Table 4.
Safety at week 16 and through week 52 (safety analysis set)
| n (%) | Week 16 | Through week 52 | |||||
|---|---|---|---|---|---|---|---|
| Placebo (n = 64) | Guselkumab 50 mg (n = 65) | Guselkumab 100 mg (n = 63) | Placebo → guselkumab 50 mg (n = 26) | Placebo → guselkumab 100 mg (n = 26) | Guselkumab 50 mg (n = 65) | Guselkumab 100 mg (n = 63) | |
| Patients with one or more TEAE | 36 (56.3) | 30 (46.2) | 29 (46.0) | 19 (73.1) | 23 (88.5) | 57 (87.7) | 54 (85.7) |
| Common TEAE † | |||||||
| Nasopharyngitis | 7 (10.9) | 14 (21.5) | 8 (12.7) | 7 (26.9) | 7 (26.9) | 28 (43.1) | 24 (38.1) |
| TEAE of infections | 14 (21.9) | 18 (27.7) | 15 (23.8) | 12 (46.2) | 13 (50.0) | 37 (56.9) | 38 (60.3) |
| Patients with one or more serious TEAE | 2 (3.1) | 1 (1.5) | 1 (1.6) | 1 (3.8) | 3 (11.5) | 4 (6.2) | 2 (3.2) |
| Acute cholecystitis ‡ | 1 (1.6) | 0 | 0 | 0 | 0 | 0 | 0 |
| Pemphigoid | 1 (1.6) | 0 | 0 | 0 | 0 | 0 | 0 |
| Psoriasis | 1 (1.6) | 0 | 0 | 0 | 0 | 0 | 0 |
| Colon adenoma | 0 | 1 (1.5) | 0 | 0 | 0 | 1 (1.5) | 0 |
| Rectal adenocarcinoma | 0 | 1 (1.5) | 0 | 0 | 0 | 1 (1.5) | 0 |
| Bacterial prostatitis ‡ | 0 | 0 | 1 (1.6) | 0 | 0 | 0 | 1 (1.6) |
| Atrial fibrillation | 0 | 0 | 0 | 1 (3.8) | 0 | 0 | 0 |
| Congestive cardiac failure | 0 | 0 | 0 | 1 (3.8) | 0 | 0 | 0 |
| Cataract | 0 | 0 | 0 | 0 | 1 (3.8) | 0 | 0 |
| Diabetic retinopathy | 0 | 0 | 0 | 0 | 1 (3.8) | 0 | 0 |
| Macular hole | 0 | 0 | 0 | 0 | 1 (3.8) | 0 | 0 |
| Wrist fracture | 0 | 0 | 0 | 0 | 1 (3.8) | 0 | 0 |
| Retinal detachment | 0 | 0 | 0 | 0 | 0 | 1 (1.5) | 0 |
| Angina pectoris | 0 | 0 | 0 | 0 | 0 | 1 (1.5) | 0 |
| Cerebral infarction | 0 | 0 | 0 | 0 | 0 | 1 (1.5) | 0 |
| Loss of consciousness | 0 | 0 | 0 | 0 | 0 | 1 (1.5) | 0 |
| Varicose vein | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1.6) |
| TEAE leading to discontinuation of study agent | 6 (9.4) | 1 (1.5) | 0 | 0 | 1 (3.8) | 3 (4.6) | 0 |
| Psoriasis | 4 (6.3) | 0 | 0 | 0 | 1 (3.8) | 0 | 0 |
| Pemphigoid | 1 (1.6) | 0 | 0 | 0 | 0 | 0 | 0 |
| Cholecystitis acute | 1 (1.6) | 0 | 0 | 0 | 0 | 0 | 0 |
| Psoriatic arthropathy | 1 (1.6) | 0 | 0 | 0 | 0 | 0 | 0 |
| Colon adenoma | 0 | 1 (1.5) | 0 | 0 | 0 | 1 (1.5) | 0 |
| Rectal adenocarcinoma | 0 | 1 (1.5) | 0 | 0 | 0 | 1 (1.5) | 0 |
| Hepatitis B DNA assay positive § | 0 | 0 | 0 | 0 | 0 | 1 (1.5) | 0 |
| Pregnancy | 0 | 0 | 0 | 0 | 0 | 1 (1.5) | 0 |
| TEAE of injection site reaction | 1 (1.6) | 1 (1.5) | 0 | 0 | 2 (7.7) | 6 (9.2) | 4 (6.3) |
†Common TEAE occurred in more than 10 patients in the guselkumab groups. ‡Serious infection. §The patient who initially tested positive for hepatitis B DNA had a negative retest; therefore, hepatitis B reactivation was not confirmed in this patient. TEAE, treatment emergent adverse event.