Table 4

AEs and serious AEs across entire treatment period

AEsAny secukinumab150 mg*(N=434)Any secukinumab75 mg*(N=292)
Exposure to study treatment (days), mean±SD754.0±509.4940.1±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 infestations15 (1.7)12 (1.6)
Candida infections12 (1.4)5 (0.7)
 Crohn’s disease0 (0)2 (0.3)
 Ulcerative colitis0 (0)1 (0.1)
 MACE3 (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.