Table 1.
Summary of the trials contributing data to the analyses
| Trial | Population | Treatments | PK sampling | Liver enzyme assessmenta |
|---|---|---|---|---|
|
TOMORROW Randomized Phase II, 52 weeks |
IPF (n = 342)b | Placebo (n = 85) | Pre-dose, Days 1, 29, 169, 365 and end of treatment | Baseline, Days 1, 15, 29, 43, 85, 127, 169, 211, 253, 309, 365 |
| Nintedanib 50 mg BID (n = 86) | ||||
| Nintedanib 100 mg BID (n = 86) | ||||
| Nintedanib 150 mg BID (n = 85) | ||||
|
INPULSIS-1 Randomized Phase III, 52 weeks |
IPF (n = 513) | Placebo (n = 204) | Days 29 and 169 | Baseline, Days 1, 15, 29, 43, 85, 127, 169, 211, 253, 309, 365 |
| Nintedanib 150 mg BID (n = 309) | ||||
|
INPULSIS-2 Randomized Phase III, 52 weeks |
IPF (n = 548) | Placebo (n = 219) | Days 29 and 169 | Baseline, Days 1, 15, 29, 43, 85, 127, 169, 211, 253, 309, 365 |
| Nintedanib 150 mg BID (n = 329) | ||||
|
SENSCIS Randomized Phase III, 52 weeks |
SSc-ILD (n = 576) | Placebo (n = 288) | Days 29 and 169 | Baseline, Days 1, 15, 29, 43, 85, 127, 169, 211, 253, 309, 365 |
| Nintedanib 150 mg BID | ||||
| (n = 288) | ||||
|
INBUILD Randomized Phase III, 52 weeks |
Progressive fibrosing ILD (n = 663) | Placebo (n = 331) | Days 29 and 169 | Baseline, Days 1, 15, 29, 43, 85, 127 (optional), 169, 211 (optional), 253, 309 (optional), 365 |
| Nintedanib 150 mg BID (n = 332) |
BID twice daily, ILD interstitial lung disease, IPF idiopathic pulmonary fibrosis, PK pharmacokinetic, SSc systemic sclerosis
aTreatment period beyond week 52 in the SENSCIS and INBUILD trials was not used for analysis
bFrom 428 patients treated in the TOMORROW trial, 342 patients are shown (86 patients randomized to 50 mg nintedanib once daily were excluded from analysis)