BACKGROUND To assess the presence of a seasonal effect on fatigue, pain and dryness in primary Sjögren's syndrome (pSS). METHODS Data (date; visual analogue scales (VAS) for pain, fatigue and dryness) were extracted from three randomised placebo-controlled trials (RCTs) evaluating infliximab (TRIPSS; n = 103 patients), hydroxychloroquine (JOQUER; n = 120 patients) and rituximab (TEARS; n = 120 patients) and from the 5-year follow-up of the ASSESS prospective cohort (n = 395 patients). Data were analysed at each visit for each patient, according to the day, the month of the year and the season. Linear mixed models were used to take into account the repeated structure of the data and to analyse a potential cyclic effect. RESULTS A total of 744, 584, 848 and 682 pain, fatigue and dryness VASs were collected on 632 subjects in spring, summer, fall and winter, respectively. No significant difference was observed in pain, fatigue and dryness, according to the month of the year or the season (all p values > 0.05). CONCLUSION In pSS, seasonality does not affect patient-reported outcomes (PROs) on fatigue, pain and dryness.

中文翻译：

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对原发性干燥综合征的疲劳，疼痛和干燥的季节性影响。

背景技术为了评估对原发性干燥综合征（pSS）疲劳，疼痛和干燥的季节性影响。方法数据（日期；疼痛，疲劳和干燥的视觉模拟量表（VAS））从评估英夫利昔单抗（TRIPSS； n = 103例患者），羟氯喹（JOQUER； n = 120例患者）的三个随机安慰剂对照试验（RCT）中提取。和利妥昔单抗（TEARS； n = 120例患者）以及ASSESS前瞻性队列的5年随访（n = 395例患者）。根据日期，一年中的月份和季节，对每位患者的每次就诊数据进行了分析。线性混合模型用于考虑数据的重复结构并分析潜在的循环效应。结果在春季，夏季，春季，春季，春季，春季，春季，春季，春季，春季，春季，春季，春季，春季，春季，春季和春季的632例受试者中共收集了744、584、848和682个疼痛，疲劳和干燥VAS 秋天和冬天分别。根据一年中的月份或季节，疼痛，疲劳和干燥无明显差异（所有p值均> 0.05）。结论在pSS中，季节性不影响患者报告的疲劳，疼痛和干燥症状。