Safety data up to week 20
| Secukinumab | Placebo N=50 n (%) | ||||
|---|---|---|---|---|---|
| 25 mg N=54 n (%) | 75 mg N=49 n (%) | 150 mg N=43 n (%) | 300 mg N=41 n (%) | ||
| Adverse events* | |||||
| Any adverse event | 28 (51.9) | 30 (61.2) | 20 (46.5) | 25 (61.0) | 29 (58.0) |
| Infections and infestations | 14 (25.9) | 9 (18.4) | 9 (20.9) | 12 (29.3) | 8 (16.0) |
| Nasopharyngitis | 4 (7.4) | 1 (2.0) | 4 (9.3) | 4 (9.8) | 3 (6.0) |
| Pharyngitis | 1 (1.9) | 1 (2.0) | 0 (0.0) | 3 (7.3) | 0 (0.0) |
| Upper respiratory tract infection | 1 (1.9) | 1 (2.0) | 2 (4.7) | 0 (0.0) | 2 (4.0) |
| Gastrointestinal disorders | 2 (3.7) | 6 (12.2) | 4 (9.3) | 2 (4.9) | 3 (6.0) |
| Musculoskeletal and connective tissue disorders | 6 (11.1) | 5 (10.2) | 5 (11.6) | 7 (17.1) | 8 (16.0) |
| General disorders and administration site conditions | 3 (5.6) | 3 (6.1) | 3 (7.0) | 5 (12.2) | 4 (8.0) |
| Respiratory, thoracic and mediastinal disorders | 4 (7.4) | 1 (2.0) | 3 (7.0) | 1 (2.4) | 5 (10.0) |
| Laboratory abnormalities | |||||
| Platelet count (direct) (<LLN) | 0 (0.0) | 0 (0.0) | 1 (2.3) | 1 (2.4) | 2 (4.0) |
| WBC (total) (<0.8×LLN) | 2 (3.7) | 4 (8.2) | 1 (2.3) | 2 (4.9) | 1 (2.0) |
| Absolute neutrophils (<0.9×LLN) | 4 (7.4) | 6 (12.2) | 2 (4.7) | 1 (2.4) | 1 (2.0) |
| Absolute eosinophils (>1.1×ULN) | 4 (7.4) | 3 (6.1) | 3 (7.0) | 1 (2.4) | 1 (2.0) |
| Absolute lymphocytes (>1.1×ULN) | 0 (0.0) | 1 (2.0) | 0 (0.0) | 0 (0.0) | 1 (2.0) |
| Hemoglobin (20 g/l decrease from baseline) | 2 (3.7) | 2 (4.1) | 1 (2.3) | 1 (2.4) | 2 (4.0) |
A patient with multiple occurrences of an adverse events (AE) under one treatment is counted only once in the AE category for that treatment.
*As reported by investigators. All affected system organ classes with at least 10% of patients. All preferred terms were experienced in more than 5% of patients in at least one group.
LLN, lower limit of normal (LLN for WBC is 3.8 10e9/l; LLN for absolute neutrophils is 1.8 10e9/l), N, total number of subjects with evaluable criterion; n, number of subjects meeting the criterion (ie, who are newly occurring clinically notable abnormal); WBC, white blood cells.