Table 3.
Exposure and rates of deaths, discontinuations, AEs, SAEs and selected AEs and SAEs of interest up to week 24†
| Variable | Secukinumab 300 mg with LD (n=222) |
Secukinumab 150 mg with LD (n=220) |
Secukinumab 150 mg without LD (n=222) |
Any secukinumab (n=822) |
Placebo (n=332) |
| Exposure | |||||
| Patient-years | 102.0 | 101.8 | 101.2 | 329.7 | 122.9 |
| Days (mean) | 167.8 | 169.0 | 166.5 | 146.5 | 135.0 |
| Death and AEs | |||||
| Death, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Discontinuation due to AE, n (%) | 3 (1.4) | 4 (1.8) | 3 (1.4) | 11 (1.3) | 7 (2.1) |
| Non-fatal SAE, n (%) | 7 (3.2) | 9 (4.1) | 6 (2.7) | 25 (3.0) | 12 (3.6) |
| Number of patients with any AE, n (%) | 140 (63.1) | 138 (62.7) | 136 (61.3) | 463 (56.3) | 206 (62.0) |
| Most common AEs, n (%)‡ | |||||
| Viral upper respiratory tract infection | 14 (6.3) | 15 (6.8) | 13 (5.9) | 44 (5.4) | 29 (8.7) |
| Upper respiratory tract infection | 7 (3.2) | 17 (7.7) | 14 (6.3) | 38 (4.6) | 11 (3.3) |
| Dyslipidaemia | 8 (3.6) | 4 (1.8) | 8 (3.6) | 23 (2.8) | 11 (3.3) |
| Headache | 5 (2.3) | 9 (4.1) | 8 (3.6) | 23 (2.8) | 13 (3.9) |
| Hypertension | 8 (3.6) | 5 (2.3) | 9 (4.1) | 22 (2.7) | 10 (3.0) |
| Diarrhoea | 9 (4.1) | 4 (1.8) | 7 (3.2) | 21 (2.6) | 22 (6.6) |
| Hypercholesterolaemia | 3 (1.4) | 9 (4.1) | 8 (3.6) | 20 (2.4) | 2 (0.6) |
| Urinary tract infection | 6 (2.7) | 8 (3.6) | 6 (2.7) | 20 (2.4) | 8 (2.4) |
| Selected AEs of interest, n (%) | |||||
| Candida infection | 1 (0.5) | 0 (0.0) | 0 (0.0) | 1 (0.1) | 0 (0.0) |
| Oral candidiasis | 2 (0.9) | 1 (0.5) | 0 (0.0) | 3 (0.4) | 1 (0.3) |
| Vulvovaginal candidiasis | 1 (0.5) | 2 (0.9) | 0 (0.0) | 3 (0.4) | 1 (0.3) |
| Injections site reactions | 6 (2.7) | 5 (2.3) | 3 (1.4) | 15 (1.8) | 4 (1.2) |
| Selected SAEs of interest, n (%) | |||||
| Crohn’s disease | 0 (0.0) | 0 (0.0) | 1 (0.5) | 1 (0.1) | 0 (0.0) |
| Ulcerative colitis | 0 (0.0) | 1 (0.5) | 0 (0.0) | 1 (0.1) | 0 (0.0) |
| Neoplasms benign, malignant and unspecified | 0 (0.0) | 0 (0.0) | 1 (0.5)§ | 2 (0.2)¶ | 0 (0.0) |
†Up to the data cut-off point for interim analysis.
‡AEs that occurred at an incidence rate of >2% in the ‘any secukinumab’ group. Any secukinumab group represents each originally randomised secukinumab patient plus patients who switched to active treatment at week 16 due to non-response.
§Bladder neoplasm reported as an non-serious AE (day 34).
¶Includes one case of melanoma (day 139) in a placebo patient switched to secukinumab (day 113).
AE, adverse event; LD, loading dose; SAE, serious adverse event.