Table 3.
Safety profile during the placebo-controlled period and the entire safety-reporting period
| Variable | Through week 16 (placebo-controlled period) | Entire safety-data period | ||||
|---|---|---|---|---|---|---|
| Secukinumab 300 mg (N = 139) | Secukinumab 150 mg (N = 138) | Placebo (N = 137) | Any secukinumab 300 mg (N = 204) | Any secukinumab 150 mg (N = 202) | Any secukinumab (N = 406) | |
| Exposure to study treatment (days), mean ± SD | 403.8 ± 108.3 | 392.3 ± 115.8 | 398.1 ± 112.1 | |||
| Any AE | 76 (54.7) | 80 (58.0) | 77 (56.2) | 164 (194.9) | 156 (192.5) | 320 (193.7) |
| Any serious AE | 3 (2.2) | 5 (3.6) | 9 (6.6) | 19 (8.8) | 21 (10.2) | 40 (9.5) |
| Discontinued due to AEsa | 3 (2.2) | 5 (3.6) | 5 (3.6) | 9 (4.4) | 13 (6.4) | 22 (5.4) |
| Deathb | 0 | 0 | 0 | 0 | 2 (1.0) | 2 (0.5) |
| Common AEsc | ||||||
| Nasopharyngitis | 13 (9.4) | 11 (8.0) | 13 (9.5) | 47 (25.0) | 30 (15.5) | 77 (20.2) |
| Upper respiratory tract infection | 7 (5.0) | 6 (4.3) | 5 (3.6) | 23 (10.9) | 19 (9.3) | 42 (10.1) |
| Diarrhea | 4 (2.9) | 7 (5.1) | 2 (1.5) | 16 (7.5) | 15 (7.2) | 31 (7.4) |
| Back pain | 5 (3.6) | 4 (2.9) | 1 (0.7) | 16 (7.5) | 12 (5.7) | 28 (6.6) |
| Headache | 6 (4.3) | 9 (6.5) | 6 (4.4) | 11 (5.1) | 15 (7.3) | 26 (6.1) |
| Arthralgia | 4 (2.9) | 1 (0.7) | 1 (0.7) | 12 (5.5) | 13 (6.3) | 25 (5.9) |
| Bronchitis | 3 (2.2) | 2 (1.4) | 5 (3.6) | 15 (6.9) | 9 (4.3) | 24 (5.6) |
| Fatigue | 5 (3.6) | 4 (2.9) | 2 (1.5) | 7 (3.2) | 15 (7.3) | 22 (5.2) |
| Urinary tract infection | 6 (4.3) | 3 (2.2) | 2 (1.5) | 13 (6.0) | 9 (4.2) | 22 (5.1) |
| AEs of special interest | ||||||
| Myocardial infarction | 0 | 0 | 0 | 0 | 1 (0.5) | 1 (0.2) |
| Neutropenia | 0 | 0 | 0 | 1 (0.4) | 2 (0.9) | 3 (0.7) |
| Candida infection | 0 | 2 (1.4) | 2 (1.5) | 6 (2.7) | 8 (3.8) | 14 (3.2) |
| IBD | 0 | 0 | 1 (0.7) | 1 (0.4) | 0 | 1 (0.2) |
Data are number (%) or number (incidence per 100 patient-years). In the analysis of the entire study period, the secukinumab groups include any patients who received the stated dose of secukinumab, including those who were randomly assigned to the placebo group at baseline and who underwent a second randomization to active treatment at week 16/24
AE adverse event, IBD inflammatory bowel disease, N number of patients, SD standard deviation
aExposure-adjusted incidence rates were not calculated for discontinuations because of AEs and death
bTwo deaths reported in the secukinumab 150 mg group: one due to pancreatic carcinoma and one due to small cell lung cancer on day 173 and day 227, respectively
cThe most common AEs are reported as the preferred terms from the Medical Dictionary for Regulatory Activities and occurred at an incidence of at least 5 per 100 patient-years in the pooled secukinumab group during the entire treatment period