Baseline demographic and disease characteristics of patients with rheumatoid arthritis participating in the PMS study of TCZ in Japan.
| Characteristics | Patients Receiving TCZ, n = 5573 |
|---|---|
| Demographics | |
| Female, n (%) | 4542 (81.5) |
| Age, yrs, mean (SD) | 58.7 (12.8) |
| Median, yrs, (range) | 60.0 (16–91) |
| ≥ 65 yrs, n (%) | 2019 (36.23) |
| Body weight, mean (SD), kg | 53.3 (10.3) |
| Disease duration, mean (SD), yrs | 10.5 (9.2) |
| Median (range), yrs | 7.9 (0.0–61.9) |
| ≥ 10 yrs, n (%) | 2149 (38.56) |
| Medical history, n (%) | |
| Infections | 647 (11.61) |
| Malignancy | 217 (3.89) |
| Cardiac dysfunction | 184 (3.30) |
| History of comorbidities, n (%) | |
| GI tract disturbance | 1177 (21.12) |
| Respiratory disease | 864 (15.50) |
| Diabetes mellitus | 585 (10.50) |
| Hepatic disorder | 401 (7.20) |
| Cardiac dysfunction | 364 (6.53) |
| Renal dysfunction | 313 (5.62) |
| Malignancy | 32 (0.57) |
| Clinical characteristics | |
| Steinbrocker radiographic stage, n (%) | |
| Stage I | 440 (7.90) |
| Stage II | 1480 (26.56) |
| Stage III | 1778 (31.90) |
| Stage IV | 1875 (33.64) |
| Steinbrocker functional class, n (%) | |
| Class 1 | 664 (11.91) |
| Class 2 | 3439 (61.71) |
| Class 3 | 1429 (25.64) |
| Class 4 | 40 (0.72) |
| Previous use of biologics, n (%) | 3502 (62.84) |
| Baseline DMARD use, n (%) | 3867 (69.39) |
| Baseline MTX use, n (%) | 2972 (53.33) |
| MTX dose > 8 mg/week, n (%) | 460 (8.25) |
| Baseline steroid use (oral and IV), n (%) | 4156 (74.57) |
| Steroid (oral and IV) dose > 5 mg/day, n (%) | 1532 (27.49) |
DMARD: disease-modifying antirheumatic drug; GI: gastrointestinal; IV: intravenous; MTX: methotrexate; PMS: postmarketing surveillance; TCZ: tocilizumab.