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Table 4 Outcomes over 52 weeks in subgroups by number of comorbidities at baseline

From: Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities

 

 < 5 comorbidities

 ≥ 5 comorbidities

 

Nintedanib (n = 452)

Placebo (n = 391)

Nintedanib (n = 443)

Placebo (n = 404)

Rate of decline in FVC (mL/year), adjusted mean (SE)

− 116.6 (14.1)

− 224.5 (16.7)

− 88.6 (15.4)

− 227.8 (17.4)

Difference (95% CI)

107.9 (65.0, 150.9)

139.3 (93.8, 184.8)

p-value for treatment-by-time-by-subgroup interaction

0.41

Change from baseline in SGRQ total score, adjusted mean (SE)

1.8 (0.9)

2.6 (1.0)

2.8 (0.9)

5.8 (1.0)

Difference (95% CI)

− 0.8 (− 3.3, 1.8)

− 3.0 (− 5.6, − 0.5)

p-value for treatment-by-subgroup interaction

0.22

Change from baseline in SGRQ symptoms score, adjusted mean (SE)

0.8 (1.1)

1.0 (1.3)

− 1.2 (1.2)

3.8 (1.3)

Difference (95% CI)

− 0.3 (− 3.5, 3.0)

− 5.0 (− 8.3, − 1.8)

p-value for treatment-by-subgroup interaction

0.04

Change from baseline in SGRQ activity score, adjusted mean (SE)

2.9 (1.0)

4.6 (1.1)

3.7 (1.0)

8.2 (1.1)

Difference (95% CI)

− 1.7 (− 4.5, 1.2)

− 4.5 (− 7.4, − 1.6)

p-value for treatment-by-subgroup interaction

0.17

Change from baseline in SGRQ impact score, adjusted mean (SE)

1.9 (1.0)

2.3 (1.1)

3.9 (1.0)

5.9 (1.1)

Difference (95% CI)

− 0.5 (− 3.3, 2.4)

− 2.0 (− 4.9, 0.9)

p-value for treatment-by-subgroup interaction

0.46

Acute exacerbation of IPF, n (%)

16 (3.5)

18 (4.6)

19 (4.3)

28 (6.9)

Hazard ratio (95% CI)

0.56 (0.28, 1.10)

0.53 (0.30, 0.96)

p-value for treatment-by-subgroup interaction

0.87

Deaths, n (%)

17 (3.8)

21 (5.4)

26 (5.9)

25 (6.2)

Hazard ratio (95% CI)

0.51 (0.27, 0.99)

0.85 (0.49, 1.48)

p-value for treatment-by-subgroup interaction

0.24

  1. FVC forced vital capacity, ILD interstitial lung disease, SGRQ St George’s Respiratory Questionnaire
  2. Not all patients provided data for all endpoints; in the nintedanib and placebo groups, SGRQ total score was analysed in 430 and 373 patients with < 5 comorbidities and 419 and 384 patients with ≥ 5 comorbidities, SGRQ symptoms score in 435 and 378 patients with < 5 comorbidities and 434 and 387 patients with ≥ 5 comorbidities, SGRQ activity score in 430 and 375 patients with < 5 comorbidities and 428 and 388 patients with ≥ 5 comorbidities, and SGRQ impact score in 431 and 378 patients with < 5 comorbidities and 422 and 387 patients with ≥ 5 comorbidities, respectively