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

From: The 23-valent pneumococcal polysaccharide vaccine in patients with rheumatoid arthritis: a double-blinded, randomized, placebo-controlled trial

  Vaccine group Placebo group  
(n = 464) (n = 436) P value
Demographics
 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
Laboratory data
 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 characteristics
 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
Comorbidity
 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
Treatment
 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
  1. Data presented as number (percentage) or mean ± standard deviation
  2. PPSV23 23-valent pneumococcal polysaccharide vaccine, CRP C-reactive protein, RA rheumatoid arthritis, HAQ Health Assessment Questionnaire Disability Index score, DAS28 Disease Activity Score 28, SDAI simplified disease activity index, CDAI clinical disease activity index, CVA cerebrovascular accident, CKD chronic kidney disease, COPD chronic obstructive pulmonary disease, NTM nontuberculous mycobacteria, PSL prednisolone, MTX methotrexate, TAC tacrolimus