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) |