Introduction
Methods
Design
Patient group
Outcomes
Data analysis
Results
Parameter | Week | HSB | DDF | PDF | LSB | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Placebo | HCQ | Placebo | HCQ | Placebo | HCQ | Placebo | HCQ | ||||||||||
Median | (LQ, UQ) | Median | (LQ, UQ) | Median | (LQ, UQ) | Median | (LQ, UQ) | Median | (LQ, UQ) | Median | (LQ, UQ) | Median | (LQ, UQ) | Median | (LQ, UQ) | ||
ESSPRI | 0 | 7.17 | (6.3, 8) | 7.33 | (6.8, 7.9) | 5 | (4.7, 5.7) | 4.33 | (4, 5.3) | 6.83 | (5.4, 7.7) | 6.67 | (5.7, 7.3) | 2.67 | (1.8, 2.8) | 2.33 | (1.5, 3.2) |
12 | 7.67 | (6.7, 8.3) | 6.33a | (5.5, 7.2) | 5.33 | (4.7, 6.3) | 5 | (3.8, 6.3) | 6.33 | (5.8, 7.6) | 7 | (5.7, 8.2) | 4.67 | (2.5, 5) | 2.67a | (1.5, 3.8) | |
24 | 7.00 | (5.7, 8) | 7.17 | (4.7, 7.3) | 5.5 | (3.8, 6.7) | 4.83 | (3.3, 5.9) | 6.33 | (4.3, 7.3) | 6.5 | (5, 7.33) | 5 | (1.7, 5.7) | 2.67 | (2, 3.8) | |
Pain | 0 | 7.5 | (6.8, 8) | 7 | (5.8, 9) | 1 | (1, 3) | 2 | (0, 3) | 7 | (5.3, 8) | 7 | (6, 8.8) | 1 | (0, 2) | 2 | (0, 2) |
12 | 7 | (6, 8) | 6 | (4, 6.5) | 3 | (1, 6) | 4a | (0, 5) | 6 | (4.25, 8) | 7 | (5.5, 8) | 3 | (1.5, 5) | 2 | (0, 3) | |
24 | 6 | (5, 8) | 5.5 | (4.3, 7.8) | 3 | (1.5, 4.3) | 2 | (0, 5) | 7 | (5, 8) | 6 | (5, 8) | 4 | (1.5, 6) | 1 | (0.5, 2.5) | |
Dryness | 0 | 7 | (5.8, 8) | 8 | (7.8, 8.3) | 7 | (6.5, 9.5) | 8 | (7.5, 8) | 7 | (6, 8) | 6 | (5, 7) | 3 | (2, 4) | 4 | (2, 6) |
12 | 7.5 | (7, 9.8) | 7a | (4, 8) | 7 | (6, 10) | 7.5 | (6, 8.8) | 7.5 | (6, 8) | 7.5 | (5, 8.8) | 5 | (1, 6) | 4 | (2, 5) | |
24 | 7 | (5, 9) | 7 | (5, 8) | 5.5 | (4.3, 9) | 7 | (5.5, 8) | 6 | (4, 8) | 6 | (5.5, 7.5) | 4 | (1.5, 6.5) | 3 | (2.5,7.5) | |
Fatigue | 0 | 7 | (6.75, 8) | 8 | (6, 8.3) | 7 | (4, 8) | 4.5 | (3.3, 5.8) | 7 | (5, 9) | 7 | (7, 9) | 3 | (1.5, 3.5) | 2 | (0.5, 3) |
12 | 7 | (6, 8) | 6a | (4, 6.5) | 3 | (1, 6) | 4 | (0, 5) | 6 | (4.3, 8) | 7 | (5.5, 8) | 3 | (1.5, 5) | 2 | (0, 3) | |
24 | 6 | (5, 8) | 5.5 | (4.3, 7.8) | 3 | (1.5, 4.3) | 2 | (0, 5) | 7 | (5, 8) | 6 | (5, 8) | 4 | (1.5, 6) | 1 | (0.5, 2.5) | |
ESSDAI | 0 | 2 | (2, 8) | 2 | (0, 5.3) | 3 | (0, 6) | 6 | (0, 10) | 2 | (0.3, 6.8) | 2 | (1.3, 5) | 3 | (2, 5.5) | 0 | (0, 3) |
12 | 2 | (0, 4) | 1.5 | (0, 2.75) | 1.5 | (0, 3.5) | 7a | (0, 12) | 2 | (0, 6.5) | 3.5 | (0.5, 5.8) | 2 | (0.5, 3.5) | 0 | (0, 2) | |
24 | 3 | (2, 7) | 1.5 | (0, 5) | 2 | (0, 5.5) | 2.5 | (0, 6.3) | 2 | (0, 5) | 2 | (0.5, 2.5) | 4 | (2, 6) | 0 | (0, 2) | |
Schirmer’s | 0 | 4.3 | (2, 7.9) | 12 | (1.9, 16.3) | 2 | (1.1, 4.5) | 7.8 | (0, 9.1) | 6.5 | (3.5, 17.5) | 6 | (4, 15) | 11.8 | (2.5, 24.3) | 20 | (0.75, 26.5) |
24 | 5.0 | (2, 7.5) | 14.5a | (7.3, 20.5) | 5 | (1.5, 17) | 6.5 | (1, 8) | 3.5 | (1.5, 9.3) | 5.8 | (5, 13.9) | 6.8 | (3.3, 21.6) | 6.3 | (5.3, 21.1) | |
USF | 0 | 0.04 | (0, 0.2) | 0.2 | (0, 0.34) | 0.3 | (0.1, 0.3) | 0.09 | (0.04, 0.1) | 0.08 | (0.01, 0.1) | 0.1 | (0.09, 0.2) | 0.3 | (0.1, 0.5) | 0.06 | (0.03, 0.2) |
24 | 0.02 | (0, 0.2) | 0.1 | (0.02, 0.2) | 0.1 | (0, 0.3) | 0.1 | (0.1, 0.7) | 0.1 | (0.03, 0.1) | 0.1 | (0.08, 0.3) | 0.34 | (0.1, 0.7) | 0.3a | (0.04, 0.3) | |
PoF | 0 | 6.0 | (5.5, 7.2) | 5.7 | (3.9, 6.6) | 3.6 | (1.7, 4.2) | 3.4 | (1.1, 4.6) | 5.3 | (3.7, 6.5) | 5.9 | (4.3, 8.1) | 2.2 | (1.2, 3.3) | 2.1 | (1.3, 3.5) |
24 | 7.0 | (5.6, 7.9) | 6.2 | (4.3, 6.6) | 3.1 | (1, 4.3) | 4.0 | (1.4, 5.3) | 4.9 | (2.2, 6.7) | 5.3 | (3.6, 7.1) | 3.8 | (3.1, 6.1) | 2a | (1.5, 2.7) | |
IFN score | 0 | 2.6 | (− 4.3, 7.8) | 8.9 | (−1.7, 18.4) | 12.2 | (0.2, 17.9) | 5.5 | (0.6, 16.5) | 9.7 | (3.8, 15.2) | 8.5 | (−2.3, 15.1) | 17.7 | (13.8, 18.6) | 15.1 | (12.4, 17.7) |
24 | 0.3 | (− 4.9, 8.4) | 3.4 | (−4.5, 12.5) | 13.6 | (8.6, 17.8) | −0.01a | (− 5, 13.5) | 10.9 | (0.5, 15.2) | 0.3a | (−5.4, 6.8) | 16.8 | (9.6, 19) | 12.8 | (11.8, 13.9) |