Safety with secukinumab during the entire treatment period through week 104
| Parameter | Any secukinumab 300 mg (N=607) | Any secukinumab 150 mg (N=593) | Any secukinumab (N=964) |
| Exposure | |||
| Mean, days±SD | 542.2±214.76 | 529.9±224.86 | 667.4±184.35 |
| Pt-yrs | 901.1 | 860.3 | 1761.5 |
| AEs, n (EAIR/100 pt-yrs) | 448 (129.2) | 478 (163.0) | 792 (139.8) |
| SAEs, n (EAIR/100 pt-yrs) | 68 (8.0) | 70 (8.6) | 131 (7.9) |
| AEs leading to discontinuation, n (%) | 27 (4.4) | 27 (4.6) | 54 (5.6) |
| Deaths, n (%) | 1 (0.2) | 2 (0.3) | 3 (0.3) |
| Most frequent AEs, n (EAIR/100 pt-yrs)* | |||
| Nasopharyngitis | 73 (8.9) | 80 (10.3) | 148 (9.4) |
| Upper respiratory tract infection | 57 (6.7) | 71 (9.0) | 121 (7.5) |
| AEs of special interest, n (EAIR/100 pt-yrs) | |||
| Neutropenia | 5 (0.6) | 10 (1.2) | 15 (0.9) |
| Oral candidiasis | 8 (0.9) | 3 (0.4) | 11 (0.6) |
| MACE | 2 (0.2) | 1 (0.1) | 3 (0.2) |
| Crohn’s disease† | 1 (0.1) | 2 (0.2) | 2 (0.1) |
| Ulcerative colitis | 0 | 1 (0.1) | 1 (0.1) |
The ‘any secukinumab’ group includes patients who experienced AEs at least once on either of the doses.
Patient-years (pt-yrs) is calculated as a sum of individual patient durations in days divided by 365.25. If a patient experienced an AE after dose escalation, the corresponding AE was counted in 300 mg group.
*AEs that occurred with an EAIR of at least 5.0 cases per 100 pt-yrs in either any secukinumab 300 mg or 150 mg mg group over the entire treatment period
†There is one patient in 150 mg no load arm who reported Crohn’s disease. After the dose escalated to 300 mg, the same patient reported Crohn’s disease again. So essentially the same patient counted in any 300 mg group and in any 150 mg group.
AEs, adverse events; EAIR, exposure-adjusted incidence rates; MACE, major adverse cardiovascular event; SAEs, serious adverse events.