Table 4. Longitudinal comparison of functional, clinical, and radiological outcomes between nintedanib and pirfenidone treatment groups over five years.
|
Year |
Parameter |
Nintedanib (n = 41) |
Pirfenidone (n = 52) |
P |
|
6 months |
Mortality (%) |
7.89% (3/38) |
0% (0/50) |
0.077 |
|
FVC (%) |
79.97±20.86 |
75.00±15.71 |
0.179 |
|
|
FEV1 (%) |
84.64±20.64 |
80.92±17.85 |
0.375 |
|
|
FEV1/FVC (%) |
86.75±9.14 |
83.86±10.01 |
0.163 |
|
|
DLCO (%) |
61.88±51.40 |
54.70±14.37 |
0.972 |
|
|
6MWT (m) |
363.82±97.78 |
372.68±132.17 |
0.803 |
|
|
Radiology, n (%) Stable Progression |
- 35 (94.6) 2 (5.4) |
- 49 (98.0) 1 (2.0) |
- - 0.572 |
|
|
Clinical n (%) Stable Progression |
- 34 (91.9%) 3 (8.1%) |
- 49 (98.0%) 1 (2.0%) |
- - 0.308 |
|
1 year |
Mortality (%) |
0% (0/32) |
0% (0/47) |
- |
|
SpO2 |
95.59±2.30 |
93.81±4.56 |
0.155 |
|
|
FVC (%) |
82.06±26.64 |
72.53±16.52 |
0.061 |
|
|
FEV1 (%) |
86.03±24.47 |
78.02±16.87 |
0.114 |
|
|
FEV1/FVC (%) |
86.56±10.31 |
84.98±10.73 |
0.656 |
|
|
DLCO (%) |
52.55±17.22 |
51.40±14.24 |
0.755 |
|
|
6MWT (m) |
369.83±103.27 |
362.17±108.03 |
0.788 |
|
|
sPAP |
41.60±17.90 |
55.80±22.54 |
0.353 |
|
|
Radiology, n (%) Stable Progression |
- 24 (75.0%) 8 (25.0%) |
- 36 (76.6%) 11 (23.4%) |
- - 0.871 |
|
|
Clinical, n (%) Stable Progression |
- 22 (68.8%) 10 (31.3%) |
- 34 (72.3%) 13 (27.7%) |
- - 0.730 |
|
|
2 year |
Mortality (%) |
7.1% (2/28) |
20.5% (9/44) |
0.183 |
|
SpO2 |
95.16±2.17 |
92.68±5.55 |
0.266 |
|
|
FVC (%) |
88.95±26.99 |
73.45±20.37 |
0.026 |
|
|
FEV1 (%) |
94.05±28.21 |
79.32±20.93 |
0.040 |
|
|
FEV1/FVC (%) |
86.11±8.24 |
85.46±9.65 |
0.920 |
|
|
DLCO (%) |
46.92±15.75 |
55.08±13.06 |
0.257 |
|
|
6MWT (m) |
368.44±69.69 |
353.75±114.94 |
0.479 |
|
|
Radiology, n (%) Stable Progression |
- 13 (68.4%) 6 (31.6%) |
- 17 (54.8%) 14 (45.2%) |
- - 0.341 |
|
|
Clinical, n (%) Stable Progression |
- 14 (73.7%) 5 (26.3%) |
- 16 (51.6%) 15 (48.4%) |
- - 0.122 |
|
|
3 year |
Mortality (%) |
3.85% (1/26) |
14.71% (5/34) |
0.377 |
|
SpO2 |
95.00±2.55 |
93.81±5.24 |
0.857 |
|
|
FVC (%) |
96.11±28.03 |
78.44±21.58 |
0.074 |
|
|
FEV1 (%) |
97.89±26.83 |
83.94±20.80 |
0.165 |
|
|
FEV1/FVC (%) |
84.56±12.22 |
85.25±8.55 |
0.609 |
|
|
DLCO (%) |
50.29±8.67 |
53.36±12.31 |
0.765 |
|
|
6MWT (m) |
406.67±20.82 |
381.36±121.32 |
0.696 |
|
|
Radiology n (%) Stable Progression |
- 7 (77.8%) 2 (22.2%) |
- 10 (62.5%) 6 (37.5%) |
- - 0.661 |
|
|
Clinical n (%) Stable Progression |
- 7 (77.8%) 2 (22.2%) |
- 10 (62.5%) 6 (37.5%) |
- - 0.661 |
|
4 year |
Mortality (%) |
0% (0/25) |
20.69% (6/29) |
0.129 |
|
SpO2 (%) |
95.8±0.84 |
95.5±2.07 |
0.747 |
|
|
FVC (%) |
107.0±15.22 |
85.2±33.30 |
0.111 |
|
|
FEV1 (%) |
107.0±19.84 |
93.2±35.67 |
0.220 |
|
|
FEV1/FVC (%) |
79.2±9.83 |
87.3±6.04 |
0.121 |
|
|
DLCO (%) |
45.5±3.54 |
48.5±14.83 |
1.000 |
|
|
6MWT (m) |
Not provided |
Not provided |
||
|
Radiology n (%) Stable Progression |
- 3 (60.0%) 2 (40.0%) |
- 7 (70.0%) 3 (30.0%) |
- - 1.000 |
|
|
Clinical n (%) Stable Progression |
- 3 (60.0%) 2 (40.0%) |
- 8 (80.0%) 2 (20.0%) |
- - 0.560 |
|
|
5 year |
Mortality (%) |
4% (1/25) |
13.04% (3/23) |
1.000 |
|
Radiology n (%) Stable Progression |
- 1 (100.0%) 0 (0.0%) |
- 1 (25.0%) 3 (75.0%) |
- - 0.400 |
|
|
Clinical n (%) Stable Progression |
- 1 (100.0%) 1 (0.0%) |
- 2 (50.0%) 2 (50.0%) |
- - 1.000 |
|
SpO2: Peripheral oxygen saturation, FVC: Forced vital capacity, FEV1/FVC: Ratio of Forced expiratory volume in the first second to forced vital capacity, DLCO: Diffusing capacity for carbon monoxide, GAP: Gender, Age, Physiology Score, sPAP: Systolic pulmonary artery pressure