TABLE 2.
The clinical outcome of the SS-1 trial for Sjögren’s syndrome patients.
| Placebo group | SS-1 group | P | |
|---|---|---|---|
| Schirmer’s test (mm) c | |||
| OS (left eye) | 1.22 (0.23–2.21) | 3.42 (2.44–4.41) | 0.003 a |
| OS (left eye) b | 3.89 (3.00–4.79) | 5.74 (4.84–6.63) | 0.005 a |
| OD (right eye) | 1.51 (0.38–2.65) | 3.45 (2.32–4.59) | 0.002 a |
| OD (right eye) b | 4.39 (3.38–5.41) | 6.37 (5.35–7.38) | 0.008 a |
| ESSPRI Score d | |||
| Dryness | −0.71 (−1.25 to −0.18) | −0.95 (−1.48 to −0.95) | 0.537 |
| Fatigue | −0.84 (−1.43 to −0.26) | −0.93 (−1.52 to −0.35) | 0.827 |
| Pain | −0.59 (−1.33 to 0.15) | 0.11 (−0.63 to 0.85) | 0.185 |
| OSDI Score e | −5.72 (−10.78 to −0.67) | −7.98 (−13.03 to −2.93) | 0.530 |
| Eyes that are sensitive to light | −0.33 (−0.70 to 0.05) | −0.39 (−0.76 to −0.01) | 0.822 |
| Eyes that feel gritty | −0.10 (−0.41 to 0.21) | −0.11 (−0.42 to 0.20) | 0.953 |
| Painful or sore eyes | −0.23 (−0.54 to 0.07) | −0.14 (−0.44 to 0.17) | 0.648 |
| Blurred vision | −0.30 (−0.64 to 0.04) | −0.21 (−0.55 to 0.13) | 0.696 |
| Poor vision | −0.26 (−0.68 to 0.16) | −0.28 (−0.70 to 0.14) | 0.945 |
| Reading | −0.17 (−0.54 to 0.20) | −0.42 (−0.79 to −0.05) | 0.336 |
| Driving at night | 0.05 (−0.27 to 0.36) | −0.19 (−0.51 to 0.12) | 0.287 |
| Working with a computer or bank machine (ATM) | −0.23 (−0.57 to 0.11) | −0.24 (−0.58 to 0.10) | 0.981 |
| Watching TV | −0.16 (−0.45 to 0.13) | −0.55 (−0.84 to −0.26) | 0.062 |
| Windy conditions | −0.30 (−0.62 to 0.03) | −0.31 (−0.63 to 0.02) | 0.963 |
| Places or areas with low humidity (very dry) | −0.31 (−0.65 to 0.03) | −0.55 (−0.89 to −0.21) | 0.324 |
| Areas that are air conditioned | −0.30 (−0.64 to 0.05) | −0.52 (−0.86 to −0.17) | 0.371 |
| SSDQ Score f | 9.36 (8.49–10.22) | 10.29 (9.43–11.15) | 0.173 |
| Sialoscintigraphy | |||
| Uptake | −0.32 (−0.84 to 0.20) | −0.60 (−1.12 to 0.08) | 0.453 |
| Excretion | −0.11 (−0.24 to 0.01) | 0.01 (−0.11 to 0.14) | 0.150 |
| Artificial tear usage (times/day) | −0.32 (−0.89 to 0.25) | −1.38 (−1.95 to −0.81) | 0.011 a |
| Cytokines (pg/ml) | |||
| IL-17A | 17.60 (−106.83 to 142.04) | −6.62 (−126.34 to 113.09) | 0.779 |
| IL-18 | 35.53 (−7.08 to 78.14) | 16.75 (−26.83 to 60.32) | 0.539 |
| IL-23 | 219.10 (10.10–428.09) | 64.09 (−238.41 to 366.58) | 0.349 |
| IL-27 | −143.36 (−1,392.53 to 1,105.81) | −501.01 (−1,675.93 to 673.92) | 0.675 |
| MMP-9 | 11,517.00 (−3,990.98 to 27,025.00) | −2,592.48 (−16545.00 to 11,360.00) | 0.180 |
| BAFF | 555.02 (53.95–1,056.09) | 295.29 (−222.46 to 813.03) | 0.473 |
| BCMA | 169.99 (121.65–218.32) | 99.16 (50.83–147.50) | 0.043 a |
The data are presented as mean and 95% confidence interval with crossover analysis.
p<0.05, which these variables were calculated as change from baseline.
Schirmer’s test of OS (left eye) and OD (right eye) were analyzed by 2×2 crossover design with original value‖Artificial tear usage: a record which the patient self-reported, ranged from 0 to 30 or much more times/per day, the more usage represents more eye dryness.
Schirmer’s test: an objective evaluation of tear secretion, ranged from 0 to 30 mm, in which less than 5 mm represents dry eye, and more the value represents much more tear secretion).
ESSPRI Score: European League Against Rheumatism Sjögren’s Syndrome Patient Reported Index is a patient self-reported questionnaire about dryness, fatigue, and pain, which it ranged from 0 to 10 for each item; while 0 represents no dryness, fatigue or pain; and 10 represents the maximal dryness, fatigue or pain.
OSDI Score: Ocular surface disease index is a patient self-reported questionnaire containing 12 sub-domains about ocular symptoms, daily activities, and environment factors, which each sub-domain ranged from 0 to 4; while 0 represents none, and 4 represents all of the time. And the total score of OSDI ranged from 0 to 100, while the higher scores represent greater dry eye disease severity and effect on vision-related functions.
SSDQ scores: Sjögren’s Syndrome dry-mouth symptom questionnaire is a patient self-reported questionnaire about dry month using in Taiwan, which it ranged from −10 to 30, in which the scores over 10 represent the efficacy of this drug for improving dry month.
Sialoscintigraphy: an objective evaluation of salivary gland functions, ranged from 0 to 4, bilateral parotid glands were evaluated as 0 represents prominent uptake or excretion; 1 represents moderate uptake or excretion; 2 represents mild uptake or excretion; 3 represents little uptake or excretion; 4 represents no uptake or excretion.