Table 3.
Efficacy of nintedanib in the treatment of adults with progressive fibrosing ILDs in the phase III INBUILD trial [36]
| Primary population | Adjusted annual rate of decline in FVC (mL/year)a | Absolute change from BL in K-BILD total score at week 52b | Acute exacerbation of ILD or death at week 52 (% of pts)b | Death at week 52 (% of pts)b |
|---|---|---|---|---|
| Overall population | ||||
| Nintedanib (n = 332) | − 80.8 | 0.55 | 7.8 | 4.8 |
| Placebo (n = 331) | − 187.8 | − 0.79 | 9.7 | 5.1 |
| Difference vs placebo (95% CI) | 107.0 (65.4 to 148.5)* | 1.34 (−0.31 to 2.98) | ||
| Hazard ratio (95% CI) | 0.80 (0.48 to 1.34) | 0.94 (0.47 to 1.86) | ||
| Pts with a UIP-like fibrotic pattern | ||||
| Nintedanib (n = 206) | − 82.9 | 0.75 | 8.3 | 5.3 |
| Placebo (n = 206) | − 211.1 | − 0.78 | 12.1 | 7.8 |
| Difference vs placebo (95% CI) | 128.2 (70.8 to 185.6)* | 1.53 (−0.68 to 3.74) | ||
| Hazard ratio (95% CI) | 0.67 (0.36 to 1.24) | 0.68 (0.32 to 1.47) | ||
BL baseline, FVC forced vital capacity, ILD(s) interstitial lung disease(s), K-BILD King’s Brief Interstitial Lung Disease questionnaire (range 0–100; higher scores represent better health status), pt(s) patient(s), UIP usual interstitial pneumonia
*p < 0.001 vs placebo
aPrimary endpoint (analysis based on all FVC measurements over 52-week period, including those from pts who prematurely discontinued study drug; analysis allowed for missing data with assumption they were missing at random)
bAbsolute change from BL in K-BILD total score at week 52, time to first acute exacerbation of ILD or death over 52-week period and time to death over 52-week period were main secondary endpoints (not adjusted for multiple comparisons); pt numbers analysed for K-BILD differ