Table 3

Exposure to study drug and rates of safety events

PBO-controlled analysis setLong term, as-treated analysis set
FIL 200 mg
N=777
FIL 100 mg
N=788
PBO
N=781
FIL 200 mg
N=2267
PYE=4047.7
FIL 100 mg
N=1647
PYE=2032.9
Exposure to study drug, years
 Mean±SD0.4±0.10.4±0.10.4±0.11.8±1.21.2±0.7
 Median (Q1, Q3)0.5 (0.5, 0.5)0.5 (0.5, 0.5)0.5 (0.3, 0.5)1.6 (1.0, 2.1)1.3 (0.5, 1.8)
Cumulative n (%) exposed to study drug
 Week 12748 (96.3)754 (95.7)649 (83.1)2165 (95.5)1547 (93.9)
 Week 52NANANA1731 (76.4)1001 (60.8)
 Week 96NANANA799 (35.2)360 (21.9)
Rates of safety events EAIR (95% CI) per 100 PYE EAIR (95% CI) per 100 PYE
TEAE195.4
(173.7 to 219.8)
n=354
176.3
(156.0 to 199.2)
n=323
175.9
(155.5 to 198.9)
n=316
40.4 (38.3 to 42.7)
n=1771
64.2 (58.9 to 69.9)
n=1140
 TEAE Grade ≥312.0 (7.4 to 19.5)
n=31
11.5 (7.0 to 18.7)
n=30
10.6 (6.4 to 17.5)
n=27
6.4 (5.6 to 7.4)
n=309
7.6 (5.3 to 10.8)
n=206
 TE SAE10.9 (6.7 to 17.8)
n=21
12.8 (8.1 to 20.4)
n=25
8.9 (5.2 to 15.2)
n=17
6.1 (5.4 to 7.0)
n=254
7.5 (5.6 to 10.1)
n=166
 TEAE leading to premature discontinuation8.7 (4.9 to 15.3)
n=15
6.3 (3.3 to 12.0)
n=11
8.8 (5.0 to 15.4)
n=15
6.0 (5.3 to 6.9)
n=239
6.8 (5.4 to 8.6)
n=93
 TEAE leading to temporary interruption27.3 (19.7 to 37.8)
n=58
25.6 (18.3 to 35.6)
n=55
21.9 (15.4 to 31.1)
n=46
12.5 (11.3 to 13.8)
n=576
14.8 (11.9 to 18.5)
n=364
All deaths0.6 (0.1 to 3.9)
n=1
0.6 (0.1 to 3.9)
n=1
0.6 (0.1 to 4.0)
n=2
0.5 (0.3 to 0.7)
n=19
0.3 (0.1 to 0.7)
n=6
Infectious AEs76.9 (63.7 to 92.9)
n=139
67.3 (55.2 to 82.1)
n=123
58.0 (47.0 to 71.7)
n=104
24.8 (23.1 to 26.5)
n=1074
34.4 (30.4 to 38.8)
n=648
 Serious infectious AEs3.9 (1.6 to 9.1)
n=8
3.3 (1.4 to 8.2)
n=7
2.4 (0.9 to 6.7)
n=5
1.6 (1.2 to 2.1)
n=67
3.1 (2.1 to 4.5)
n=51
 Opportunistic infections0000.1 (0.1 to 0.3)
n=5*
0.2 (0.1 to 0.5)
n=4†
Active TB00000.1 (0.0 to 0.5)
n=3
 Herpes zoster0.6 (0.1 to 3.9)
n=1
1.1 (0.3 to 4.4)
n=2
1.1 (0.3 to 4.5)
n=2
1.8 (1.4 to 2.3)
n=74
1.1 (0.8 to 1.7)
n=23
 Herpes simplex virus1 (0.1)1 (0.1)2 (0.3)0.6 (0.4 to 1.1)
n=33
0.9 (0.6 to 1.4)
n=18
Adjudicated MACE01.7 (0.3 to 4.8)
n=3
1.1 (0.1 to 4.0)
n=2
0.4 (0.2 to 0.7)
n=19
0.6 (0.4 to 1.1)
n=13
 CV death00.6 (0.0 to 3.1)
n=1
00.1 (0.1 to 0.3)
n=6
0.2 (0.1 to 0.5)
n=4
 Nonfatal MI01.1 (0.1 to 4.0)
n=2
0.6 (0.0 to 3.1)
n=1
0.1 (0.0 to 0.3)
n=4
0.2 (0.1 to 0.6)
n=5
 Nonfatal stroke000.6 (0.0 to 3.1)
n=1
0.2 (0.1 to 0.5)
n=10
0.2 (0.1 to 0.5)
n=4
Adjudicated ATE0000.0 (0.0 to 0.2)
n=1
0
Adjudicated VTE0000.2 (0.1 to 0.4)
n=8
0.0 (0.0 to 0.3)
n=1
 PE0000.1 (0.1 to 0.3)
n=6
0.0 (0.0 to 0.3)
n=1
 DVT0000.1 (0.1 to 0.3)
n=6
0
Malignancy excluding NMSC00.6 (0.0 to 3.1)
n=1
0.6 (0.0 to 3.1)
n=1
0.6 (0.4 to 0.9)
n=22
0.5 (0.3 to 1.0)
n=11
NMSC0000.2 (0.1 to 0.4)
n=9
0.1 (0.0 to 0.5)
n=3
Gastrointestinal perforations0000.1 (0.0 to 0.2)
n=3
0
  • The PBO-controlled analysis set only included data up to 12 weeks.

  • *Two patients reported oesophageal candidiasis, one patient reported pneumonia cryptococcal, one patient reported herpes zoster disseminated and one patient reported both oesophageal candidiasis and pneumonia cryptococcal.

  • †One patient reported oesophageal candidiasis, one patient reported TB, one patient reported lymph node TB, one patient reported meningitis TB and one patient reported pulmonary TB.

  • AE, adverse event; ATE, arterial thrombotic event; CV, cardiovascular; DVT, deep vein thrombosis; EAIR, exposure-adjusted incidence rate; FIL, filgotinib; MACE, major adverse cardiovascular event; MI, myocardial infarction; NA, not applicable; NMSC, non-melanoma skin cancer; PBO, placebo; PE, pulmonary embolism; PYE, patient-years exposure; SAE, serious adverse event; TB, tuberculosis; TE, treatment-emergent; TEAE, treatment-emergent adverse event; VTE, venous thromboembolism.