| Pirfenidone treatment | No-antifibrotic treatment | P-value (pirfenidone vs no-antifibrotics) | |
---|---|---|---|---|
A) FVC %, predicted | ||||
6 mo | Decline FVC %, predicted | 1.0 ± 8.2* | − 2.1 ± 10.2 | 0.028 |
% patients with decline ≥5%/decline < 5% | 17.3%/82.7% | 35.0%/65.0% | 0.004 | |
% patients with decline ≥10%/decline < 10% | 5.3%/94.7% | 18.3%/81.7% | 0.558 | |
12 mo | Decline FVC %, predicted | 0.2 ± 9.2 | − 4.9 ± 10.5* | < 0.001 |
% patients with decline ≥5%/decline < 5% | 25.2%/74.8% | 44.4%/55.6% | 0.003 | |
% patients with decline ≥10%/decline < 10% | 10.7%/89.3% | 25.0%/75.0% | 0.064 | |
18 mo | Decline FVC %, predicted | −1.1 ± 10.4 | − 6.0 ± 11.1* | 0.016 |
% patients with decline ≥5%/decline < 5% | 35.5%/64.5% | 51.5%/48.5% | 0.116 | |
% patients with decline ≥10%/decline < 10% | 16.6%/83.4% | 24.2%/75.8% | 0.818 | |
24 mo | Decline FVC %, predicted | −0.9 ± 10.7 | −6.7 ± 11.3* | 0.003 |
% patients with decline ≥5%/decline < 5% | 34.8%/65.2% | 50.0%/50.0% | 0.102 | |
% patients with decline ≥10%/decline < 10% | 17.0%/83.0% | 31.0%/69.0% | 0.420 | |
B) DLCO (%), predicted | ||||
6 mo | Decline DLCO (%), predicted | −1.6 ± 10.0* | − 4.6 ± 10.3* | 0.036 |
% patients with decline ≥10%/decline < 10% | 15.4%/84.6% | 18.6%/81.4% | 0.558 | |
% patients with decline ≥15%/decline < 15% | 6.1%/93.9% | 8.5%/91.5% | 0.559 | |
12 mo | Decline DLCO (%), predicted | −2.4 ± 11.0* | − 6.0 ± 11.6* | 0.021 |
% patients with decline ≥10%/decline < 10% | 19.7%/80.3% | 30.8%/69.2% | 0.064 | |
% patients with decline ≥15%/decline < 15% | 11.3%/88.7% | 18.5%/81.5% | 0.143 | |
18 mo | Decline DLCO (%), predicted | −3.6 ± 12.1* | − 6.1 ± 12.6* | 0.294 |
% patients with decline ≥10%/decline < 10% | 22.4%/77.6% | 25.0%/75.0% | 0.818 | |
% patients with decline ≥15%/decline < 15% | 11.5%/88.5% | 12.5%/87.5% | 0.772 | |
24 mo | Decline DLCO (%), predicted | −4.7 ± 11.8* | − 8.5 ± 10.1* | 0.072 |
% patients with decline ≥10%/decline < 10% | 26.3%/73.7% | 33.3%/66.7% | 0.420 | |
% patients with decline ≥15%/decline < 15% | 14.3%/85.7% | 25.6%/74.4% | 0.142 |