Table 3

Treatment-emergent adverse events during blinded treatment with Blisibimod

Placebo pooledBlisibimod pooledBlisibimod 200 mg Q4WBlisibimod 100 mg QWBlisibimod 200 mg QW
N=266N=280N=92N=96N=92
n (%)n (%)n (%)n (%)n (%)
Adverse events (AEs)226 (85)231 (82.5)72 (78.3)82 (85.4)77 (83.7)
Serious adverse events (SAEs)42 (15.8)31 (11.1)12 (13)12 (12.5)7 (7.6)
 AEs related to study drug99 (37.2)112 (40)29 (31.5)38 (39.6)45 (48.9)
 AEs leading to withdrawal21 (7.9)16 (5.7)3 (3.3)7 (7.3)6 (6.5)
 AEs leading to death3 (1.1)4 (1.4)1 (1.1)2 (2.1)1 (1.1)
 Severe infection AEs3 (1.1)4 (1.4)02 (2.1)2 (2.2)
 Severe injection site Reactions00000
SAEs reported in ≥2 subjects
 Herpes zoster2 (0.8)2 (0.7)1 (1.1)1 (1.0)0
 Pneumonia4 (1.5)3 (1.1)01 (1.0)2 (2.2)
 Urinary tract infections2 (0.8)2 (0.7)1 (1.1)1 (1.0)0
 SLE3 (1.1)2 (0.7)02 (2.1)0
 Deep vein thrombosis2 (0.8)3 (1.1)02 (2.1)1 (1.1)
Infections reported as a SAE
 Gastroenteritis02 (0.7)2 (2.2)00
 Herpes zoster2 (0.8)2 (0.7)1 (1.1)1 (1.0)0
 Meningitis1 (0.4)1 (0.4)01 (1.0)0
 Pneumonia4 (1.5)3 (1.1)01 (1.0)2 (2.2)
 Pneumonia bacterial2 (0.8)0000
 Subcutaneous abscess1 (0.4)1 (0.4)1 (1.1)00
 Urinary tract infection2 (0.8)2 (0.7)1 (1.1)1 (1.0)0
AEs reported in >3% of subjects
 Diarrhoea26 (9.8)20 (7.1)8 (8.7)5 (5.2)7 (7.6)
 Injection site erythema2 (0.8)26 (9.3)3 (3.3)15 (15.6)8 (8.7)
 Influenza17 (6.4)22 (7.9)4 (4.3)11 (11.5)7 (7.6)
 Nasopharyngitis18 (6.8)21 (7.5)4 (4.3)8 (8.3)9 (9.8)
 Pharyngitis17 (6.4)11 (3.9)3 (3.3)3 (3.1)5 (5.4)
 Sinusitis6 (2.3)12 (4.3)3 (3.3)1 (1)8 (8.7)
 Upper respiratory tract infection31 (11.7)34 (12.1)10 (10.9)15 (15.6)9 (9.8)
 Urinary tract infection38 (14.3)40 (14.3)14 (15.2)15 (15.6)11 (12.0)
 Headache29 (10.9)39 (13.9)12 (13.0)17 (17.7)10 (10.9)
 Hypertension20 (7.5)13 (4.6)2 (2.2)5 (5.2)6 (6.5)
Critical laboratory abnormalities
 White blood cells (<2×109 L)15 (5.6)4 (1.4)2 (2.2)1 (1.0)1 (1.1)
 Neutrophils (<1×109 L)10 (3.8)6 (2.1)2 (2.2)3 (3.1)1 (1.1)
 Lymphocytes (<5×108 L)63 (23.7)56 (20.0)16 (17.4)21 (21.9)19 (20.7)
 Haemoglobin (≤80 g/L)4 (1.5)6 (2.1)1 (1.1)3 (3.1)2 (2.2)
 IgG (<4 g/L)01 (0.4)1 (1.1)00