AEs | Any secukinumab150 mg*(N=434) | Any secukinumab75 mg*(N=292) |
Exposure to study treatment (days), mean±SD | 754.0±509.4 | 940.1±340.3 |
Death, n (%) | 2 (0.5) | 3 (1.0) |
Discontinuation due to AEs, n (%) | 20 (4.6) | 20 (6.8) |
Any AEs, n (EAIR) | 321 (158.8) | 248 (128.9) |
Any serious AEs, n (EAIR) | 73 (9.3) | 45 (6.4) |
AEs of special interest, n (EAIR) | ||
Serious infections and infestations | 15 (1.7) | 12 (1.6) |
Candida infections | 12 (1.4) | 5 (0.7) |
Crohn’s disease | 0 (0) | 2 (0.3) |
Ulcerative colitis | 0 (0) | 1 (0.1) |
MACE | 3 (0.3) | 6 (0.8) |
*Includes all patients who were administered with at least one dose of study treatment during the core or the extension study. Patients who were up-titrated (N=139) were counted in either secukinumab groups depending on the timing of the event. If a patient experienced an AE after up-titration, the corresponding AE was counted at the up-titrated dose.
AE data presented as n (EAIR per 100 patient-years) unless otherwise stated.
AE, adverse event; EAIR, exposure-adjusted incidence rate; IV, intravenous; MACE, major adverse cardiac events; SC, subcutaneous.