Table 1 Baseline characteristics of 900 rheumatoid arthritis patients at randomization to PPSV23 or placebo

 Age (years)

63.3 ± 12.1

62.7 ± 11.8

0.529

 Gender, male/female

90 (19.4%)/374 (80.6%)

106 (24.3%)/330 (75.7%)

0.074

 Smoking history

90 (19.4%)

116 (26.6%)

0.010

 CRP (mg/dl)

0.49 ± 1.11

0.51 ± 0.99

0.298

 Serum albumin (g/dl)

4.06 ± 0.38

4.06 ± 0.37

0.926

 Serum creatinine (mg/dl)

0.68 ± 0.36

0.68 ± 0.22

0.934

 RA duration (years)

12.1 ± 10.4

11.6 ± 9.7

0.747

 HAQ

0.66 ± 0.74

0.67 ± 0.75

0.918

 DAS28 (CRP)

2.43 ± 1.10

2.51 ± 1.15

0.324

 SDAI

8.00 ± 7.72

8.73 ± 8.55

0.252

 CDAI

7.50 ± 7.38

8.24 ± 8.33

0.257

 Cardiovascular disease

127 (27.4%)

131 (30.0%)

0.375

  CVA

14 (3.0%)

10 (2.3%)

0.501

  Ischemic heart disease

9 (1.9%)

9 (2.1%)

0.894

  Hypertension

109 (23.5%)

116 (26.6%)

0.281

  Arrythmia

6 (1.3%)

5 (1.1%)

0.842

  Cardiac failure

6 (1.3%)

4 (0.9%)

0.415

 Metabolic disease

111 (23.9%)

96 (22.0%)

0.498

  Hyperlipidemia

72 (15.5%)

56 (12.8%)

0.251

  Hyperuricemia

0

9 (2.1%)

0.001

  Diabetes

48 (10.3%)

45 (10.3%)

0.991

 CKD

17 (3.7%)

18 (4.1%)

0.719

 Autoimmune disease

23 (5.0%)

14 (3.2%)

0.187

 Rheumatoid lung

81 (17.5%)

71 (16.3%)

0.890

  Interstitial pneumonia

56 (12.1%)

46 (10.6%)

0.473

  Bronchial lesion

19 (4.1%)

19 (4.4%)

0.845

  Pleural lesion

6 (1.3%)

6 (1.4%)

0.914

 COPD

11 (2.4%)

16 (3.7%)

0.254

 NTM

7 (1.5%)

8 (1.8%)

0.702

 PSL

242 (52.2%)

214 (49.1%)

0.357

 Dose of PSL (mg/day)

4.54 ± 2.79

4.71 ± 2.84

0.530

 PSL ≥ 5 mg/day

130 (28.0%)

117 (26.8%)

0.691

 MTX

300 (64.7%)

304 (69.7%)

0.106

 Dose of MTX (mg/week)

8.01 ± 2.75

8.33 ± 2.85

0.227

 MTX alone

40 (8.6%)

47 (10.8%)

0.273

 MTX + PSL

54 (11.6%)

49 (11.2%)

0.851

 MTX + biologics

103 (22.2%)

107 (24.5%)

0.406

 TAC

60 (12.9%)

60 (13.8%)

0.714

 Biologics

257 (55.4%)

253 (58.0%)

0.425