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.

Willeke et al. Arthritis Research & Therapy 2007 9:R115   doi:10.1186/ar2322

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