Variable | Week 0 | Week 4 | Week 12 | Week 16 | Week 24 | Week 36 | Week 48 |
---|---|---|---|---|---|---|---|
ESSDAI | 11±5 (11) | 6±4 (6)* | 6±8 (3)* | – | 3±3 (2)* | 10±6 (7)† | 14±8 (11)† |
ESSPRI | 7.0±1.5 (7.5) | 6.0±1.7 (6.0)* | 5.6±1.6 (6.0)* | – | 5.8±2.3 (5.8)* | 5.7±2.2 (5.7) | 6.6±1.8 (7.0) |
Patient's GDA | 59±15 (58) | 53±19 (53) | 48±21 (50)* | – | 48±26 (54) | 54±24 (53) | 59±23 (65) |
Physician's GDA | 46±8 (45) | 36±14 (34)* | 31±10 (36)* | – | 33±18 (28)* | 42±19 (43)† | 48±15 (48)† |
SWS (mL/min) | 0.43±0.25 (0.39) | 0.47±0.39 (0.34) | 0.50±0.31 (0.56) | – | 0.41±0.33 (0.24) | 0.38±0.26 (0.32) | 0.31±0.22 (0.28)† |
UWS (mL/min) | 0.17±0.17 (0.12) | 0.16±0.13 (0.15) | 0.14±0.15 (0.08) | – | 0.16±0.15 (0.10) | 0.14±0.14 (0.10) | 0.15±0.14 (0.11) |
Parotid saliva, stimulated (mL/min) | 0.16±0.19 (0.08) | 0.13±0.12 (0.10) | 0.15±0.13 (0.13) | – | 0.11±0.11 (0.07) | 0.11±0.07 (0.12) | 0.09±0.06 (0.07) |
Schirmer (mm/5 min) | 9.8±6.7 (9.5) | 10.4±8.8 (6.0) | 12.4±11.1 (7.5) | – | 8.9±8.5 (5.0) | 9.6±8.2 (6.5) | 8.3±10.9 (1.0) |
TBUT (s) | 8.1±1.9 (8.0) | 8.0±2.3 (9.0) | 8.1±2.7 (9.0) | – | 8.0±2.4 (10.0) | 7.5±2.9 (8.0) | 6.7±3.0 (7.0)† |
Rheumatoid factor (klU/L) | 89±94 (43) | 72±73 (45)* | 57±62 (35)* | 56±63 (31)* | 56±63 (28)* | 82±113 (31)† | 87±103 (36)† |
IgG (g/L) | 21.5±7.3 (20.2) | 19±6.2 (17.1)* | 19.1±8.3 (15.5)* | 18.2±7.5 (16.5)* | 18.2±7.2 (16.5)* | 20.6±9.6 (17.2)† | 21.1±10.3 (18.6)† |
Generalised estimating equations were used to analyse variables over time within subjects during treatment (weeks 0–24) and off treatment (weeks 24–48). Values are presented as mean±SD (median).
*p<0.05 compared with baseline.
†p<0.05 compared with week 24.
ESSDAI, EULAR Sjögren's Syndrome Disease Activity Index; ESSPRI, EULAR Sjögren's Syndrome Patients Reported Index; GDA, global disease activity scale; pSS, primary Sjögren's syndrome; SWS, stimulated whole salivary flow rate; TBUT, tear breakup time test; UWS, unstimulated whole salivary flow rate.