Summary of TEAEs in all patients, baseline–week 12, patients who continued on the same treatment from baseline to week 24 and patients who switched treatment group, week 12–week 24
| Patients with: | Baseline–week 12 | Continued treatment Baseline–week 24* | Switchers Week 12–week 24† | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo (N=72) | Filgotinib 50 mg (N=72) | Filgotinib 100 mg (N=70) | Filgotinib 200 mg (N=69) | Filgotinib 50 mg (N=57) | Filgotinib 100 mg (N=70) | Filgotinib 200 mg (N=69) | Placebo to filgotinib 100 mg (N=65) | Filgotinib 50 mg to 100 mg (N=15) | |
| TEAE, n (%) | 28 (38.9) | 29 (40.3) | 23 (32.9) | 30 (43.5) | 30 (52.6) | 31 (44.3) | 35 (50.7) | 10 (15.4) | 4 (26.7) |
| Serious TEAE, n (%) | 1 (1.4) | 1 (1.4) | 0 | 3 (4.3) | 2 (3.5) | 2 (2.9) | 3 (4.3) | 1 (1.5) | 0 |
| Serious TE infection, n (%)‡ | 0 | 1 (1.4) | 0 (0) | 1 (1.4) | 1 (2) | 1 (1) | 1 (1) | 1 (1.5) | 0 (0) |
| Death, n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Related TEAE, n (%) | 7 (9.7) | 11 (15.3) | 7 (10.0) | 9 (13.0) | 14 (24.6) | 12 (17.1) | 12 (17.4) | 5 (7.7) | 1 (6.7) |
| TEAE leading to permanent discontinuation of study treatment, n (%) | 4 (5.6) | 1 (1.4) | 0 (0) | 1 (1.4) | 2 (3.5) | 2 (2.9) | 2 (2.9) | 1 (1.5) | 0 |
| TE laboratory abnormalities, n (%) | |||||||||
| Decreased haemoglobin, g/dL | |||||||||
| Grade 1 (10, LLN) | 18 (25) | 15 (20.8) | 1 (10) | 6 (8.7) | 12 (21.1) | 9 (12.9) | 8 (11.6) | 19 (26.4) | 5 (33.3) |
| Grade 2 (<10–8) | 1 (1.4) | 3 (4.2) | 2 (2.9) | 1 (1.4) | 4 (7.0) | 4 (5.7) | 1 (1.4) | 1 (1.4) | 1 (6.7) |
| Grade 3 (<8–6.5) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Grade 4 (<6.5) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Decreased neutrophils, ×109/L | |||||||||
| Grade 1 (1.5, LLN) | 1 (1.4) | 0 (0) | 0 (0) | 2 (2.9) | 2 (3.5) | 2 (2.9) | 3 (4.3) | 2 (2.8) | 0 (0) |
| Grade 2 (<1.5–1.0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Grade 3 (<1.0–0.5) | 0 (0) | 0 (0) | 1 (1.4) | 1 (1.4) | 0 (0) | 1 (1.4) | 1 (1.4) | 0 (0) | 0 (0) |
| Grade 4 (<0.5) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Decreased lymphocytes, ×109/L | |||||||||
| Grade 1 (0.8, LLN) | 1 (1.4) | 1 (1.4) | 2 (2.9) | 2 (2.9) | 1 (1.8) | 2 (2.9) | 1 (1.4) | 1 (1.4) | 0 (0) |
| Grade 2 (<0.8–0.5) | 5 (6.9) | 2 (2.8) | 2 (2.9) | 1 (1.4) | 2 (3.5) | 5 (7.1) | 6 (8.7) | 5 (6.9) | 2 (13.3) |
| Grade 3 (<0.5–0.2) | 0 (0) | 1 (1.4) | 0 (0) | 0 (0) | 1 (1.8) | 1 (1.4) | 0 (0) | 1 (1.5) | 0 (0) |
| Grade 4 (<0.2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Decreased platelets, ×109/L | |||||||||
| Grade 1 (75, LLN) | 0 (0) | 0 (0) | 0 (0) | 1 (1.4) | 0 (0) | 1 (1.4) | 1 (1.4) | 0 (0) | 0 (0) |
| Grade 2 (<75–50) | 0 (0) | 0 (0) | 1 (1.4) | 0 (0) | 0 (0) | 1 (1.4) | 0 (0) | 0 (0) | 0 (0) |
| Grade 3 (<50–25) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Grade 4 (<25) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| NK cells (CD16–CD56), ×109/L | |||||||||
| Decrease to <LLN | 6 (8.3) | 4 (5.6) | 3 (4.3) | 3 (4.3) | 4 (7.0) | 4 (5.7) | 5 (7.2) | 6 (8.3) | 0 (0) |
| Increase to >ULN | 0 (0) | 1 (1.4) | 0 (0) | 2 (2.9) | 2 (3.5) | 1 (1.4) | 5 (7.2) | 2 (2.8) | 0 (0) |
| Elevated creatinine, μmol/L | |||||||||
| Grade 1 (1–1.5×ULN) | 0 (0) | 1 (1.4) | 0 (0) | 3 (4.3) | 2 (3.5) | 0 (0) | 3 (4.3) | 1 (1.4) | 0 (0) |
| Grade 2 (1.5–3×ULN) | 0 (0) | 0 (0) | 1 (1.4) | 1 (1.4) | 0 (0) | 1 (1.4) | 1 (1.4) | 0 (0) | 0 (0) |
| Grade 3 (3–6×ULN) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Grade 4 (>6×ULN) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Elevated ALT | |||||||||
| Grade 1 (1–2.5×ULN) | 0 (0) | 1 (1.4) | 5 (7.1) | 2 (2.9) | 1 (1.4) | 8 (11.4) | 4 (5.8) | 1 (1.4) | 1 (6.7) |
| Grade 2 (2.5–5×ULN) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (1.4) | 0 (0) | 0 (0) | 0 (0) |
| Grade 3 (5–20×ULN) | 0 (0) | 1 (1.4) | 0 (0) | 0 (0) | 1 (1.8) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Grade 4 (>20×ULN) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Elevated AST | |||||||||
| Grade 1 (1–2.5×ULN) | 1 (1.4) | 4 (5.6) | 1 (1.4) | 1 (1.4) | 4 (7.0) | 4 (5.7) | 3 (4.3) | 3 (4.2) | 0 (0) |
| Grade 2 (2.5–5×ULN) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Grade 3 (5–20×ULN) | 0 (0) | 1 (1.4) | 0 (0) | 0 (0) | 1 (1.8) | 1 (1.4) | 0 (0) | 0 (0) | 0 (0) |
| Grade 4 (>20×ULN) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Ratio LDL/HDL increase to >ULN | 4 (5.6) | 12 (16.7) | 10 (14.3) | 4 (5.8) | 10 (17.5) | 11 (15.7) | 6 (8.7) | 5 (6.9) | 3 (20.0) |
*Patients receiving continued treatment on the same dose of filgotinib.
†Patients in the placebo group, and patients without an ACR20 response in the 50 mg filgotinib group, were switched to the 100 mg dose at week 12.
‡Four serious infections: one in the filgotinib 200 mg group (pneumonia), one in the filgotinib 100 mg group (cellulitis), one in the filgotinib 50 mg group (gastroenteritis) and one in the group that was switched from placebo to filgotinib 100 mg (chronic pyelonephritis).
ACR, American College of Rheumatology; ALT, alanine transaminase; AST, aspartate transaminase; HDL, high-density lipoprotein; LDL, low-density lipoprotein; LLN, lower limit of normal; N, number of patients per group; n, number of patients with event; NK, natural killer; SAE, serious adverse event; TE, treatment-emergent; TEAE, treatment-emergent adverse event; ULN, upper limit of normal.