Exposure-adjusted incidence rate (95% CI) of AEs per 100 PYE by baseline BMI
| FIL dose (mg) | BMI (kg/m2) | |||
|---|---|---|---|---|
| <25 | 25–<30 | ≥30 | ||
| PYE 3062.8 | PYE 2640.1 | PYE 2382.2 | ||
| TEAEs | 200 | 34.5 (32.0, 37.1) | 35.7 (33.0, 38.6) | 36.6 (33.7, 39.8) |
| 100 | 44.3 (40.4, 48.6) | 43.0 (38.9, 47.5) | 45.3 (41.1, 50.0) | |
| Serious TEAEs | 200 | 5.3 (4.4, 6.4) | 5.8 (4.8, 7.1) | 7.1 (5.8, 8.5) |
| 100 | 7.6 (6.0, 9.4) | 6.5 (5.0, 8.4) | 8.1 (6.4, 10.2) | |
| Deaths | 200 | 0.3 (0.2, 0.7) | 0.5 (0.3, 1.0) | 0.5 (0.2, 1.0) |
| 100 | 0.4 (0.1, 1.0) | 0.3 (0.1, 1.0) | 0.2 (0.1, 0.9) | |
| Venous thrombotic and embolic events | 200 | 0.1 (0.0, 0.4) | 0.1 (0.0, 0.5) | 0.5 (0.2, 1.0) |
| 100 | 0.1 (0.0, 0.7) | 0.1 (0.0, 0.8) | 0.2 (0.1, 0.9) | |
| Major adverse cardiovascular events | 200 | 0.3 (0.2, 0.7) | 0.3 (0.1, 0.7) | 0.5 (0.2, 1.0) |
| 100 | 0.6 (0.3, 1.3) | 0.3 (0.1, 1.0) | 0.6 (0.2, 1.4) | |
| Serious infections | 200 | 1.1 (0.7, 1.7) | 1.7 (1.2, 2.5) | 1.8 (1.2, 2.6) |
| 100 | 2.6 (1.8, 3.9) | 1.2 (0.7, 2.2) | 2.2 (1.4, 3.4) | |
| Herpes zoster | 200 | 1.6 (1.1, 2.2) | 1.4 (1.0, 2.1) | 1.8 (1.2, 2.6) |
| 100 | 1.0 (0.5, 1.8) | 1.2 (0.7, 2.2) | 1.0 (0.5, 2.0) | |
| Malignancy excluding nonmelanoma skin cancer | 200 | 0.5 (0.3, 1.0) | 0.7 (0.4, 1.3) | 0.5 (0.3, 1.1) |
| 100 | 0.6 (0.3, 1.3) | 0.4 (0.2, 1.2) | 0.8 (0.4, 1.7) | |
BMI, body mass index; FIL, filgotinib; PYE, patient years of exposure; (TE)AE, (treatment-emergent) adverse event