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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
  1. Changes from baseline are adjusted mean (SE). HR Hazard ratio. aBased on the annual rate of decline in weight