Table 1.
Baseline characteristics of 900 rheumatoid arthritis patients at randomization to PPSV23 or placebo
| 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 |
Data presented as number (percentage) or mean ± standard deviation
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