< 5 comorbidities | ≥ 5 comorbidities | |||
---|---|---|---|---|
Nintedanib (n = 452) | Placebo (n = 391) | Nintedanib (n = 443) | Placebo (n = 404) | |
Rate of decline in FVC (mL/year), adjusted mean (SE) | − 116.6 (14.1) | − 224.5 (16.7) | − 88.6 (15.4) | − 227.8 (17.4) |
Difference (95% CI) | 107.9 (65.0, 150.9) | 139.3 (93.8, 184.8) | ||
p-value for treatment-by-time-by-subgroup interaction | 0.41 | |||
Change from baseline in SGRQ total score, adjusted mean (SE) | 1.8 (0.9) | 2.6 (1.0) | 2.8 (0.9) | 5.8 (1.0) |
Difference (95% CI) | − 0.8 (− 3.3, 1.8) | − 3.0 (− 5.6, − 0.5) | ||
p-value for treatment-by-subgroup interaction | 0.22 | |||
Change from baseline in SGRQ symptoms score, adjusted mean (SE) | 0.8 (1.1) | 1.0 (1.3) | − 1.2 (1.2) | 3.8 (1.3) |
Difference (95% CI) | − 0.3 (− 3.5, 3.0) | − 5.0 (− 8.3, − 1.8) | ||
p-value for treatment-by-subgroup interaction | 0.04 | |||
Change from baseline in SGRQ activity score, adjusted mean (SE) | 2.9 (1.0) | 4.6 (1.1) | 3.7 (1.0) | 8.2 (1.1) |
Difference (95% CI) | − 1.7 (− 4.5, 1.2) | − 4.5 (− 7.4, − 1.6) | ||
p-value for treatment-by-subgroup interaction | 0.17 | |||
Change from baseline in SGRQ impact score, adjusted mean (SE) | 1.9 (1.0) | 2.3 (1.1) | 3.9 (1.0) | 5.9 (1.1) |
Difference (95% CI) | − 0.5 (− 3.3, 2.4) | − 2.0 (− 4.9, 0.9) | ||
p-value for treatment-by-subgroup interaction | 0.46 | |||
Acute exacerbation of IPF, n (%) | 16 (3.5) | 18 (4.6) | 19 (4.3) | 28 (6.9) |
Hazard ratio (95% CI) | 0.56 (0.28, 1.10) | 0.53 (0.30, 0.96) | ||
p-value for treatment-by-subgroup interaction | 0.87 | |||
Deaths, n (%) | 17 (3.8) | 21 (5.4) | 26 (5.9) | 25 (6.2) |
Hazard ratio (95% CI) | 0.51 (0.27, 0.99) | 0.85 (0.49, 1.48) | ||
p-value for treatment-by-subgroup interaction | 0.24 |