Table 3.
Safety and tolerability of secukinumab during the entire treatment period through Wk208
| Variable | Any secukinumab 150 mg (N = 218)a | Any secukinumab 75 mg (N = 179)a | Any secukinumab (N = 360) |
|---|---|---|---|
| Total exposure to study treatment (days)b | 1002.7 (617.93) | 1278.0 (504.58) | 1242.6 (524.05) |
| Number of patients with event, n (%) | |||
| Any AE | 175 (80.3) | 151 (84.4) | 313 (86.9) |
| SAEc | 36 (20.1) | 26 (11.9) | 62 (17.2) |
| Any AE leading to discontinuationd | 19 (8.9) | 13 (7.3)e | 32 (8.9) |
| Death, n (%)f | 0 (0.0) | 2 (1.1) | 2 (0.6) |
| Common AEs (seen in >5% of subjects on secukinumab), n (%) | |||
| Viral upper respiratory tract infection | 46 (21.1) | 36 (20.1) | 80 (22.2) |
| Diarrhoea | 29 (13.3) | 25 (14.0) | 52 (14.4) |
| Headache | 25 (11.5) | 26 (14.5) | 51 (14.2) |
| Upper respiratory tract infection | 19 (8.7) | 29 (16.2) | 48 (13.3) |
| Influenza | 23 (10.6) | 19 (10.6) | 42 (11.7) |
| Pharyngitis | 23 (10.6) | 13 (7.3) | 36 (10.0) |
| Dyslipidaemia | 14 (6.4) | 18 (10.1) | 32 (8.9) |
| Arthralgia | 17 (7.8) | 16 (8.9) | 32 (8.9 |
| Back pain | 19 (8.7) | 12 (6.7) | 31 (8.6) |
| Oropharyngeal pain | 17 (7.8) | 14 (7.8) | 31 (8.6) |
| Cough | 15 (6.9) | 12 (6.7) | 27 (7.5) |
| Ankylosing spondylitis | 14 (6.4) | 11 (6.1) | 25 (6.9) |
| Nausea | 11 (5.0) | 12 (6.7) | 23 (6.4) |
| Bronchitis | 14 (6.4) | 9 (5.0) | 23 (6.4) |
| Nasopharyngitis | 14 (6.4) | 9 (5.0) | 23 (6.4) |
| Leukopenia | 8 (3.7) | 14 (7.8) | 22 (6.1) |
| Uveitis | 13 (6.0) | 9 (5.0) | 21 (5.8) |
| Urinary tract infection | 11 (5.0) | 10 (5.6) | 21 (5.8) |
| Hypertension | 8 (3.7) | 13 (7.3) | 21 (5.8) |
| Gastroenteritis | 9 (4.1) | 10 (5.6) | 19 (5.3) |
| Selected AEs of interest, n (exposure-adjusted incidence rate per 100 patient-years) | |||
| Serious infections | 3 (0.5) | 9 (1.5) | 12 (1.0) |
| Candida infections | 3 (0.5) | 2 (0.3) | 5 (0.4) |
| Crohn’s disease | 2 (0.3) | 5 (0.8) | 7 (0.6) |
| Ulcerative colitis | 1 (0.2) | 1 (0 2) | 2 (0.2) |
| MACE (adjudicated) | 2 (0.3) | 5 (0.8) | 7 (0.6) |
| Malignant/unspecified tumours | 4 (0.7) | 2 (0.3) | 6 (0.5) |
| Neutropenia | 3 (0.5) | 5 (0.8) | 8 (0.7) |
| Uveitis | 2.3 | 1.5 | 1.8 |
aIncludes patients originally randomized to secukinumab and those re-randomized from placebo to secukinumab at Wk16/24; AE data in patients who up-titrated from secukinumab 75–150 mg are attributed to their dose at the time of AE onset.
bMean (s.d.).
cInclude deaths.
dUp to Wk104; 2 additional patients discontinued secukinumab after Wk104.
eIncludes one case of new-onset latent tuberculosis infection and one case of primary pulmonary tuberculoma.
AEs: treatment-emergent adverse events; IV: intravenous; MACE: major adverse cardiac events; n, number of subjects who received ≥1 dose of secukinumab at any time during the core trial or extension, including those randomized at baseline to secukinumab or placebo; SAE: serious adverse event; TB: tuberculosis; Wk, week.