Long-term changes in Sjögren's disease: a 9-year prospective follow-up study from the SJOGRENSER Registry.

The objective of SjögrenSER Prospective (SjD-PROS) was to evaluate the improvement, stability or progression of SjD in clinical practice. SjD-PROS is an observational, longitudinal, multicenter study of SjD in Spain. Participants from the prior transversal phase were invited to a follow-up visit after 9.5 years. Data were collected via interviews and medical records. Variables were analyzed using means, medians and frequencies. Statistical associations were assessed using T student test, Kruskal-Wallis and the Chi-square test. We included 314 patients, 95% women (mean age of 66 years; mean disease duration of 17 years). At follow-up visit, the most frequent systemic manifestations were arthralgias (54%) and hematological involvement (49%), with arthralgias being significantly less frequent than at baseline visit (p < 0.001); the most affected organs were the lung (15.6%) and the kidney (11.5%). Half of the patients in SjD-PROS, had positive rheumatoid factor, 16% less than at baseline visit; β2-microglobulin was significantly elevated compared to baseline visit (62.5%, p < 0.001). Articular, pulmonary, hematological and biological domains of ESSDAI index showed the greatest changes, both in improvement and worsening, and the greatest activity. Systemic treatments use was significantly higher in patients showing activity in ESSDAI. This study offers valuable insights into the most variable clinical and serological manifestations throughout the course of SjD. ESSDAI domains showing the greatest changes reflected the greatest treatments needs. These findings allow for patient stratification based on phenotype, a crucial step in designing follow-up protocols.