Summary of patients experiencing AEs over the 24-week study
| Safety population, n (%) | Placebo QW (n=49) | Romilkimab 200 mg QW (n=48) |
| Any TEAE | 41 (84) | 40 (80) |
| Any treatment-emergent SAE* | 5 (10) | 4 (8) |
| Acute pyelonephritis | 1 (2) | 0 |
| Cardiac failure† | 1 (2) | 0 |
| Cardiomyopathy† | 1 (2) | 0 |
| Dyspnoea | 1 (2) | 0 |
| Intestinal pseudo-obstruction | 1 (2) | 0 |
| Abnormal echocardiogram | 1 (2) | 0 |
| Bacterial pneumonia | 0 | 1 (2) |
| Pneumonia | 0 | 1 (2) |
| Bronchiolitis | 0 | 1 (2) |
| Acute cholecystitis | 0 | 1 (2) |
| Scleroderma renal crisis | 0 | 1 (2) |
| Chest pain | 0 | 1 (2) |
| TEAEs occurring in ≥5% of patients in either treatment group* | ||
| Skin ulcer | 15 (31) | 8 (17) |
| Nasopharyngitis | 6 (12) | 6 (13) |
| Diarrhoea | 4 (8) | 7 (15) |
| Upper respiratory tract infection | 2 (4) | 5 (10) |
| Cystitis | 2 (4) | 3 (6) |
| Pruritus | 1 (2) | 3 (6) |
| Arthralgia | 1 (2) | 4 (8) |
| Headache | 1 (2) | 4 (8) |
| Oral herpes | 1 (2) | 5 (10) |
| Pharyngitis | 0 | 3 (6) |
| Cough | 0 | 5 (10) |
| Gastro-oesophageal reflux disease | 0 | 3 (6) |
| Any TEAE leading to permanent treatment discontinuation | 1 (2) | 2 (4) |
| Cardiomyopathy | 1 (2) | 0 |
| Oesophageal stenosis | 0 | 1 (2) |
| Scleroderma renal crisis | 0 | 1 (2) |
| Any TEAE leading to death‡ | 1 (2) | 1 (2) |
| Scleroderma renal crisis | 0 | 1 (2) |
| Cardiomyopathy | 1 (2) | 0 |
*Preferred terms.
†These were two different patients.
‡No death event was considered treatment-related by the investigator.
AE, adverse event; QW, one time per week; SAE, serious adverse event; TEAE, treatment-emergent adverse event.