Table 3.
Continuously treated (AE occurring in maintenance regardless of relapse status) | Withdrawal to relapse (AE before relapse or occurring in maintenance period for non‐relapsers) | Withdrawn, relapsed and retreated (AEs occurring during retreatment) | ||||
---|---|---|---|---|---|---|
IXEQ2W/Q4W N = 221 | IXEQ4W/Q4W N = 195 | IXEQ2W/PBO N = 211 | IXEQ4W/PBO N = 191 | IXEQ2W/PBO N = 176 | IXEQ4W/PBO N = 157 | |
Total person‐years | 189.2 | 158.1 | 101.5 | 86.8 | 74.2 | 62.2 |
TEAE, n (%) [IR] | 175 (79.2) [92.5] | 156 (80.0) [98.7] | 58 (27.5) [57.2] | 70 (36.6) [80.6] | 85 (48.3) [114.5] | 78 (49.7) [125.3] |
Mild | 84 (38.0) [44.4] | 55 (28.2) [34.8] | 28 (13.3) [27.6] | 42 (22.0) [48.4] | 36 (20.5) [48.5] | 46 (29.3) [73.9] |
Moderate | 74 (33.5) [39.1] | 85 (43.6) [53.8] | 24 (11.4) [23.7] | 25 (13.1) [28.8] | 38 (21.6) [51.2] | 30 (19.1) [48.2] |
Severe | 17 (7.7) [9.0] | 16 (8.2) [10.1] | 6 (2.8) [5.9] | 3 (1.6) [3.5] | 11 (6.3) [14.8] | 2 (1.3) [3.2] |
Common TEAEs b , n (%) [IR] | — | — | — | — | — | — |
Nasopharyngitis | 38 (17.2) [20.1] | 44 (22.6) [27.8] | 4 (1.9) [3.9] | 9 (4.7) [10.4] | 15 (8.5) [20.2] | 20 (12.7) [32.1] |
Upper respiratory infection | 22 (10.0) [11.6] | 21 (10.8) [13.3] | 4 (1.9) [3.9] | 4 (2.1) [4.6] | 12 (6.8) [16.2] | 13 (8.3) [20.9] |
Sinusitis | 11 (5.0) [5.8] | 7 (3.6) [4.4] | 2 (0.9) [2.0] | 1 (0.5) [1.2] | 3 (1.7) [4.0] | 4 (2.5) [6.4] |
Arthralgia | 13 (5.9) [6.9] | 8 (4.1) [5.1] | 6 (2.8) [5.9] | 6 (3.1) [6.9] | 2 (1.1) [2.7] | 0 (0) [0] |
Injection‐site reactionc | 14 (6.3) [7.4] | 13 (6.7) [8.2] | 0 (0) [0] | 0 (0) [0] | 0 (0) [0] | 2 (1.3) [3.2] |
Headache | 9 (4.1) [4.8] | 12 (6.2) [7.6] | 2 (0.9) [2.0] | 1 (0.5) [1.2] | 6 (3.4) [8.1] | 3 (1.9) [4.8] |
SAE, n (%) [IR] | 10 (4.5) [5.3] | 17 (8.7) [10.8] | 6 (2.8) [5.9] | 4 (2.1) [4.6] | 6 (3.4) [8.1] | 1 (0.6) [1.6] |
Common SAEs, n (%) [IR] d | — | — | — | — | — | — |
Fall | 2 (0.9) [1.1] | 0 (0) [0] | 0 (0) [0] | 0 (0) [0] | 2 (1.1) [2.7] | 0 (0) [0] |
Osteoarthritis | 0 (0) [0] | 2 (1.0) [1.3] | 0 (0) [0] | 0 (0) [0] | 0 (0) [0] | 0 (0) [0] |
Discontinuations of study drug due to AE (includes death), n (%) [IR] | 8 (3.6) [4.2] | 8 (4.1) [5.1] | 2 (0.9) [2.0] | 6 (3.1) [6.9] | 0 (0) [0] | 0 (0) [0] |
TEAEs of special interest, n (%) [IR] | — | — | — | — | — | — |
Infection | 131 (59.3) [69.2] | 111 (56.9) [70.2] | 17 (8.1) [16.8] | 23 (12.0) [26.5] | 55 (31.3) [74.1] | 54 (34.4) [86.8] |
Injection‐site reactionse | 21 (9.5) [11.1] | 16 (8.2) [10.1] | 2 (0.9) [2.0] | 0 (0) [0] | 2 (1.1) [2.7] | 4 (2.5) [6.4] |
Cerebro‐cardiovascular events | 1 (0.5) [0.5] | 3 (1.5) [1.9] | 0 (0) [0] | 1 (0.5) [1.2] | 1 (0.6) [1.3] | 0 (0) [0] |
Malignancies | 2 (0.9) [1.1] | 0 (0) [0] | 0 (0) [0] | 1 (0.5) [1.2] | 0 (0) [0] | 0 (0) [0] |
Depression | 1 (0.5) [0.5] | 5 (2.6) [3.2] | 1 (0.5) [1.0] | 1 (0.5) [1.2] | 1 (0.6) [1.3] | 0 (0) [0] |
Crohn's disease | 1 (0.5) [0.5] | 0 (0) [0] | 3 (1.4) [3.0] | 0 (0) [0] | 1 (0.6) [1.3] | 0 (0) [0] |
Ulcerative colitis | 0 (0) [0] | 1 (0.5) [0.6] | 0 (0) [0] | 0 (0) [0] | 0 (0) [0] | 0 (0) [0] |
AE, adverse event; IR, exposure‐adjusted incidence rate; IXEQ2W, ixekizumab 80 mg every 2 weeks; IXEQ4W, ixekizumab 80 mg every 4 weeks; N, population size; n, number in group; PBO, placebo; SAE, serious adverse event; TEAE, treatment‐emergent adverse event.
Patients with multiple occurrences of these categories are counted once for each category.
Occurring in ≥5% of patients in any arm in any group.
Preferred term.
Occurring in ≥2 patients in any arm in any group.
A composite of several injection‐site reaction‐related preferred terms.