Table 3.
Treatment-emergent adverse events over 16-weeks and entire treatment period
| Variables | Up to week 16 | During entire period | |||||
|---|---|---|---|---|---|---|---|
| Secukinumab 150 mg (N = 213) | Secukinumab 75 mg (N = 210) | Any secukinumab (N = 423) | Placebo (N = 214) | Any secukinumab 150 mg (N = 392) | Any secukinumab 75 mg (N = 301) | Any secukinumab (N = 601) | |
| Any AE, N (%) | 116 (54.5) | 122 (58.1) | 238 (56.3) | 122 (57.0) | 237 (78.7) | 298 (76.0) | 488 (81.2) |
| SAEs, N (%) | 6 (2.8) | 13 (6.2) | 19 (4.5) | 7 (3.3) | 48 (12.2) | 33 (11.0) | 79 (13.1) |
| Discontinued study treatment due AE(s), n (%) | 6 (2.8) | 6 (2.9) | 12 (2.8) | 10 (4.7) | 22 (5.6) | 13 (4.3) | 35 (5.8) |
| Deaths, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.5) | 2 (0.5) | 3 (1.0) | 5 (0.8) |
| Common adverse events, n (%) | |||||||
| Rheumatoid arthritis | 2 (0.9) | 3 (1.4) | 5 (1.2) | 12 (5.6) | 20 (5.1) | 22 (7.3) | 41 (6.8) |
| Nasopharyngitis | 10 (4.7) | 8 (3.8) | 18 (4.3) | 11 (5.1) | 63 (16.1) | 49 (16.3) | 102 (17.0) |
| Pharyngitis | 1 (0.5) | 15 (7.1) | 16 (3.8) | 4 (1.9) | 18 (4.6) | 23 (7.6) | 40 (6.7) |
| Bronchitis | 10 (4.7) | 4 (1.9) | 14 (3.3) | 1 (0.5) | 31 (7.9) | 16 (5.3) | 45 (7.5) |
| Upper respiratory tract infection | 10 (4.7) | 4 (1.9) | 14 (3.3) | 10 (4.7) | 39 (9.9) | 25 (8.3) | 63 (10.5) |
| Headache | 4 (1.9) | 8 (3.8) | 12 (2.8) | 8 (3.7) | 18 (4.6) | 15 (5.0) | 33 (5.5) |
| Hypertension | 2 (0.9) | 8 (3.8) | 10 (2.4) | 5 (2.3) | 13 (3.3) | 18 (6.0) | 30 (5.0) |
| Diarrhea | 3 (1.4) | 6 (2.9) | 9 (2.1) | 5 (2.3) | 22 (5.6) | 14 (4.7) | 35 (5.8) |
| Urinary tract infection | 3 (1.4) | 6 (2.9) | 9 (2.1) | 7 (3.3) | 33 (8.4) | 28 (9.3) | 58 (9.7) |
| n (%) | n (EAIR) | ||||||
|---|---|---|---|---|---|---|---|
| AEs of special interest | |||||||
| MACE | 0 (0.0) | 1 (0.5) | 1 (0.2) | 2 (0.9) | 2 (0.3) | 3 (0.7) | 5 (0.5) |
| Neutropenia | 3 (1.4) | 3 (1.4) | 6 (1.4) | 1 (0.5) | 6 (1.0) | 7 (1.8) | 13 (1.3) |
| Fungal infections | 5 (2.3) | 2 (1.0) | 7 (1.7) | 0 | 21 (3.8) | 12 (3.1) | 33 (3.5) |
| Esophageal candidiasis | 1 (0.5) | 2 (1.0) | 3 (0.7) | 2 (0.9) | 8 (1.4) | 6 (1.5) | 14 (1.4) |
Cases of esophageal candidiasis as reported without requirement for culture or endoscopy confirmation
EAIR exposure adjusted incidence rate, MACE major adverse cardiovascular event (myocardial infarction, stroke, cardiovascular death)