Table 3.
Treatment-emergent adverse events through week 24 and week 52
| PBO-controlled period (weeks 0–24) | Weeks 0–52 | |||||||||
| FIL200 (n=475) |
FIL100 (n=480) |
ADA (n=325) |
PBO (n=475) |
FIL200 (n=475) |
FIL100 (n=480) |
ADA (n=325) |
PBO | |||
| On FIL200 period (n=190) |
On FIL100 period (n=191) |
On PBO period (n=475) |
||||||||
| TEAEs, n (%) | ||||||||||
| Any TEAE | 287 (60.4) | 287 (59.8) | 186 (57.2) | 252 (53.1) | 352 (74.1) | 350 (72.9) | 239 (73.5) | 92 (48.4) | 97 (50.8) | 254 (53.5) |
| TE SAE | 21 (4.4) | 24 (5.0) | 14 (4.3) | 20 (4.2) | 35 (7.4) | 40 (8.3) | 22 (6.8) | 7 (3.7) | 8 (4.2) | 21 (4.4) |
| TEAE leading to treatment discontinuation | 15 (3.2) | 9 (1.9) | 13 (4.0) | 15 (3.2) | 26 (5.5) | 15 (3.1) | 18 (5.5) | 6 (3.2) | 2 (1.0) | 15 (3.2) |
| Deaths | 2 (0.4) | 1 (0.2) | 0 | 2 (0.4) | 3 (0.6) | 1 (0.2) | 1 (0.3) | 1 (0.5) | 1 (0.5) | 2 (0.4) |
| TEAEs in >5% of patients* | ||||||||||
| Nasopharyngitis | 31 (6.5) | 29 (6.0) | 15 (4.6) | 25 (5.3) | 43 (9.1) | 48 (10.0) | 24 (7.4) | 7 (3.7) | 6 (3.1) | 25 (5.3) |
| URTI | 25 (5.3) | 33 (6.9) | 17 (5.2) | 14 (2.9) | 41 (8.6) | 49 (10.2) | 21 (6.5) | 8 (4.2) | 6 (3.1) | 14 (2.9) |
| ALT increased | 13 (2.7) | 15 (3.1) | 14 (4.3) | 11 (2.3) | 17 (3.6) | 25 (5.2) | 22 (6.8) | 7 (3.7) | 3 (1.6) | 11 (2.3) |
| AST increased | 9 (1.9) | 14 (2.9) | 11 (3.4) | 9 (1.9) | 12 (2.5) | 20 (4.2) | 18 (5.5) | 8 (4.2) | 3 (1.6) | 9 (1.9) |
| Nausea | 19 (4.0) | 10 (2.1) | 4 (1.2) | 7 (1.5) | 26 (5.5) | 16 (3.3) | 6 (1.8) | 4 (2.1) | 1 (0.5) | 7 (1.5) |
| Urinary tract infection | 11 (2.3) | 8 (1.7) | 8 (2.5) | 5 (1.1) | 19 (4.0) | 20 (4.2) | 17 (5.2) | 10 (5.3) | 8 (4.2) | 6 (1.3) |
| TEAEs of special interest | ||||||||||
| Infectious AEs | 133 (28.0) | 128 (26.7) | 88 (27.1) | 105 (22.1) | 206 (43.4) | 194 (40.4) | 129 (39.7) | 45 (23.7) | 39 (20.4) | 106 (22.3) |
| Serious infectious AEs | 8 (1.7) | 8 (1.7) | 8 (2.5) | 4 (0.8) | 13 (2.7) | 13 (2.7) | 10 (3.1) | 1 (0.5) | 2 (1.0) | 4 (0.8) |
| Herpes zoster | 2 (0.4) | 2 (0.4) | 2 (0.6) | 2 (0.4) | 6 (1.3) | 4 (0.8) | 2 (0.6) | 2 (1.1) | 1 (0.5) | 2 (0.4) |
| Hepatitis B or C | 0 | 0 | 1 (0.3) | 0 | 1 (0.2) | 1 (0.2) | 1 (0.3) | 1 (0.5) | 1 (0.5) | 0 |
| Opportunistic infections | 0 | 0 | 1 (0.3) | 0 | 0 | 0 | 2 (0.6) | 0 | 0 | 0 |
| Active tuberculosis | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.3) | 0 | 0 | 0 |
| MACE† | 0 | 1 (0.2) | 1 (0.3) | 2 (0.4) | 0 | 2 (0.4) | 1 (0.3) | 1 (0.5) | 1 (0.5) | 2 (0.4) |
| Malignancy | ||||||||||
| Excluding NMSC | 0 | 1 (0.2) | 1 (0.3) | 3 (0.6) | 2 (0.4) | 2 (0.4) | 2 (0.6) | 0 | 0 | 3 (0.6) |
| NMSC | 0 | 0 | 0 | 0 | 1 (0.2) | 1 (0.2) | 0 | 0 | 0 | 0 |
| VTE† | 1 (0.2) | 0 | 0 | 2 (0.4) | 1 (0.2) | 0 | 1 (0.3) | 1 (0.5) | 0 | 2 (0.4) |
| GI perforation | 0 | 0 | 0 | 0 | 1 (0.2) | 0 | 0 | 0 | 0 | 0 |
*TEAEs occurring in >5% of patients in a single treatment arm during either study period.
†Positively adjudicated.
ADA, adalimumab; AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; FIL100, filgotinib 100 mg; FIL200, filgotinib 200 mg; GI, gastrointestinal; MACE, major adverse cardiac event; NMSC, non-melanoma skin cancer; PBO, placebo; SAE, serious AE; TE, treatment-emergent; TEAE, treatment-emergent AE; URTI, upper respiratory tract infection; VTE, venous thromboembolism.