Table 2 Dose reductions and treatment interruptions in the INPULSIS® trials
From: Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis
N (%) | Nintedanib | Placebo |
|---|---|---|
(n = 638) | (n = 423) | |
Dose reductions | ||
Patients with ≥1 dose reduction | 178 (27.9) | 16 (3.8) |
Dose reductions per patient | ||
1 | 163 (25.5) | 16 (3.8) |
2 | 13 (2.0) | 0 (0.0) |
> 2 | 2 (0.3) | 0 (0.0) |
Time to first dose reduction | ||
≤ 1 month | 20 (3.1) | 1 (0.2) |
> 1 month to ≤2 months | 28 (4.4) | 4 (0.9) |
> 2 month to ≤3 months | 19 (3.0) | 0 (0.0) |
> 3 month to ≤4 months | 18 (2.8) | 3 (0.7) |
> 4 month to ≤5 months | 24 (3.8) | 1 (0.2) |
> 5 month to ≤6 months | 22 (3.4) | 1 (0.2) |
> 6 months | 47 (7.4) | 6 (1.4) |
Patients with ≥1 dose increase to 150 mg bid | 40 (6.3) | 7 (1.7) |
Patients who took 150 mg bid as last dose | 487 (76.3) | 414 (97.9) |
Treatment interruptions | ||
Patients with ≥1 treatment interruption | 151 (23.7) | 42 (9.9) |
Treatment interruptions per patient | ||
1 | 113 (17.7) | 39 (9.2) |
2 | 30 (4.7) | 3 (0.7) |
> 2 | 8 (1.3) | 0 (0.0) |
Time to first treatment interruption | ||
≤ 1 month | 32 (5.0) | 3 (0.7) |
> 1 month to ≤2 months | 18 (2.8) | 4 (0.9) |
> 2 month to ≤3 months | 18 (2.8) | 6 (1.4) |
> 3 month to ≤4 months | 21 (3.3) | 4 (0.9) |
> 4 month to ≤5 months | 18 (2.8) | 2 (0.5) |
> 5 month to ≤6 months | 11 (1.7) | 3 (0.7) |
> 6 months | 33 (5.2) | 20 (4.7) |
Patients re-introduced at the same dose of 100 mg bid after treatment interruptiona | 20 (13.2) | 1 (2.4) |
Patients re-introduced at a reduced dose of 100 mg bid after treatment interruptiona | 81 (53.6) | 9 (21.4) |
Patients re-introduced at the same dose of 150 mg bid after treatment interruptiona | 49 (32.5) | 32 (76.2) |
Patients re-introduced at an increased dose of 150 mg bid after treatment interruptiona | 1 (0.7) | 0 (0.0) |