Age < 75 years | Age ≥ 75 years | |||
---|---|---|---|---|
Nintedanib (n = 717) | Placebo (n = 647) | Nintedanib (n = 178) | Placebo (n = 148) | |
Rate of decline in FVC (mL/year), adjusted mean (SE) | − 104.3 (11.8) | − 229.5 (13.5) | − 96.0 (20.9) | − 201.3 (26.1) |
Difference (95% CI) | 125.2 (90.1, 160.4) | 105.3 (39.3, 171.2) | ||
p-value for treatment-by-time-by-subgroup interaction | 0.6 | |||
Change from baseline in SGRQ total score, adjusted mean (SE) | 2.4 (0.6) | 3.8 (0.6) | 0.8 (1.4) | 6.0 (1.6) |
Difference (95% CI) | − 1.4 (− 3.0, 0.2) | − 5.2 (− 9.0, − 1.3) | ||
p-value for treatment-by-subgroup interaction | 0.79 | |||
Change from baseline in SGRQ symptoms score, adjusted mean (SE) | 0.3 (0.9) | 2.8 (1.0) | − 2.3 (1.9) | 0.5 (2.4) |
Difference (95% CI) | − 2.6 (− 5.1, − 0.1) | − 2.8 (− 8.7, 3.1) | ||
p-value for treatment-by-subgroup interaction | 0.94 | |||
Change from baseline in SGRQ activity score, adjusted mean (SE) | 3.2 (0.8) | 5.9 (0.9) | 3.3 (1.7) | 9.3 (2.1) |
Difference (95% CI) | − 2.7 (− 4.9, − 0.5) | − 6.0 (− 11.2, − 0.7) | ||
p-value for treatment-by-subgroup interaction | 0.26 | |||
Change from baseline in SGRQ impact score, adjusted mean (SE) | 2.9 (0.8) | 3.7 (0.9) | 2.4 (1.7) | 7.2 (2.1) |
Difference 95% CI) | − 0.7 (− 2.9, 1.5) | − 4.9 (− 10.1, 0.3) | ||
p-value for treatment-by-subgroup interaction | 0.15 | |||
Acute exacerbation of IPF, n (%) | 27 (3.8) | 37 (5.7) | 8 (4.5) | 9 (6.1) |
Hazard ratio (95% CI) | 0.56 (0.34, 0.93) | 0.45 (0.17, 1.20) | ||
p-value for treatment-by-subgroup interaction | 0.96 | |||
Deaths, n (%) | 33 (4.6) | 32 (4.9) | 10 (5.6) | 14 (9.5) |
Hazard ratio (95% CI) | 0.78 (0.48, 1.26) | 0.39 (0.17, 0.89) | ||
p-value for treatment-by-subgroup interaction | 0.19 |