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/L | 2 (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) | 0 | 0 | 4 (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) | 0 | 1 (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/L | 6 (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) | 0 | 5 (1.1) |
| AST, U/L | 6 (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) | 0 | 1 (0.2) |
| Creatinine, mg/dL | 0.1 (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 (%) | 0 | 1 (0.2) | 0 | 2 (0.4) | 0 | 1 (0.2) | 0 | 0 | 0 | 2 (0.4) |
| Creatine kinase, U/L | 54 (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) | 0 | 3 (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 |
| % change | 16 (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 |
| % change | 21 (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.