Safety profile of SEC until week 16 (placebo-controlled period)
| Patients with AEs, n (%) | SEC 300 mg, n = 103 | SEC 150 mg, n = 103 | Placebo, n = 52 |
|---|---|---|---|
| Any AE | 59 (57.3) | 61 (59.2) | 27 (51.9) |
| Serious AEs | 2 (1.9) | 2 (1.9) | 2 (3.8) |
| Death | 0 | 0 | 1 (1.9) |
| Discontinuation due to AEs | 1 (1.0) | 1 (1.0) | 0 |
| Common AEs (≥ 3% in any treatment group) | |||
| Diarrhea | 6 (5.8) | 6 (5.8) | 1 (1.9) |
| Upper respiratory tract infection | 6 (5.8) | 2 (1.9) | 0 |
| Hypertension | 5 (4.9) | 4 (3.9) | 0 |
| Sinus congestion | 4 (3.9) | 0 | 0 |
| Fatigue | 3 (2.9) | 5 (4.9) | 0 |
| Headache | 3 (2.9) | 4 (3.9) | 2 (3.8) |
| Nasopharyngitis | 3 (2.9) | 4 (3.9) | 1 (1.9) |
| Abdominal pain | 2 (1.9) | 2 (1.9) | 2 (3.8) |
| Musculoskeletal pain | 2 (1.9) | 1 (1.0) | 3 (5.8) |
| Sinusitis | 2 (1.9) | 1 (1.0) | 2 (3.8) |
| Arthralgia | 1 (1.0) | 2 (1.9) | 4 (7.7) |
| Back pain | 1 (1.0) | 4 (3.9) | 0 |
| Pain in extremity | 1 (1.0) | 3 (2.9) | 3 (5.8) |
| Peripheral edema | 1 (1.0) | 0 | 2 (3.8) |
| Psoriasis | 1 (1.0) | 4 (3.9) | 0 |
| Psoriatic arthropathy | 1 (1.0) | 4 (3.9) | 0 |
| Respiratory tract congestion | 0 | 0 | 2 (3.8) |
| Selected AEs of interest | |||
| Candidiasis | |||
| Candida infection | 1 (1.0) | 2 (1.9) | 0 |
| Skin Candida | 0 | 1 (1.0) | 0 |
| Major cardiac AEs | |||
| Myocardial infarction | 0 | 1 (1.0) | 0 |
| Ischemic stroke | 0 | 0 | 1 (1.9) |
| Neutropenia | 1 (1.0) | 0 | 0 |
Values are expressed as n (%) unless otherwise stated. AE: adverse event; SEC: secukinumab.