Table 3 |
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|
Baseline values and changes in efficacy parameters |
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| Parameter |
Baseline |
Week 12 |
Week 24 |
|
|
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| Glandular function tests |
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| 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 |
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| 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 |
|
|
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|
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. |
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|
Willeke et al. Arthritis Research & Therapy 2007 9:R115 doi:10.1186/ar2322 |
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