Table 3

Summary of adverse events through week 56 of COSMOS

Placebo*Placebo→guselkumabRandomised to guselkumab†All guselkumab‡
(Weeks 0–24)(Weeks 16–56)§(Weeks 24–56)¶(Weeks 0–24)(Weeks 24–56)(Weeks 0–56)
Randomised patients by treatment received964545189174279
Patient-years of follow-up28.132.927.287.7107.6255.4
 AEs
  Events/100PY (95% CI)369.8
(302.2 to 448.1)
127.5
(91.9 to 172.4)
143.3
(101.9 to 195.9)
229.2
(198.6 to 263.2)
81.8
(65.6 to 100.8)
144.9
(130.5 to 160.4)
  Patients with ≥1 AE46 (47.9%)21 (46.7%)20 (44.4%)80 (42.3%)53 (30.5%)139 (49.8%)
  Common AEs (>3% in any group)
   Nasopharyngitis5 (5.2%)2 (4.4%)010 (5.3%)5 (2.9%)16 (5.7%)
   Upper respiratory tract infection3 (3.1%)1 (2.2%)1 (2.2%)7 (3.7%)2 (1.1%)10 (3.6%)
   Alanine aminotransferase increased4 (4.2%)1 (2.2%)3 (6.7%)5 (2.6%)3 (1.7%)11 (3.9%)
   Faecal calprotectin increased3 (3.1%)01 (2.2%)2 (1.1%)1 (0.6%)4 (1.4%)
   Psoriatic arthropathy4 (4.2%)2 (4.4%)03 (1.6%)4 (2.3%)10 (3.6%)
   Hyperglycaemic5 (5.2%)1 (2.2%)03 (1.6%)04 (1.4%)
   Hypertension3 (3.1%)001 (0.5%)3 (1.7%)4 (1.4%)
Infections
 Events/100PY (95% CI)99.6
(66.2 to 143.9)
30.4
(14.6 to 55.9)
29.4
(12.7 to 57.9)
63.9
(48.2 to 82.9)
19.5
(12.1 to 29.8)
37.2
(30.1 to 45.5)
 Patients with ≥1 infection19 (19.8%)7 (15.6%)6 (13.3%)40 (21.2%)16 (9.2%)61 (21.9%)
  Serious infections
   Events/100PY (95% CI)003.7
(0.1 to 20.5)
1.1
(0.03 to 6.4)
00.8
(0.1 to 2.8)
   Patients with ≥1 serious infection001 (2.2%)1 (0.5%)02 (0.7%)
SAEs
 Events/100PY (95% CI)10.7
(2.2 to 31.2)
6.1
(0.7 to 21.9)
7.4
(0.9 to 26.5)
8.0
(3.2 to 16.5)
4.7
(1.5 to 10.8)
6.3
(3.6 to 10.2)
 Patients with ≥1 SAE3 (3.1%)2 (4.4%)2 (4.4%)7 (3.7%)5 (2.9%)15 (5.4%)
  Abdominal pain00001 (0.6%)1 (0.4%)
  Acute coronary syndrome00001 (0.6%)1 (0.4%)
  Atrial fibrillation00001 (0.6%)1 (0.4%
  Buttock injury01 (2.2%)0001 (0.4%)
  Conversion disorder0001 (0.5%)1 (0.6%)1 (0.4%)
  Depression0001 (0.5%)01 (0.4%)
  Increased alanine aminotransferase0001 (0.5%)01 (0.4%)
  Increased liver enzymes001 (2.2%)001 (0.4%)
  Intervertebral disc protrusion1 (1.0%)001 (0.5%)01 (0.4%)
  Lumbosacral radiculopathy0001 (0.5%)01 (0.4%)
  Pneumonia001 (2.2%)1 (0.5%)02 (0.7%)
  Prostate cancer0001 (0.5%)01 (0.4%)
  Pulmonary embolism00001 (0.6%)1 (0.4%)
  Umbilical hernia1 (1.0%)00000
  Varicose vein01 (2.2%)0001 (0.4%)
  Vomiting1 (1.0%)00000
AEs leading to study agent discontinuation
 Events/100PY (95% CI)7.1
(0.9 to 25.7)
004.6
(1.2 to 11.7)
2.8
(0.6 to 8.2)
2.7
(1.1 to 5.7)
 Patients with an AE leading to study agent discontinuation2 (2.1%)004 (2.1%)3 (1.7%)7 (2.5%)
  Arthralgia1 (1.0%)00000
  Conversion disorder00001 (0.6%)1 (0.4%)
  Fatigue00001 (0.6%)1 (0.4%)
  Increased alanine aminotransferase0001 (0.5%)01 (0.4%)
  Influenza-like illness0001 (0.5%)01 (0.4%)
  Prostate cancer0001 (0.5%)01 (0.4%)
  Psoriatic arthropathy00001 (0.6%)1 (0.4%)
  Urticaria0001 (0.5%)01 (0.4%)
  Vomiting1 (1.0%)00000
Participants with ≥1 malignancy0001 (0.5%)01 (0.4%)
Participants with ≥1 ISR1 (1.0%)01 (2.2%)4 (2.1%)05 (1.8%)
  • Highlighted SAEs also led to study agent discontinuation in the same patient.

  • *AEs that occurred during placebo treatment in placebo-randomised patients.

  • †Includes guselkumab-randomised patients who received an EE placebo injection at week 16.

  • ‡AEs that occurred in all patients who received at least one administration of guselkumab, including those randomised to placebo.

  • §AEs that occurred during guselkumab treatment in placebo-randomised patients who crossed over to guselkumab prior to week 24.

  • ¶AEs that occurred in placebo-randomised patients who crossed over to guselkumab at week 24.

  • AE, adverse event; EE, early escape; ISR, injection-site reaction; PY, patient-years; SAE, serious adverse event.