Table 1 Outcomes in subgroups of patients by BMI at baseline
From: Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis
BMI < 25 kg/m2 at baseline | BMI ≥ 25 and < 30 kg/m2 at baseline | BMI ≥ 30 kg/m2 at baseline | ||||
|---|---|---|---|---|---|---|
Nintedanib (n = 167) | Placebo (n = 140) | Nintedanib (n = 285) | Placebo (n = 168) | Nintedanib (n = 186) | Placebo (n = 115) | |
Annual rate of decline in FVC (mL/year) over 52 weeks | −142.9 (20.8) | −283.3 (22.4) | −104.0 (16.0) | −207.9 (20.9) | − 104.5 (21.4) | −175.7 (27.0) |
Difference versus placebo (95% CI) | 140.4 (80.5, 200.4) | 103.9 (52.1, 155.7) | 71.1 (3.2, 139.1) | |||
p-value for treatment-by-time-by-subgroup interaction | 0.31 | |||||
Absolute change from baseline in FVC (mL) over 52 weeks | −142.1 (23.1) | − 295.4 (25.1) | − 94.1 (17.6) | −175.4 (22.9) | −95.0 (21.5) | − 175.7 (27.1) |
Difference versus placebo (95% CI) | 153.4 (86.2, 220.5) | 81.2 (24.4, 138.0) | 80.8 (12.5, 149.0) | |||
p-value for treatment-by-subgroup interaction | 0.16 | |||||
Absolute change from baseline in FVC (% predicted) over 52 weeks | −4.7 (0.7) | − 9.0 (0.8) | −2.8 (0.5) | − 5.1 (0.7) | −2.6 (0.6) | − 5.1 (0.7) |
Difference versus placebo (95% CI) | 4.3 (2.2, 6.4) | 2.2 (0.6, 3.9) | 2.6 (0.7, 4.4) | |||
p-value for treatment-by-subgroup interaction | 0.11 | |||||
Absolute change from baseline in SGRQ total score over 52 weeks | 5.2 (1.3) | 7.0 (1.4) | 3.4 (1.0) | 4.5 (1.3) | 2.9 (1.2) | 4.2 (1.5) |
Difference versus placebo (95% CI) | −1.8 (− 5.6, 2.0) | −1.1 (−4.4, 2.2) | − 1.3 (− 5.0, 2.3) | |||
p-value for treatment-by-subgroup interaction | 0.45 | |||||
Patients with absolute decline in FVC ≥10% predicted or death at week 52, n (%) | 52 (31.1) | 69 (49.3) | 70 (24.6) | 60 (35.7) | 51 (27.4) | 46 (40.0) |
HR (95% CI) | 0.48 (0.33, 0.69) | 0.68 (0.48, 0.96) | 0.62 (0.41, 0.92) | |||
p-value for treatment-by-subgroup interaction | 0.58 | |||||
Patients with ≥1 acute exacerbation of IPF over 52 weeks | 11 (6.6) | 11 (7.9) | 15 (5.3) | 13 (7.7) | 5 (2.7) | 8 (7.0) |
HR (95% CI) | 0.81 (0.35, 1.91) | 0.69 (0.32, 1.45) | 0.42 (0.14, 1.30) | |||
p-value for treatment-by-subgroup interaction | 0.64 | |||||
Deaths over 52 weeks, n (%) | 10 (6.0) | 15 (10.7) | 16 (5.6) | 10 (6.0) | 9 (4.8) | 8 (7.0) |
HR (95% CI) | 0.49 (0.22, 1.11) | 0.92 (0.42, 2.04) | 0.69 (0.27, 1.81) | |||
p-value for treatment-by-subgroup interaction | 0.60 | |||||