Table 3

Summary of patients experiencing AEs over the 24-week study

Safety population, n (%)Placebo
QW
(n=49)
Romilkimab
200 mg QW
(n=48)
Any TEAE41 (84)40 (80)
Any treatment-emergent SAE*5 (10)4 (8)
 Acute pyelonephritis1 (2)0
 Cardiac failure†1 (2)0
 Cardiomyopathy†1 (2)0
 Dyspnoea1 (2)0
 Intestinal pseudo-obstruction1 (2)0
 Abnormal echocardiogram1 (2)0
 Bacterial pneumonia01 (2)
 Pneumonia01 (2)
 Bronchiolitis01 (2)
 Acute cholecystitis01 (2)
 Scleroderma renal crisis01 (2)
 Chest pain01 (2)
TEAEs occurring in ≥5% of patients in either treatment group*
 Skin ulcer15 (31)8 (17)
 Nasopharyngitis6 (12)6 (13)
 Diarrhoea4 (8)7 (15)
 Upper respiratory tract infection2 (4)5 (10)
 Cystitis2 (4)3 (6)
 Pruritus1 (2)3 (6)
 Arthralgia1 (2)4 (8)
 Headache1 (2)4 (8)
 Oral herpes1 (2)5 (10)
 Pharyngitis03 (6)
 Cough05 (10)
 Gastro-oesophageal reflux disease03 (6)
Any TEAE leading to permanent treatment discontinuation1 (2)2 (4)
 Cardiomyopathy1 (2)0
 Oesophageal stenosis01 (2)
 Scleroderma renal crisis01 (2)
Any TEAE leading to death 1 (2)1 (2)
 Scleroderma renal crisis01 (2)
 Cardiomyopathy1 (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.