Table 1.
Characteristic | Abatacept (n=92) |
Placebo (n=95) |
Total (n=187) |
Age, years | 51.2 (12.3) | 52.9 (13.5) | 52.0 (12.9) |
Weight, kg | 71.4 (18.6) | 67.5 (17.3) | 69.4 (18.0) |
Female, n (%) | 85 (92.4) | 92 (96.8) | 177 (94.7) |
Race, white, n (%) | 60 (65.2) | 60 (63.2) | 120 (64.2) |
Disease duration, years | 5.0 (5.0) | 5.1 (5.3) | 5.0 (5.2) |
ESSDAI total score | 8.7 (3.4) | 10.1 (5.0) | 9.4 (4.3) |
ESSPRI total score | 6.6 (2.1) | 6.5 (1.9) | 6.5 (2.0) |
SWSF, mL/min | 1.1 (0.9) | 0.9 (0.9) | 1.0 (0.9) |
SWSF ≥0.1 mL/min, n (%) | 84 (91.3) | 86 (90.5) | 170 (90.9) |
Concomitant treatment at day 1, n (%) | |||
Non-steroidal anti-inflammatory drugs | 44 (47.8) | 31 (32.6) | 75 (40.1) |
Topical eye preparation | 13 (14.1) | 14 (14.7) | 27 (14.4) |
Parasympathomimetics | 15 (16.3) | 21 (22.1) | 36 (19.3) |
Hydroxychloroquine | 37 (40.2) | 36 (37.9) | 73 (39.0) |
Oral corticosteroids* | 22 (23.9) | 22 (23.2) | 44 (23.5) |
Concomitant treatment prior to day 1, n (%) | |||
Non-steroidal anti-inflammatory drugs | 49 (53.3) | 37 (38.9) | 86 (46.0) |
Topical eye preparation | 17 (18.5) | 16 (16.8) | 33 (17.6) |
Parasympathomimetics | 17 (18.5) | 22 (23.2) | 39 (20.9) |
Hydroxychloroquine | 48 (52.2) | 45 (47.4) | 93 (49.7) |
Methotrexate | 20 (21.7) | 15 (15.8) | 35 (18.7) |
Oral corticosteroids | 32 (34.8) | 27 (28.4) | 59 (31.6) |
Data are mean (SD) unless otherwise stated.
*≤10mg/day prednisone equivalent.
ESSDAI, EULAR Sjögren’s Syndrome Disease Activity Index; ESSPRI, EULAR Sjögren’s Syndrome Patient Reported Index; SWSF, stimulated whole salivary flow.