Table 1. Summary of baseline characteristics of included studies.
| Trial name | Year of publication | Intervention | Patient number | Duration of triala | Randomization | Study population | Age (yr)b | Male (%) | Interval since diagnosis of IPF (yr)b |
|---|---|---|---|---|---|---|---|---|---|
| INBUILD [15] | 2019 | Nintedanib 150 mg bid | 332 | 52 weeks | 1:1 ratio with interactive-response technology and stratified according to UIP-like fibrotic pattern or not. An enrichment design was performed to ensure two thirds of patients having UIP-like pattern. | At least 18 y/o with fibrosing interstitial lung disease and with a more progressive fibrotic phenotype. Having features of fibrosing lung disease affecting more than 10% of lung volume on HRCT. FVC≧ 45% of predicted value and DLCO between 30% and 80% of predicted value. | 65.2±9.7 | 53.9 | NR |
| Placebo | 331 | 66.3±9.8 | 53.5 | NR | |||||
| INPULSIS-1 [7] | 2014 | Nintedanib 150 mg bid | 309 | 52 weeks | 3:2 ratio by an interactive telephone and web-based response system. | At least 40 y/o with diagnosis of IPF within 5 years and had an FVC≧50% of predicted value, and had DLCO between 30% and 79%. | 66.9±8.4 | 81.2 | 1.7±1.4 |
| Placebo | 204 | 66.9±8.2 | 79.9 | 1.6±1.4 | |||||
| INPULSIS-2 [7] | 2014 | Nintedanib 150 mg bid | 329 | 52 weeks | The same as above. | The same as above. | 66.4±7.9 | 77.8 | 1.6±1.3 |
| Placebo | 219 | 67.1±7.5 | 78.1 | 1.6±1.3 | |||||
| NCT01979952 [25] | 2016c | Nintedanib 150 mg bid | 56 | 6 months (up to 18 months) | NR | At least 40 y/o with IPF diagnosis confirmed by HRCT and had an FVC≧50% of predicted value, and had DLCO between 30% and 79%. | NR | 80.4 | NR |
| Placebo | 57 | NR | 64.9 | NR | |||||
| SENSCIS [14] | 2019 | Nintedanib 150 mg bid | 288 | 52 weeks | 1:1 ratio with an interactive response system and stratified by the presence of antitopoisonmerase I antibody. | At least 18 y/o and had systemic sclerosis with the first onset of non-Raynaud’s symptom within 7 years, had an FVC≧40% of predicted value, and had DLCO between 30% and 89% of predicted value. ILD was defined as fibrosis affecting at least 10% of lungs by HRCT. | 54.6±11.8 | 23.3 | NR |
| Placebo | 288 | 53.4±12.6 | 26.4 | NR | |||||
| TOMORROW [6] | 2011 | Nintedanib 50 mg qd | 86 | 52 weeks | Patients were randomized into four treatment groups and placebo group. A stepwise increasing-dose approach was used. | At least 40 y/o with IPF and had a FVC≧50% of predicted value, had DLCO between 30% and 79% of predicted value, and had a partial PaO2 either when breathing ambient air≧55 mmHg or greater at altitudes up to 1500 m. | 65.3±9.4 | 75.6 | 1.4±1.3 |
| Nintedanib 50 mg bid | 86 | 64.9±8.5 | 72.1 | 1.1±1.2 | |||||
| Nintedanib 100 mg bid | 86 | 65.1±8.6 | 75.6 | 1.2±1.2 | |||||
| Nintedanib 150 mg bid | 85 | 65.4±7.8 | 76.5 | 1.0±1.2 | |||||
| Placebo | 85 | 64.8±8.6 | 74.1 | 1.4±1.5 |
IPF, idiopathic pulmonary fibrosis; FVC, forced vital capacity; DLCO, diffusing capacity of the lung for carbon monoxide; SpO2, oxygen saturation of peripheral blood; NR, not reported.
aDefined by the duration from start of trial to the time of end points measurements.
bPresented as mean±standard deviation.