Table 2.
Summary of most commonly reported adverse events (incidence rates per 100 PY)
| Event type | Double-blind period (weeks 0–24) |
All-IXE treatment periods (N = 1822.2) IR (95% CI) |
||
|---|---|---|---|---|
| Placebo N = 224 n (IR) |
IXE80Q4W (N = 229) n (IR) |
IXE80Q2W (N = 225) n (IR) |
||
| Patients with ≥ 1 TEAE | 127 (148.2) | 153 (155.6) | 156 (163.4) | 50.0 (46.9, 53.4) |
| Milda | 60 (70.0) | 91 (92.6) | 81 (84.8) | 20.4 (18.4, 22.5) |
| Moderatea | 63 (73.5) | 54 (54.9) | 61 (63.9) | 24.3 (22.1, 26.6) |
| Severea | 4 (4.7) | 8 (8.1) | 14 (14.7) | 5.4 (4.5, 6.6) |
| Patients discontinuing from study drug due to AEs | 8 (9.3) | 7 (7.1) | 12 (12.6) | 5.3 (4.3, 6.4) |
| Patients with ≥ 1 SAEs | 6 (7.0) | 9 (9.2) | 11 (11.5) | 6.4 (5.3, 7.6) |
| Deaths | 0 (0) | 0 (0) | 0 (0) | 0.3 (0.1, 0.7) |
| Patients with ≥ 1 most frequent TEAEs (preferred term) | ||||
| Upper respiratory tract infection | 16 (18.7) | 16 (16.3) | 15 (15.7) | 8.8 (7.6, 10.3) |
| Nasopharyngitis | 9 (10.5) | 15 (15.3) | 7 (7.3) | 8.2 (7.0, 9.7) |
| Injection-site reaction | 1 (1.2) | 22 (22.4) | 32 (33.5) | 7.8 (6.6, 9.2) |
| Bronchitis | 7 (8.2) | 4 (4.1) | 7 (7.3) | 4.4 (3.6, 5.5) |
| Sinusitis | 5 (5.8) | 9 (9.2) | 6 (6.3) | 3.7 (2.9, 4.7) |
| Urinary tract infection | 5 (5.8) | 8 (8.1) | 4 (4.2) | 3.2 (2.5, 4.1) |
| Injection-site erythema | 0 (0.0) | 9 (9.2) | 17 (17.8) | 2.9 (2.2, 3.7) |
| Patients with ≥ 1 AESIs | ||||
| Cytopenias | 2 (2.3) | 2 (2.0) | 4 (4.2) | 2.5 (1.9, 3.4) |
| Hepatic | 10 (11.7) | 7 (7.1) | 11 (11.5) | 4.9 (4.0, 6.0) |
| Infection | 62 (72.3) | 77 (78.3) | 72 (75.4) | 34.2 (31.6, 37.0) |
| Serious infections | 0 (0) | 1 (1.0) | 5 (5.2) | 1.3 (0.8, 1.9) |
| Candida infections | 1 (1.2) | 4 (4.1) | 8 (8.4) | 2.1 (1.6, 2.9) |
| Esophageal candidiasis | 0 (0) | 0 (0) | 1 (1.0) | 0.1 (0.0, 0.4) |
| Active tuberculosis | 0 (0) | 0 (0) | 0 (0) | 0 (0.0, 0.0) |
| Latent tuberculosis | 0 (0) | 0 (0) | 0 (0) | 0.7 (0.4, 1.2) |
| Injection-site reactions | 10 (11.7) | 40 (40.7) | 57 (59.7) | 12.7 (11.2, 14.5) |
| Allergic reactions/hypersensitivities | 4 (4.7) | 10 (10.2) | 14 (14.7) | 4.8 (3.9, 6.0) |
| Confirmed cerebro-cardiovascular events | 2 (2.3) | 0 (0) | 0 (0) | 1.2 (0.8, 1.8) |
| Confirmed MACE events | 0 (0) | 0 (0) | 0 (0) | 0.6 (0.3, 1.1) |
| Malignancies | 0 (0) | 2 (2.0) | 0 (0) | 0.7 (0.4, 1.2) |
| Depression | 3 (3.5) | 4 (4.1) | 4 (4.2) | 1.6 (1.2, 2.4) |
| Adjudicated inflammatory bowel disease (narrow and broad terms) | 0 (0) | 0 (0) | 0 (0) | 0.1 (0.0, 0.4)b |
| Adjudicated Crohn’s disease | 0 (0) | 0 (0) | 0 (0) | 0.1 (0.0, 0.4) |
| Adjudicated ulcerative colitis | 0 (0) | 0 (0) | 0 (0) | 0.1 (0.0, 0.4) |
All-IXE treatment period defined as all patients who received ≥ 1 dose of IXE
aPatients with multiple occurrences of the same event are counted under the highest severity
AEs are listed according to the preferred term in MedDRA, and AEs occurred in ≥ 3.0% of the patients in the combined (total) ixekizumab group
bThe data presented is for All-IXE treatment period
AEs adverse events, AESIs adverse events of special interest, CI confidence interval, IR incidence rate, IXE ixekizumab, MACE major adverse cardiac events, MedDRA Medical Dictionary for Regulatory Activities, N population size, n number in group, PsA psoriatic arthritis, PY patient-years, Q2W every 2 weeks, Q4W every 4 weeks, SAE serious adverse event, TEAE treatment-emergent adverse event