Table 3.
Safety overview of ixekizumab treatment in Japanese patients and all patients with moderate‐to‐severe plaque psoriasis participating in UNCOVER‐1
| Variable† | Induction period (week 0–12) | Maintenance period (week 12–60) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo | IXEQ4W | IXEQ2W | IXE → Placebo | IXE → IXEQ12W | IXE → IXEQ4W | |||||||
| JPN (n = 13) | All (n = 431) | JPN (n = 12) | All (n = 432) | JPN (n = 8) | All (n = 433) | JPN (n = 6) | All (n = 226) | JPN (n = 5) | All (n = 227) | JPN (n = 5) | All (n = 229) | |
| Patients with ≥1 TEAE, n (%) | 10 (76.9) | 210 (48.7) | 9 (75.0) | 264 (61.1) | 7 (87.5) | 257 (59.4) | 4 (66.7) | 123 (54.4) | 5 (100) | 168 (74.0) | 5 (100) | 182 (79.5) |
| TEAE by severity, n (%) | ||||||||||||
| Mild | 9 (69.2) | 104 (24.1) | 7 (58.3) | 147 (34.0) | 7 (87.5) | 164 (37.9) | 4 (66.7) | 59 (26.1) | 2 (40.0) | 72 (31.7) | 3 (60.0) | 78 (34.1) |
| Moderate | 0 | 88 (20.4) | 2 (16.7) | 100 (23.1) | 0 | 79 (18.2) | 0 | 55 (24.3) | 3 (60.0) | 84 (37.0) | 2 (40.0) | 85 (37.1) |
| Severe | 1 (7.7) | 18 (4.2) | 0 | 17 (3.9) | 0 | 14 (3.2) | 0 | 9 (4.0) | 0 | 12 (5.3) | 0 | 19 (8.3) |
| TEAE possibly related to study drug, n (%) | 0 | 49 (11.4) | 6 (50.0) | 111 (25.7) | 3 (37.5) | 127 (29.3) | 1 (16.7) | 39 (17.3) | 1 (20.0) | 42 (18.5) | 1 (20.0) | 71 (31.0) |
| Discontinuation because of TEAE, n (%) | 1 (7.7) | 6 (1.4) | 3 (25.0) | 10 (2.3) | 0 | 10 (2.3) | 1 (16.7) | 4 (1.8) | 0 | 2 (0.9) | 0 | 9 (3.9) |
| Death, n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (0.9) |
| SAE, n (%) | 1 (7.7) | 5 (1.2) | 1 (8.3) | 12 (2.8) | 0 | 6 (1.4) | 0 | 7 (3.1) | 0 | 9 (4.0) | 0 | 15 (6.6) |
| Selected TEAE of special interest, n (%)‡ | ||||||||||||
| Infection | 3 (23.1) | 106 (24.6) | 3 (25.0) | 128 (29.6) | 2 (25.0) | 124 (28.6) | 2 (33.3) | 74 (32.7) | 5 (100) | 116 (51.1) | 3 (60.0) | 129 (56.3) |
| Cytopenias | 0 | 6 (1.4) | 0 | 3 (0.7) | 0 | 4 (0.9) | 0 | 2 (0.9) | 1 (20.0) | 3 (1.3) | 1 (20.0) | 7 (3.1) |
| Allergic/hypersensitivity reactions | 0 | 10 (2.3) | 1 (8.3) | 19 (4.4) | 1 (12.5) | 14 (3.2) | 1 (16.7) | 7 (3.1) | 1 (20.0) | 10 (4.4) | 1 (20.0) | 21 (9.2) |
| Injection‐site reactions | 0 | 13 (3.0) | 1 (8.3) | 52 (12.0) | 1 (12.5) | 69 (15.9) | 0 | 2 (0.9) | 0 | 12 (5.3) | 0 | 16 (7.0) |
| Malignancies | 1 (7.7) | 2 (0.5) | 0 | 3 (0.7) | 0 | 0 | 0 | 0 | 0 | 2 (0.9) | 0 | 0 |
| Abnormal liver function | 0 | 6 (1.4) | 1 (8.3) | 7 (1.6) | 0 | 4 (0.9) | 0 | 4 (1.8) | 0 | 5 (2.2) | 2 (40.0) | 12 (5.2) |
| CVD | 0 | 0 | 0 | 3 (0.7) | 0 | 0 | 0 | 1 (0.4) | 0 | 3 (1.3) | 0 | 3 (1.3) |
| IBD | 0 | 0 | 0 | 1 (0.2) | 0 | 1 (0.2) | 0 | 1 (0.4) | 0 | 0 | 0 | 0 |
CVD, cerebrocardiovascular disease; IBD, inflammatory bowel disease; IXE, ixekizumab; IXEQ2W, ixekizumab 80 mg once every 2 weeks; IXEQ4W, ixekizumab 80 mg once every 4 weeks; IXEQ12W, ixekizumab 80 mg once every 12 weeks; JPN, Japanese; SAE, serious adverse event; TEAE, treatment‐emergent adverse event.
†For all variables, n (%) refers to the number (%) of patients.
‡Adverse events were coded and summarized using the Medical Dictionary for Regulatory Activities, Version 16.1.