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Background: The EULAR Sjögren’s syndrome disease activity index (ESSDAI) is considered the gold standard for measuring Sjögren’s syndrome disease activity in clinical trials, but there is limited evidence of its application in the real-world.
Objectives: To describe the distribution of ESSDAI scores in the real-world and it’s association with patient outcomes.
Methods: Data were drawn from the Adelphi Primary Sjögren’s syndrome (pSS) Disease Specific Programme™, a real-world point-in-time survey of rheumatologists and their consulting pSS patients in the United States. Proxy ESSDAI scores were calculated for each patient by assigning a score to the rheumatologists’ perception of “not present”, “mild”, “moderate” or “severe” for each of the twelve domains of the ESSDAI. ESSDAI scores were then grouped according to the definitions of mild (ESSDAI 0-4), moderate (ESSDAI 5-13) and severe (ESSDAI ≥14). Rheumatologists provided data about patient demographics and clinical characteristics. Patients self-completed patient reported outcome (PRO) tools including the EuroQol 5-dimension 5-level utility score (EQ-5D), Work Productivity and Activity Impairment questionnaire (WPAI) and The Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F). Differences in clinical characteristics and patient-reported outcomes were examined according to ESSDAI severity score. Spearman’s Rho association was used to assess the correlation of ESSDAI severity with PROs.
Results: Rheumatologists (n=84) provided data for 511 pSS patients, mean age 53.3 years, 88.5% female, 79.8% white/Caucasian and mean time since diagnoses 4.6 years. Of the 511 patients, 44.2% were considered to be mild, 30.9% moderate and 24.9% severe in terms of their calculated ESSDAI score. Demographic characteristics of the three ESSDAI groups were similar,
Increasing ESSDAI severity was associated with worse EQ-5D utility scores (rho=-0.346, p<0.0001), worse FACIT-F scores (rho=-0.277, p<0.0001) and worse overall work impairment (rho=0.462, p<0.0001).
Demographic characteristics of pSS patients in the US, by ESSDAI severity
| Total
| Mild ESSDAI
| Moderate ESSDAI
| Severe ESSDAI
|
|
| Patient age, mean (SD) years | 53.3 (14.2) | 52.6 (15.0) | 53.6 (14.0) | 54.2 (12.9) |
| % (n) female | 88.5 (452) | 89.4 (226) | 88.6 (158) | 86.6 (127) |
| Ethnicity, % (n) | ||||
| White/Caucasian | 79.8 (408) | 86.3 (195) | 74.7 (118) | 74.8 (95) |
| African-American | 9.2 (47) | 6.2 (14) | 10.1 (16) | 13.4 (17) |
| Hispanic/Latino | 6.1 (31) | 5.3 (12) | 8.2 (13) | 4.7 (6) |
| Other | 4.9 (25) | 2.2 (5) | 7.0 (11) | 7.1 (9) |
| Time since diagnosis, mean (SD) years [n] | 4.6 (5.4) [379] | 4.0 (4.9) [162] | 4.9 (5.6) [118] | 5.1 (5.8) [99] |
| Insurance type, % (n) | ||||
| Commercial (including employer provided) | 59.9 (306) | 62.4 (141) | 56.3 (89) | 59.8 (76) |
| Medicare | 20.5 (105) | 18.1 (41) | 23.4 (37) | 21.3 (27) |
| Health insurance exchange plan | 9.6 (49) | 10.2 (23) | 10.1 (16) | 7.9 (10) |
| Other | 9.6 (49) | 8.8 (20) | 9.5 (15) | 11.0 (14) |
| None | - (2) | - (1) | - (1) | - (0) |
| Employment status, % (n) | ||||
| Working full or part time | 58.9 (301) | 61.9 (140) | 53.2 (84) | 60.6 (77) |
| Long-term sick/unemployed/retired | 24.5 (125) | 20.8 (47) | 27.2 (43) | 27.6 (35) |
| Homemaker | 12.7 (65) | 10.2 (23) | 17.1 (27) | 11.8 (15) |
| Other/unknown | 3.9 (20) | 7.1 (16) | 2.5 (4) | - (0) |
| Smoking status, % (n) current smoker | 6.8 (35) | 3.5 (8) | 5.7 (9) | 14.2 (18) |
Conclusion: A worsening severity on the ESSDAI scale is associated with worse outcomes for patients in the real-world. Treating systemic disease beyond symptomatic treatments is important to improve patient outcomes.
Disclosure of Interests: Briana Ndife Shareholder of: Novartis Pharmaceuticals Corp, Employee of: Novartis Pharmaceuticals Corp, Ben Hoskin: None declared, Nicola Booth: None declared