Table 1.
Patient characteristics
| Present study (n = 30) | Nintedanib group in INPULSIS trials | ||
|---|---|---|---|
| Japanese (n = 76) | Overall (n = 638) | ||
| Baseline characteristics | |||
| Age | 72.0 [68.0, 74.8] | 68.4 ± 7.6a | 66.6 ± 8.1a |
| Gender (male/female) | 24/6 | 62/14 | 507/131 |
| Current or former smoker (%) | 26 (86.7%) | 66 (86.8%) | 464 (72.7%) |
| Physique | |||
| Body weight (kg) | 54.9 [49.7, 64.4] | 63.8 ± 11.6a | 79.2 ± 16.6a |
| Body mass index | 21.0 [19.0, 23.6] | 24.4 ± 3.4a | 28.1 ± 4.6a |
| Body surface area (DuBois, m2) | 1.59 [1.48, 1.72] | – | – |
| Concomitant therapy | |||
| Prednisolone (%) | 3 (10.0%) | 9 (11.8%) | 136 (21.3%) |
| Tacrolimus (%) | 1 (3.3%) | 0 | 0 |
| Laboratory data | |||
| Aspartate aminotransferase (IU/L) | 21.5 [18.0, 24.8] | – | – |
| Alanine aminotransferase (IU/L) | 16.0 [11.0, 24.3] | – | – |
| Total bilirubin (mg/dL) | 0.50 [0.30, 0.60] | – | – |
| γ-glutamyl transpeptidase (IU/L) | 31.0 [21.3, 48.0] | – | – |
| Creatinine (mg/dL) | 0.80 [0.68, 0.87] | – | – |
| Krebs von den Lungen-6 (U/mL) | 1021 [829, 1903] | – | – |
| Surfactant protein D (ng/dL) | 382 [259, 452] | – | – |
| Lung function test | |||
| Forced vital capacity (L) | 1.68 [1.34, 1.99] | 2.42 ± 0.67a | 2.71 ± 0.76a |
| % Forced vital capacity (%) | 52.9 [43.7, 69.7] | 80.9 ± 16.6a | 79.7 ± 17.6a |
| % DLco (%) | 44.2 [40.9, 58.5] | 44.6 ± 11.4a | 47.4 ± 13.5a |
| Administration history of pirfenidone | |||
| Administration period (months) | 8.30 [4.23, 13.9] | – | – |
| Time from discontinuation to nintedanib initiation | |||
| 0 (direct switch) | 20 (66.6%) | – | – |
| < 1 month | 3 (10.0%) | – | – |
| ≥ 1 month | 7 (23.3%) | – | – |
| Reason for discontinuation (%) | |||
| Decline of FVC | 15 (50.0%) | – | – |
| Adverse events | 15 (50.0%) | – | – |
| Maintenance dose (%) | |||
| < 1200 mg | 10 (33.3%) | – | – |
| 1200 mg | 16 (53.3%) | – | – |
| 1800 mg | 4 (13.3%) | – | – |
Categorical data are presented as numbers (percentages) and continuous data are presented as medians (interquartile ranges)
Abbreviation: DLco diffusing capacity for lung carbon monoxide
aContinuous data in INPULSIS trials are presented as the mean ± standard deviation