Table 1.
Patient characteristics.
| Our patients | Nintedanib group in INPULSIS trials | ||
|---|---|---|---|
| Japanese | Overall | ||
| Number of patients | 68 | 76 | 638 |
| Age | 72.0 (68.0–76.0) | 68.4 ± 7.6* | 66.6 ± 8.1* |
| Gender (male/female) | 52/16 | 62/14 | 507/131 |
| Physique | |||
| Height (cm) | 164 (158–169) | — | — |
| Body weight (kg) | 57.7 (51.2–69.8) | 63.8 ± 11.6* | 79.2 ± 16.6* |
| Body mass index | 22.1 (19.6–25.0) | 24.4 ± 3.4* | 28.1 ± 4.6* |
| Body surface area (DuBois, m2) | 1.64 (1.48–1.79) | — | — |
| Laboratory data | |||
| Aspartate aminotransferase (IU/L) | 21.0 (17.8–24.5) | — | — |
| Alanine aminotransferase (IU/L) | 14.0 (11.0–22.0) | — | — |
| Alkaline phosphatase (IU/L) | 241 (194–283) | — | — |
| Total bilirubin (mg/dL) | 0.50 (0.40–0.62) | — | — |
| γ-glutamyl transpeptidase (IU/L) | 28.0 (20.0–52.8) | — | — |
| Creatinine (mg/dL) | 0.82 (0.69–0.92) | — | — |
| Krebs von den Lungen-6 (U/mL) | 1067 (694–1560) | — | — |
| Surfactant protein D (ng/dL) | 294 (182–409) | — | — |
| Pulmonary function test | |||
| forced vital capacity (L) | 1.90 (1.41–2.35) | 2.42 ± 0.67* | 2.71 ± 0.76* |
| % forced vital capacity (%) | 62.3 (50.1–72.1) | 80.9 ± 16.6* | 79.7 ± 17.6* |
| % DLCO (%) | 50.8 (41.3–63.6) | 44.6 ± 11.4* | 47.4 ± 13.5* |
| Six minute walk test | |||
| lowest SpO2 (%) | 82.0 (76.0–87.0) | — | — |
| walking distance (meter) | 410 (340–480) | — | — |
| Concomitant therapy | |||
| Prednisolone (%) | 11 (16.2%) | 9 (11.8%) | 136 (21.3%) |
| Cyclosporine (%) | 2 (2.9%) | 0 | 0 |
| Cyclophosphamide (%) | 2 (2.9%) | 0 | 0 |
| Tacrolimus (%) | 5 (7.4%) | 0 | 0 |
| Pirfenidone (%) | 2 (2.9%) | 0 | 0 |
Categorical data are presented as numbers (percentages) and continuous data are presented as medians (interquartile ranges). *Continuous data in INPULSIS trials are presented as the mean ± standard deviation. Abbreviations: DLCO = diffusing capacity for lung carbon monoxide.