Characteristics of patients with rheumatoid arthritis (RA) participating in the all-patient postmarketing surveillance of tocilizumab (TCZ) in Japan.
| Characteristics | TCZ, n = 7901, 3831.8 PY, 25.3 ± 6.4 Weeks |
|---|---|
| Demographics | |
| Female, n (%) | 6445 (81.6) |
| Age, yrs, mean (SD) | 58.7 (12.9) |
| Median, range | 60.0 (15.0–91.0) |
| ≥ 70, n (%) | 1635 (20.7) |
| Body weight, kg, mean (SD) | 53.3 (10.2) |
| Body weight < 40 kg, n (%) | 426 (5.4) |
| Disease duration, yrs, mean (SD) | 10.4 (9.2) |
| Median, range | 7.8 (0.0–61.9) |
| History of tuberculosis, n (%) | 360 (4.6) |
| History of comorbidities, n (%) | |
| Respiratory disease | 2064 (26.1) |
| Interstitial lung disease | 914 (11.6) |
| Cardiac disorder | 523 (6.6) |
| Hepatic disorder | 562 (7.1) |
| Renal disorder | 482 (6.1) |
| Diabetes mellitus | 796 (10.1) |
| Clinical characteristics | |
| Steinbrocker radiographic stage, n (%) | |
| I | 635 (8.0) |
| II | 2145 (27.1) |
| III | 2583 (32.7) |
| IV | 2532 (32.0) |
| Steinbrocker functional class, n (%) | |
| 1 | 943 (11.9) |
| 2 | 4884 (61.8) |
| 3 | 1994 (25.2) |
| 4 | 71 (0.9) |
| Baseline DAS28-ESR, mean (SD) | 5.3 (1.4) |
| Previous use of biologics, n (%) | 4964 (62.8) |
| 1 drug | 3484 (44.1) |
| 2 drugs | 1368 (17.3) |
| 3 drugs | 112 (1.4) |
| Concomitant DMARD usea, n (%) | 5724 (72.4) |
| Concomitant MTXa, n (%) | 4405 (55.8) |
| MTX dose, mg/week, mean (SD) | 7.0 (2.4) |
| MTX dose, mg/week, min-max | 1–20 |
| Concomitant oral corticosteroid usea, n (%) | 5843 (74.0) |
| Corticosteroid dose, mg/day, mean (SD) | 5.3 (3.3) |
| Corticosteroid dose, mg/day, min-max | 0.1–60 |
↵a Concomitant use at any timepoint during the observation period, including baseline. DAS28-ESR: Disease Activity Score based on 28-joint-erythrocyte sedimentation rate; DMARD: disease-modifying antirheumatic drug; MTX: methotrexate; PY: patient-years; RA: rheumatoid arthritis; TCZ: tocilizumab.