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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
  1. Changes from baseline are adjusted mean (SE). HR Hazard ratio