, such as the ESSDAI and ESSPRI, are useful. Since these 2 facets weakly overlap, one should identify which of both components is the main target of the treatment to test, when designing clinical trials in primary SS.
欧洲抗风湿病联盟（EULAR）干燥综合征（SS）疾病活动指数（ESSDAI）和 EULAR SS 患者报告指数（ESSPRI）最近已经开发出来。我们旨在确定原发性 SS 患者中，有系统性受累和无系统性受累患者的症状是否存在差异，以及疾病特异性指数之间是否相互关联。
15 个法国中心纳入了评估干燥综合征队列中的 395 例原发性 SS 患者。在入组时，医生完成了 ESSDAI、SS 疾病活动指数（SSDAI）和干燥综合征系统临床活动指数（SCAI），患者完成了 ESSPRI、干燥症状量表和疲劳与不适量表。比较了有和无系统性受累患者的所有评分。获得了系统活动评分与患者症状之间的相关性。
入组时，120 例（30.4%）患者从未经历过系统性并发症，155 例（39.2%）和 120 例（30.4%）患者分别仅有过去或当前的系统性表现。过去或当前有系统性表现的患者症状水平更高，除了干燥感。ESSDAI 与患者评分的 ESSPRI 不相关（rho=0.06，P=0.30），而包括主观项目的 SSDAI 和 SCAI 相关（rho=0.28 和 0.25，均 P<0.0001）。
原发性 SS 患者的常见患者报告结果均发生改变，包括有系统性并发症的患者。然而，患者症状和系统性并发症是原发性 SS 的两个不同方面。因此，使用系统性和患者指数（如 ESSDAI 和 ESSPRI）都是有用的。由于这两个方面的重叠较弱，在原发性 SS 中设计临床试验时，应该确定是治疗的哪个方面是主要目标，以进行检验。
