Selected baseline characteristics of subjects with both baseline and follow-up data in salivary gland ultrasound substudy
| Placebo (n=26) | Rituximab (n=26) | All (n=52) | |
| Age (years) | 57.4 (11.1) | 56.7 (10.92) | 57.1 (10.91) |
| Years since diagnosis | 6.6 (5.67) | 5.38 (4.82) | 6.0 (5.25) |
| ≥10 years since diagnosis, n (%) | 6 (23.1) | 4 (15.4) | 10 (19.2) |
| Female sex, n (%) | 23 (88.5) | 25 (96.2) | 48 (92.3) |
| Current medications (prior to randomisation) | |||
| Pilocarpine, n (%) | 1 (3.8) | 4 (15.4) | 5 (9.6) |
| Hydroxychloroquine, n (%) | 13 (50.0) | 15 (57.7) | 28 (53.8) |
| Corticosteroids, n (%) | 6 (23.1) | 2 (7.7) | 8 (15.4) |
| NSAIDS: n (%) | 7 (26.9) | 5 (19.2) | 12 (23.1) |
| Unstimulated salivary flow (mL/15 min) | 1.4 (2.34) | 0.8 (0.71) | 1.1 (1.72) |
| Stimulated salivary flow (mL/10 min) | 3.8 (4.08) | 3.7 (5.51) | 3.7 (4.82) |
| IgG (g/L) | 17.2 (7.67) | 17.8 (6.02) | 17.5 (6.82) |
| IgA (g/L) | 3.7 (2.87) | 3.0 (1.0) | 3.3 (2.14) |
| IgM (g/L) | 1.2 (0.64) | 1.4 (0.65) | 1.28 (0.64) |
| Anti-Ro autoantibody positive, n (%) | 26 (100) | 25 (96.2) | 51 (98.1) |
| Reduced C4, n (%) | 4 (15.4) | 4 (15.4) | 8 (15.4) |
| Visual analogue scales (average over last two weeks, mm; 100=severe, except global) | |||
| Fatigue | 74.5 (13.46) | 67.0 (18.22) | 70.8 (16.30) |
| Oral dryness | 75.6 (15.13) | 73.8 (13.30) | 74.7 (14.14) |
| Ocular dryness | 64.7 (23.25) | 65.7 (19.25) | 65.2 (21.09) |
| Overall dryness | 73.4 (15.64) | 71.3 (13.17) | 72.4 (14.36) |
| Joint pain | 56.4 (28.40) | 47.2 (27.21) | 51.8 (27.93) |
| Global assessment (100=PSS very active) | 73.4 (14.08) | 62.2 (18.90) | 67.8 (17.45) |
| ESSPRI (10=maximal symptom severity) | 6.7 (1.63) | 6.4 (1.64) | 6.6 (1.64) |
| ESSDAI (123=maximal disease activity) | 6.8 (3.82) | 5.1 (4.55) | 6.0 (4.24) |
| ESSDAI glandular domain, n (%) | |||
| No activity | 17 (65.4) | 22 (84.6) | 39 (75.0) |
| Low activity | 8 (30.8) | 3 (11.5) | 11 (21.2) |
| Moderate activity | 1 (3.8) | 1 (3.8) | 2 (3.8) |
| TUS | 5.02 (3.06) | 6.5 (2.04) | 5.9 (2.65) |
| TUS domains | |||
| Echogenicity | 0.5 (0.51) | 0.8 (0.43) | 0.7 (0.48) |
| Consistency | 1.3 (1.00) | 1.5 (0.91) | 1.4 (0.95) |
| Definition | 0.8 (0.83) | 1.3 (0.74) | 1.0 (0.82) |
| Glands involved | 1.5 (0.81) | 1.9 (0.43) | 1.7 (0.67) |
| Hypoechoic foci size | 1.0 (0.68) | 1.1 (0.48) | 1.1 (0.58) |
Values are mean and SD unless otherwise stated.
ESSDAI, European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index; ESSPRI, European Sjögren’s Syndrome Patient Reported Index; NSAID, non-steroidal anti-inflammatory drugs; PSS, primary Sjögren’s syndrome; TUS, total ultrasound score.