• essdai
• esspri
• fibromyalgia
• patient reported outcome
• Sjogren's syndrome

Definition: Primary Sjogren's disease (pSS) is a systemic inflammatory autoimmune disease with multifactorial etiology, generally affecting middle-aged women and is characterized by systemic constitutional symptoms, by a characteristic commitment at the glandular level, with xerostomia and xerophthalmia, and by a systemic extraglandular commitment that can affect any organ, causing a significant deterioration in the quality of life and work activity. According to the literature, among patients with pSS, as in other rheumatological diseases, there is a significantly high prevalence of fibromyalgia (FM) and in some cases significant phenotypic differences have been demonstrated between patients with FM and without FM.
Objective: This study aims to measure the prevalence of FM in consecutive patients with pSS. The aim is also to make a comparison in the pSS phenotype between patients with pSS and those with pSS/FM from a clinical, laboratory and therapeutic point of view with the help of PRO (Patient Reported Outcome).
Materials: a sample population of 331 patients diagnosed with pSS using ACR 2016 criteria was included in the study, excluding patients who had not yet received the diagnosis at the time of the visit. In order to compare the characteristics of patients with pSS and pSS/FM, different PRO questionnaires were used including HADS-A/D, FACIT and different VAS/NRS scales. The ESSDAI was also calculated, which together with imaging and laboratory tests was used to evaluate the systemic involvement of the disease, and the ESSPRI to evaluate the intensity of the symptoms.
Results: From the population under examination it emerged that the prevalence of fibromyalgia, diagnosed with the ACR 2016 criteria, is 127 patients out of 331 (38.4%). Patients with pSS/FM have a higher ESSPRI (p < 0.001) and lower ESSDAI (p < 0.05) compared to patients with pSS alone. In patients with pSS/FM, higher symptoms were observed with FACIT and VAS/NR (p < 0.001), a lower use of hydroxychloroquine (p < 0.05), a lower systemic burden, in particular a lower prevalence of thrombocytopenia, preserved urinary density and b2-microglobulin in range, a higher platelet count and less immune activation with a greater prevalence of normal C3 levels, lower levels of SSB antibodies, rheumatoid factor (RF) and IgA (p < 0.05). Furthermore, anxiety and depression were found more frequently in the same cohort (p < 0.001).
Conclusions: in pSS patients with FM compared to pSS without FM there is less systemic involvement of the disease, less autoimmune activation but more relevant symptoms with greater pain, dryness, anxiety and depression