TABLE 1.
Baseline characteristics of the SS-1 trial for Sjögren’s syndrome patients.
| Group Placebo-SS-1 (N = 36) | Group SS-1-Placebo (N = 34) | p | |
|---|---|---|---|
| Female sex — no. of patients (%) | 34 (94) | 33 (97) | |
| Age, year | 52.5 ± 12.3 | 51.7 ± 10.9 | 0.775 |
| Time to diagnosis, year | 3.9 ± 4.0 | 4.8 ± 4.2 | 0.376 |
| Conventional medicine | |||
| Hydroxychloroquine | 245.8 ± 83.3 | 245.8 ± 83.3 | 1 |
| Artificial tear usage (times/day) | 2.8 ± 1.8 | 3.0 ± 2.3 | 0.718 |
| Outcome | |||
| Schirmer’s test (mm) a | |||
| OS (left eye) | 3.3 ± 4.6 | 3.1 ± 3.5 | 0.824 |
| OD (right eye) | 2.7 ± 3.5 | 3.3 ± 5.7 | 0.580 |
| ESSPRI Score b | |||
| Dryness | 6.3 ± 1.8 | 5.8 ± 2.6 | 0.321 |
| Fatigue | 6.1 ± 1.8 | 5.6 ± 2.6 | 0.345 |
| Pain | 5.0 ± 3.0 | 4.2 ± 3.1 | 0.276 |
| OSDI Score c | 49.8 ± 21.7 | 46.8 ± 24.4 | 0.560 |
| Eyes that are sensitive to light | 2.4 ± 1.3 | 2.4 ± 1.4 | 0.775 |
| Eyes that feel gritty | 2.1 ± 1.4 | 1.9 ± 1.2 | 0.580 |
| Painful or sore eyes | 1.4 ± 1.3 | 1.3 ± 1.1 | 0.812 |
| Blurred vision | 2.3 ± 1.3 | 1.2 ± 1.3 | 0.144 |
| Poor vision | 2.1 ± 1.3 | 1.9 ± 1.4 | 0.586 |
| Reading | 2.0 ± 1.3 | 1.9 ± 1.4 | 0.856 |
| Driving at night | 1.1 ± 1.3 | 1.1 ± 1.6 | 0.921 |
| Working with a computer or bank machine (ATM) | 1.5 ± 1.5 | 1.5 ± 1.5 | 0.996 |
| Watching TV | 1.6 ± 1.3 | 1.8 ± 1.3 | 0.608 |
| Windy conditions | 2.4 ± 1.3 | 2.1 ± 1.5 | 0.326 |
| Places or areas with low humidity (very dry) | 2.2 ± 1.2 | 1.9 ± 1.3 | 0.304 |
| Areas that are air conditioned | 2.0 ± 1.2 | 1.9 ± 1.4 | 0.851 |
| Sialoscintigraphy | |||
| Uptake | 3.0 ± 1.0 | 3.0 ± 1.1 | 1.000 |
| Excretion | 1.8 ± 1.1 | 1.4 ± 1.4 | 0.140 |
| Laboratory data | |||
| White blood cells (103/µL) | 5.2 ± 1.2 | 4.9 ± 1.9 | 0.511 |
| Red blood cells (106/µL) | 4.4 ± 0.47 | 4.5 ± 0.6 | 0.209 |
| Hemoglobin (g/dl) | 13.1 ± 1.1 | 12.9 ± 1.1 | 0.470 |
| Platelet (103/µL) | 219.7 ± 51.9 | 221.7 ± 49.1 | 0.872 |
| Aspartate aminotransferase (µ/L) | 25.6 ± 7.4 | 24.6 ± 4.8 | 0.531 |
| Alanine aminotransferase (µ/L) | 20.1 ± 4.4 | 18.9 ± 9.7 | 0.591 |
| Blood urea nitrogen (mg/dl) | 11.9 ± 3.4 | 12.7 ± 4.1 | 0.381 |
| Serum creatinine (mg/dl) | 0.7 ± 0.2 | 0.6 ± 0.1 | 0.078 |
| Erythrocyte sedimentation rate (mm/hr) | 17.7 ± 18.4 | 15.9 ± 10.8 | 0.625 |
| Positive rates — no. of patients (%) | |||
| Rheumatoid factor (RF) | 9 (25.0) | 11 (32.3) | |
| Anti-Ro | 28 (77.8) | 25 (73.5) | |
| Anti-La | 14 (38.9) | 10 (29.4) | |
| Anti-Mitochondrial | 0 (0) | 2 (5.8) | |
| Cytokines (pg/ml) | |||
| IL-1β | 742.27 ± 1,141.66 | 572.95 ± 550.63 | 0.754 |
| IL-17A | 42.99 ± 112.73 | 290.34 ± 1,010.63 | 0.188 |
| IL-18 | 149.01 ± 109.62 | 196.51 ± 255.12 | 0.323 |
| IL-23 | 100.97 ± 207.90 | 23.17 ± 25.07 | 0.344 |
| IL-27 | 721.87 ± 1,182.47 | 849.23 ± 1,683.65 | 0.809 |
| MMP-9 | 34,514.58 ± 23,578.48 | 43,423.26 ± 41,234.96 | 0.278 |
| IFN-α | 84.07 ± 44.87 | 16.36 ± 0.00 | 0.321 |
| IFN-γ | 42.74 ± 28.23 | 43.09 ± 37.37 | 0.967 |
| BAFF | 1,331.00 ± 839.79 | 1,480.14 ± 1,363.08 | 0.581 |
| BCMA | 293.07 ± 195.20 | 301.22 ± 173.64 | 0.854 |
SS, Sjögren's syndrome; ESSPRI, EULAR Sjogren's Syndrome Patient Reported Index; OSDI, ocular surface disease index; MMP-9, matrix metalloproteinase-9; BAFF, B-cell-activating factor; BCMA, B-cell-maturation antigen; IL, interleukin; IFN, interferon. The baseline demographic data and medical conditions were analyzed using ANOVA test for continuous variables, and the baseline characteristics data in the text and tables are expressed as mean ± standard deviation (SD). And there were no significant differences in the baseline characteristics between the two treatment groups. ‖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.
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.