Table 1.
Study population and patient demographics and clinical characteristics
| Study population, n (%) | Physician survey | Physician- reported PRFs | Patient- reported PSCsa | |
|---|---|---|---|---|
| Total | 316 (100) | 1879 (100) | 888 (100) | |
| France | 52 (16.5) | 287 (15.3) | 95 (10.7) | |
| Germany | 60 (19.0) | 360 (19.2) | 226 (25.5) | |
| Italy | 61 (19.3) | 360 (19.2) | 79 (8.9) | |
| Spain | 60 (19.0) | 361 (19.2) | 179 (20.2) | |
| US | 83 (26.3) | 511 (27.2) | 308 (34.7) | |
|
Patient demographics and clinical characteristics based on physician-reported PRFs | ||||
|---|---|---|---|---|
| Overall (N = 1879) | Mild (n = 914) | Moderate (n = 895) | Severe (n = 70) | |
| Age, years, mean (s.d.) | 53.2 (12.2) | 52.2 (12.9) | 54.1 (11.2) | 55.3 (13.3) |
| Female, n (%) | 1677 (89.2) | 813 (88.9) | 801 (89.5) | 63 (90.0) |
| Years since diagnosis, mean (s.d.) | 4.5 (5.1) | 4.3 (5.2) | 4.6 (4.9) | 6.1 (6.5) |
| Ethnicity, n (%) | ||||
| White/Caucasian | 1678 (89.3) | 814 (89.1) | 805 (89.9) | 59 (84.3) |
| Non-white/non-Caucasian | 201 (10.7) | 100 (10.9) | 90 (10.1) | 11 (15.7) |
| Employment status, n (%) | ||||
| Working full time | 762 (40.6) | 431 (47.2) | 312 (34.9) | 19 (27.1) |
| Working part time | 231 (12.3) | 101 (11.1) | 121 (13.5) | 9 (12.9) |
| On long-time sick leave | 39 (2.1) | 13 (1.4) | 22 (2.5) | 4 (5.7) |
| Homemaker | 414 (22.0) | 168 (18.4) | 236 (26.4) | 10 (14.3) |
| Student | 18 (1.0) | 14 (1.5) | 4 (0.4) | 0 (0.0) |
| Retired | 316 (16.8) | 149 (16.3) | 148 (16.5) | 19 (27.1) |
| Unemployed | 55 (2.9) | 21 (2.3) | 28 (3.1) | 6 (8.6) |
| Don’t know | 44 (2.3) | 17 (1.9) | 24 (2.7) | 3 (4.3) |
| Organ involvement at diagnosis, n (%) | ||||
| Any | 1589 (84.6) | 795 (87.0) | 729 (81.5) | 65 (92.9) |
| Organ involvement at time of PRF completion, n (%) | ||||
| Any | 1816 (96.6) | 867 (94.9) | 880 (98.3) | 69 (98.6) |
| Articular | 1366 (72.7) | 636 (69.6) | 680 (76.0) | 50 (71.4) |
| Glandular | 714 (38.0) | 294 (32.2) | 376 (42.0) | 44 (62.9) |
| Cutaneous | 376 (20.0) | 143 (15.6) | 217 (24.2) | 16 (22.9) |
| Muscular | 341 (18.1) | 110 (12.0) | 218 (24.4) | 13 (18.6) |
| Pulmonary | 299 (15.9) | 109 (11.9) | 163 (18.2) | 27 (38.6) |
| Haematological | 350 (18.6) | 166 (18.2) | 167 (18.7) | 17 (24.3) |
| Lymphadenopathy | 190 (10.1) | 96 (10.5) | 83 (9.3) | 11 (15.7) |
| Peripheral nervous system | 155 (8.2) | 61 (6.7) | 83 (9.3) | 11 (15.7) |
| Renal | 100 (5.3) | 36 (3.9) | 54 (6.0) | 10 (14.3) |
| CNS | 96 (5.1) | 38 (4.2) | 51 (5.7) | 7 (10.0) |
| Current treatment classes, n (%) | ||||
| OTC | 1188 (63.2) | 555 (60.7) | 592 (66.1) | 41 (58.6) |
| Corticosteroids | 885 (47.1) | 377 (41.2) | 471 (52.6) | 37 (52.9) |
| csDMARDs | 816 (43.4) | 329 (36.0) | 455 (50.8) | 32 (45.7) |
| Secretagogues | 765 (40.7) | 313 (34.2) | 425 (47.5) | 27 (38.6) |
| Antimalarials | 696 (37.0) | 354 (38.7) | 317 (35.4) | 25 (35.7) |
| Biologic/biosimilar | 223 (11.9) | 80 (8.8) | 126 (14.1) | 17 (24.3) |
| Prescription eye drops | 172 (9.2) | 56 (6.1) | 108 (12.1) | 8 (11.4) |
| Other treatments | 1344 (71.5) | 643 (70.4) | 652 (72.8) | 49 (70.0) |
| Patient-reported outcomes (collected in the PSCs) | ||||
|---|---|---|---|---|
| Overall (N = 888) | Mild (n = 381) | Moderate (n = 475) | Severe (n = 32) | |
| Health status, mean (s.d.)b | ||||
| EQ-5D-3L | N = 877, 0.7 (0.24) | n = 378, 0.8 (0.19) | n = 468, 0.7 (0.24) | n = 31, 0.5 (0.33) |
| EQ-5D-VAS | N = 874, 63.5 (19.02) | n = 373, 70.3 (18.01) | n = 469, 59.2 (17.41) | n = 32, 46.3 (23.84) |
| Fatigue, mean (s.d.) b | ||||
| FACIT-fatigue | N = 879, 31.3 (10.91) | n = 377, 35.6 (10.06) | n = 470, 28.5 (10.22) | n = 32, 21.9 (11.45) |
| Work productivity and activity impairment due to pSS, mean (s.d.)c | ||||
| WPAI: percent activity impairment | N = 841, 37.8 (21.65) | n = 357, 29.3 (20.47) | n = 453, 42.8 (19.57) | n = 31, 61.6 (23.82) |
| WPAI: percent overall work impairment | N = 375, 31.4 (21.93) | n = 177, 25.7 (21.35) | n = 192, 36.1 (20.78) | n = 6, 50.8 (31.05) |
| WPAI: percent impairment while working | N = 464, 29.8 (21.07) | n = 228, 25.2 (20.66) | n = 229, 34.0 (20.38) | n = 7, 42.9 (25.63) |
| WPAI: percent work time missed | N = 383, 5.0 (15.55) | n = 181, 4.4 (15.15) | n = 196, 5.3 (15.75) | n = 6, 12.5 (20.92) |
a
A total of 888 patients completed a PSC, a lower value indicates that patients did not complete the question.
b
A lower score indicates a higher burden. cA higher score indicates a higher burden.
csDMARD: conventional synthetic DMARD; EQ-5D-3L: EuroQol-5 Dimension-3 Level; EQ-5D-VAS: EuroQol-Visual Analogue Scale; OTC: over the counter; PRF: patient record form; PSC: patient self-completion questionnaire; pSS: primary Sjögren’s Syndrome; WPAI: Work Productivity and Activity Impairment questionnaire.