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Table 2 Clinical assessment result changes from baseline to week 120 in the rituximab and DMARD treatment groups

From: Efficacy and safety of rituximab treatment in early primary Sjögren's syndrome: a prospective, multi-center, follow-up study

 

BASELINE

Week 12

Week 24

Week 48

Week 72

Week 96

Week 120

 

DMARDs

RTX

DMARDs

RTX

DMARDs

RTX

DMARDs

RTX

DMARDs

RTX

DMARDs

RTX

DMARDs

RTX

Global disease activity VAS (mm)

88.7 ± 3.3

88.7 ± 3.3

77 ± 2.2†

72.4 ± 4.0‡

71 ± 3.2‡

68.5 ± 4.6‡

63 ± 3.9*

60.0 ± 4.6*

54 ± 3.5*

51.8 ± 3.0*

50.5 ± 3.7*

47.1 ± 3.5*

52.1 ± 4.8*

45.3 ± 3.9*

Pain VAS (mm)

70.1 ± 9.0

71.1 ± 8.7

59.8 ± 7.8†

55 ± 7.4†

56.7 ± 7.8‡

53.5 ± 7.5‡

51.3 ± 7.5*

44.1 ± 8.5*

41 ± 7.6*

36.3 ± 7.9*

40.5 ± 7.5*

33.1 ± 7.0*

39.3 ± 8.3*

29.8 ± 7.8*

Fatigue VAS (mm)

85.1 ± 4.6

83.8 ± 4.1

73 ± 4.5†

63.1 ± 4.3‡

63.1 ± 4.7‡

58.7 ± 5.1‡

60.1 ± 4.4*

56.2 ± 5.5*

52.2 ± 4.0*

47.8 ± 4.7*

50.5 ± 3.8*

42.5 ± 4.1*

51.8 ± 4.5*

41.1 ± 4.2*

Dryness VAS (mm)

71.0 ± 8.3

72 ± 8.5

61.1 ± 8.3

55.3 ± 7.6‡

58 ± 8.2†

52.2 ± 7.6‡

56.3 ± 8.4‡

44.1 ± 8.5*

53.8 ± 11.0*

36.3 ± 7.9*

51.8 ± 10.4*

30.7 ± 8.0*

51.8 ± 11.1*

25.1 ± 7.7*

Physician GA VAS (mm)

89.7 ± 3.0

87.1 ± 2.3

78.6 ± 2.6†

69.1 ± 3.0†

73.1 ± 3.4‡

65 ± 4.4‡

65.0 ± 3.9*

56.6 ± 4.3*

56.6 ± 3.8*

50.3 ± 3.0*

54.7 ± 4.5*

45.8 ± 3.3*

56.1 ± 4.9*

44.0 ± 3.7*

Unstimulated salivary flow (ml/minute)

0.08 ± 0.03

0.08 ± 0.04

0.1 ± 0.04

0.2 ± 0.04‡

0.1 ± 0.04

0.3 ± 0.04‡

0.1 ± 0.07

0.4 ± 0.02*

0.1 ± 0.06

0.3 ± 0.001*

0.1 ± 0.08

0.4 ± 0.04*

0.1 ± 0.08

0.4 ± 0.04*

Schirmer I test (mm/5 minutes)

3.8 ± 0.6

3.8 ± 0.6

4 ± 0.5

5.5 ± 0.4‡

4.5 ± 0.7

6.0 ± 0.5†

5.1 ± 0.8

6.3 ± 0.6‡

5.1 ± 0.7

7.0 ± 0.7*

5.3 ± 0.7†

7.0 ± 0.7*

5.5 ± 0.8‡

7.3 ± 0.8*

ESSDAI

19.8 ± 3.1

20.3 ± 2.9

17.6 ± 3.2

14.2a ± 2.8

14.2 ± 3.0‡

9.8 ± 2.0‡

12.3 ± 2.0*

9.4 ± 1.6‡

10.2 ± 2.0*

5.7 ± 1.0*

9.7 ± 2.0*

5.7 ± 1.0*

8.8 ± 1.7*

5.2 ± 0.9*

  1. Data presented as mean ± standard error of the mean. DMARD, disease-modifying anti-rheumatic drug; ESSDAI, EULAR Sjögren’s syndrome disease activity index; GA, global assessment; RTX, rituximab; VAS, visual analogic scale. *P <0.001;‡P <0.01; †P <0.05.