Table 2.
Safety and tolerability of antifibrotic agents in selective clinical trials.
| ASCEND
37
|
INBUILD
29
|
SENCIS
40
|
INJOURNEY
71
|
|||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Pl | Pi | Pl | Ni | Pl | MMF | Ni | Ni + MMF | Ni | Ni + Pi | |
| Any AE† | n.r. | n.r. | 89.4% | 95.5% | 95% | 96% | 99% | 98% | 88.2% | 88.7% |
| Nausea | 13.4% | 36.0% | 9.4% | 28.9% | 11% | 16% | 32% | 31% | 11.8% | 41.5% |
| Vomiting | 8.7% | 12.9% | 5.1% | 18.4% | 9% | 12% | 26% | 23% | 11.8% | 28.3% |
| Diarrhea | 21.7% | 22.3% | 23.9% | 66.9% | 29% | 34% | 75% | 76% | 31.4% | 37.7% |
| Abdominal pain | n.r. | n.r. | 2.4% | 10.2% | 10% | 4% | 13% | 10% | 7.8% | 13.2% |
| Fatigue | 17.3% | 20.9% | n.r. | n.r. | 4% | 10% | 8% | 14% | 11.8% | 18.9% |
| Headache | 23.1% | 25.9% | 6.9% | 10.5% | 6% | 11% | 7% | 12% | 2.0% | 13.2% |
| Weight loss | 7.9% | 12.6% | 3.3% | 12.3% | 5% | 3% | 16% | 7% | n.r. | n.r. |
| SAE | 24.9% | 19.8% | 32.2% | 32.2% | 27% | 13% | 22% | 26% | 9.8% | 3.8% |
| Transaminitis ‡ | 0.9% | 2.7% | 3.6% | 13.0% | n.r. | n.r. | n.r. | n.r. | 0 | 5.7% |
| Treatment discontinuation | 10.8% | 14.4% | 10.3% | 19.6% | 11% | 6% | 21% | 11% | 21.4% | 35.8% § |
AE, adverse event; MMF, mycophenolate mofetil; Ni, nintedanib; n.r., not reported; Pi, Pirfenidone; Pl, placebo; SAE, serious adverse event.
†
Adverse events were attributed by adjudicators to being due to pirfenidone, nintedanib, or combination therapy.
‡
Greater than three-fold the upper limit of normal.
§
Unable to tolerate combination therapy.