Table 3.
Baseline values and changes in efficacy parameters
| Parameter | Baseline | Week 12 | Week 24 |
| Glandular function tests | |||
| Schirmer's test (millimeters per 5 minutes) | 2.0 ± 3.2 | 3.4 ± 3.5 | 4.4 ± 4.9 |
| Whole saliva (grams per 5 minutes) | 0.49 ± 0.41 | 0.48 ± 0.41 | 0.56 ± 0.41 |
| Laboratory tests | |||
| Erythrocyte sedimentation rate (mm/hour) | 47.6 ± 20.5 | 44.1 ± 23.3 | 44.2 ± 21.0 |
| Gamma globulins (g/L) | 21.3 ± 6.3 | 19.5 ± 8.6a | 18.8 ± 7.5b |
| IgG (mg/dL) | 2,159 ± 949 | 2,048 ± 755 | 2,025 ± 895 |
| IgM (mg/dL) | 189 ± 108 | 144 ± 62.7a | 142 ± 62.8a |
| IgA (mg/dL) | 399 ± 417 | 359 ± 363 | 329 ± 305 |
| Rheumatoid factor IgM (IU/mL) | 275 ± 504 | 193 ± 380 | 179 ± 317a |
| Anti-SSA antibodies (U/mL) | 5,863 ± 5,321 | 6,308 ± 4,008 | 5,892 ± 8,859 |
| Anti-SSB antibodies (U/mL) | 1,217 ± 1,386 | 1,424 ± 1,925 | 1,320 ± 1,668 |
| C3 (mg/dL) | 99.3 ± 30.2 | 101 ± 33.5 | 108 ± 34.7b |
| C4 (mg/dL) | 14.9 ± 8.8 | 16.4 ± 9.5a | 16.8 ± 8.9b |
| Subjective findings | |||
| VAS sicca syndrome (0 to 100 mm) | 68.7 ± 15.6 | 56.4 ± 19.9 | 52.8 ± 20.8a |
| VAS arthralgia (0 to 100 mm) | 62.1 ± 23.4 | 45.1 ± 34.3 | 47.5 ± 30.0 |
| VAS fatigue (0 to 100 mm) | 63.4 ± 24.0 | 57.4 ± 33.4 | 65.3 ± 22.6 |
| Use of artificial teardrops (times per day) | 3.7 ± 2.3 | 1.8 ± 1.3a | 1.6 ± 1.9b |
| Health Assessment Questionnaire score | 0.73 ± 0.77 | 0.81 ± 0.84 | 0.73 ± 0.80 |
ap < 0.05 versus baseline value analyzed by Wilcoxon signed rank test; bp < 0.02 versus baseline value analyzed by Wilcoxon signed rank test. Table presents outcome parameters in the eight patients with primary Sjögren syndrome who completed the study. Data are presented as mean ± standard deviation. Ig, immunoglobulin; VAS, visual analogue scale.