Table 2

Summary of secukinumab safety at 5 years (week 260)

VariableAny secukinumab (n=360)*
Exposure (days), mean (1)1446.1 (631.2)
Death, n (%)†3 (0.8)
Discontinuation due to AE, n (%)36 (10.0)
 EAIR per 100 patient-years
Any AEs, n (EAIR/100 patient-years)319 (108.4)
Any SAEs, n (EAIR/100 patient-years)66 (5.3)
Most common AEs, n (EAIR/100 patient-years)
 Nasopharyngitis102 (9.3)
 Headache54 (4.3)
 Diarrhoea53 (4.3)
 URTI49 (3.9)
Selected AEs of interest, n (EAIR/100 patient-years)
 Serious infections‡14 (1.0)
 Crohn’s disease§7 (0.5)
Candida infections¶5 (0.4)
 Colitis ulcerative§2 (0.1)
 MACE§9 (0.6)
 Malignancies**8 (0.6)
 Uveitis§24 (1.8)
  • Data for death and discontinuation due to AEs were not adjusted for exposure. Any secukinumab column includes patients that experienced AEs at least once on either treatments. A patient with multiple occurrences of an AE under one treatment was counted only once for the same AE for that treatment and exposure time is censored at the time of first event. Patients who escalated were counted in either treatment groups, depending on the timing of the AE.

  • *Includes all patients who were administered with at least one dose of secukinumab during the entire treatment period.

  • †One death occurred due to acute respiratory failure during core period; two deaths occurred during the extension period due to cardiac failure and stroke.

  • ‡Rates are for events by primary system organ class (infections and infestations).

  • §Rates are for events by preferred term.

  • ¶Rates are for events by high-level term.

  • **Rates are for events by standardised MedDRA query (narrow search).

  • AE, adverse event; EAIR, exposure adjusted incidence rate per 100 patient-years; MACE, major adverse cardiac event; n, number of patients with an event; N, total number of patients in the safety set; SAE, serious adverse event; URTI, upper respiratory tract infection.