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) |