Table 2 Outcomes in subgroups of patients by weight loss over 52 weeksa
From: Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis
Weight loss ≤ 5% | Weight loss > 5% | |||
|---|---|---|---|---|
Nintedanib (n = 397) | Placebo (n = 338) | Nintedanib (n = 241) | Placebo (n = 85) | |
Annual rate of decline in FVC (mL/year) assessed over 52 weeks | − 121.0 (13.2) | −199.5 (14.4) | − 103.0 (19.5) | −312.7 (32.2) |
Difference versus placebo (95% CI) | 78.5 (40.1, 116.9) | 209.6 (135.7, 283.6) | ||
p-value for treatment-by-time-by-subgroup interaction | 0.0008 | |||
Absolute change from baseline in FVC (mL) over 52 weeks | − 114.2 (14.6) | − 197.3 (15.9) | −94.4 (20.1) | − 278.9 (33.4) |
Difference versus placebo (95% CI) | 83.1 (40.8, 125.4) | 184.5 (107.8, 261.2) | ||
p-value for treatment-by-subgroup interaction | 0.54 | |||
Absolute change from baseline in FVC % predicted over 52 weeks | −3.3 (0.4) | −5.6 (0.5) | −3.1 (0.6) | −9.1 (1.0) |
Difference versus placebo (95% CI) | 2.3 (1.1, 3.5) | 6.0 (3.6, 8.4) | ||
p-value for treatment-by-subgroup interaction | 0.54 | |||
Absolute change from baseline in SGRQ total score over 52 weeks | 3.3 (0.8) | 3.0 (0.9) | 4.2 (1.1) | 13.6 (1.7) |
Difference versus placebo (95% CI) | 0.3 (−2.1, 2.7) | −9.5 (−13.5, −5.4) | ||
p-value for treatment-by-subgroup interaction | 0.20 | |||
Patients with absolute decline in FVC ≥10% predicted or death at week 52, n (%) | 100 (25.2) | 128 (37.9) | 73 (30.3) | 47 (55.3) |
HR (95% CI) | 0.62 (0.48, 0.81) | 0.51 (0.35, 0.73) | ||
p-value for treatment-by-subgroup interaction | 0.32 | |||
Patients with ≥1 acute exacerbation of IPF over 52 weeks | 14 (3.5) | 22 (6.5) | 17 (7.1) | 10 (11.8) |
HR (95% CI) | 0.53 (0.27, 1.04) | 0.63 (0.29, 1.38) | ||
p-value for treatment-by-subgroup interaction | 0.84 | |||
Deaths over 52 weeks, n (%) | 19 (4.8) | 28 (8.3) | 16 (6.6) | 5 (5.9) |
HR (95% CI) | 0.58 (0.32, 1.04) | 1.24 (0.45, 3.41) | ||
p-value for treatment-by-subgroup interaction | 0.23 | |||