Table 3

Summary of overall safety through week 52

VariablePlacebo
(n=556)		Sirukumab*†
50 mg q4w
(n=663)		100 mg q2w
(n=662)		Combined
(n=1325)
Mean duration of follow-up, weeks36.1845.7645.1245.44
Mean number of study agent administrations17.4521.8821.5621.72
Patients with ≥1 AE, n (%)
p Value versus placebo		364 (65.5)528 (79.6)
<0.001		531 (80.2)
<0.001		1059 (79.9)
<0.001
Patients with ≥1 SAE, n (%)
p Value versus placebo		38 (6.8)73 (11.0)
0.012		65 (9.8)
NS		138 (10.4)
0.015
Patients with ≥1 AE that caused study agent discontinuation, n (%)
p Value versus placebo		18 (3.2)53 (8.0)
<0.001		51 (7.7)
<0.001		104 (7.8)
<0.001
Patients with ≥1 serious infection, n (%)
p Value versus placebo		10 (1.8)27 (4.1)
0.021		22 (3.3)
NS		49 (3.7)
0.031
Patients with ≥1 injection site reaction, n (%)
p Value versus placebo		14 (2.5)71 (10.7)
<0.001		108 (16.3)
<0.001		179 (13.5)
<0.001
Patients with ≥1 MACE, n (%)
p Value versus placebo‡		2 (0.4)8 (1.2)
NS		3 (0.5)
NS		11 (0.8)
NS
Patients with ≥1 malignancy, n (%)
p Value versus placebo‡		2 (0.4)2 (0.3)
NS		5 (0.8)
NS		7 (0.5)
NS
Patients with ≥1 GI perforation, n (%)
p Value versus placebo‡		1 (0.2)1 (0.2)
NS		0
NS		1 (0.1)
NS
Death, n (%)
p Value versus placebo‡		1 (0.2)7 (1.1)
NS		3 (0.5)
NS		10 (0.8)
NS
Events of ≥5% frequency in any sirukumab group, n (%)
Alanine aminotransferase increased
p Value versus placebo		25 (4.5)102 (15.4)
<0.001		124 (18.7)
<0.001		226 (17.1)
<0.001
Aspartate aminotransferase increased
p Value versus placebo		19 (3.4)58 (8.7)
<0.001		82 (12.4)
<0.001		140 (10.6)
<0.001
Upper respiratory tract infection
p Value versus placebo		63 (11.3)65 (9.8)
NS		66 (10.0)
NS		131 (9.9)
NS
Injection site erythema
p Value versus placebo		6 (1.1)50 (7.5)
<0.001		80 (12.1)
<0.001		130 (9.8)
<0.001
Nasopharyngitis
p Value versus placebo		57 (10.3)62 (9.4)
NS		56 (8.5)
NS		118 (8.9)
NS
Leucopaenia
p Value versus placebo		7 (1.3)37 (5.6)
<0.001		37 (5.6)
<0.001		74 (5.6)
<0.001
Bronchitis
p Value versus placebo		27 (4.9)39 (5.9)
NS		31 (4.7)
NS		70 (5.3)
NS
Neutropaenia
p Value versus placebo		5 (0.9)38 (5.7)
<0.001		29 (4.4)
<0.001		67 (5.1)
<0.001
Hypertension
p Value versus placebo		21 (3.8)28 (4.2)
NS		33 (5.0)
NS		61 (4.6)
NS
Headache
p Value versus placebo		22 (4.0)33 (5.0)
NS		26 (3.9)
NS		59 (4.5)
NS
Injection site pruritus
p Value versus placebo		1 (0.2)11 (1.7)
0.009		41 (6.2)
<0.001		52 (3.9)
<0.001

  • *Includes patients from the placebo group rerandomised to treatment with sirukumab; thus, patients may be represented in >1 treatment group.

  • †p Values are nominal and from χ2 tests, unless otherwise noted.

  • ‡p Values are nominal and from Fisher’s exact tests.

  • AE, adverse event; GI, gastrointestinal; MACE, major adverse cardiovascular event; NS, not significant; q2w, every 2 weeks; q4w, every 4 weeks; SAE, serious adverse event.