Table 3

Summary of patients with AE categories of interest through Week60 of the DISCOVER-1 rial

Placebo→guselkumab 100 mg Q4WGuselkumab 100 mg (Week0–60)All guselkumab
Placebo (Week0–24)Q4W (Week24–60)Q4W (Week0–60)Q8W (Week0–60)
Treated patients, N126114*128127369
Weeks of follow-up, mean24.035.359.558.351.6
Overall PY5877146142365
All AEs
 Total PY38536971193
 Number (%) of patients76 (60.3)55 (48.2)89 (69.5)†87 (68.5)†231 (62.6)
 Incidence/100PY201.4104.3129.0121.9119.6
 95% CI158.7 to 252.178.6 to 135.7103.6 to 158.897.6 to 150.4104.7 to 136.1
SAEs
 Total PY5775144136356
 Number (%) of patients5 (4.0)4 (3.5)4 (3.1)‡8 (6.3)‡16 (4.3)
 Incidence/100PY8.85.32.85.94.5
 95% CI2.8 to 20.51.4 to 13.60.8 to 7.12.5 to 11.62.6 to 7.3
AEs leading to study agent D/C
 Total PY5776146141363
 Number (%) of patients3 (2.4)3 (2.6)1 (0.8)§5 (3.9)§9 (2.4)
 Incidence/100PY5.23.90.73.62.5
 95% CI1.1 to 15.30.8 to 11.50.0 to 3.81.2 to 8.31.1 to 4.7
Infections
 Total PY5066110104280
 Number (%) of patients32 (25.4)30 (26.3)49 (38.3)¶54 (42.5)¶133 (36.0)
 Incidence/100PY63.645.444.651.747.4
 95% CI43.5 to 89.830.6 to 64.833.0 to 59.038.8 to 67.439.7 to 56.2
Serious infections
 Total PY5876146141363
 Number (%) of patients2 (1.6)**2 (1.8)††02 (1.6)‡‡4 (1.1)
 Incidence/100PY3.52.60.01.41.1
 95% CI0.4 to 12.60.3 to 9.50.0 to 2.00.2 to 5.10.3 to 2.8
  • All number-needed-to-harm statistics for guselkumab versus placebo were negative.

  • *These 114 patients were randomised to placebo followed by guselkumab 100mg Q4W; only AEs reported during or after the first dose of guselkumab are summarised.

  • †During Week0–24, 71 (55.5%) and 68 (53.5%), respectively, guselkumab 100mg Q4W-randomised and Q8W-randomised patients reported AEs.14

  • ‡During Week0–24, 0 and 4 (3.1%), respectively, guselkumab 100mg Q4W-randomised and Q8W-randomised patients had SAEs.14

  • §During Week0–24, 1 (0.8%) and 3 (2.4%), respectively, guselkumab 100mg Q4W-randomised and Q8W-randomised patients had AEs leading to discontinuation of study agent.14

  • ¶During Week0–24, 31 (24.2%) and 33 (26.0%), respectively, guselkumab 100 mg Q4W-randomised and Q8W-randomised patients had infections reported as AEs.14

  • **One patient each with pneumonia/upper respiratory infection and limb abscess/pustular psoriasis during Week0–24.14

  • ††One patient each with pyelonephritis and urosepsis during Week24–60.

  • ‡‡One patient each with bronchitis and cellulitis during Week24–60.

  • AE, adverse event; D/C, discontinuation; PY, patient-years of follow-up; Q4/8W, every 4/8 weeks; SAE, serious adverse event.