Methods: Surveys were mailed to 8,694 US patients who are members of the Sjögren’s Syndrome Foundation. Half the SS patients were asked to give a similar survey to a friend without a diagnosis of SS and of the same gender and age to create a demographically similar control group. Survey items included the Profile of Fatigue and Discomfort-Sicca Symptoms Inventory (PROFAD-SSI), Short Form 36 (SF-36) Quality of Life Scale, Center for Epidemiologic Studies Depression (CESD) Scale, FACIT-Fatigue, Thinking Scale, and the Brief Pain Inventory (BPI). Patients were classified as primary or secondary SS (pSS, sSS) based on their self-reported positive lip gland biopsy and/or anti-SS-A/SS-B antibody results and concurrent diagnosis of other rheumatic conditions (e.g., Rheumatoid Arthritis, Systemic Lupus Erythematosus, Myositis, or Scleroderma). We compared pSS, sSS and controls on all scales using ANOVAs and t-tests.
Results: Data in this abstract are based on 1,225 pSS, 1,278 sSS patients and 606 controls. The median age of respondents was 62 years (pSS = 61 yrs; sSS = 63 yrs; control = 61 yrs), and over 90% in each group were women. As shown in Table 1, all SS patients reported significantly poorer health and functioning in all domains of the SF-36, greater fatigue and dryness on the PROFAD-SSI and FACIT-F scales, and higher scores on the pain, depression, and impaired thinking scales than controls (all p’s <0.05). These levels of fatigue, disability, and functioning are comparable to those previously measured in European SS patients. All instruments were correlated with one another, suggesting a complex underlying relationship between the symptoms and outcomes of SS (r’s between 0.17 - 0.90, p’s < 0.05). Validation of these data in a physician-derived cohort of patients diagnosed with SS according to the American-European criteria is in progress.
Conclusions: This is the first large study to show that SS patients in the US experience significant disability and burden of illness. The comparison to the controls suggests that these experiences are disease related and not merely attributable to the natural processes of aging. Comparison to previously reported European studies indicates the consistency of experiences across SS populations.
S.J. Bowman, Genentech <10,000, 5; B.M. Segal, Lupus Foundation of America 10,000 to 100,000;, 2; Arthritis Foundation Minnesota Chapter: 10,000 to 100,000, 2; Degge Group, Limited in support of their Genetech contracted epidemiology study<10,000, 5; P.C. Fox, HGSI (<10,000), 1; BMY (<10,000), 1; Genentech, 5; GlaxoSmithKline, 5; Sjögren's Syndrome Foundation, immediate past Chair, Board of Directors, 6; Oral Medicine Foundation, 6; F.B. Vivino, Daiichi-Sankyo <10,000, 5; Genentech, Inc <10,000, 5; Daiichi-Sankyo<10,000, 8; N. Murukutla, None; T.V. Kamath, Full Time Employee of Genentech, 1; Full time employee at Genentech, 3; M. Yin, Full, 3; YES, 1; L. McLean, For this abstract only GNE holdings are pertinent, 1; Genentech, 3; Genentech, 4.