Table 4

Laboratory values and grade ≥3 abnormalities 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)
Haemoglobin, g/L2 (11)1 (10)2 (10)0 (9)5 (11)3 (11)5 (10)5 (9)2 (9)NA
 Grade 3, n (%)2 (0.4)3 (0.6)2 (0.6)4 (0.9)4 (0.8)5 (1.0)3 (0.9)004 (0.9)
Neutrophils, 109/L−1.0 (1.9)−0.9 (2.0)−1.2 (2.0)−0.2 (1.9)−1.0 (2.0)−0.9 (1.9)−1.3 (2.3)−0.8 (1.8)−0.5 (1.7)NA
 Grade 3 or 4, n (%)5 (1.1)5 (1.0)*1 (0.3)2 (0.4)5 (1.1)6 (1.3)1 (0.3)01 (0.5)2 (0.4)
Lymphocytes, 109/L−0.1 (0.6)−0.1 (0.6)0.3 (0.6)−0.1 (0.5)−0.2 (0.6)−0.1 (0.5)0.4 (0.6)−0.1 (0.5)−0.0 (0.6)NA
 Grade 3 or 4†, n (%)11 (2.3)*6 (1.3)2 (0.6)3 (0.6)15 (3.2)11 (2.3)3 (0.9)4 (2.1)2 (1.1)3 (0.6)
Platelets, 109/L−30 (61.0)−28 (62.4)−34 (63.8)−8 (65.3)−26 (66.8)−31 (56.6)−31 (70.9)−17 (59.2)−7 (65.2)NA
ALT, U/L6 (23.8)4 (20.7)6 (19.2)2 (19.2)6 (33.0)6 (23.7)6 (18.7)5 (25.3)2 (18.3)NA
 Grade 3 or 4, n (%)3 (0.6)4 (0.8)6 (1.9)5 (1.1)9 (1.9)8 (1.7)8 (2.5)2 (1.1)05 (1.1)
AST, U/L6 (16.8)5 (14.0)4 (13.2)2 (14.3)7 (22.7)6 (14.5)4 (12.6)6 (18.9)3 (15.3)NA
 Grade 3 or 4, n (%)3 (0.6)2 (0.4)2 (0.6)1 (0.2)6 (1.3)3 (0.6)3 (0.9)1 (0.5)01 (0.2)
Creatinine, mg/dL0.1 (0.1)0.1 (0.1)0.0 (0.1)0.0 (0.1)0.1 (0.1)0.1 (0.1)0.0 (0.1)0.1 (0.1)0.0 (0.1)NA
 Grade 3 or 4, n (%)01 (0.2)02 (0.4)01 (0.2)0002 (0.4)
Creatine kinase, U/L54 (89.5)34 (64.4)9 (70.1)4 (78.6)56 (92.3)37 (63.9)15 (77.0)57 (163.6)26 (46.5)NA
 Grade 3 or 4, n (%)4 (0.8)‡2 (0.4)*1 (0.3)3 (0.6)6 (1.3)3 (0.6)1 (0.3)1 (0.5)03 (0.6)
LDL cholesterol, mg/dL§15 (29.1)12 (25.9)7 (21.7)5 (23.4)24 (27.6)20 (26.8)12 (25.0)13 (29.6)10 (22.7)NA
 % change16 (29.2)13 (27.7)9 (20.5)7 (23.6)25 (29.3)21 (28.5)12 (22.6)13 (22.9)11 (21.3)NA
HDL cholesterol, mg/dL§12 (14.9)5 (12.8)3 (11.8)−1 (11.0)13 (14.4)7 (13.3)4 (11.0)12 (11.7)6 (14.3)NA
 % change21 (25.7)11 (22.0)7 (20.6)0 (20.5)24 (26.5)14 (23.4)9 (20.1)24 (22.6)11 (26.3)NA
LDL:HDL ratio§−0.1 (0.6)0.1 (0.6)0.0 (0.5)0.1 (0.7)0.0 (0.6)0.1 (0.6)0.1 (0.5)−0.2 (0.6)0.0 (0.5)NA
 % change−0.6 (31.1)6.4 (36.4)4.5 (23.6)10.3 (29.2)3.8 (30.8)9.5 (29.5)6.0 (24.5)−6.5 (23.0)2.6 (23.6)NA
  • Absolute values are presented as mean (SD) change from baseline at weeks 24 and 52 unless otherwise specified.

  • Severity was graded using Common Terminology Criteria for Adverse Events Version 4.03.

  • *Grade 4 in one patient.

  • †Lymphocytes decreased.

  • ‡Grade 4 in two patients.

  • §Fasting values; not available for all patients.

  • ADA, adalimumab; ALT, alanine aminotransferase; AST, aspartate aminotransferase; FIL100, filgotinib 100 mg; FIL200, filgotinib 200 mg; HDL, high-density lipoprotein; LDL, low-density lipoprotein; NA, not assessed; PBO, placebo.