Table 3.
Summary safety data at week 104
| Any secukinumab s.c. 300 mg (N = 136) | Any secukinumab s.c. 150 mg (N = 334) | |
|---|---|---|
| Mean duration of exposure, days (SD) | 278.0 (90.46) | 501.2 (193.05) |
| Exposure, patient-years | 103.5 | 458.4 |
| No. of patients (no. of events/100 patient-years) | ||
| Patients reporting any AE, n (%) | 103 (75.7) | 285 (85.3) |
| SAEs, n (%) | 12 (8.8) | 47 (14.1) |
| Death, n (%) | 1 (0.7)a | 1 (0.3) |
| Discontinuation due to AEs, n (%) | 1 (0.7) | 16 (4.8) |
| Common AEse, EAIR (n) | ||
| Nasopharyngitis | 23.4 (21) | 23.3 (86) |
| URTI | 11.3 (11) | 11.6 (48) |
| Bronchitis | 8.0 (8) | 7.2 (31) |
| Sinusitis | 11.0 (11) | 6.7 (29) |
| Diarrhea | 4.0 (4) | 6.7 (29) |
| Selected AEs of interest, EAIR (n) | ||
| Candida infectionb | 0.0 (0) | 0.2 (1) |
| Serious infections and infestations | 1.9 (2) | 2 (9) |
| Major adverse cardiac events | 1.0 (1) | 0.7 (3) |
| Crohn’s disease | 0 | 0.2 (1) |
| Malignant or unspecified tumorsc | 1 (1) | 1.3 (6) |
| Inflammatory bowel diseased | 1 (1) | 0.2 (1) |
MedDRA version 20.1 was used for reporting
AE adverse event, EAIR exposure-adjusted incidence rate, SAE serious adverse event, SD standard deviation, URTI upper respiratory tract infection, IR incidence rate per 100 patient-years
aPatient died from pneumonia during follow-up period
bCandida infection (esophageal candidiasis) is reported as ‘Novartis MedDRA query’
cMalignant or unspecified tumor data are reported as ‘standard MedDRA query’ excluding basal cell carcinoma and squamous cell carcinoma
dData for inflammatory bowel disease is reported as Novartis MedDRA query
eThe 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