Skip to main content

Table 2 Outcomes over 52 weeks in subgroups by age at baseline

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

 

Age < 75 years

Age ≥ 75 years

 

Nintedanib (n = 717)

Placebo (n = 647)

Nintedanib (n = 178)

Placebo (n = 148)

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

− 104.3 (11.8)

− 229.5 (13.5)

− 96.0 (20.9)

− 201.3 (26.1)

Difference (95% CI)

125.2 (90.1, 160.4)

105.3 (39.3, 171.2)

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

0.6

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

2.4 (0.6)

3.8 (0.6)

0.8 (1.4)

6.0 (1.6)

Difference (95% CI)

− 1.4 (− 3.0, 0.2)

− 5.2 (− 9.0, − 1.3)

p-value for treatment-by-subgroup interaction

0.79

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

0.3 (0.9)

2.8 (1.0)

− 2.3 (1.9)

0.5 (2.4)

Difference (95% CI)

− 2.6 (− 5.1, − 0.1)

− 2.8 (− 8.7, 3.1)

p-value for treatment-by-subgroup interaction

0.94

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

3.2 (0.8)

5.9 (0.9)

3.3 (1.7)

9.3 (2.1)

Difference (95% CI)

− 2.7 (− 4.9, − 0.5)

− 6.0 (− 11.2, − 0.7)

p-value for treatment-by-subgroup interaction

0.26

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

2.9 (0.8)

3.7 (0.9)

2.4 (1.7)

7.2 (2.1)

Difference 95% CI)

− 0.7 (− 2.9, 1.5)

− 4.9 (− 10.1, 0.3)

p-value for treatment-by-subgroup interaction

0.15

Acute exacerbation of IPF, n (%)

27 (3.8)

37 (5.7)

8 (4.5)

9 (6.1)

Hazard ratio (95% CI)

0.56 (0.34, 0.93)

0.45 (0.17, 1.20)

p-value for treatment-by-subgroup interaction

0.96

Deaths, n (%)

33 (4.6)

32 (4.9)

10 (5.6)

14 (9.5)

Hazard ratio (95% CI)

0.78 (0.48, 1.26)

0.39 (0.17, 0.89)

p-value for treatment-by-subgroup interaction

0.19

  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 682 and 619 patients aged < 75 years and 167 and 138 patients aged ≥ 75 years, SGRQ symptoms score in 697 and 624 patients aged < 75 years and 172 and 141 patients aged ≥ 75 years, SGRQ activity score in 691 and 624 patients aged < 75 years and 167 and 139 patients aged ≥ 75 years, and SGRQ impact score in 684 and 625 patients aged < 75 years and 169 and 140 patients aged ≥ 75 years, respectively