Table 2

Overall adverse events

n (%)Placebo →
50 mg q4w n=305
Placebo →
100 mg q2w n=291
50 mg q4w
Start n=605
100 mg q2w
Start n=619
50 mg q4w
Combined n=910
100 mg q2w
Combined n=910
Combined
N=1820
Patients with ≥1 TEAE233 (76.4)234 (80.4)483 (79.8)489 (79.0)716 (78.7)723 (79.5)1439 (79.1)
Serious AEs65 (21.3)81 (27.8)160 (26.4)143 (23.1)225 (24.7)224 (24.6)449 (24.7)
Serious AEs occurring in >10 patients overall
 Pneumonia4 (1.3)8 (2.7)9 (1.5)19 (3.1)13 (1.4)27 (3.0)40 (2.2)
 Cellulitis3 (1.0)4 (1.4)12 (2.0)10 (1.6)15 (1.6)14 (1.5)29 (1.6)
 Osteoarthritis2 (0.7)9 (3.1)3 (0.5)9 (1.5)5 (0.5)18 (2.0)23 (1.3)
 Sepsis1 (0.3)6 (2.1)3 (0.5)5 (0.8)4 (0.4)11 (1.2)15 (0.8)
 Rheumatoid arthritis02 (0.7)6 (1.0)5 (0.8)6 (0.7)7 (0.8)13 (0.7)
Leading to discontinuation27 (8.9)35 (12.0)62 (10.2)69 (11.1)89 (9.8)104 (11.4)193 (10.6)
 Cellulitis02 (0.7)3 (0.5)3 (0.5)3 (0.3)5 (0.5)8 (0.4)
 Diverticulitis2 (0.7)2 (0.7)02 (0.3)3 (0.3)4 (0.4)7 (0.4)
 Pneumonia02 (0.7)1 (0.2)4 (0.6)1 (0.1)6 (0.7)7 (0.4)
 Sepsis02 (0.7)1 (0.2)4 (0.6)1 (0.1)6 (0.7)7 (0.4)
 Thrombocytopenia02 (0.7)04 (0.6)06 (0.7)6 (0.3)
AEs of interest
Deaths5 (1.6)6 (2.1)13 (2.1)8 (1.3)18 (2.0)14 (1.5)32 (1.8)
Malignancies3 (1.0)10 (3.4)9 (1.5)11 (1.8)12 (1.3)21 (2.3)33 (1.8)
Hepatobiliary abnormalities*01 (0.3)1 (0.2)1 (0.2)1 (0.1)2 (0.2)3 (0.2)
MACE6 (2.0)2 (0.7)14 (2.3)7 (1.1)20 (2.2)9 (1.0)29 (1.6)
 MI1 (0.3)02 (0.3)3 (0.5)3 (0.3)3 (0.3)6 (0.3)
 Stroke3 (1.0)2 (0.7)5 (0.8)3 (0.5)8 (0.9)5 (0.5)13 (0.7)
Gastrointestinal perforations2 (0.7)4 (1.4)4 (0.7)3 (0.5)6 (0.7)7 (0.8)13 (0.7)
Injection-site reactions11 (3.6)27 (9.3)23 (3.8)41 (6.6)34 (3.7)68 (7.5)102 (5.6)
Demyelination0000000
Hypersensitivity reaction or serum sickness AE1 (0.3)2 (0.7)1 (0.2)2 (0.3)2 (0.2)4 (0.4)6 (0.3)
Deep vein thrombosis3 (1.0)2 (0.7)4 (0.7)4 (0.6)7 (0.8)6 (0.7)13 (0.7)
Thrombosis†0001 (0.2)01 (0.1)1 (0.1)
  • *Hepatobiliary abnormalities defined as occurrence of any of the following: (1) ALT or AST≥8× ULN; (2) ALT or AST≥5× ULN for ≥2 weeks; (3) ALT or AST≥3× ULN and total bilirubin ≥2× ULN; (4) ALT or AST≥3× ULN accompanied by clinical symptoms believed to be related to hepatitis or hypersensitivity (eg, new or worsening of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever or rash) and (5) ALT or AST≥5× ULN but <8× ULN and cannot be monitored at least weekly for ≥2 weeks.

  • †Thrombosis other than deep vein thrombosis.

  • AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; MACE, major adverse cardiovascular events; MI, myocardial infarction; q2w, every 2 weeks; q4w, every 4 weeks; TEAE, treatment-emergent adverse event; ULN, upper limit of normal.