Table 3.
Safety data for all patients who received ≥1 dose of ixekizumab
| Safety population (n=932) (weeks 0–116) |
||||
| IXE Q4W* N=454 |
IXE Q2W* N=518 |
|||
| n (%) | IR (95% CI) PY=713.3 |
n (%) | IR (95% CI) PY=885.6 |
|
| TEAE | 374 (82.4) | 52.4 (47.4 to 58.0) | 423 (81.7) | 47.8 (43.4 to 52.5) |
| Mild | 150 (33.0) | 21.0 (17.9 to 24.7) | 165 (31.9) | 18.6 (16.0 to 21.7) |
| Moderate | 186 (41.0) | 26.1 (22.6 to 30.1) | 207 (40.0) | 23.4 (20.4 to 26.8) |
| Severe | 38 (8.4) | 5.3 (3.9 to 7.3) | 51 (9.8) | 5.8 (4.4 to 7.6) |
| SAE | 41 (9.0) | 5.7 (4.2 to 7.8) | 44 (8.5) | 5.0 (3.7 to 6.7) |
| Discontinuation due to AE | 26 (5.7) | 3.6 (2.5 to 5.4) | 34 (6.6) | 3.8 (2.7 to 5.4) |
| Death | 2 (0.4) | 0.3 (0.1 to 1.1) | 1 (0.2) | 0.1 (0.0 to 0.8) |
| TEAEs of special interest | ||||
| Infections | 238 (52.4) | 33.4 (29.4 to 37.9) | 280 (54.1) | 31.6 (28.1 to 35.5) |
| Serious infections | 9 (2.0) | 1.3 (0.7 to 2.4) | 11 (2.1) | 1.2 (0.7 to 2.2) |
| Tuberculosis (active cases) | 0 | 0 | 0 | 0 |
| IBD (adjudicated)† | 10 (2.2) | 1.4 (0.8 to 2.6) | 5 (1.0) | 0.6 (0.2 to 1.4) |
| Crohn’s disease | 4 (0.9) | 0.6 (0.2 to 1.5) | 2 (0.4) | 0.2 (0.1 to 0.9) |
| Ulcerative colitis | 6 (1.3) | 0.8 (0.4 to 1.9) | 3 (0.6) | 0.3 (0.1 to 1.1) |
| Anterior uveitis | 25 (5.5) | 3.5 (2.4 to 5.2) | 27 (5.2) | 3.0 (2.1 to 4.4) |
| Injection-site reactions | 53 (11.7) | 7.4 (5.7 to 9.7) | 107 (20.7) | 12.1 (10.0 to 14.6) |
| Mild | 40 (8.8) | 5.6 (4.1 to 7.6) | 79 (15.3) | 8.9 (7.2 to 11.1) |
| Moderate | 12 (2.6) | 1.7 (1.0 to 3.0) | 23 (4.4) | 2.6 (1.7 to 3.9) |
| Severe | 1 (0.2) | 0.1 (0.0 to 1.0) | 5 (1.0) | 0.6 (0.2 to 1.4) |
| Confirmed cerebrocardiovascular events | 7 (1.5) | 1.0 (0.5 to 2.1) | 7 (1.4) | 0.8 (0.4 to 1.7) |
| MACE‡ | 1 (0.2) | 0.1 (0.0 to 1.0) | 1 (0.2) | 0.1 (0.0 to 0.8) |
*During COAST-X, 40 patients switched from IXE Q4W to Q2W. AEs for these patients were counted for the dose regimen they were receiving when the AE occurred. These patients were counted in the total for both dose regimens.
†Events of suspected IBD were confirmed by adjudication by an external clinical events committee with expertise in IBD. EPIdemiologique des Maladies de l’Appareil Digestif criteria for adjudication of suspected IBD define ‘probable’ and ‘definite’ classifications as confirmed cases; two additional cases of IBD occurred, one during the long-term extension period (weeks 64–104) and one case during the post-treatment follow-up period.
‡Includes confirmed cases of vascular death (including cardiovascular and cerebrovascular deaths and excluding haemorrhagic deaths outside of the CNS), nonfatal myocardial infarction and nonfatal stroke.
AE, adverse event; IBD, inflammatory bowel disease; IR, incidence rate per 100 patient-years; IXE, ixekizumab; MACE, major adverse cardiovascular event; PY, patient-years; Q2W, every 2 weeks; Q4W, every 4 weeks; SAE, serious adverse event; TEAE, treatment-emergent adverse event.