Treatment-emergent AEs in patients with four PPFs and the overall population
| FIL 200 mg + MTX | FIL 100 mg + MTX | FIL 200 mg | MTX | |||||
| PPF-4 | Overall | PPF-4 | Overall | PPF-4 | Overall | PPF-4 | Overall | |
| n | 172 | 416 | 85 | 207 | 87 | 210 | 166 | 416 |
| All AEs | 125 (72.7) | 318 (76.4) | 68 (80.0) | 164 (79.2) | 57 (65.5) | 143 (68.1) | 118 (71.1) | 305 (73.3) |
| Grade ≥3 AEs | 17 (9.9) | 50 (12.0) | 15 (17.6) | 26 (12.6) | 6 (6.9) | 18 (8.6) | 15 (9.0) | 40 (9.6) |
| Serious AEs | 8 (4.7) | 26 (6.3) | 9 (10.6) | 13 (6.3) | 7 (8.0) | 17 (8.1) | 15 (9.0) | 28 (6.7) |
| AEs leading to temporary interruption of study drug | 40 (23.3) | 102 (24.5) | 19 (22.4) | 46 (22.2) | 14 (16.1) | 28 (13.3) | 31 (18.7) | 97 (23.3) |
| AEs leading to premature discontinuation of study drug | 12 (7.0) | 28 (6.7) | 8 (9.4) | 13 (6.3) | 1 (1.1) | 5 (2.4) | 13 (7.8) | 25 (6.0) |
| Death* | 0 | 3 (0.7) | 1 (1.2) | 1 (0.5) | 0 | 0 | 0 | 0 |
| Infections | 56 (32.6) | 148 (35.6) | 35 (41.2) | 76 (36.7) | 37 (42.5) | 75 (35.7) | 55 (33.1) | 157 (37.7) |
| Serious infections | 4 (2.3) | 5 (1.2) | 3 (3.5) | 3 (1.4) | 1 (1.1) | 5 (2.4) | 3 (1.8) | 8 (1.9) |
| Opportunistic infections | 1 (0.6) | 1 (0.2) | 0 | 0 | 0 | 0 | 1 (0.6) | 2 (0.5) |
| Herpes zoster | 2 (1.2) | 6 (1.4) | 2 (2.4) | 3 (1.4) | 3 (3.4) | 4 (1.9) | 1 (0.6) | 4 (1.0) |
| Active tuberculosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| MACE | 0 | 4 (1.0) | 1 (1.2) | 1 (0.5) | 1 (1.1) | 2 (1.0) | 1 (0.6) | 2 (0.5) |
| VTE | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.6) | 2 (0.5) |
| Malignancy (excluding NMSC) | 0 | 1 (0.2) | 0 | 0 | 0 | 0 | 0 | 4 (1.0) |
| NMSC | 1 (0.6) | 2 (0.5) | 0 | 0 | 0 | 0 | 1 (0.6) | 1 (0.2) |
| Gastrointestinal perforation | 1 (0.6) | 1 (0.2) | 0 | 0 | 0 | 0 | 0 | 0 |
Data are presented as n (%).
Only positively adjudicated MACE and VTE are reported.
*The causes of death included lupus myocarditis (possible overlapping systemic autoimmune disease), intracranial aneurysm, interstitial lung disease and sudden cardiovascular death, which occurred 68 days after treatment discontinuation.
AE, adverse event; FIL, filgotinib; MACE, major adverse cardiovascular event; MTX, methotrexate; NMSC, non-melanoma skin cancer; PPF-4, patients with all four poor prognostic factors; VTE, venous thromboembolism.