Objectives 1) to explore patient-reported symptoms in a large series of patients with primary Sjögren's syndrome using the recently-proposed ESSPRI questionnaire and to assess the relationship between the ESSPRI and patient demographics and disease characteristics (duration, activity, organ damage) 2) to evaluate the impact of patient-reported symptoms on oral and ocular health-related quality of life (HRQoL)
Methods This multicenter cross-sectional involved five Italian reference centers with substantial experience in the management of pSS. Between July 2014 and November 2014, 360 pSS patients (AECG criteria) seen consecutively, were enrolled. A standardized data set including demographic, clinical and serological disease manifestations was collected prospectively. The ESSDAI and the SSDDI were used to assess disease activity and organ damage, respectively. All patients completed the ESSPRI questionnaire. Oral HRQoL was evaluated using the Oral Health Impact Profile (OHIP-14), whereas ocular HRQoL was assed using the Ocular Surface Disease Index (OSDI). Contingency table, Chi square test, t-test, Mann-Whitney test and Spearman's rank correlation coefficient were employed for statistical analysis.
Results 360 pSS patients (346 F:14 M) were included; mean age (S.D.) at diagnosis was 51 (14) yrs, mean age (S.D.) at study inclusion was 58 (15) yrs, mean disease duration (S.D.) was 6 (7) yrs. Out of 360 patients, 270 (75%) presented a low disease activity (ESSDAI<5), 85 (23.6%) a moderate activity (5≤ESSDAI≤13) and 5 (1.4%) a high disease activity (ESSDAI≥14). A SSDDI≥2 was detected in 40.2% of the patients. The mean (S.D.) ESSPRI was 6.4 (2.3). Female patients and patients with a concomitant fibromyalgia presented significantly higher ESSPRI scores (total and single items).The ESSPRI correlated with age both at diagnosis and at study inclusion, with the disease duration and with the SSDDI, particularly the oral dryness measured by the corresponding ESSPRI item. No correlation was detected between the ESSPRI and the disease activity (ESSDAI) or the ESSPRI and patients' immunological profile. A moderate correlation was observed between the ESSPRI, the OHIP and the OSDI, and between these two indexes and the oral and ocular damage, respectively.
Conclusions We documented a significant correlation between the ESSPRI, patient demographics, disease duration and organ damage, but not with the disease activity and immunological pSS features. ESSPRI index demonstrated to be useful in assessing HRQoL associated with oral and ocular dryness in patients with pSS; however, a comorbid fibromyalgia may have an added effect on patient-reported outcomes and quality of life and should be taken into account in clinical practice.
Disclosure of Interest None declared
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