Safety outcomes through week 52
| Event, n (%) | FIL 200 mg + MTX (n = 416) | FIL 100 mg + MTX (n = 207) | FIL 200 mg (n = 210) | MTX (n = 416) |
|---|---|---|---|---|
| All AEs | 318 (76.4) | 164 (79.2) | 143 (68.1) | 305 (73.3) |
| Serious AEs | 26 (6.3) | 13 (6.3) | 17 (8.1) | 28 (6.7) |
| Infection | 148 (35.6) | 76 (36.7) | 75 (35.7) | 157 (37.7) |
| Serious infection | 5 (1.2) | 3 (1.4) | 5 (2.4) | 8 (1.9) |
| Herpes zoster | 6 (1.4) | 3 (1.4) | 4 (1.9) | 4 (1.0) |
| VTE | 0 | 0 | 0 | 4 (1.0) |
| MACE (adjudicated) | 4 (1.0) | 1 (0.5) | 2 (1.0) | 2 (0.5) |
| Malignancya | 1 (0.2) | 0 | 0 | 4 (1.0) |
| NMSC | 2 (0.5) | 0 | 0 | 1 (0.2) |
| Death | 3 (0.7)b | 1 (0.5)c | 0 | 0 |
aExcluding NMSC.
b1 lupus cardiomyopathy, 1 atypical interstitial pneumonia, 1 non–treatment-emergent cardiovascular death.
cDissecting cerebral and vertebral aneurysm.
AE, adverse event; FIL, filgotinib; MACE, major adverse cardiovascular event; MTX, methotrexate; NMSC, nonmelanoma skin cancer; VTE, venous thromboembolism.