Table 2.
Efficacy of nintedanib in the treatment of adults with idiopathic pulmonary fibrosis [9]
| Study | Adjusted annual rate of decline in FVC (mL/year)a | Adjusted mean change from BL in SGRQ total scoreb | ≥ 1 Investigator-reported acute exacerbation (% of pts)b |
|---|---|---|---|
| INPULSIS-1 | |||
| Nintedanib (n = 309) | − 114.7 | 4.34 | 6.1 |
| Placebo (n = 204) | − 239.9 | 4.39 | 5.4 |
| Difference vs placebo (95% CI) | 125.3 (77.7 to 172.8)** | − 0.05 (− 2.50 to 2.40) | |
| Hazard ratio (95% CI) | 1.15 (0.54 to 2.42) | ||
| INPULSIS-2 | |||
| Nintedanib (n = 329) | − 113.6 | 2.80 | 3.6 |
| Placebo (n = 219) | − 207.3 | 5.48 | 9.6 |
| Difference vs placebo (95% CI) | 93.7 (44.8 to 142.7)** | − 2.69 (− 4.95 to − 0.43)* | |
| Hazard ratio (95% CI) | 0.38 (0.19 to 0.77)* | ||
| INPULSIS-1 and -2 (prespecified pooled analyses) | |||
| Nintedanib (n = 638) | − 113.6 | 3.53 | 4.9 |
| Placebo (n = 423) | − 223.5 | 4.96 | 7.6 |
| Difference vs placebo (95% CI) | 109.9 (75.9 to 144.0)** | − 1.43 (− 3.09 to 0.23) | |
| Hazard ratio (95% CI) | 0.64 (0.39 to 1.05) | ||
BL baseline, FVC forced vital capacity, pts patients, SGRQ St. George’s Respiratory Questionnaire (range 0–100 points; higher scores indicate worse health-related quality of life)
*p < 0.05, **p < 0.001 vs placebo
aPrimary endpoint for both INPULSIS trials (analyses included all available FVC values from BL to week 52, including measurements at follow-up visits for pts who prematurely discontinued study drug; analyses allowed for missing data, assuming they were missing at random)
bAdjusted mean change from BL in SGRQ total score and time to first investigator-reported acute exacerbation were key secondary endpoints in both INPULSIS trials (assessed over 52-week treatment period and evaluated hierarchically) [fewer pts were included in SQRQ analysis]