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 TEAE287 (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 SAE21 (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 discontinuation15 (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)
 Deaths2 (0.4)1 (0.2)02 (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*
 Nasopharyngitis31 (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)
 URTI25 (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 increased13 (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 increased9 (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)
 Nausea19 (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 infection11 (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 AEs133 (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 AEs8 (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 zoster2 (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 C001 (0.3)01 (0.2)1 (0.2)1 (0.3)1 (0.5)1 (0.5)0
  Opportunistic infections001 (0.3)0002 (0.6)000
  Active tuberculosis0000001 (0.3)000
 MACE†01 (0.2)1 (0.3)2 (0.4)02 (0.4)1 (0.3)1 (0.5)1 (0.5)2 (0.4)
 Malignancy
  Excluding NMSC01 (0.2)1 (0.3)3 (0.6)2 (0.4)2 (0.4)2 (0.6)003 (0.6)
  NMSC00001 (0.2)1 (0.2)0000
 VTE†1 (0.2)002 (0.4)1 (0.2)01 (0.3)1 (0.5)02 (0.4)
 GI perforation00001 (0.2)00000
  • *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.