Characteristics of patients participating in postmarketing surveillance of etanercept (ETN) in Japan.
| Characteristic | ETN Cases, n (%) |
|---|---|
| Male/female | 1345/5746 (19.0/81.0) |
| Age, yrs, 15–19, 20–29, 30–39, 40–49, 50–59, 60–69, ≥ 70 | 32 (0.5), 190 (2.7), 468 (6.6), 801 (11.3), 1983 (28.0), 2212 (31.2), 1405 (19.8) |
| Mean weight, kg (range) | 53.3 (27–130) |
| Steinbrocker* stage: I, II, III, IV | 368 (5.2), 1551 (21.9), 2598 (36.7), 2567 (36.2) |
| Steinbrocker* function: I, II, III, IV | 498 (7.0), 3984 (56.2) 2343 (33.1), 259 (3.7) |
| History of tuberculosis: yes | 453†† (6.5) |
| Comorbidities: yes | 4128 (58.2) |
| History of smoking: yes | 1030 (16.5) |
| History of steroid use: yes | 6066 (88.1) |
| No. patients receiving | |
| Chest radiographs | 6988 (98.5) |
| Tuberculin tests | 6649 (93.8) |
| Dose of ETN† administered to patients, no. of patients (%) | |
| > 50 mg | 5866 (82.7) |
| < 20 mg | 14 (0.2) |
| 20–50 mg | 1077 (15.2) |
| Concomitant use of DMARD: yes | 5037 (71.0) |
| No. concomitant DMARD: 1/2/3/4 | 3758/1117/144/18 (53.0/15.8/2.0/0.3) |
| Dose of MTX | |
| No MTX | 3355 (47.3) |
| < 6 mg | 1076 (15.3) |
| ≥ 6 mg ≤ 8 mg | 1273 (18.0) |
| > 8 mg | 1387 (19.6) |
| Concomitant use of steroid: yes | 5317 (75.0) |
| History of infliximab use: yes | 808 (11.4) |
↵DMARD: disease modifying antirheumatic drug; MTX: methotrexate. * A system to define RA, classify the stages of RA progression, criteria for therapeutic response of RA disease activity, and classification of functional impairment8. †Dose and administration in Japanese labeling is 10 to 25 mg × 2 per week. ††444 (98%) received chemoprophylaxis (isoniazid).