Table 3.
Summary of adverse events through week 56 of COSMOS
| Placebo* | Placebo→guselkumab | Randomised 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 received | 96 | 45 | 45 | 189 | 174 | 279 |
| Patient-years of follow-up | 28.1 | 32.9 | 27.2 | 87.7 | 107.6 | 255.4 |
| 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 AE | 46 (47.9%) | 21 (46.7%) | 20 (44.4%) | 80 (42.3%) | 53 (30.5%) | 139 (49.8%) |
| Common AEs (>3% in any group) | ||||||
| Nasopharyngitis | 5 (5.2%) | 2 (4.4%) | 0 | 10 (5.3%) | 5 (2.9%) | 16 (5.7%) |
| Upper respiratory tract infection | 3 (3.1%) | 1 (2.2%) | 1 (2.2%) | 7 (3.7%) | 2 (1.1%) | 10 (3.6%) |
| Alanine aminotransferase increased | 4 (4.2%) | 1 (2.2%) | 3 (6.7%) | 5 (2.6%) | 3 (1.7%) | 11 (3.9%) |
| Faecal calprotectin increased | 3 (3.1%) | 0 | 1 (2.2%) | 2 (1.1%) | 1 (0.6%) | 4 (1.4%) |
| Psoriatic arthropathy | 4 (4.2%) | 2 (4.4%) | 0 | 3 (1.6%) | 4 (2.3%) | 10 (3.6%) |
| Hyperglycaemic | 5 (5.2%) | 1 (2.2%) | 0 | 3 (1.6%) | 0 | 4 (1.4%) |
| Hypertension | 3 (3.1%) | 0 | 0 | 1 (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 infection | 19 (19.8%) | 7 (15.6%) | 6 (13.3%) | 40 (21.2%) | 16 (9.2%) | 61 (21.9%) |
| Serious infections | ||||||
| Events/100PY (95% CI) | 0 | 0 | 3.7 (0.1 to 20.5) |
1.1 (0.03 to 6.4) |
0 | 0.8 (0.1 to 2.8) |
| Patients with ≥1 serious infection | 0 | 0 | 1 (2.2%) | 1 (0.5%) | 0 | 2 (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 SAE | 3 (3.1%) | 2 (4.4%) | 2 (4.4%) | 7 (3.7%) | 5 (2.9%) | 15 (5.4%) |
| Abdominal pain | 0 | 0 | 0 | 0 | 1 (0.6%) | 1 (0.4%) |
| Acute coronary syndrome | 0 | 0 | 0 | 0 | 1 (0.6%) | 1 (0.4%) |
| Atrial fibrillation | 0 | 0 | 0 | 0 | 1 (0.6%) | 1 (0.4% |
| Buttock injury | 0 | 1 (2.2%) | 0 | 0 | 0 | 1 (0.4%) |
| Conversion disorder | 0 | 0 | 0 | 1 (0.5%) | 1 (0.6%) | 1 (0.4%) |
| Depression | 0 | 0 | 0 | 1 (0.5%) | 0 | 1 (0.4%) |
| Increased alanine aminotransferase | 0 | 0 | 0 | 1 (0.5%) | 0 | 1 (0.4%) |
| Increased liver enzymes | 0 | 0 | 1 (2.2%) | 0 | 0 | 1 (0.4%) |
| Intervertebral disc protrusion | 1 (1.0%) | 0 | 0 | 1 (0.5%) | 0 | 1 (0.4%) |
| Lumbosacral radiculopathy | 0 | 0 | 0 | 1 (0.5%) | 0 | 1 (0.4%) |
| Pneumonia | 0 | 0 | 1 (2.2%) | 1 (0.5%) | 0 | 2 (0.7%) |
| Prostate cancer | 0 | 0 | 0 | 1 (0.5%) | 0 | 1 (0.4%) |
| Pulmonary embolism | 0 | 0 | 0 | 0 | 1 (0.6%) | 1 (0.4%) |
| Umbilical hernia | 1 (1.0%) | 0 | 0 | 0 | 0 | 0 |
| Varicose vein | 0 | 1 (2.2%) | 0 | 0 | 0 | 1 (0.4%) |
| Vomiting | 1 (1.0%) | 0 | 0 | 0 | 0 | 0 |
| AEs leading to study agent discontinuation | ||||||
| Events/100PY (95% CI) | 7.1 (0.9 to 25.7) |
0 | 0 | 4.6 (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 discontinuation | 2 (2.1%) | 0 | 0 | 4 (2.1%) | 3 (1.7%) | 7 (2.5%) |
| Arthralgia | 1 (1.0%) | 0 | 0 | 0 | 0 | 0 |
| Conversion disorder | 0 | 0 | 0 | 0 | 1 (0.6%) | 1 (0.4%) |
| Fatigue | 0 | 0 | 0 | 0 | 1 (0.6%) | 1 (0.4%) |
| Increased alanine aminotransferase | 0 | 0 | 0 | 1 (0.5%) | 0 | 1 (0.4%) |
| Influenza-like illness | 0 | 0 | 0 | 1 (0.5%) | 0 | 1 (0.4%) |
| Prostate cancer | 0 | 0 | 0 | 1 (0.5%) | 0 | 1 (0.4%) |
| Psoriatic arthropathy | 0 | 0 | 0 | 0 | 1 (0.6%) | 1 (0.4%) |
| Urticaria | 0 | 0 | 0 | 1 (0.5%) | 0 | 1 (0.4%) |
| Vomiting | 1 (1.0%) | 0 | 0 | 0 | 0 | 0 |
| Participants with ≥1 malignancy | 0 | 0 | 0 | 1 (0.5%) | 0 | 1 (0.4%) |
| Participants with ≥1 ISR | 1 (1.0%) | 0 | 1 (2.2%) | 4 (2.1%) | 0 | 5 (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.