The study aims to compare dry eye disease (DED) prevalence and severity between seropositive and seronegative Sjögren disease (SjD). Prospective, consecutive, comparative cross-sectional cohort study. A total of 160 eyes of 80 patients with SjD by The American College of Rheumatology and the European League Against Rheumatism 2016 criteria were included: 55 seropositive and 25 seronegative SjD. Associated SjD was excluded. Patients had dry eye tests performed. Generalized estimating equations were used to account for intereye correlation of the same participant. Mean age was 52.2 ± 12.7, 96.3% were women, no differences were observed between groups (P > 0.05). Seronegative SjD had positive minor salivary gland biopsy more often (100% vs. 82%, P = 0.024), but with lower focus score (2.0 ± 1.2 vs. 4.1 ± 3.5, P = 0.006) than seropositive SjD group. DED prevalence was similar in seropositive and seronegative SjD (92.7% and 84%; P = 0.088). Only noninvasive break-up time (NIBUT) average was significantly reduced in seropositive SjD (6.6 ± 3.2 vs. 8.8 ± 2.4, P = 0.011), and the rest of the evaluated DED tests were not significant. In the seropositive group, nonstatistically significant trends toward more severe DED signs, including matrix metalloproteinase-9, osmolarity, Schirmer I without anesthesia, fluorescein tear break-up time, NIBUT first, and Sicca Ocular Staining Score, were observed. Both groups were highly symptomatic in ocular surface disease index score (43 ± 23 vs. 46 ± 30, P = 0.779) and had a reduction in quality of life in National Eye Institute visual health questionnaire-25 test (72 ± 21 vs. 70 ± 24, P = 0.650). Patients with seropositive SjD showed significantly reduced NIBUT and a trend of more severe DED signs. Patients with seronegative and seropositive SjD were similarly highly symptomatic, experienced important reductions in vision-related quality of life, and had similar DED prevalence.
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