Table 3.
Summary of secukinumab safety
| Treatment period 1 (week 12) | Entire treatment period (week 52) | ||||
| Secukinumab 300 mg, s.c. (n=167) |
Secukinumab 150 mg, s.c. (n=165) |
Placebo (n=166) |
Any Secukinumab 300 mg, s.c. (n=248) |
Any Secukinumab 150 mg, s.c. (n=245) |
|
| Duration of exposure, days, Mean (SD) | 84.6 (7.1) | 84.9 (7.6) | 84.9 (7.4) | 313.4 (61.0)* | 325.7 (39.4)* |
| Any AE, n (%) | 67 (40.1) | 61 (37.0) | 80 (48.2.) | 169 (68.1) | 158 (64.5) |
| Any SAE, n (%) | 4 (2.4) | 1 (0.6) | 4 (2.4) | 13 (5.2) | 14 (5.7) |
| AEs leading to study treatment discontinuation, n (%) | 1 (0.6) | 3 (1.8) | 1 (0.6) | 9 (3.6) | 6 (2.4) |
| Death | 0 | 0 | 0 | 1 (0.4) | 0 |
| Common AEs† | n (%) | EAIR (95% CI) | |||
| Nasopharyngitis | 9 (5.4) | 4 (2.4) | 11 (6.6) | 14.8 (10.2 to 20.6) | 9.4 (5.9 to 14.3) |
| URTI | 3 (1.8) | 5 (3.0) | 5 (3.0) | 4.9 (2.6 to 8.6) | 5.9 (3.2 to 9.9) |
| Diarrhoea | 4 (2.4) | 2 (1.2) | 4 (2.4) | 6.7 (3.8 to 10.8) | 2.9 (1.2 to 6.0) |
| AEs of special interest | n (%) | EAIR (95% CI) | |||
| Candida infection‡ | 3 (1.8) | 2 (1.2) | 1 (0.6) | 2.0 (0.7 to 4.7) | 1.2 (0.3 to 3.6) |
| Crohn’s disease | 0 | 0 | 0 | 0.0 (0.0 to 1.5) | 0.4 (0.0 to 2.3) |
| MACE | 1 (0.6) | 0 | 0 | 0.8 (0.1 to 2.9) | 0.4 (0.0 to 2.3) |
| Malignancy§ | 0 | 0 | 0 | 0.8 (0.1 to 2.9) | 0.4 (0.0 to 2.3) |
*Exposure data for treatment period two in originally randomised groups (secukinumab 300 mg (n=167) and 150 mg (n=165)).
†AEs with an EAIR ≥5 in either of the secukinumab treatment groups over the entire treatment period.
‡Candida infections are reported as HLT (high level term).
§Malignancy are reported for standardised MedDRA query term malignant or unspecified tumours excluding basal cell carcinoma and squamous cell carcinoma.
AE, adverse event; EAIR, exposure adjusted incidence rate per 100-patient years; MACE, major adverse cardiovascular event; MedDRA, Medical Dictionary for Regulatory Activities; N, total number of randomised patients; s.c., subcutaneous; URTI, upper respiratory tract infection.