Real-World Assessment of Systemic Disease Activity in Seropositive and Seronegative Patients with Sjögren's Disease...

Sjögren's disease (SjD) is often characterized by the presence of anti-SSA/Ro and anti-SSB/La autoantibodies. The Clinical European Alliance of Associations for Rheumatology (EULAR) Sjögren's Syndrome Disease Activity Index (ClinESSDAI) and Patient-Reported Index (ESSPRI) assess disease activity and patient-reported symptomatology; however, their association with patient-reported outcome measures (PROMs) remains unclear. We aimed to describe systemic disease activity in seropositive and seronegative SjD patients and evaluate the association between proxy ClinESSDAI and ESSPRI scores with PROMs.

Data were drawn from the Adelphi Real World SjD Disease Specific Programme™, a cross-sectional survey conducted in France, Germany, Italy, Spain and the United States between June and October 2018. Physicians reported patient demographics and clinical characteristics. Patients completed the EQ-5D-3L and Visual Analogue Scale (EQ-VAS), and the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F). Proxy ClinESSDAI and ESSPRI scores were calculated using physician-reported organ activity and averaged patient ratings of dryness, pain, and fatigue, respectively. Associations between ClinESSDAI, ESSPRI, physician-reported disease severity, and PROMs were determined using linear and logistic regression modeling. Statistical significance was p < 0.05 for all tests.

Overall, 319 rheumatologists provided data on 1879 patients with SjD. Mean (standard deviation) patient age was 53.2 (12.2) years, 89% were female, and 89% were White. Of patients who received serum antibody testing for both anti-SSA/Ro and anti-SSB/La antibodies (n = 1344), 69% were double seropositive and 6% were double seronegative. The most common symptoms experienced by double seropositive and double seronegative SjD patients, respectively, included dry eyes (94% and 74%), and physical fatigue (82% and 60%). ClinESSDAI and ESSPRI were significantly associated with EQ-5D-3L, EQ-VAS, and FACIT-F (all p < 0.001).

Systemic disease activity and patient-reported symptomatology were significantly associated with health-related quality of life measures, highlighting the need for disease management that considers both clinical outcomes and the patient experience.