Table 2.

Summary of adverse events through week 52 (safety analysis set)

	Sirukumab 50 mg q4w (N = 61)	Sirukumab 100 mg q2w (N = 61)	All (N = 122)
AEs	56 (91.8)	58 (95.1)	114 (93.4)
Serious AEs	4 (6.6)	5 (8.2)	9 (7.4)
AEs in ≥ 10% patients
Infections and infestations	39 (63.9)	38 (62.3)	77 (63.1)
Nasopharyngitis	27 (44.3)	27 (44.3)	54 (44.3)
Pharyngitis	6 (9.8)	7 (11.5)	13 (10.7)
General disorders and administration site conditions	26 (42.6)	27 (44.3)	53 (43.4)
Injection-site erythema	19 (31.1)	20 (32.8)	39 (32.0)
Injection-site swelling	10 (16.4)	12 (19.7)	22 (18.0)
Injection-site pruritus	7 (11.5)	13 (21.3)	20 (16.4)
Investigations	28 (45.9)	21 (34.4)	49 (40.2)
Alanine aminotransferase increased	10 (16.4)	10 (16.4)	20 (16.4)
Aspartate aminotransferase increased	9 (14.8)	11 (18.0)	20 (16.4)
White blood cell count decreased	7 (11.5)	7 (11.5)	14 (11.5)
Platelet count decreased	9 (14.8)	3 (4.9)	12 (9.8)
Neutrophil count decreased	7 (11.5)	4 (6.6)	11 (9.0)
Skin and subcutaneous tissue disorders	15 (24.6)	25 (41.0)	40 (32.8)
Eczema	7 (11.5)	7 (11.5)	14 (11.5)
Vascular disorders	5 (8.2)	7 (11.5)	12 (9.8)
Hypertension	5 (8.2)	7 (11.5)	12 (9.8)
Serious AEs
Infections and infestations	1 (1.6)	2 (3.3)	3 (2.5)
Acute sinusitis	0	1 (1.6)	1 (0.8)
Hepatitis E	0	1 (1.6)	1 (0.8)
Osteomyelitis	1 (1.6)	0	1 (0.8)
Gastrointestinal disorders	1 (1.6)	1 (1.6)	2 (1.6)
Gastroesophageal reflux disease	0	1 (1.6)	1 (0.8)
Large intestine polyp	1 (1.6)	0	1 (0.8)
Injury, poisoning and procedural complications
Comminuted fracture	1 (1.6)	0	1 (0.8)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	0	1 (1.6)	1 (0.8)
Neoplasms benign, malignant and unspecified
Borderline serous tumor of ovary	0	1 (1.6)	1 (0.8)
Psychiatric disorders
Schizophrenia	1 (1.6)	0	1 (0.8)
Reproductive system and breast disorders
Endometriosis	0	1 (1.6)	1 (0.8)

Data presented as n (%)

AE adverse event, q2w once in 2 weeks, q4w once in 4 weeks