Table 3.
Safety in patients with or four or fewer than four PPFs
| Patients with 4 PPFs | Patients with < 4 PPFs | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FIL200 (n = 191) | FIL100 (n = 189) | ADA (n = 126) | PBO after switch to FIL200 (n = 83) | PBO after switch to FIL100 (n = 66) | PBO before switch (n = 181) | FIL200 (n = 284) | FIL100 (n = 291) | ADA (n = 199) | PBO after switch to FIL200 (n = 107) | PBO after switch to FIL100 (n = 125) | PBO before switch (n = 294) | |
| All TEAEs | 146 (76.4) | 136 (72.0) | 85 (67.5) | 44 (53.0) | 35 (53.0) | 90 (49.7) | 206 (72.5) | 214 (73.5) | 154 (77.4) | 48 (44.9) | 62 (49.6) | 164 (55.8) |
| TEAE leading to premature discontinuation of study drug | 10 (5.2) | 7 (3.7) | 10 (7.9) | 1 (1.2) | 0 | 7 (3.9) | 16 (5.6) | 8 (2.7) | 8 (4.0) | 5 (4.7) | 2 (1.6) | 8 (2.7) |
| Serious TEAE | 10 (5.2) | 12 (6.3) | 10 (7.9) | 3 (3.6) | 3 (4.5) | 13 (7.2) | 25 (8.8) | 28 (9.6) | 12 (6.0) | 4 (3.7) | 5 (4.0) | 8 (2.7) |
| Deaths | 1 (0.5) | 0 | 0 | 1 (1.2) | 0 | 1 (0.6) | 2 (0.7) | 1 (0.3) | 1 (0.5) | 0 | 1 (0.8) | 1 (0.3) |
| Neutrophil count decreased | 0 | 1 (0.5) | 0 | 0 | 0 | 0 | 1 (0.4) | 1 (0.3) | 2 (1.0) | 0 | 0 | 0 |
| Lymphocyte count decreased | 1 (0.5) | 0 | 1 (0.8) | 0 | 0 | 0 | 2 (0.7) | 1 (0.3) | 0 | 1 (0.9) | 0 | 0 |
| Blood creatine phosphokinase increased | 2 (1.0) | 1 (0.5) | 0 | 0 | 1 (1.5) | 1 (0.6) | 7 (2.5) | 0 | 2 (1.0) | 0 | 1 (0.8) | 0 |
| Lipids increased | 1 (0.5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Liver function test increased | 1 (0.5) | 1 (0.5) | 0 | 0 | 0 | 0 | 2 (0.7) | 1 (0.3) | 0 | 0 | 0 | 0 |
| Infections | ||||||||||||
| Serious infectious TEAE | 5 (2.6) | 4 (2.1) | 6 (4.8) | 0 | 0 | 2 (1.1) | 8 (2.8) | 9 (3.1) | 4 (2.0) | 1 (0.9) | 2 (1.6) | 2 (0.7) |
| Opportunistic infections | 0 | 0 | 1 (0.5) | 0 | 0 | 0 | 0 | 0 | 1 (0.5) | 0 | 0 | 0 |
| Active tuberculosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.5) | 0 | 0 | 0 |
| Herpes zoster | 1 (0.5) | 1 (0.5) | 1 (0.8) | 0 | 1 (1.5) | 0 | 5 (1.8) | 3 (1.0) | 1 (0.5) | 2 (1.9) | 0 | 2 (0.7) |
| MACE | 0 | 1 (0.5) | 0 | 1 (1.2) | 0 | 1 (0.6) | 0 | 1 (0.3) | 1 (0.5) | 0 | 1 (0.8) | 1 (0.3) |
| VTE | 0 | 0 | 1 (0.8) | 1 (1.2) | 0 | 1 (0.6) | 1 (0.4) | 0 | 0 | 0 | 0 | 1 (0.3) |
| DVT | 0 | 0 | 1 (0.8) | 1 (1.2) | 0 | 1 (0.6) | 0 | 0 | 0 | 0 | 0 | 1 (0.3) |
| PE | 0 | 0 | 0 | 1 (1.2) | 0 | 0 | 1 (0.4) | 0 | 0 | 0 | 0 | 0 |
| Malignancy (non-NMSC) | 0 | 0 | 0 | 0 | 0 | 3 (1.7) | 2 (0.7) | 2 (0.7) | 2 (1.0) | 0 | 0 | 0 |
| GI perforation | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.4) | 0 | 0 | 0 | 0 | 0 |
All treatment groups also received methotrexate. Malignancies included one incidence each of breast cancer stage I, malignant glioma, and prostate cancer in PBO before switch among the four-PPF group; one incidence each of intraductal proliferative breast lesion, metastases to liver, and pancreatic carcinoma in FIL200 in the fewer-than-four-PPF group; one incidence each of cervix carcinoma stage III and leiomyosarcoma metastatic in FIL100 in the fewer-than-four-PPF group; and one incidence each of breast cancer and lymphocyte morphology abnormal in ADA in the four-PPF group. One patient in the fewer-than-four-PPF subgroup who was treated with FIL100 had latent tuberculosis that was first identified at week 12
ADA adalimumab, DVT deep vein thrombosis, FIL100 filgotinib 100 mg, FIL200 filgotinib 200 mg, GI gastrointestinal, MACE major adverse cardiac event, NMSC nonmelanoma skin cancer, PBO placebo, PE pulmonary embolism, PPF poor prognostic factor, TEAE treatment-emergent adverse event, VTE venous thromboembolism