Incidence of treatment-emergent adverse events (AEs) during the entire treatment period through to week 104
| Variable | Any secukinumab 150 mg (n=181)* | Any secukinumab 75 mg (n=179)* | Any secukinumab pooled (n=360)* |
|---|---|---|---|
| Exposure to study treatment (days)† | 621.3 (187.5) | 642.0 (180.9) | 631.6 (184.3) |
| Number of patients with event (%) | |||
| Any AE | 157 (86.7) | 144 (80.4) | 301 (83.6) |
| Serious AE‡ | 22 (12.2) | 24 (13.4) | 46 (12.8) |
| Any AE leading to discontinuation§ | 17 (9.4) | 8 (4.5) | 25 (6.9) |
| Infection or infestation¶ | 110 (60.8) | 100 (55.9) | 210 (58.3) |
| Common AEs (seen in >5% of patients on secukinumab), n (%) | |||
| Nasopharyngitis | 44 (24.3) | 35 (19.6) | 79 (21.9) |
| Diarrhoea | 25 (13.8) | 22 (12.3) | 47 (13.1) |
| Headache | 22 (12.2) | 20 (11.2) | 42 (11.7) |
| Upper respiratory tract infection | 17 (9.4) | 21 (11.7) | 38 (10.6) |
| Pharyngitis | 21 (11.6) | 12 (6.7) | 33 (9.2) |
| Dyslipidaemia | 14 (7.7) | 16 (8.9) | 30 (8.3) |
| Influenza | 17 (9.4) | 13 (7.3) | 30 (8.3) |
| Oropharyngeal pain | 16 (8.8) | 13 (7.3) | 29 (8.1) |
| Arthralgia | 13 (7.2) | 11 (6.1) | 24 (6.7) |
| Back pain | 13 (7.2) | 7 (3.9) | 20 (5.6) |
| Leucopenia | 8 (4.4) | 12 (6.7) | 20 (5.6) |
| Cough | 10 (5.5) | 9 (5.0) | 19 (5.3) |
| Nausea | 10 (5.5) | 9 (5.0) | 19 (5.3) |
| AEs of special interest, n (exposure-adjusted incidence rate per 100 patient-years) | |||
| Candida infections | 2 (0.7) | 2 (0.6) | 4 (0.7) |
| Serious infections | 3 (1.0) | 3 (1.0) | 6 (1.0) |
| Crohn's disease | 1 (0.3) | 4 (1.3) | 5 (0.8) |
| Major adverse cardiac events (adjudicated) | 2 (0.7) | 2 (0.6) | 4 (0.6) |
| Malignancy | 3 (1.0) | 1 (0.3) | 4 (0.6) |
| Neutropenia (preferred term) | 9 (3.1) | 14 (4.8) | 23 (3.9) |
*Includes patients randomised to secukinumab at baseline and patients who were randomised to placebo who switched to secukinumab at weeks 16 or 24.
†Reported as mean (SD).
‡Serious AEs also include deaths.
§Up to week 104; an additional two patients discontinued secukinumab due to any AEs after week 104.
¶System organ class category.